A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants with Non-Segmental Vitiligo (MK-6194)

D
David Rosmarin

Primary Investigator

Recruiting
18-75 years
All
Phase 2
5 participants needed
2 Locations

Brief description of study

What is the purpose of this study?
  • To evaluate the safety and tolerability of MK-6194
  • To evaluate the efficacy of MK-6194 

Detailed description of study

What will happen during the study?
  • Vitiligo is a common condition that affects 0.5% to 1% of people worldwide, causing the skin to lose its color in patches. This happens because the cells that give your skin its color, called melanocytes, are destroyed.
  • MK-6194 is a new medication that helps control inflammation. In vitiligo, your immune system mistakenly attacks and destroys melanocytes. MK-6194 aims to manage this immune response, reduce inflammation, and potentially stop the skin from losing more color.
  • This study will look at how well MK-6194 works and how safe it is for people with non-segmental vitiligo, a type that affects both sides of the body in a similar pattern. Researchers will see if the skin color improves and check for any side effects to ensure the medication is safe.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non-Segmental Vitiligo
  • Age: Between 18 Years - 75 Years
  • Gender: All

Inclusion Criteria

  • Type of Participant and Disease Characteristics
  • 1. Has a clinical diagnosis of non-segmental vitiligo
  • Note: Vitiligo diagnosis must be made by a trained physician who is a board-certified
  • dermatologist (or local equivalent)
  • 2. Has non-segmental vitiligo with disease duration of at least 6 months
  • Note: Disease duration is defined as the length of time since onset of symptoms
  • 3. Has depigmentation contributing to F-VASI ≥ 0.3 at screening and baseline
  • 4. Has depigmented facial 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 candidate for systemic therapy based on investigator judgment at screening and
  • baseline
  • Demographics
  • 8. Is an individual of any sex/gender, from 18 years to 75 years of age inclusive, at the time
  • of providing the informed consent
  • Female Participants
  • 9. A participant assigned female sex at birth is eligible to participate if not pregnant or
  • breastfeeding, and at least one of the following conditions applies:
  • • Is not a POCBP
  • OR
  • • Is a POCBP and:
  • Uses a contraceptive method that is highly effective (with a failure rate of <1% per
  • year), or is abstinent from penile-vaginal intercourse as their preferred and usual
  • lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5
  • during the intervention period and for at least 28 days after the last dose of study
  • intervention. The investigator should evaluate the potential for contraceptive method
  • failure (ie, noncompliance, recently initiated) in relationship to the first dose of study
  • intervention. Contraceptive use by POCBPs should be consistent with local
  • regulations regarding the methods of contraception for those participating in clinical
  • studies. If the contraception requirements in the local label for any of the study
  • interventions are more stringent than the requirements above, the local label
  • requirements are to be followed.
  • Has a negative highly sensitive pregnancy test (urine or serum) as required by local
  • regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the
  • first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an
  • ambiguous result), a serum pregnancy test is required. In such cases, the participant
  • must be excluded from participation if the serum pregnancy result is positive.
  • Additional requirements for pregnancy testing during and after study intervention are
  • in Section 8.3.5.
  • bstains from breastfeeding during the study intervention period and for at least 28
  • days after study intervention MK-6194 is last administered.
  •  Medical history, menstrual history, and recent sexual activity has been reviewed by
  • the investigator to decrease the risk for inclusion of a POCBP with an early
  • undetected pregnancy.
  • Informed Consent
  • 10. The participant (or legally acceptable representative) has provided documented informed
  • consent for the study. The participant may also provide consent for FBR. However, the
  • participant may participate in the study without participating in FBR. See Appendix 7 for
  • country-specific requirements.
  • Additional Categories
  • 11. Is willing and considered able by the investigator to comply with study procedures,
  • including adherence with study intervention, visit schedule, and completion of PROs.
  • Participant must be able to read, understand, and complete the PROs.
Exclusion Criteria
  • Medical Conditions
  • 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 IL-2, or modified IL-2 including MK-6194, or
  • its inactive ingredients
  • Note: Refer to the IB for details regarding excipients for MK-6194
  • 6. Has a known history of hypereosinophilic syndrome or an eosinophil-related condition
  • (eg, eosinophilic pulmonary disease including eosinophilic asthma, eosinophilic
  • esophagitis, eosinophilic nephritis, eosinophilic granulomatosis with polyangiitis
  • [formerly known as Churg-Strauss syndrome], etc.)
  • 7. Has an active clinically significant infection, or any infection requiring hospitalization or
  • treatment with IV anti-infectives within 4 weeks prior to Randomization, or any infection
  • requiring oral/intramuscular anti-infective therapy within 2 weeks prior to Randomization
  • 8. 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
