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NCT04345367 · ClinicalTrials.gov registry record · Phase 3
Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 727
- Enrollment target
NCT04345367 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 727 participants.
The verdict
NCT04345367, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 727 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will be enrolled from approximately 220 sites globally. Approximately 600 participants will be randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints will be assessed throughout the entire study. Exploratory endpoints related to hand eczema efficacy will be assessed throughout the study.
Interventions
- DRUG Abrocitinib 200 mg
- COMBINATION_PRODUCT Dupilumab 300 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 727 participants |
| Start Date | 2020-06-11 |
| Est. Completion | 2021-07-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04345367
The ClinicalTrials.gov registry entry for NCT04345367 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 727 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 2 interventions - of which Abrocitinib 200 mg is the first listed.
NCT04345367 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04345367 about?
NCT04345367 is a clinical study titled "Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy". This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines)...
What is the current status of trial NCT04345367?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 727 participants. The study started on 2020-06-11. Estimated completion is 2021-07-13.
What interventions are being tested in trial NCT04345367?
The interventions under investigation include: Abrocitinib 200 mg (DRUG), Dupilumab 300 mg (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04345367?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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