Trial Outcomes & Findings for A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism (NCT NCT04009291)
NCT ID: NCT04009291
Last Updated: 2026-06-18
Results Overview
The percentage of subjects with albumin-adjusted serum calcium within the normal range, and spot morning fractional excretion of calcium (spot AM FECa) within normal range (≤2%) or a reduction by at least 50% from baseline, and not taking active vitamin D supplements, and taking ≤1000 mg/day of calcium supplements
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
Week 4
Results posted on
2026-06-18
Participant Flow
A total of 104 subjects were screened and 59 of these met eligibility criteria and were enrolled into the study. All participants who completed the 4-week double-blind period entered the open-label extension (OLE) period, where they received TransCon PTH.
Participant milestones
| Measure |
Double Blind: TransCon PTH 15 mcg
TransCon PTH 15 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
Double Blind: TransCon PTH 18 mcg
TransCon PTH 18 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
Double Blind: TransCon PTH 21 mcg
TransCon PTH 21 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
Double Blind: Placebo
Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection
Placebo for TransCon PTH: Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection.
|
Open-Label Extension Period: TransCon PTH
Participants who completed the 4-week double-blind period continued into the open-label extension period and received treatment with TransCon PTH up to Week 266, with up to an initial 14 weeks of TransCon PTH titration and standard of care optimization, followed by approximately 248 weeks of individualized doses of TransCon PTH (allowable dose range: 6 to 60 mcg/day).
|
|---|---|---|---|---|---|
|
Blinded Period (Weeks 0 to 4)
STARTED
|
14
|
15
|
15
|
15
|
0
|
|
Blinded Period (Weeks 0 to 4)
COMPLETED
|
14
|
15
|
15
|
15
|
0
|
|
Blinded Period (Weeks 0 to 4)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Open-Label Period (Weeks 4 to 266)
STARTED
|
0
|
0
|
0
|
0
|
59
|
|
Open-Label Period (Weeks 4 to 266)
COMPLETED
|
0
|
0
|
0
|
0
|
56
|
|
Open-Label Period (Weeks 4 to 266)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Double Blind: TransCon PTH 15 mcg
TransCon PTH 15 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
Double Blind: TransCon PTH 18 mcg
TransCon PTH 18 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
Double Blind: TransCon PTH 21 mcg
TransCon PTH 21 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
Double Blind: Placebo
Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection
Placebo for TransCon PTH: Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection.
|
Open-Label Extension Period: TransCon PTH
Participants who completed the 4-week double-blind period continued into the open-label extension period and received treatment with TransCon PTH up to Week 266, with up to an initial 14 weeks of TransCon PTH titration and standard of care optimization, followed by approximately 248 weeks of individualized doses of TransCon PTH (allowable dose range: 6 to 60 mcg/day).
