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NCT06161116 · ClinicalTrials.gov registry record · Phase 2
Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Terminated
- Registry status
- Phase 2
- Development phase
- 149
- Enrollment target
NCT06161116: Clinical Trial Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT06161116 is a Phase 2 study that was terminated before completion, run by Merck Sharp & Dohme. The registered enrollment target is 149 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06161116, a Phase 2 study, was terminated before completion, sponsored by Merck Sharp & Dohme.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 149 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of MK-6194 in adult participants with Systemic Lupus Erythematosus. The primary hypothesis is that at least 1 of the MK-6194 arms is superior to placebo in the primary endpoint of percentage of participants with systemic lupus erythematosus responder index (SRI-4) response at Week 28.
Primary Outcome
The SRI was a composite index used to assess clinical improvement in participants with SLE. The SRI-4 response evaluated global improvement, any significant worsening in unaffected organ systems, and improvements in disease activity, without compromise to the participant's overall condition. SRI-4 response was binary and either achieved or not achieved by the participant, thus there was no associated score. Due to insufficient sample size, no statistical analysis was performed. Descriptive stati
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL MK-6194
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2023-12-27 |
| Est. Completion | 2025-07-30 |
| Phase | Phase 2 |
Why NCT06161116 stopped before completion
NCT06161116 is an interventional study that assigns participants to a tested intervention. The registered 149 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 (12% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06161116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06161116 about?
NCT06161116 is a clinical study titled "Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)". The purpose of this study is to evaluate the efficacy and safety of MK-6194 in adult participants with Systemic Lupus Erythematosus. The primary hypothesis is that at least 1 of the MK-6194 arms is superior to placebo in the primary endpoint of percentage of participants with systemic lupus erythema...
What is the current status of trial NCT06161116?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 149 participants. The study started on 2023-12-27. Estimated completion is 2025-07-30.
What interventions are being tested in trial NCT06161116?
The interventions under investigation include: Placebo (BIOLOGICAL), MK-6194 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06161116?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06161116's enrollment target sits among peer trials
149 491st of 2000 higher than 1,510 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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