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MK-6194 in Adult Participants With Non-Segmental Vitiligo
NCT06113328Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2023
- Primary completion
- Mar 2025
- Countries
- 18
- Sponsor
- Merck & Co.
- Modality
- Fc-Fusion Proteins
- Drugs
- PT101
- Conditions
- Vitiligo
01
Overview
Phase 2, randomised, double-blind trial of PT101 in Vitiligo (3 arms), sponsored by Merck & Co. Primary endpoints: Facial Vitiligo Area Scoring Index at 24 weeks, Adverse Events at 28 weeks and 1 more. Started Nov 2023; status: terminated.
02
Design
3 arms- Study design
- RandomizedDouble-blind
MK-6194 3 mg Q2W
MK-6194 3 mg Q2W for 24 weeks, then continue in extension.
MK-6194 3 mg Q4W
MK-6194 3 mg Q4W for 24 weeks, then continue in extension.
Placebo
Placebo for 24 weeks, then re-randomized to MK-6194 in extension.
03
Who it enrols
Adults with non-segmental vitiligo for at least 6 months, with specific facial and total body surface area involvement (F-VASI >= 0.3, T-VASI >= 4). Excludes those with segmental vitiligo, significant leukotrichia, recent severe infections, heart failure, or inadequate response to prior JAK inhibitors.
04
Endpoints
Primary
Facial Vitiligo Area Scoring Index
Adverse Events
Discontinuations due to Adverse Events
Secondary
Total Vitiligo Area Scoring Index
05
Results
Not all primary endpoints met
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