|
|---|---|---|---|---|---|
|
Open-Label Period (Weeks 4 to 266)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label Period (Weeks 4 to 266)
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label Period (Weeks 4 to 266)
Other
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism
Baseline characteristics by cohort
| Measure |
TransCon PTH 15 mcg
n=14 Participants
TransCon PTH 15 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
TransCon PTH 18 mcg
n=15 Participants
TransCon PTH 18 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
TransCon PTH 21 mcg
n=15 Participants
TransCon PTH 21 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
Placebo
n=15 Participants
Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection
Placebo for TransCon PTH: Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.03 years
STANDARD_DEVIATION 13.230 • n=20 Participants
|
46.58 years
STANDARD_DEVIATION 11.157 • n=20 Participants
|
53.67 years
STANDARD_DEVIATION 11.287 • n=40 Participants
|
51.80 years
STANDARD_DEVIATION 12.345 • n=5 Participants
|
49.82 years
STANDARD_DEVIATION 12.094 • n=9 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
12 Participants
n=5 Participants
|
48 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
15 Participants
n=5 Participants
|
58 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
15 Participants
n=5 Participants
|
54 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Height
|
166.92 cm
STANDARD_DEVIATION 8.806 • n=20 Participants
|
166.71 cm
STANDARD_DEVIATION 8.385 • n=20 Participants
|
165.37 cm
STANDARD_DEVIATION 10.961 • n=40 Participants
|
164.07 cm
STANDARD_DEVIATION 10.368 • n=5 Participants
|
165.75 cm
STANDARD_DEVIATION 9.520 • n=9 Participants
|
|
Weight
|
76.58 kg
STANDARD_DEVIATION 22.479 • n=20 Participants
|
80.04 kg
STANDARD_DEVIATION 11.279 • n=20 Participants
|
72.26 kg
STANDARD_DEVIATION 18.621 • n=40 Participants
|
76.43 kg
STANDARD_DEVIATION 14.256 • n=5 Participants
|
76.32 kg
STANDARD_DEVIATION 16.869 • n=9 Participants
|
|
Body Mass Index
|
27.08 kg/m^2
STANDARD_DEVIATION 5.723 • n=20 Participants
|
28.76 kg/m^2
STANDARD_DEVIATION 3.148 • n=20 Participants
|
26.12 kg/m^2
STANDARD_DEVIATION 4.647 • n=40 Participants
|
28.30 kg/m^2
STANDARD_DEVIATION 3.775 • n=5 Participants
|
27.57 kg/m^2
STANDARD_DEVIATION 4.415 • n=9 Participants
|
PRIMARY outcome
Timeframe: Week 4The percentage of subjects with albumin-adjusted serum calcium within the normal range, and spot morning fractional excretion of calcium (spot AM FECa) within normal range (≤2%) or a reduction by at least 50% from baseline, and not taking active vitamin D supplements, and taking ≤1000 mg/day of calcium supplements
Outcome measures
| Measure |
TransCon PTH 15 mcg
n=14 Participants
TransCon PTH 15 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
TransCon PTH 18 mcg
n=15 Participants
TransCon PTH 18 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
TransCon PTH 21 mcg
n=15 Participants
TransCon PTH 21 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
Placebo
n=15 Participants
Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection
Placebo for TransCon PTH: Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection.
|
|---|---|---|---|---|
|
Efficacy - Primary Endpoint During the Blinded Period
|
50.0 Percentage of participants
Interval 23.0 to 77.0
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
60.0 Percentage of participants
Interval 32.3 to 83.7
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
SECONDARY outcome
Timeframe: Week 4The percentage of subjects with albumin-adjusted serum calcium within the normal range, and spot AM FECa within the normal range (≤2%) or a reduction by at least 50% from baseline, and not taking active vitamin D supplements, and taking ≤ 500 mg/day of calcium supplements
Outcome measures
| Measure |
TransCon PTH 15 mcg
n=14 Participants
TransCon PTH 15 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
TransCon PTH 18 mcg
n=15 Participants
TransCon PTH 18 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
TransCon PTH 21 mcg
n=15 Participants
TransCon PTH 21 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
Placebo
n=15 Participants
Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection
Placebo for TransCon PTH: Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection.
|
|---|---|---|---|---|
|
Efficacy - Key Secondary Endpoint During the Blinded Period
|
50.0 Percentage of participants
Interval 23.0 to 77.0
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
60.0 Percentage of participants
Interval 32.3 to 83.7
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
Adverse Events
Double Blind: TransCon PTH 15 mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Double Blind: TransCon PTH 18 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Double Blind: TransCon PTH 21 mcg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Double Blind: Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Total TransCon PTH Period
Serious events: 8 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double Blind: TransCon PTH 15 mcg
n=14 participants at risk
TransCon PTH 15 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
Double Blind: TransCon PTH 18 mcg
n=15 participants at risk
TransCon PTH 18 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
Double Blind: TransCon PTH 21 mcg
n=15 participants at risk
TransCon PTH 21 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
Double Blind: Placebo
n=15 participants at risk
Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection
Placebo for TransCon PTH: Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection.
