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NCT03843125 · ClinicalTrials.gov registry record · Phase 3
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)
A Phase 3 study, sponsored by Eli Lilly and Company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,147
- Enrollment target
NCT03843125: Clinical Trial Phase 3 study, sponsored by Eli Lilly and Company.
NCT03843125 is a Phase 3 study that was terminated before completion, run by Eli Lilly and Company. The registered enrollment target is 1,147 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03843125, a Phase 3 study, was terminated before completion, sponsored by Eli Lilly and Company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,147 participants
- Enrollment target
Study Summary
The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).
Primary Outcome
Percentage of participants with TEAEs. A treatment-emergent AE (TEAE) is defined as an event that first occurred or worsened in severity after the first dose of study treatment in Study JAIM and on or prior to the last visit date during the analysis period. The analysis period is defined as the treatment period plus up to 30 days off-drug follow-up time. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Interventions
- DRUG Placebo
- DRUG Baricitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,147 participants |
| Start Date | 2019-09-09 |
| Est. Completion | 2022-04-01 |
| Phase | Phase 3 |
Why NCT03843125 stopped before completion
NCT03843125 is an interventional study that assigns participants to a tested intervention. Its 1,147 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03843125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03843125 about?
NCT03843125 is a clinical study titled "A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)". The reason for this long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).
What is the current status of trial NCT03843125?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,147 participants. The study started on 2019-09-09. Estimated completion is 2022-04-01.
What interventions are being tested in trial NCT03843125?
The interventions under investigation include: Placebo (DRUG), Baricitinib (DRUG).
Who is sponsoring clinical trial NCT03843125?
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 NCT03843125's enrollment target sits among peer trials
1,147 242nd of 2000 higher than 1,759 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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