A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002)
NCT ID: NCT04924114
Last Updated: 2025-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
57 participants
INTERVENTIONAL
2021-10-14
2024-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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MK-6194 Low Dose - Interval 1 (Less Frequent)
Participants received low dose of MK-6194 at specified less frequent intervals
MK-6194
Subcutaneous injection
MK-6194 Medium Dose- Interval 2 (More Frequent)
Participants received medium dose of MK-6194 at specified more frequent intervals
MK-6194
Subcutaneous injection
MK-6194 High Dose- Interval 2 (More Frequent)
Participants received high dose of MK-6194 at specified more frequent intervals
MK-6194
Subcutaneous injection
MK-6194 High Dose- Interval 1 (Less Frequent)
Participants received high dose MK-6194 at specified less frequent intervals
MK-6194
Subcutaneous injection
Placebo
Participants received MK- 6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
MK-6194-matching placebo
Subcutaneous injection
Interventions
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MK-6194
Subcutaneous injection
MK-6194-matching placebo
Subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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PT101-201
Identifier Type: OTHER
Identifier Source: secondary_id
2021-000093-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
6194-002
Identifier Type: -
Identifier Source: org_study_id
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