Trials / Terminated
TerminatedNCT06161116
Efficacy And Safety Of MK-6194 In Adult Participants With Systemic Lupus Erythematosus (MK-6194-006)
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 149 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MK-6194 | SC Injection |
| BIOLOGICAL | Placebo | SC Injection |
Timeline
- Start date
- 2023-12-27
- Primary completion
- 2025-07-30
- Completion
- 2025-07-30
- First posted
- 2023-12-07
- Last updated
- 2025-08-06
Locations
127 sites across 17 countries: United States, Argentina, Brazil, Canada, Chile, China, Colombia, France, Guatemala, Italy, Japan, Malaysia, Mexico, Philippines, Poland, Spain, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06161116. Inclusion in this directory is not an endorsement.