Clinical Trial Finder

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 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.

• - Any uncontrolled or clinically significant concurrent systemic disease other than UC.

Arms

Experimental: MK-6194

Participants will be enrolled in sequential cohorts treated with successively higher doses of MK-6194 via subcutaneous injection.

Placebo Comparator: Placebo

Participants will receive MK-6194-matching placebo via subcutaneous injection.

Interventions

Drug: - MK-6194

Subcutaneous injection

Drug: - MK-6194-matching placebo

Subcutaneous injection