Trial Outcomes & Findings for An Open-label Study (OLE) for Non-responders of VRDN-001-101 and VRDN-001-301 (NCT NCT06179875)
NCT ID: NCT06179875
Last Updated: 2026-08-14
Results Overview
Proptosis response in the most proptotic eye was defined as a reduction of proptosis of ≥2 millimeters (mm) from baseline in the most proptotic eye (without a corresponding increase of ≥2 mm in the other eye) as measured by exophthalmometer. Missing data were not imputed.
COMPLETED
PHASE3
139 participants
Baseline to Week 15
2026-08-14
Participant Flow
As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. The primary and secondary efficacy analyses and safety analysis were measured in the pre-specified study eye per individual participant.
Ocular assessments were performed in both eyes at baseline. The study eye for the purpose of determining eligibility remained the same as that identified at baseline (last assessment performed prior to the Day 1 IV infusion) in the THRIVE (NCT05176639) or THRIVE-2 (NCT06021054) study.
Participant milestones
| Measure |
Veligrotug/Veligrotug
Non-responder participants who received veligrotug in the parent Study VRDN-001-101 or VRDN-001-301 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
Placebo/Veligrotug
Non-responder participants who received placebo in the parent Study VRDN-001-101 or VRDN-001-301 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
82
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
57
|
82
|
|
Overall Study
COMPLETED
|
54
|
70
|
|
Overall Study
NOT COMPLETED
|
3
|
12
|
Reasons for withdrawal
| Measure |
Veligrotug/Veligrotug
Non-responder participants who received veligrotug in the parent Study VRDN-001-101 or VRDN-001-301 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
Placebo/Veligrotug
Non-responder participants who received placebo in the parent Study VRDN-001-101 or VRDN-001-301 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
General or Study Specific Changes
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
5
|
|
Overall Study
Non-compliance
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
An Open-label Study (OLE) for Non-responders of VRDN-001-101 and VRDN-001-301
Baseline characteristics by cohort
| Measure |
Veligrotug/Veligrotug
n=57 Participants
Non-responder participants who received veligrotug in the parent Study VRDN-001-101 or VRDN-001-301 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
Placebo/Veligrotug
n=82 Participants
Non-responder participants who received placebo in the parent Study VRDN-001-101 or VRDN-001-301 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
15 Participants
n=11 Participants
|
21 Participants
n=11 Participants
|
36 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=11 Participants
|
16 Participants
n=11 Participants
|
27 Participants
n=22 Participants
|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 13.17 • n=11 Participants
|
50.2 years
STANDARD_DEVIATION 12.49 • n=11 Participants
|
48.5 years
STANDARD_DEVIATION 12.88 • n=22 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=11 Participants
|
61 Participants
n=11 Participants
|
103 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=11 Participants
|
62 Participants
n=11 Participants
|
107 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=11 Participants
|
4 Participants
n=11 Participants
|
5 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=11 Participants
|
7 Participants
n=11 Participants
|
9 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
7 Participants
n=11 Participants
|
4 Participants
n=11 Participants
|
11 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
42 Participants
n=11 Participants
|
63 Participants
n=11 Participants
|
105 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
0 Participants
n=11 Participants
|
1 Participants
n=11 Participants
|
1 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
3 Participants
n=11 Participants
|
4 Participants
n=11 Participants
|
7 Participants
n=22 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
3 Participants
n=11 Participants
|
3 Participants
n=11 Participants
|
6 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 15Population: mITT population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Proptosis response in the most proptotic eye was defined as a reduction of proptosis of ≥2 millimeters (mm) from baseline in the most proptotic eye (without a corresponding increase of ≥2 mm in the other eye) as measured by exophthalmometer. Missing data were not imputed.
Outcome measures
| Measure |
Veligrotug/Veligrotug
n=57 Participants
Non-responder participants who received veligrotug in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
Placebo/Veligrotug
n=82 Participants
Non-responder participants who received placebo in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
|---|---|---|
|
Proptosis Responder Rate (PRR) in the Most Proptotic Eye as Measured by Exophthalmometer
|
21.1 percentage of participants
|
51.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 15Population: mITT population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Proptosis was defined as distance between the lateral orbital rim and the most anterior position of the cornea in mm, measured using an exophthalmometer. Missing data were not imputed.
