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NCT03738397 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 673
- Enrollment target
NCT03738397: Completed Phase 3 study, sponsored by AbbVie.
NCT03738397 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 673 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03738397, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 673 participants
- Enrollment target
Study Summary
This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
Primary Outcome
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scrat
Interventions
- BIOLOGICAL Dupilumab
- BIOLOGICAL Upadacitinib
- DRUG Placebo to dupilumab
- DRUG Placebo to upadacitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 673 participants |
| Start Date | 2019-02-21 |
| Est. Completion | 2020-12-09 |
| Phase | Phase 3 |
What the finished NCT03738397 record still lists
NCT03738397 is an interventional study that assigns participants to a tested intervention. The registered 673 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 4 interventions - of which Dupilumab is the first listed.
NCT03738397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03738397 about?
NCT03738397 is a clinical study titled "A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis". This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
What is the current status of trial NCT03738397?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 673 participants. The study started on 2019-02-21. Estimated completion is 2020-12-09.
What interventions are being tested in trial NCT03738397?
The interventions under investigation include: Dupilumab (BIOLOGICAL), Upadacitinib (BIOLOGICAL), Placebo to dupilumab (DRUG), Placebo to upadacitinib (DRUG).
Who is sponsoring clinical trial NCT03738397?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03738397's enrollment target sits among peer trials
673 544th of 2000 higher than 1,457 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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