Trial Outcomes & Findings for Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN) (NCT NCT05660538)
NCT ID: NCT05660538
Last Updated: 2025-07-01
Results Overview
Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing average pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
194 participants
Primary outcome timeframe
Baseline, At Week 12
Results posted on
2025-07-01
Participant Flow
A total of 194 participants were randomized in this study, out of which 192 participants received the study drug. Of these 192 participants, 19 participants from one of the sites were excluded due to lack of compliance with the study drug. Therefore, 173 participants are reported below for Baseline section and Efficacy outcomes and 192 participants are reported for Safety outcome and Adverse event section.
Participant milestones
| Measure |
Pregabalin
Participants received Pregabalin 100 mg 3 times per day (tid) for 12 weeks.
|
Suzetrigine (SUZ): Low Dose
Participants received SUZ 23 mg tablet once daily (qd) for 12 weeks.
|
Suzetrigine (SUZ): Mid Dose
Participants received SUZ 46 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): High Dose
Participants received SUZ 69 mg tablet qd for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
28
|
55
|
56
|
|
Overall Study
Safety Set
|
54
|
28
|
55
|
55
|
|
Overall Study
Modified Full Analysis Set (mFAS)
|
49
|
24
|
50
|
50
|
|
Overall Study
COMPLETED
|
46
|
24
|
46
|
47
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
9
|
9
|
Reasons for withdrawal
| Measure |
Pregabalin
Participants received Pregabalin 100 mg 3 times per day (tid) for 12 weeks.
|
Suzetrigine (SUZ): Low Dose
Participants received SUZ 23 mg tablet once daily (qd) for 12 weeks.
|
Suzetrigine (SUZ): Mid Dose
Participants received SUZ 46 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): High Dose
Participants received SUZ 69 mg tablet qd for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal of consent (not due to AE)
|
1
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
1
|
0
|
0
|
1
|
|
Overall Study
Randomized but did not receive study drug
|
1
|
0
|
0
|
1
|
|
Overall Study
Enrolled at clinical trial site excluded from mFAS due to lack of compliance with study drug
|
5
|
4
|
5
|
5
|
Baseline Characteristics
Baseline weekly average pain intensity is defined as the average of non-missing pain intensity scores collected Days -7 to -1. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain.Here "Number analyzed" signifies those participants who are evaluated for this specific baseline measure.
Baseline characteristics by cohort
| Measure |
Pregabalin
n=49 Participants
Participants received Pregabalin 100 mg tid for 12 weeks.
|
Suzetrigine (SUZ): Low Dose
n=24 Participants
Participants received SUZ 23 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): Mid Dose
n=50 Participants
Participants received SUZ 46 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): High Dose
n=50 Participants
Participants received SUZ 69 mg tablet qd for 12 weeks.
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 7.9 • n=49 Participants
|
60.9 years
STANDARD_DEVIATION 6.6 • n=24 Participants
|
61.7 years
STANDARD_DEVIATION 8.6 • n=50 Participants
|
61.4 years
STANDARD_DEVIATION 8.8 • n=50 Participants
|
61.9 years
STANDARD_DEVIATION 8.2 • n=173 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=49 Participants
|
12 Participants
n=24 Participants
|
22 Participants
n=50 Participants
|
21 Participants
n=50 Participants
|
77 Participants
n=173 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=49 Participants
|
12 Participants
n=24 Participants
|
28 Participants
n=50 Participants
|
29 Participants
n=50 Participants
|
96 Participants
n=173 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
7 Participants
n=49 Participants
|
2 Participants
n=24 Participants
|
9 Participants
n=50 Participants
|
4 Participants
n=50 Participants
|
22 Participants
n=173 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
42 Participants
n=49 Participants
|
22 Participants
n=24 Participants
|
41 Participants
n=50 Participants
|
46 Participants
n=50 Participants
|
151 Participants
n=173 Participants
|
|
Race/Ethnicity, Customized
White
|
32 Participants
n=49 Participants
|
15 Participants
n=24 Participants
|
33 Participants
n=50 Participants
|
35 Participants
n=50 Participants
|
115 Participants
n=173 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
16 Participants
n=49 Participants
|
7 Participants
n=24 Participants
|
15 Participants
n=50 Participants
|
14 Participants
n=50 Participants
|
52 Participants
n=173 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=49 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=173 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=49 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=173 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=49 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=173 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=49 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=173 Participants
|
|
Baseline Weekly Average Pain Intensity as Recorded on Numeric Pain Rating Scale (NPRS)
|
5.99 units on a scale
STANDARD_DEVIATION 1.27 • n=48 Participants • Baseline weekly average pain intensity is defined as the average of non-missing pain intensity scores collected Days -7 to -1. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain.Here "Number analyzed" signifies those participants who are evaluated for this specific baseline measure.
