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NCT03422822 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,166
- Enrollment target
NCT03422822 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 3,166 participants.
The verdict
NCT03422822, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,166 participants
- Enrollment target
Study Summary
B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying parent study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg taken orally once daily, will be evaluated over variable lengths of study participation. The study consists of a 92 week initial treatment period followed by a variable length secondary treatment period during which subjects will receive treatment with open-label abrocitinib until availability of commercial product in their country, or until the sponsor terminates the study in that country. The B7451015 study also includes a sub-study evaluating whether abrocitinib has any potential effects on adolescent bone with regard to abnormal bone findings in knee MRI. The sub-study will be conducted in selected countries at selected sites. Eligible subjects are those who were 12 to \<18 years of age at the screening visit of the qualifying parent study and who are currently participating in the main B7451015 study. The sub-study will include serial Magnetic Resonance Imaging (MRI) annually and continue until all enrolled subjects are 18 years of age and have been imaged at least once or have discontinued/withdrawn.
Interventions
- DRUG Placebo
- DRUG Abrocitinib 200 mg
- DRUG Abrocitinib 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,166 participants |
| Start Date | 2018-03-08 |
| Est. Completion | 2025-12-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03422822
The ClinicalTrials.gov registry entry for NCT03422822 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,166 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.
NCT03422822 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03422822 about?
NCT03422822 is a clinical study titled "Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis". B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying parent study. The efficacy and safety of two dosage strengths of Abrocitinib, 100 mg and 200 mg ta...
What is the current status of trial NCT03422822?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,166 participants. The study started on 2018-03-08. Estimated completion is 2025-12-22.
What interventions are being tested in trial NCT03422822?
The interventions under investigation include: Placebo (DRUG), Abrocitinib 200 mg (DRUG), Abrocitinib 100 mg (DRUG).
Who is sponsoring clinical trial NCT03422822?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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