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

Study Purpose

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of MK-6194 in participants with active UC.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04924114
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Merck Sharp & Dohme LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Medical Director
Principal Investigator Affiliation Merck Sharp & Dohme LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Georgia, Germany, Moldova, Republic of, Ukraine, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Arms & Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rialto, California

Status

Recruiting

Address

Inland Empire Clinical Trials, LLC ( Site 0102)

Rialto, California, 92377

Site Contact

Study Coordinator

Trialsites@merck.com

909-883-2999

IHS. Health, LLC ( Site 0104), Kissimmee, Florida

Status

Recruiting

Address

IHS. Health, LLC ( Site 0104)

Kissimmee, Florida, 34741

Site Contact

Study Coordinator

Trialsites@merck.com

407-530-4370

Carolina's GI Research, LLC ( Site 0105), Raleigh, North Carolina

Status

Recruiting

Address

Carolina's GI Research, LLC ( Site 0105)

Raleigh, North Carolina, 27607

Site Contact

Study Coordinator

Trialsites@merck.com

919-783-4888

Pinnacle Clinical Research ( Site 0103), San Antonio, Texas

Status

Recruiting

Address

Pinnacle Clinical Research ( Site 0103)

San Antonio, Texas, 78229

Site Contact

Study Coordinator

Trialsites@merck.com

210-982-0320

San Antonio, Texas

Status

Recruiting

Address

Southern Star Research Institute ( Site 0101)

San Antonio, Texas, 78229

Site Contact

Study Coordinator

Trialsites@merck.com

210-271-0606

International Sites

Tbilisi, Georgia

Status

Recruiting

Address

ARENSIA Exploratory Medicine Georgia ( Site 0801)

Tbilisi, , 0112

Site Contact

Study Coordinator

Trialsites@merck.com

+995 599 50 72 52

Berlin, Germany

Status

Recruiting

Address

Charite Research Organisation GmbH ( Site 0201)

Berlin, , 10117

Site Contact

Study Coordinator

Trialsites@merck.com

+49 30 450 539 200

Chisinau, Moldova, Republic of

Status

Recruiting

Address

ARENSIA Exploratory Medicine ( Site 0401)

Chisinau, , 2025

Site Contact

Study Coordinator

Trialsites@merck.com

+373 69 115 584

Kyiv, Kyivska Oblast, Ukraine

Status

Recruiting

Address

Arensia Exploratory Medicine GmbH Ukraine ( Site 0701)

Kyiv, Kyivska Oblast, 01135

Site Contact

Study Coordinator

Trialsites@merck.com

+380 673 216 127

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