Outcome measures
| Measure |
Veligrotug/Veligrotug
n=54 Participants
Non-responder participants who received veligrotug in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
Placebo/Veligrotug
n=71 Participants
Non-responder participants who received placebo in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Proptosis in the Most Proptotic Eye as Measured by Exophthalmometer
|
-1.235 mm
Standard Deviation 1.2113 • Interval 1.2113 to
|
-2.418 mm
Standard Deviation 1.6804 • Interval 1.6804 to
|
SECONDARY outcome
Timeframe: Baseline to Week 15Population: mITT population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Proptosis responder in the most proptotic eye by MRI/CT was defined as a reduction of proptosis of ≥2 mm from baseline in the most proptotic eye by MRI/CT (without a corresponding increase of ≥2 mm in the other eye) as measured by MRI/CT. Missing data were not imputed.
Outcome measures
| Measure |
Veligrotug/Veligrotug
n=57 Participants
Non-responder participants who received veligrotug in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
Placebo/Veligrotug
n=82 Participants
Non-responder participants who received placebo in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
|---|---|---|
|
PRR in the Most Proptotic Eye as Measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT)
|
3.5 percentage of participants
|
41.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 15Population: mITT population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Measurement of proptosis was conducted by the central imaging reading center using MRI/CT of the orbits acquired without contrast. Measurements were conducted by 2 independent readers with adjudication if the difference between the 2 primary readers in proptosis measurement exceeded 5% (calculated as the difference divided by the larger measurement). The average of 2 (or 3 if adjudicated) measurements were used for analyses. Missing data were not imputed.
Outcome measures
| Measure |
Veligrotug/Veligrotug
n=48 Participants
Non-responder participants who received veligrotug in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
Placebo/Veligrotug
n=63 Participants
Non-responder participants who received placebo in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Proptosis in the Most Proptotic Eye as Measured by MRI/CT
|
-0.458 mm
Standard Deviation 0.7174 • Interval 0.7174 to
|
-2.360 mm
Standard Deviation 1.7035 • Interval 1.7035 to
|
SECONDARY outcome
Timeframe: Week 15Population: mITT population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
Clinical activity responder in the most proptotic eye was defined as no worsening in clinical activity score (CAS) from baseline in the most proptotic eye without a corresponding increase of ≥2 points in the other eye. Missing data were not imputed.
Outcome measures
| Measure |
Veligrotug/Veligrotug
n=57 Participants
Non-responder participants who received veligrotug in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
Placebo/Veligrotug
n=82 Participants
Non-responder participants who received placebo in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
|---|---|---|
|
Clinical Activity Responder Rate in the Most Proptotic Eye as Measured by Exophthalmometer
|
89.5 percentage of participants
|
84.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 15Population: mITT population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
ORR was comprised of PRR in the most proptotic eye (reduction of proptosis of ≥2 mm from baseline in the most proptotic eye \[without a corresponding increase of ≥2 mm in the other eye\]) as measured by exophthalmometer at Week 15 and clinical activity responder rate in the most proptotic eye (no worsening in CAS from baseline in the most proptotic eye without a corresponding increase of ≥2 points in the other eye) as measured by exophthalmometer at Week 15. Missing data were not imputed.
Outcome measures
| Measure |
Veligrotug/Veligrotug
n=57 Participants
Non-responder participants who received veligrotug in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
Placebo/Veligrotug
n=82 Participants
Non-responder participants who received placebo in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
|---|---|---|
|
ORR Comprising PRR and Clinical Activity Responder Rate in the Most Proptotic Eye as Measured by Exophthalmometer
|
19.3 percentage of participants
|
48.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 15Population: mITT population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Data for this outcome measure were only collected in participants with a Gorman subjective diplopia score of \>0 at baseline.
A diplopia responder was defined as having a decrease of ≥1 from baseline for participants with a baseline Gorman subjective diplopia score \>0. Gorman subjective diplopia score (range, 0 to 3) includes 4 categories: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3). Missing data were not imputed.