|
Total TransCon PTH Period
n=59 participants at risk
Participants who completed the 4-week double blind treatment period in placebo and TransCon PTH groups, continued into the open-label extension period and received treatment with TransCon PTH up to Week 266. This period refers to total period of exposure to TransCon PTH. For participants randomized to TransCon PTH at enrollment, the "TransCon PTH Period" was the time from first dose of blinded TransCon PTH until final analysis in OLE period. The TransCon PTH Period for participants randomized to placebo at enrollment was the time from first exposure to TransCon PTH at the time of cross-over from placebo, until final analysis in the OLE period.
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • Number of events 1 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • Number of events 1 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • Number of events 1 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • Number of events 1 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • Number of events 1 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • Number of events 1 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
3.4%
2/59 • Number of events 2 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • Number of events 1 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • Number of events 1 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • Number of events 1 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • Number of events 1 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • Number of events 1 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary tumour of renal pelvis
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • Number of events 1 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue sarcoma
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • Number of events 1 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • Number of events 1 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • Number of events 1 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
Other adverse events
| Measure |
Double Blind: TransCon PTH 15 mcg
n=14 participants at risk
TransCon PTH 15 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
Double Blind: TransCon PTH 18 mcg
n=15 participants at risk
TransCon PTH 18 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
Double Blind: TransCon PTH 21 mcg
n=15 participants at risk
TransCon PTH 21 mcg delivered once daily by subcutaneous injection
TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
|
Double Blind: Placebo
n=15 participants at risk
Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection
Placebo for TransCon PTH: Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection.
|
Total TransCon PTH Period
n=59 participants at risk
Participants who completed the 4-week double blind treatment period in placebo and TransCon PTH groups, continued into the open-label extension period and received treatment with TransCon PTH up to Week 266. This period refers to total period of exposure to TransCon PTH. For participants randomized to TransCon PTH at enrollment, the "TransCon PTH Period" was the time from first dose of blinded TransCon PTH until final analysis in OLE period. The TransCon PTH Period for participants randomized to placebo at enrollment was the time from first exposure to TransCon PTH at the time of cross-over from placebo, until final analysis in the OLE period.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
3.4%
2/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
16.9%
10/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.1%
3/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.8%
4/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.1%
3/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.1%
3/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.1%
3/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Bronchiolitis
|
7.1%
1/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.1%
3/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
COVID-19
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
35.6%
21/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.1%
3/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Cystitis
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.1%
3/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
13.3%
2/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
10.2%
6/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Ear infection
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.1%
3/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.1%
1/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.1%
3/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
General disorders
Fatigue
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
13.6%
8/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.8%
4/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Nervous system disorders
Headache
|
21.4%
3/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
27.1%
16/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Eye disorders
Keratitis
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
3.4%
2/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.1%
3/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
13.3%
2/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.8%
4/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
16.9%
10/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
18.6%
11/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Influenza
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.8%
4/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
General disorders
Injection site erythema
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
General disorders
Injection site pain
|
7.1%
1/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
3.4%
2/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
General disorders
Injection site swelling
|
7.1%
1/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
7.1%
1/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
3.4%
2/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Injury, poisoning and procedural complications
Limb injury
|
7.1%
1/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
3.4%
2/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
1/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
18.6%
11/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
3.4%
2/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
8.5%
5/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
11.9%
7/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.1%
3/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
1/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
8.5%
5/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
10.2%
6/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
15.3%
9/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
General disorders
Pyrexia
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
3.4%
2/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
10.2%
6/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
7.1%
1/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
10.2%
6/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
General disorders
Thirst
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
3.4%
2/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Surgical and medical procedures
Ureteral stent insertion
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
8.5%
5/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
7.1%
1/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
1.7%
1/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
3.4%
2/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Investigations
Weight increased
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.7%
1/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
6.8%
4/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
0.00%
0/15 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
5.1%
3/59 • From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place