  • 9. Has a severe chronic pulmonary disease requiring oxygen therapy
  • 10. Has a transplanted organ, which requires continued immunosuppression
  • 11. Has a history of any malignancy, except for successfully treated non-melanoma skin
  • cancer or localized carcinoma in situ of the cervix
  • 12. Is known to be infected with HBV, HCV, or HIV
  • • Participants with positive HBsAg are excluded from the study. Participants with
  • negative HBsAg and positive HBcAb must have further testing for HBV DNA.
  • Participants with HBV DNA ≥LLOQ are not eligible for the study. Participants with
  • HBV DNA <LLOQ are eligible.
  • • Participants with positive HCV antibodies at Screening must have further testing for
  • HCV-RNA. Participants with HCV-RNA ≥LLOQ are not eligible for the study.
  • Participants with positive HCV antibodies, but HCV-RNA <LLOQ are eligible.
  • • Participants with a history of HIV infection or have a positive antibody test are not
  • eligible for the study.
  • 13. Has evidence of active TB, latent TB, or inadequately treated TB (for participants with
  • history of TB) as evidenced by one of the following:
  • • Positive QuantiFERON-TB Gold test or equivalent test
  • o Note: If a participant had a TB IGRA such as QuantiFERON-TB Gold, T-SPOT
  • TB, or PPD test within 90 days prior to Screening and source documentation is
  • available, QuantiFERON test does not need to be performed at Screening
  • provided nothing has changed in the participant’s medical history to warrant a
  • repeat test. If the past test was PPD, it must be read by a licensed health care
  • professional between 48 and 72 hours after administration; a reaction of ≥5 mm is
  • considered a positive reaction. The result should be reported in mm; the absence
  • of induration should be recorded as “0 mm”, not “negative”.
  • o Note: If the QuantiFERON-TB test is indeterminate, a second test should be
  • performed through the central laboratory or local TB IGRA test such as
  • QuantiFERON-TB Gold, or T-SPOT TB. If the test remains indeterminate or is
  • positive, the participant is considered to be positive. If the test is negative, the
  • participant is considered to be negative.
  • • Positive findings of active TB on CXR (or CT scan if locally required)
  •  Note: CXR is not required if the participant had a previous normal CXR per local
  • standard of care or chest CT within 90 days prior to Screening, provided all
  • source documentation is available and nothing has changed in the participant’s
  • medical history to warrant a repeat test.
  • o Note: For participants with history of active or latent TB, documentation of
  • treatment must be provided to the investigative site. Participants who are fully
  • treated per local standard of care are eligible for the study. These participants do
  • not require QuantiFERON testing. CXR is still required at Screening; normal
  • CXR or CT within 90 days prior to Screening is acceptable.
  • 14. Has confirmed or suspected COVID-19 infection
  • Note: Participants with recent confirmed or suspected COVID-19 infection may
  • participate under the following conditions:
  • • Participants with COVID-19 infection confirmed by a PCR or an antigen test:
  • o For asymptomatic participants, Randomization must be at least 10 days after the
  • positive COVID-19 test.
  • o For symptomatic participants, Randomization must be at least 10 days after onset
  • of symptoms and at least 3 days after resolution of fever without the use of
  • fever-reducing medications, and the participant must have clinically meaningful
  • improvement in symptoms.
  • • Participants with suspected COVID-19 infection
  • o For participants with signs/symptoms suggestive of COVID-19 infection, a
  • molecular (ie, PCR) test must be performed to rule out COVID-19 infection prior
  • to Randomization;
  • OR
  • – Randomization must be at least 10 days after onset of symptoms and at least 3
  • days after resolution of fever without the use of fever-reducing medications, and
  • the participant must have clinically meaningful improvement in symptoms.
  • 15. Has history of drug or alcohol abuse within 6 months prior to Screening (can be
  • participant reported)
  • 16. Has had major surgery within 3 months prior to Screening OR has a major surgery
  • planned during the study
  • 17. Has a concurrent clinically significant disease or clinically relevant laboratory
  • abnormalities, or a history of any illness or medical condition that, in the opinion of the
  • investigator, might confound the results of the study or poses an additional risk to the
  • participant by their participation in the study
  • Prior/Concomitant Therapy
  • 18. Has had an inadequate response (as evaluated by a dermatologist or local physician
  • specialist equivalent) to previous treatment with a JAKi after an appropriate treatment
  • duration (eg, ≥12 weeks)
  • Note: Up to approximately 50% of participants with previous JAKi use study wide are
  • eligible if the following criteria are met:
  •  Response to previous treatment with a JAKi after an appropriate treatment duration
  • (ie, ≥12 weeks)
  •  History of previous JAKi use for <12 weeks regardless of response status
  • For these participants, the last dose of the JAKi should be ≥4 weeks prior to
  • Randomization.
  • 19. Has received prohibited medications within the specified timeframes prior to
  • Randomization (Table 1). These medications are also prohibited during the study

Updated on 11 Sep 2024. Study ID: DERM-MERCK-MK-6194, 21014

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