Last reviewed · How we verify
Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis (JADE MOA)
B7451037 is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2a study to investigate the mechanism of action of PF-04965842 by correlating efficacy outcomes with changes from baseline in key skin and blood biomarkers in adult participants at least 18 years of age with moderate-to-severe atopic dermatitis. Participants will be screened within 28 days prior to the first dose of study intervention to confirm eligibility. A total of approximately 51 participants will be randomized in a 1:1:1 ratio to receive PF-04965842 200 mg once daily (QD), PF004965842 100 mg QD, or matching placebo QD for 12 weeks. At the end of the 12-week study treatment, qualified participants will have the option to enter the long-term extension study B7451015 (NCT03422822). Participants discontinuing early from this study will undergo a 4-week off-treatment follow-up period.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | PHASE2 |
| Status | COMPLETED |
| Enrolment | 46 |
| Start date | Thu Jun 18 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Nov 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Atopic Dermatitis
Interventions
- PF-04965842 200 mg
- PF-04965842 100 mg
- Placebo
Countries
Canada, United States