A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002)

  • STATUS
    Recruiting
  • End date
    Jan 4, 2024
  • participants needed
    30
  • sponsor
    Merck Sharp & Dohme LLC
Updated on 4 October 2022
body mass index
cancer

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of MK-6194 in participants with active UC.

Details
Condition Ulcerative Colitis
Treatment MK-6194, MK-6194-matching placebo
Clinical Study IdentifierNCT04924114
SponsorMerck Sharp & Dohme LLC
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of UC at least 3 months prior to screening
Mildly to severely active UC
Inadequate response, loss of response, or intolerance to at least 1 prior conventional therapy, and no more than 2 prior advanced therapies
Participants at risk for colorectal cancer must have a colonoscopy prior to or at screening as follows
Participants > 50 years of age must have documentation of a colonoscopy within 3 years of the screening visit to exclude adenomatous polyps. Participants whose adenomas have been completely excised at screening are eligible
Participants with extensive colitis for ≥ 8 years, or disease limited to the left side of the colon for ≥ 10 years, must either have had a full colonoscopy to assess for the presence of dysplasia within 1 year before first administration of study drug or a full colonoscopy to assess for the presence of malignancy at the screening visit
No evidence of active tuberculosis (TB), latent TB, or inadequately treated TB
Women of childbearing potential (WOCBP) and males with female partners of childbearing potential must utilize highly effective contraceptive methods beginning 4 weeks prior to first dose of study drug and continue for 30 days after the last dose of study drug
Body mass index (BMI) 18 to 35 kg/m^2 inclusive and weight ≥ 50 kg

Exclusion Criteria

Prior treatment with recombinant IL-2 or modified IL-2 therapy, including MK-6194 (PT101)
Known sensitivity to MK-6194 (PT101) or its excipients
Known history of hypersensitivity to interleukin-2 (IL-2)
Disease limited to the rectum (i.e., within 15 cm of the anal verge)
Diagnosis of toxic megacolon
Suspected or known colon stricture or stenosis
Diagnosis of Crohn's disease, or indeterminant colitis
Has severe colitis as evidenced by
Current hospitalization for the treatment of UC
Likely to require a colectomy within 12 weeks of baseline in the opinion of the Investigator
At least 4 symptoms of severe colitis as identified at screening or baseline visits
Previously had surgery for UC, or likely to require surgery for UC during the study
History of abnormal thallium stress test or functional cardiac function test
period in the opinion of the Investigator
History of significant cardiac, pulmonary, renal, hepatic, or central nervous system (CNS) impairment
Active clinically significant infection, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 8 weeks of randomization, or any infection requiring oral anti-infective therapy within 6 weeks of randomization
History of opportunistic infection
History of symptomatic herpes zoster within 16 weeks of randomization, or any history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic zoster, or central nervous system (CNS) zoster
Currently on any chronic systemic (oral or IV) anti-infective therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypical mycobacteria)
Currently receiving lymphocyte depleting therapy
History of abnormal pulmonary function tests
Participants with organ or tissue allograft
Malignancy within 5 years of screening, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin
Exposure to advanced therapy within 5 half-lives of the Day 1 visit, or documentation of detectable drug during screening
Received a live attenuated vaccine < 1 month prior to screening or is planning to receive a live attenuated vaccine during the study period or within 12 weeks of the end of participation in the study
Is pregnant or nursing or is planning to become pregnant during the study
Any uncontrolled or clinically significant concurrent systemic disease other than UC
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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