Outcome measures
| Measure |
Veligrotug/Veligrotug
n=19 Participants
Non-responder participants who received veligrotug in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
Placebo/Veligrotug
n=46 Participants
Non-responder participants who received placebo in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
|---|---|---|
|
Diplopia Responder Rate
|
36.8 percentage of participants
|
34.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 15Population: mITT population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated. Data for this outcome measure were only collected in participants with a Gorman subjective diplopia score of \>0 at baseline.
Diplopia resolution was defined as reduction in Gorman subjective diplopia score to 0 from baseline for participants with baseline Gorman subjective diplopia score \>0. Gorman subjective diplopia score (range, 0 to 3) includes 4 categories: no diplopia (absent, scored as 0), diplopia in the primary position of gaze when the participant is tired or awakening (intermittent, scored as 1), diplopia at extremes of gaze (inconstant, scored as 2), and continuous diplopia in the primary or reading position (constant, scored as 3). Missing data were not imputed.
Outcome measures
| Measure |
Veligrotug/Veligrotug
n=19 Participants
Non-responder participants who received veligrotug in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
Placebo/Veligrotug
n=46 Participants
Non-responder participants who received placebo in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
|---|---|---|
|
Diplopia Resolution Rate
|
15.8 percentage of participants
|
15.2 percentage of participants
|
Adverse Events
Veligrotug/Veligrotug
Placebo/Veligrotug
Serious adverse events
| Measure |
Veligrotug/Veligrotug
n=57 participants at risk
Non-responder participants who received veligrotug in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
Placebo/Veligrotug
n=82 participants at risk
Non-responder participants who received placebo in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
|---|---|---|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/57 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.2%
1/82 • Number of events 1 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
Other adverse events
| Measure |
Veligrotug/Veligrotug
n=57 participants at risk
Non-responder participants who received veligrotug in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
Placebo/Veligrotug
n=82 participants at risk
Non-responder participants who received placebo in the parent Study VRDN-001-101 received veligrotug 10 mg/kg Q3W for 12 weeks.
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
7.0%
4/57 • Number of events 5 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.5%
7/82 • Number of events 8 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.8%
5/57 • Number of events 9 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.5%
7/82 • Number of events 8 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Ear and labyrinth disorders
Ear discomfort
|
7.0%
4/57 • Number of events 4 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
9.8%
8/82 • Number of events 8 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
General disorders
Fatigue
|
5.3%
3/57 • Number of events 4 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.5%
7/82 • Number of events 17 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
General disorders
Pyrexia
|
7.0%
4/57 • Number of events 6 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
3.7%
3/82 • Number of events 3 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Nasopharyngitis
|
3.5%
2/57 • Number of events 2 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
6.1%
5/82 • Number of events 5 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.8%
1/57 • Number of events 1 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
11.0%
9/82 • Number of events 11 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Investigations
Glycosylated haemoglobin increased
|
7.0%
4/57 • Number of events 4 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
2.4%
2/82 • Number of events 2 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Investigations
Blood creatine phosphokinase increased
|
5.3%
3/57 • Number of events 3 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
2.4%
2/82 • Number of events 3 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
24.6%
14/57 • Number of events 19 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
30.5%
25/82 • Number of events 32 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Nervous system disorders
Headache
|
7.0%
4/57 • Number of events 9 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.5%
7/82 • Number of events 10 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Nervous system disorders
Dizziness
|
1.8%
1/57 • Number of events 1 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
6.1%
5/82 • Number of events 5 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.5%
6/57 • Number of events 6 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
8.5%
7/82 • Number of events 8 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
15.8%
9/57 • Number of events 9 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
2.4%
2/82 • Number of events 2 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Vascular disorders
Hypertension
|
0.00%
0/57 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
7.3%
6/82 • Number of events 6 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
8.0%
2/25 • Number of events 2 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
22.2%
6/27 • Number of events 6 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
|
Infections and infestations
Conjunctivitis
|
5.3%
3/57 • Number of events 3 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
1.2%
1/82 • Number of events 1 • Baseline up to Week 24
Safety Population included all randomized participants who received at least 1 dose of study drug. As prespecified, data were collected and reported for the participants. Therefore, the 'Ns' reported below = number of participants analyzed regardless of which eye was evaluated.
|
Additional Information
Viridian Clinical Trials Desk
Viridian Therapeutics, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place