Trials / Completed
CompletedNCT03575871
Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04965842 MONOTHERAPY IN SUBJECTS AGED 12 YEARS AND OLDER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 391 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-04965842 100 mg | PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks |
| DRUG | PF-04965842 200 mg | PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks |
| DRUG | Placebo | Placebo, administered as two tablets to be taken orally once daily for 12 weeks |
Timeline
- Start date
- 2018-06-29
- Primary completion
- 2019-08-13
- Completion
- 2019-08-13
- First posted
- 2018-07-03
- Last updated
- 2020-04-21
- Results posted
- 2020-04-21
Locations
115 sites across 13 countries: United States, Australia, Bulgaria, Canada, China, Czechia, Germany, Hungary, Japan, Latvia, Poland, South Korea, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03575871. Inclusion in this directory is not an endorsement.