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

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 57

Inclusion Criteria

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Adverse Events (AEs);Percentage of Participants Discontinuing Study Treatment Due to an AE

Secondary Outcome Measures

Name	Time	Method
Maximum Concentration (Cmax) of MK-6194;Time to Cmax (Tmax) of MK-6194;Area Under the Concentration Time-curve From Time 0 to the Last Quantifiable Concentration (AUC0-t);Minimum Concentration (Cmin) of MK-6194;Area Under the Curve From Time 0 to Infinity (AUC0-inf) of MK-6194;Apparent Half-life (t1/2) of MK-6194;Apparent Clearance (CL/F) of MK-6194;Apparent Volume of Distribution (Vd/F) of MK-6194;Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood;Change in Number of Natural Killer (NK) Cells in Whole Blood;Change in Number of Conventional T Cells (Tcons) in Whole Blood;Titer of anti-drug antibody (ADA) to MK-6194