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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: Completed Phase 3 study, sponsored by Pfizer.
NCT04345367 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 727 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The severity of itch (pruritus) due to atopic dermatitis (AD) was assessed using the PP-NRS, a validated horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on an NRS with scale ranging from 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
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 |
What the finished NCT04345367 record still lists
NCT04345367 is an interventional study that assigns participants to a tested intervention. The registered 727 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Abrocitinib 200 mg is the first listed.
NCT04345367 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04345367's enrollment target sits among peer trials
727 490th of 2000 higher than 1,511 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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