|
5.70 units on a scale
STANDARD_DEVIATION 1.32 • n=24 Participants • Baseline weekly average pain intensity is defined as the average of non-missing pain intensity scores collected Days -7 to -1. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain.Here "Number analyzed" signifies those participants who are evaluated for this specific baseline measure.
|
5.88 units on a scale
STANDARD_DEVIATION 0.97 • n=48 Participants • Baseline weekly average pain intensity is defined as the average of non-missing pain intensity scores collected Days -7 to -1. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain.Here "Number analyzed" signifies those participants who are evaluated for this specific baseline measure.
|
5.83 units on a scale
STANDARD_DEVIATION 1.23 • n=49 Participants • Baseline weekly average pain intensity is defined as the average of non-missing pain intensity scores collected Days -7 to -1. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain.Here "Number analyzed" signifies those participants who are evaluated for this specific baseline measure.
|
5.87 units on a scale
STANDARD_DEVIATION 1.18 • n=169 Participants • Baseline weekly average pain intensity is defined as the average of non-missing pain intensity scores collected Days -7 to -1. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0=no pain and 10=worst imaginable pain.Here "Number analyzed" signifies those participants who are evaluated for this specific baseline measure.
|
PRIMARY outcome
Timeframe: Baseline, At Week 12Population: Modified Full Analysis Set (mFAS) included all randomized participants who have received at least 1 dose of study drug and are not from Site 115. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome measure.
Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing average pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.
Outcome measures
| Measure |
Pregabalin
n=47 Participants
Participants received Pregabalin 100 mg tid for 12 weeks.
|
Suzetrigine (SUZ): Low Dose
n=24 Participants
Participants received SUZ 23 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): Mid Dose
n=48 Participants
Participants received SUZ 46 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): High Dose
n=48 Participants
Participants received SUZ 69 mg tablet qd for 12 weeks.
.
|
|---|---|---|---|---|
|
Change From Baseline in the Weekly Average of Daily Pain Intensity on a Numeric Pain Rating Scale (NPRS)
|
-2.09 units on a scale
Interval -2.65 to -1.52
|
-2.18 units on a scale
Interval -2.94 to -1.41
|
-2.11 units on a scale
Interval -2.67 to -1.55
|
-2.26 units on a scale
Interval -2.82 to -1.7
|
SECONDARY outcome
Timeframe: Baseline, At Week 12Population: mFAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome measure.
Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) score, which asks participants to describe how pain interfered with the participant's sleep. Response options for the DSIS range from 0 (none) to 10 (severe).
Outcome measures
| Measure |
Pregabalin
n=47 Participants
Participants received Pregabalin 100 mg tid for 12 weeks.
|
Suzetrigine (SUZ): Low Dose
n=24 Participants
Participants received SUZ 23 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): Mid Dose
n=49 Participants
Participants received SUZ 46 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): High Dose
n=47 Participants
Participants received SUZ 69 mg tablet qd for 12 weeks.
.
|
|---|---|---|---|---|
|
Change From Baseline in the Weekly Average of the Daily Sleep Interference Scale (DSIS) Score
|
-2.42 units on a scale
Interval -3.02 to -1.83
|
-2.20 units on a scale
Interval -3.0 to -1.41
|
-2.44 units on a scale
Interval -3.01 to -1.87
|
-2.15 units on a scale
Interval -2.74 to -1.55
|
SECONDARY outcome
Timeframe: Baseline, At Week 12Population: mFAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome measure.
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with ≥30% reduction from baseline in the weekly average NPRS score at Week 12 was reported.
Outcome measures
| Measure |
Pregabalin
n=49 Participants
Participants received Pregabalin 100 mg tid for 12 weeks.
|
Suzetrigine (SUZ): Low Dose
n=24 Participants
Participants received SUZ 23 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): Mid Dose
n=50 Participants
Participants received SUZ 46 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): High Dose
n=50 Participants
Participants received SUZ 69 mg tablet qd for 12 weeks.
.
|
|---|---|---|---|---|
|
Percentage of Participants With Greater Than or Equal to (≥) 30 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
|
44.9 percentage of participants
|
70.8 percentage of participants
|
46.0 percentage of participants
|
48.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, At Week 12Population: mFAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome measure.
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.The percentage of participants with ≥50% reduction from baseline in the weekly average NPRS score at Week 12 was reported.
