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NCT03915496 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT03915496 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 46 participants.
The verdict
NCT03915496, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG PF-04965842 100 mg
- DRUG PF-04965842 200 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2020-06-18 |
| Est. Completion | 2021-11-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03915496
The ClinicalTrials.gov registry entry for NCT03915496 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03915496 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03915496 about?
NCT03915496 is a clinical study titled "Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis". 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-t...
What is the current status of trial NCT03915496?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2020-06-18. Estimated completion is 2021-11-16.
What interventions are being tested in trial NCT03915496?
The interventions under investigation include: Placebo (DRUG), PF-04965842 100 mg (DRUG), PF-04965842 200 mg (DRUG).
Who is sponsoring clinical trial NCT03915496?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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