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

Completed · Phase 1 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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

Key facts

Study ID

NCT04924114

Run by

Merck Sharp & Dohme LLC

People needed

57

Starts

2021-10-14

Expected to finish

2024-07-15

Last updated by the study team

2025-08-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 period 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 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.

Where it is running

• Inland Empire Clinical Trials, LLC ( Site 0102) — Rialto, California, United States
• IHS. Health, LLC ( Site 0104) — Kissimmee, Florida, United States
• Carolina's GI Research, LLC ( Site 0105) — Raleigh, North Carolina, United States
• Pinnacle Clinical Research ( Site 0103) — San Antonio, Texas, United States
• Southern Star Research Institute ( Site 0101) — San Antonio, Texas, United States
• ARENSIA Exploratory Medicine Georgia ( Site 0801) — Tbilisi, Georgia
• Charite Research Organisation GmbH ( Site 0201) — Berlin, Germany
• PRA Magyarorszag Kutatasi es Fejlesztesi Kft. ( Site 0302) — Budapest, Hungary
• ARENSIA Exploratory Medicine ( Site 0401) — Chisinau, Moldova
• Allmedica Badania Kliniczne Sp z o. o. Sp. K. ( Site 0502) — Nowy Targ, Lesser Poland Voivodeship, Poland
• WIP Warsaw IBD Point Professor Kierkus ( Site 0501) — Warsaw, Masovian Voivodeship, Poland
• Arensia Exploratory Medicine GmbH Ukraine ( Site 0701) — Kyiv, Kyivska Oblast, Ukraine
• MAC Clinical Research Prescot ( Site 0604) — Prescot, Knowsley, United Kingdom
• Memory Assessment Clinics Ltd ( Site 0601) — Blackpool, Lancashire, United Kingdom
• MAC Clinical Research ( Site 0602) — Barnsley, United Kingdom
• MAC Clinical Research Centre Leeds ( Site 0603) — Leeds, United Kingdom
• MAC Clinical Research Ltd. ( Site 0605) — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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