Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03616964 · ClinicalTrials.gov registry record · Phase 3
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE-BRAVE II)
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 778
- Enrollment target
NCT03616964: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT03616964 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 778 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03616964, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 778 participants
- Enrollment target
Study Summary
The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).
Primary Outcome
SRI-4 response defined as 1)greater than or equal to (\>=) 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score 2)no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and 3)no worsening in Physician Global Assessment (PGA) of Disease Activity (worsening defined as an increase of \>=0.3 from baseline on a 0-3 visual analogue scale). SLEDAI-2K assessment consists of 24 items with total score of 0(no symp
Interventions
- DRUG Placebo
- DRUG Baricitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 778 participants |
| Start Date | 2018-08-02 |
| Est. Completion | 2021-10-20 |
| Phase | Phase 3 |
What the finished NCT03616964 record still lists
NCT03616964 is an interventional study that assigns participants to a tested intervention. The registered 778 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03616964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03616964 about?
NCT03616964 is a clinical study titled "A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE-BRAVE II)". The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).
What is the current status of trial NCT03616964?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 778 participants. The study started on 2018-08-02. Estimated completion is 2021-10-20.
What interventions are being tested in trial NCT03616964?
The interventions under investigation include: Placebo (DRUG), Baricitinib (DRUG).
Who is sponsoring clinical trial NCT03616964?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03616964's enrollment target sits among peer trials
778 438th of 2000 higher than 1,563 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06841679 · 778 participants · Phase 2
Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
- NCT05642611 · 777 participants · Phase 3
Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy
- NCT05046613 · 780 participants
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
- NCT05100862 · 780 participants · Phase 3
A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI