A clinical study of MK-6194 for the treatment of vitiligo (MK-6194-007)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

24 Jan 2024 → 30 Jul 2025

Decision date (initial)

2024-01-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2023-503502-37-00

WHO UTN

U1111-1287-4329

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacokinetic, Pharmacoeconomic, Safety, Pharmacogenetic, Efficacy, Pharmacodynamic

1. To evaluate the efficacy of MK-6194 on the percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
2. To evaluate the safety and tolerability of MK-6194

Secondary objectives 1

1. 1. To evaluate the efficacy of MK-6194 on the percent change from baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24

Conditions and MedDRA coding

Non segmental vitiligo

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Has a clinical diagnosis of non-segmental vitiligo
2. Has non-segmental vitiligo with disease duration of at least 6 months
3. Has depigmentation contributing to F-VASI ≥ 0.3 at screening and baseline
4. Has depigmented facial body surface area (BSA) ≥0.3% at screening and baseline
5. Has T-VASI ≥4 at screening and baseline
6. Has total body vitiligo area ≥4% at screening and baseline excluding hands and feet involvement
7. Is 18 to 75 years of age inclusive at the time of providing informed consent

Exclusion criteria 19

1. Has segmental vitiligo
2. Has ≥50% leukotrichia on face or body
3. Has any other dermatological diseases that would interfere with vitiligo assessments
4. Has history of or current inflammatory condition other than vitiligo that, in the opinion of the investigator, could interfere with the evaluation of vitiligo
5. Has a known systemic hypersensitivity to interleukin 2 (IL-2), or modified IL-2 including MK-6194, or its inactive ingredients
6. Has an active or clinically significant infection, requiring hospitalization or treatment with intravenous (IV) anti-infectives within 4 weeks prior to Randomization, or oral/intramuscular anti-infective therapy within 2 weeks prior to Randomization
7. 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
8. Has a severe chronic pulmonary disease requiring oxygen therapy
9. Has a transplanted organ, which requires continued immunosuppression
10. Has a history of any malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix
11. Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB
12. Has confirmed or suspected COVID-19 infection
13. Has history of drug or alcohol abuse within 6 months prior to Screening
14. Has had major surgery within 3 months prior to Screening OR has a major surgery planned during the study
15. 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)
16. Has received prohibited medications within protocol-specified timeframes prior to Randomization
17. Has participated in another investigational clinical study within 4 weeks prior to Randomization
18. Has donated or lost ≥1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit
19. Has received cosmetic or other procedures that could interfere with evaluation of vitiligo during the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Change from Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
2. Number of Participants Who Experience an Adverse Event (AE)
3. Number of Participants Who Discontinue Study Treatment Due to an AE

Secondary endpoints 1

1. Change from Baseline in Total Vitiligo Area Scoring Index (T-VASI) at Week 24

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Claudia Kaiser-Albers

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Claudia Kaiser-Albers

Third parties 5

Locations

5 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 57 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications