Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 80 Years|
- - 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 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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Merck Sharp & Dohme LLC|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Merck Sharp & Dohme LLC|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Georgia, Germany, Hungary, Moldova, Republic of, Poland, Ukraine, United Kingdom, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Drug: - MK-6194
Drug: - MK-6194-matching placebo
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.