Outcome measures
| Measure |
Pregabalin
n=49 Participants
Participants received Pregabalin 100 mg tid for 12 weeks.
|
Suzetrigine (SUZ): Low Dose
n=24 Participants
Participants received SUZ 23 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): Mid Dose
n=50 Participants
Participants received SUZ 46 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): High Dose
n=50 Participants
Participants received SUZ 69 mg tablet qd for 12 weeks.
.
|
|---|---|---|---|---|
|
Percentage of Participants With ≥50 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
|
22.4 percentage of participants
|
41.7 percentage of participants
|
32.0 percentage of participants
|
34.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, At Week 12Population: mFAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome measure.
Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain. The percentage of participants with ≥70% reduction from baseline in the weekly average NPRS score at Week 12 was reported.
Outcome measures
| Measure |
Pregabalin
n=49 Participants
Participants received Pregabalin 100 mg tid for 12 weeks.
|
Suzetrigine (SUZ): Low Dose
n=24 Participants
Participants received SUZ 23 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): Mid Dose
n=50 Participants
Participants received SUZ 46 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): High Dose
n=50 Participants
Participants received SUZ 69 mg tablet qd for 12 weeks.
.
|
|---|---|---|---|---|
|
Percentage of Participants With ≥70 Percent Reduction From Baseline in the Weekly Average of Daily Pain Intensity on the NPRS
|
10.2 percentage of participants
|
8.3 percentage of participants
|
22.0 percentage of participants
|
22.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, At Week 12Population: mFAS.Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome measure.
PGIC is an instrument that measures change in participants' overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Pregabalin
n=49 Participants
Participants received Pregabalin 100 mg tid for 12 weeks.
|
Suzetrigine (SUZ): Low Dose
n=24 Participants
Participants received SUZ 23 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): Mid Dose
n=50 Participants
Participants received SUZ 46 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): High Dose
n=50 Participants
Participants received SUZ 69 mg tablet qd for 12 weeks.
.
|
|---|---|---|---|---|
|
Percentage of Participants Categorized as "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Assessment
|
46.9 percentage of participants
|
50.0 percentage of participants
|
52.0 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Week 14Population: Safety set included all participants who had received at least 1 dose of study drug.
Outcome measures
| Measure |
Pregabalin
n=54 Participants
Participants received Pregabalin 100 mg tid for 12 weeks.
|
Suzetrigine (SUZ): Low Dose
n=28 Participants
Participants received SUZ 23 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): Mid Dose
n=55 Participants
Participants received SUZ 46 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): High Dose
n=55 Participants
Participants received SUZ 69 mg tablet qd for 12 weeks.
.
|
|---|---|---|---|---|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with TEAEs
|
20 Participants
|
14 Participants
|
21 Participants
|
31 Participants
|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
Pregabalin
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Suzetrigine (SUZ): Low Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Suzetrigine (SUZ): Mid Dose
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Suzetrigine (SUZ): High Dose
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
n=54 participants at risk
Participants received Pregabalin 100 mg 3 tid for 12 weeks.
|
Suzetrigine (SUZ): Low Dose
n=28 participants at risk
Participants received SUZ 23 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): Mid Dose
n=55 participants at risk
Participants received SUZ 46 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): High Dose
n=55 participants at risk
Participants received SUZ 69 mg tablet qd for 12 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
1/54 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/28 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/54 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/28 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
1.8%
1/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/54 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/28 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
1.8%
1/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/54 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/28 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
1.8%
1/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Pregabalin
n=54 participants at risk
Participants received Pregabalin 100 mg 3 tid for 12 weeks.
|
Suzetrigine (SUZ): Low Dose
n=28 participants at risk
Participants received SUZ 23 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): Mid Dose
n=55 participants at risk
Participants received SUZ 46 mg tablet qd for 12 weeks.
|
Suzetrigine (SUZ): High Dose
n=55 participants at risk
Participants received SUZ 69 mg tablet qd for 12 weeks.
|
|---|---|---|---|---|
|
General disorders
Oedema peripheral
|
5.6%
3/54 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
3.6%
1/28 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
|
Investigations
Creatinine renal clearance decreased
|
1.9%
1/54 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/28 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
1.8%
1/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
10.9%
6/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
7.4%
4/54 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/28 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/54 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
10.7%
3/28 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
9.3%
5/54 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/28 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
1.8%
1/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
3.7%
2/54 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
0.00%
0/28 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
5.5%
3/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
1.8%
1/55 • Day 1 up to Week 14
Safety set included all participants who had received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place