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NCT03627767 · ClinicalTrials.gov registry record · Phase 3
Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,235
- Enrollment target
NCT03627767: Completed Phase 3 study, sponsored by Pfizer.
NCT03627767 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 1,235 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03627767, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,235 participants
- Enrollment target
Study Summary
B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
Primary Outcome
Percentage of participants with loss of response requiring rescue treatment during double blind period was determined. Loss of response denoted as flare and was define as a loss of at least 50% of EASI total score at Week 12 and with an IGA score of 2 or higher. EASI quantifies severity of participant's atopic dermatitis (AD) based on both severity of lesion clinical signs and % of body surface area (BSA) affected. EASI is a composite scoring by AD clinical evaluator of degree of erythema, indur
Interventions
- DRUG Placebo
- DRUG PF-04965842 100 mg
- DRUG PF-04965842 200 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,235 participants |
| Start Date | 2018-06-11 |
| Est. Completion | 2020-10-07 |
| Phase | Phase 3 |
What the finished NCT03627767 record still lists
NCT03627767 is an interventional study that assigns participants to a tested intervention. Its 1,235 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03627767 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03627767 about?
NCT03627767 is a clinical study titled "Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects". B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will b...
What is the current status of trial NCT03627767?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,235 participants. The study started on 2018-06-11. Estimated completion is 2020-10-07.
What interventions are being tested in trial NCT03627767?
The interventions under investigation include: Placebo (DRUG), PF-04965842 100 mg (DRUG), PF-04965842 200 mg (DRUG).
Who is sponsoring clinical trial NCT03627767?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03627767's enrollment target sits among peer trials
1,235 214th of 2000 higher than 1,787 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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