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NCT03725202 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 429
- Enrollment target
NCT03725202: Completed Phase 3 study, sponsored by AbbVie.
NCT03725202 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 429 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03725202, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 429 participants
- Enrollment target
Study Summary
This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of Period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in Period 1.
Primary Outcome
Sustained remission is defined as having achieved absence of giant cell arteritis (GCA) signs and symptoms from Week 12 through Week 52, and adherence to the protocol-defined corticosteroid (CS) taper regimen.
Interventions
- OTHER Placebo
- DRUG Upadacitinib
- DRUG Corticosteroid (CS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 429 participants |
| Start Date | 2019-01-24 |
| Est. Completion | 2025-03-11 |
| Phase | Phase 3 |
What the finished NCT03725202 record still lists
NCT03725202 is an interventional study that assigns participants to a tested intervention. The registered 429 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 (44% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03725202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03725202 about?
NCT03725202 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis". This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained rem...
What is the current status of trial NCT03725202?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 429 participants. The study started on 2019-01-24. Estimated completion is 2025-03-11.
What interventions are being tested in trial NCT03725202?
The interventions under investigation include: Placebo (OTHER), Upadacitinib (DRUG), Corticosteroid (CS) (DRUG).
Who is sponsoring clinical trial NCT03725202?
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 NCT03725202's enrollment target sits among peer trials
429 878th of 2000 higher than 1,123 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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