A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Non-segmental Vitiligo

Treatments: Biological: MK-6194; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06113328

MK-6194-007 (Other Identifier)

U1111-1287-4329 (Other Identifier)

6194-007

jRCT2031230622 (Registry Identifier)

2023-503502-37-00 (Registry Identifier)

Details and patient eligibility

About

Researchers are looking for a new way to treat people with non-segmental vitiligo (NSV). The goal of this study is to learn about the safety of MK-6194 and how well people tolerate it. Researchers also want to learn if people who take MK-6194 have more of a decrease in the amount of vitiligo on their face compared to people who take placebo.

Full description

This study will consist of two periods. During the Double-Blind Treatment Period, participants will be randomized to one of three treatment arms to receive MK-6194 at one of two doses or placebo and will be evaluated for safety and efficacy. Participants who complete this period may enter the Blinded Extension Period, during which MK-6194 treatment will continue or placebo recipients will be re-randomized to MK-6194 at one of two doses.

Enrollment: 169 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a clinical diagnosis of non-segmental vitiligo
• Has non-segmental vitiligo with disease duration of at least 6 months
• Has depigmentation contributing to Facial Vitiligo Area Scoring Index (F-VASI) ≥ 0.3 at screening and baseline
• Has depigmented facial body surface area (BSA) ≥0.3% at screening and baseline
• Has Total Vitiligo Area Scoring Index (T-VASI) ≥4 at screening and baseline
• Has total body vitiligo area ≥4% at screening and baseline excluding hands and feet involvement

Exclusion criteria

• Has segmental vitiligo
• Has ≥50% leukotrichia on face or body
• Has any other dermatological diseases that would interfere with vitiligo assessments
• Has history of or current inflammatory condition other than vitiligo that, in the opinion of the investigator, could interfere with the evaluation of vitiligo
• Has a known systemic hypersensitivity to interleukin 2 (IL-2), or modified IL-2 including MK-6194, or its inactive ingredients
• Has an active or clinically significant infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks prior to Randomization, or oral/intramuscular anti-infective therapy within 2 weeks prior to Randomization
• Has symptomatic heart failure (New York Heart Association class III or IV) or myocardial infarction or unstable angina pectoris within 6 months prior to Screening
• Has a severe chronic pulmonary disease requiring oxygen therapy
• Has a transplanted organ, which requires continued immunosuppression
• Has a history of any malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix
• Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB
• Has confirmed or suspected COVID-19 infection
• Has history of drug or alcohol abuse within 6 months prior to Screening
• Has had major surgery within 3 months prior to Screening OR has a major surgery planned during the study
• Has had an inadequate response (as evaluated by a dermatologist or local physician specialist equivalent) to previous treatment with a Janus kinase inhibitor (JAKi) after an appropriate treatment duration (eg, ≥12 weeks)
• Has received prohibited medications within protocol-specified timeframes prior to Randomization
• Has participated in another investigational clinical study within 4 weeks prior to Randomization
• Has donated or lost ≥1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit
• Has received cosmetic or other procedures that could interfere with evaluation of vitiligo during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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169 participants in 7 patient groups, including a placebo group

MK-6194 3 mg Q2W

Experimental group

Description:

Participants will receive subcutaneous (SC) MK-6194 3 mg every two weeks (Q2W).

Treatment:

Biological: MK-6194

MK-6194 3 mg Q4W

Experimental group

Description:

Participants will receive SC MK-6194 3 mg every four weeks (Q4W).

Treatment:

Biological: MK-6194

Placebo

Placebo Comparator group

Description:

Participants will receive SC Placebo Q2W.

Treatment:

Drug: Placebo

MK-6194 3 mg Q2W (double-blind) / MK-6194 3 mg Q2W (extension)

Experimental group

Description:

After completing 24 weeks of treatment with SC MK-6194 administered 3 mg Q2W in the Double-Blind Treatment Period, participants will continue to receive SC MK-6194 3 mg Q2W in the Blinded Extension Period.

Treatment:

Biological: MK-6194

MK-6194 3 mg Q4W (double-blind) / MK-6194 3 mg Q4W (extension)

Experimental group

Description:

After completing 24 weeks of treatment with SC MK-6194 administered 3 mg Q4W in the Double-Blind Treatment Period, participants will continue to receive SC MK-6194 3 mg Q4W in the Blinded Extension Period.

Treatment:

Biological: MK-6194

Placebo (double-blind)/ MK-6194 3 mg Q2W (extension)

Experimental group

Description:

After completing 24 weeks of treatment with SC Placebo administered Q2W in the Double-Blind Treatment Period, participants will be re-randomized to receive SC MK-6194 3 mg Q2W in the Blinded Extension Period.

Treatment:

Biological: MK-6194

Placebo (double-blind)/ MK-6194 3 mg Q4W (extension)

Experimental group

Description:

After completing 24 weeks of treatment with SC Placebo administered Q2W in the Double-Blind Treatment Period, participants will be re-randomized to receive SC MK-6194 3 mg Q4W in the Blinded Extension Period.

Treatment:

Biological: MK-6194