Phase
Condition
Ulcerative Colitis
Bowel Dysfunction
Colic
Treatment
MK-6194
MK-6194-matching placebo
Clinical Study ID
Ages 18-80 All Genders
Study Summary
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
Connect with a study center
ARENSIA Exploratory Medicine Georgia ( Site 0801)
Tbilisi, 0112
GeorgiaSite Not Available
Charite Research Organisation GmbH ( Site 0201)
Berlin, 10117
GermanySite Not Available
PRA Magyarorszag Kutatasi es Fejlesztesi Kft. ( Site 0302)
Budapest, 1007
HungarySite Not Available
ARENSIA Exploratory Medicine ( Site 0401)
Chisinau, 2025
Moldova, Republic ofSite Not Available
Allmedica Badania Kliniczne Sp z o. o. Sp. K. ( Site 0502)
Nowy Targ, Malopolskie 34-400
PolandSite Not Available
WIP Warsaw IBD Point Professor Kierkus ( Site 0501)
Warszawa, Mazowieckie 00-728
PolandSite Not Available
Arensia Exploratory Medicine GmbH Ukraine ( Site 0701)
Kyiv, Kyivska Oblast 01135
UkraineSite Not Available
MAC Clinical Research Prescot ( Site 0604)
Prescot, Knowsley L34 1BH
United KingdomSite Not Available
Memory Assessment Clinics Ltd ( Site 0601)
Blackpool, Lancashire FY2 0JH
United KingdomSite Not Available
MAC Clinical Research ( Site 0602)
Barnsley, S75 3DL
United KingdomSite Not Available
MAC Clinical Research Centre Leeds ( Site 0603)
Leeds, LS10 1DU
United KingdomSite Not Available
MAC Clinical Research Ltd. ( Site 0605)
Manchester, M13 9NQ
United KingdomSite Not Available
Inland Empire Clinical Trials, LLC ( Site 0102)
Rialto, California 92377
United StatesSite Not Available
IHS. Health, LLC ( Site 0104)
Kissimmee, Florida 34741
United StatesSite Not Available
Carolina's GI Research, LLC ( Site 0105)
Raleigh, North Carolina 27607
United StatesSite Not Available
Pinnacle Clinical Research ( Site 0103)
San Antonio, Texas 78229
United StatesSite Not Available
Southern Star Research Institute ( Site 0101)
San Antonio, Texas 78229
United StatesSite Not Available
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