a study of mk-6194 (pt101) in participants with active ulcerative colitis (uc) (mk-6194-002)

Conditions: Ulcerative Colitis

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 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.