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NCT03978520 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
A Phase 2 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 2
- Development phase
- 341
- Enrollment target
NCT03978520: Completed Phase 2 study, sponsored by AbbVie.
NCT03978520 is a Phase 2 study that has completed, run by AbbVie. The registered enrollment target is 341 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (156% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03978520, a Phase 2 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 341 participants
- Enrollment target
Study Summary
The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.
Primary Outcome
SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline: * ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score * No worsening of the overall condition (\< 0.3 point increase in Physician's Global Assessment \[PhGA\]) * No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system change
Interventions
- DRUG Upadacitinib
- DRUG Placebo for upadacitinib
- DRUG Elsubrutinib
- DRUG Placebo for elsubrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 341 participants |
| Start Date | 2019-07-25 |
| Est. Completion | 2022-07-14 |
| Phase | Phase 2 |
What the finished NCT03978520 record still lists
NCT03978520 is an interventional study that assigns participants to a tested intervention. The registered 341 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (156% higher).
The record links to 0 conditions, and to 4 interventions - of which Upadacitinib is the first listed.
NCT03978520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03978520 about?
NCT03978520 is a clinical study titled "A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)". The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with mod...
What is the current status of trial NCT03978520?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 341 participants. The study started on 2019-07-25. Estimated completion is 2022-07-14.
What interventions are being tested in trial NCT03978520?
The interventions under investigation include: Upadacitinib (DRUG), Placebo for upadacitinib (DRUG), Elsubrutinib (DRUG), Placebo for elsubrutinib (DRUG).
Who is sponsoring clinical trial NCT03978520?
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 NCT03978520's enrollment target sits among peer trials
341 137th of 2000 higher than 1,864 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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