Trial Outcomes & Findings for Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis (NCT NCT05763082)
NCT ID: NCT05763082
Last Updated: 2026-08-26
Results Overview
percentage of subjects at Day 56 who achieve Treatment Success, which is defined as an IGA score of None (0) or Minimal (1) with a 2-grade improvement from Day 1
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
416 participants
Primary outcome timeframe
Day 1 to Day 56
Results posted on
2026-08-26
Participant Flow
Participant milestones
| Measure |
Padagis Active Product
Padagis roflumilast cream
|
Reference Product
Zoryve cream
|
Padagis Placebo Product
Padagis vehicle cream
|
|---|---|---|---|
|
Overall Study
STARTED
|
169
|
166
|
81
|
|
Overall Study
COMPLETED
|
154
|
155
|
75
|
|
Overall Study
NOT COMPLETED
|
15
|
11
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Padagis Active Product
n=169 Participants
Padagis roflumilast cream
|
Reference Product
n=166 Participants
Zoryve cream
|
Padagis Placebo Product
n=81 Participants
Padagis vehicle cream
|
Total
n=416 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 13.8 • n=31 Participants
|
49.0 years
STANDARD_DEVIATION 13.9 • n=49 Participants
|
48.8 years
STANDARD_DEVIATION 13.2 • n=80 Participants
|
49.3 years
STANDARD_DEVIATION 13.6 • n=29 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=31 Participants
|
66 Participants
n=49 Participants
|
34 Participants
n=80 Participants
|
177 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=31 Participants
|
100 Participants
n=49 Participants
|
47 Participants
n=80 Participants
|
239 Participants
n=29 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
2 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
2 Participants
n=80 Participants
|
10 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
2 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=31 Participants
|
32 Participants
n=49 Participants
|
14 Participants
n=80 Participants
|
78 Participants
n=29 Participants
|
|
Race (NIH/OMB)
White
|
129 Participants
n=31 Participants
|
123 Participants
n=49 Participants
|
61 Participants
n=80 Participants
|
313 Participants
n=29 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
3 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=31 Participants
|
4 Participants
n=49 Participants
|
3 Participants
n=80 Participants
|
8 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
98 Participants
n=31 Participants
|
98 Participants
n=49 Participants
|
50 Participants
n=80 Participants
|
246 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=31 Participants
|
68 Participants
n=49 Participants
|
31 Participants
n=80 Participants
|
170 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=29 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 56percentage of subjects at Day 56 who achieve Treatment Success, which is defined as an IGA score of None (0) or Minimal (1) with a 2-grade improvement from Day 1
Outcome measures
| Measure |
Padagis Active Product
n=129 Participants
Padagis roflumilast cream
|
Reference Product
n=131 Participants
Zoryve cream
|
Padagis Placebo Product
n=65 Participants
Padagis vehicle cream
|
|---|---|---|---|
|
Investigator's Global Assessment (IGA)
|
78 Participants
|
79 Participants
|
22 Participants
|
Adverse Events
Padagis Active Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reference Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Padagis Placebo Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60