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NCT03653026 · ClinicalTrials.gov registry record · Phase 3
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 522
- Enrollment target
NCT03653026: Completed Phase 3 study, sponsored by AbbVie.
NCT03653026 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 522 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03653026, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 522 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).
Primary Outcome
The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher
Interventions
- DRUG Placebo
- DRUG Upadacitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 522 participants |
| Start Date | 2018-12-06 |
| Est. Completion | 2021-01-14 |
| Phase | Phase 3 |
What the finished NCT03653026 record still lists
NCT03653026 is an interventional study that assigns participants to a tested intervention. The registered 522 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 (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03653026 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03653026 about?
NCT03653026 is a clinical study titled "A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis". The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).
What is the current status of trial NCT03653026?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 522 participants. The study started on 2018-12-06. Estimated completion is 2021-01-14.
What interventions are being tested in trial NCT03653026?
The interventions under investigation include: Placebo (DRUG), Upadacitinib (DRUG).
Who is sponsoring clinical trial NCT03653026?
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 NCT03653026's enrollment target sits among peer trials
522 716th of 2000 higher than 1,284 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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