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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 is a Phase 2 study that has completed, run by AbbVie. The registered enrollment target is 1,302 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02819635
The ClinicalTrials.gov registry entry for NCT02819635 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,302 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02819635 reports 0 study locations.
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.
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