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NCT01205438 · ClinicalTrials.gov registry record · Phase 3
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,124
- Enrollment target
NCT01205438: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01205438 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,124 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01205438, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,124 participants
- Enrollment target
Study Summary
The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in participants with active SLE.
Primary Outcome
Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild
Interventions
- DRUG LY2127399
- DRUG Placebo every 2 weeks
- DRUG Placebo every 4 weeks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,124 participants |
| Start Date | 2011-01 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
What the finished NCT01205438 record still lists
NCT01205438 is an interventional study that assigns participants to a tested intervention. Its 1,124 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 (46% higher).
The record links to 0 conditions, and to 3 interventions - of which LY2127399 is the first listed.
NCT01205438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01205438 about?
NCT01205438 is a clinical study titled "A Study of LY2127399 in Participants With Systemic Lupus Erythematosus". The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in participants with active SLE.
What is the current status of trial NCT01205438?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,124 participants. The study started on 2011-01. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01205438?
The interventions under investigation include: LY2127399 (DRUG), Placebo every 2 weeks (DRUG), Placebo every 4 weeks (DRUG).
Who is sponsoring clinical trial NCT01205438?
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 NCT01205438's enrollment target sits among peer trials
1,124 248th of 2000 higher than 1,753 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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