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NCT02819635 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
A Phase 2 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,302
- Enrollment target
NCT02819635: Completed Phase 2 study, sponsored by AbbVie.
NCT02819635 is a Phase 2 study that has completed, run by AbbVie. The registered enrollment target is 1,302 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (879% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02819635, a Phase 2 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,302 participants
- Enrollment target
Study Summary
This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.
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 sc
Interventions
- DRUG Placebo
- DRUG Upadacitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,302 participants |
| Start Date | 2016-09-26 |
| Est. Completion | 2021-12-13 |
| Phase | Phase 2 |
What the finished NCT02819635 record still lists
NCT02819635 is an interventional study that assigns participants to a tested intervention. Its 1,302 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (879% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02819635 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02819635 about?
NCT02819635 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)". This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective ...
What is the current status of trial NCT02819635?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,302 participants. The study started on 2016-09-26. Estimated completion is 2021-12-13.
What interventions are being tested in trial NCT02819635?
The interventions under investigation include: Placebo (DRUG), Upadacitinib (DRUG).
Who is sponsoring clinical trial NCT02819635?
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 NCT02819635's enrollment target sits among peer trials
1,302 13th of 2000 higher than 1,988 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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