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

Last updated: March 10, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

1

Condition

Ulcerative Colitis

Bowel Dysfunction

Colic

Treatment

MK-6194

MK-6194-matching placebo

Clinical Study ID

NCT04924114
6194-002
PT101-201
2021-000093-28
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 priorconventional therapy, and no more than 2 prior advanced therapies.

  • Participants at risk for colorectal cancer must have a colonoscopy prior to or atscreening as follows:

  • Participants > 50 years of age must have documentation of a colonoscopy within 3 years of the screening visit to exclude adenomatous polyps. Participantswhose adenomas have been completely excised at screening are eligible.

  • Participants with extensive colitis for ≥ 8 years, or disease limited to theleft side of the colon for ≥ 10 years, must either have had a full colonoscopyto assess for the presence of dysplasia within 1 year before firstadministration of study drug or a full colonoscopy to assess for the presenceof 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 ofchildbearing potential must utilize highly effective contraceptive methods beginning 4 weeks prior to first dose of study drug and continue for 30 days after the lastdose of study drug.

  • Body mass index (BMI) 18 to 35 kg/m^2 inclusive and weight ≥ 50 kg.

Exclusion

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 theInvestigator

  • At least 4 symptoms of severe colitis as identified at screening or baselinevisits.

  • Previously had surgery for UC, or likely to require surgery for UC during the studyperiod in the opinion of the Investigator.

  • History of abnormal thallium stress test or functional cardiac function test.

  • History of significant cardiac, pulmonary, renal, hepatic, or central nervous system (CNS) impairment.

  • Active clinically significant infection, or any infection requiring hospitalizationor treatment with intravenous anti-infectives within 8 weeks of randomization, orany 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 anyhistory of disseminated herpes simplex, disseminated herpes zoster, ophthalmiczoster, or central nervous system (CNS) zoster.

  • Currently on any chronic systemic (oral or IV) anti-infective therapy for chronicinfection (such as pneumocystis, cytomegalovirus, herpes zoster, or atypicalmycobacteria).

  • 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 orexcised non-metastatic basal cell or squamous cell cancer of the skin.

  • Exposure to advanced therapy within 5 half-lives of the Day 1 visit, ordocumentation of detectable drug during screening.

  • Received a live attenuated vaccine < 1 month prior to screening or is planning toreceive a live attenuated vaccine during the study period or within 12 weeks of theend 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 thanUC.

Study Design

Total Participants: 57
Treatment Group(s): 2
Primary Treatment: MK-6194
Phase: 1
Study Start date:
October 14, 2021
Estimated Completion Date:
July 15, 2024

Connect with a study center

  • ARENSIA Exploratory Medicine Georgia ( Site 0801)

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Charite Research Organisation GmbH ( Site 0201)

    Berlin, 10117
    Germany

    Site Not Available

  • PRA Magyarorszag Kutatasi es Fejlesztesi Kft. ( Site 0302)

    Budapest, 1007
    Hungary

    Site Not Available

  • ARENSIA Exploratory Medicine ( Site 0401)

    Chisinau, 2025
    Moldova, Republic of

    Site Not Available

  • Allmedica Badania Kliniczne Sp z o. o. Sp. K. ( Site 0502)

    Nowy Targ, Malopolskie 34-400
    Poland

    Site Not Available

  • WIP Warsaw IBD Point Professor Kierkus ( Site 0501)

    Warszawa, Mazowieckie 00-728
    Poland

    Site Not Available

  • Arensia Exploratory Medicine GmbH Ukraine ( Site 0701)

    Kyiv, Kyivska Oblast 01135
    Ukraine

    Site Not Available

  • MAC Clinical Research Prescot ( Site 0604)

    Prescot, Knowsley L34 1BH
    United Kingdom

    Site Not Available

  • Memory Assessment Clinics Ltd ( Site 0601)

    Blackpool, Lancashire FY2 0JH
    United Kingdom

    Site Not Available

  • MAC Clinical Research ( Site 0602)

    Barnsley, S75 3DL
    United Kingdom

    Site Not Available

  • MAC Clinical Research Centre Leeds ( Site 0603)

    Leeds, LS10 1DU
    United Kingdom

    Site Not Available

  • MAC Clinical Research Ltd. ( Site 0605)

    Manchester, M13 9NQ
    United Kingdom

    Site Not Available

  • Inland Empire Clinical Trials, LLC ( Site 0102)

    Rialto, California 92377
    United States

    Site Not Available

  • IHS. Health, LLC ( Site 0104)

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Carolina's GI Research, LLC ( Site 0105)

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Pinnacle Clinical Research ( Site 0103)

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Southern Star Research Institute ( Site 0101)

    San Antonio, Texas 78229
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.