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NCT04195698 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 475
- Enrollment target
NCT04195698: Completed Phase 3 study, sponsored by AbbVie.
NCT04195698 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 475 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04195698, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 475 participants
- Enrollment target
Study Summary
This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed. Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.
Primary Outcome
Treatment-emergent adverse events (TEAEs) are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Lead-In Study M16-046 for the UPA/UPA arm or this Study M19-850 DUPI/UPA arm through 30 days following the last dose of upadacitinib.
Interventions
- DRUG Upadacitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 475 participants |
| Start Date | 2020-01-15 |
| Est. Completion | 2023-09-11 |
| Phase | Phase 3 |
What the finished NCT04195698 record still lists
NCT04195698 is an interventional study that assigns participants to a tested intervention. The registered 475 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 (38% lower).
The record links to 0 conditions, and to 1 intervention - of which Upadacitinib is the first listed.
NCT04195698 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04195698 about?
NCT04195698 is a clinical study titled "Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis". This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 3...
What is the current status of trial NCT04195698?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 475 participants. The study started on 2020-01-15. Estimated completion is 2023-09-11.
What interventions are being tested in trial NCT04195698?
The interventions under investigation include: Upadacitinib (DRUG).
Who is sponsoring clinical trial NCT04195698?
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 NCT04195698's enrollment target sits among peer trials
475 808th of 2000 higher than 1,191 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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