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

NCT04924114 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: 6194-002PT101-2012021-000093-28
• Study Type: interventional
• Target: 57
• Locations: 8 countries
• Sites: 17

Brief Summary

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced an Adverse Event (AE)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  Up to approximately 85 days

• Number of Participants Who Interrupted or Discontinued Study Treatment Due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to thestudy intervention

  Up to approximately 72 days

Secondary Outcomes (12)

• Maximum Concentration (Cmax) of MK-6194

  Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85.

• Time to Cmax (Tmax) of MK-6194

  Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85

• Minimum Concentration (Cmin) of MK-6194

  Predose on all days of dosing; 12, 24-48, and 120 hours (as available) post dose on the first and last day of dosing; and once each week up to approximately day 85

• Apparent Half-life (t1/2) of MK-6194

  Final day of dosing at 12, 24-48 hours, and 120 hours (as available) post-dose; from the last day of dosing once each week up to approximately day 85

• Apparent Clearance (CL/F) of MK-6194

  Final day of dosing at 12, 24-48 hours, and 120 hours (as available) post-dose; from the last day of dosing once each week up to approximately day 85

Study Arms (5)

MK-6194 Low Dose - Interval 1 (Less Frequent)

EXPERIMENTAL

Participants received low dose of MK-6194 at specified less frequent intervals

Drug: MK-6194

MK-6194 Medium Dose- Interval 2 (More Frequent)

EXPERIMENTAL

Participants received medium dose of MK-6194 at specified more frequent intervals

Drug: MK-6194

MK-6194 High Dose- Interval 2 (More Frequent)

EXPERIMENTAL

Participants received high dose of MK-6194 at specified more frequent intervals

Drug: MK-6194

MK-6194 High Dose- Interval 1 (Less Frequent)

EXPERIMENTAL

Participants received high dose MK-6194 at specified less frequent intervals

Drug: MK-6194

Placebo

PLACEBO COMPARATOR

Participants received MK- 6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2

Drug: MK-6194-matching placebo

Interventions

MK-6194 DRUG

Subcutaneous injection

Also known as: PT101

MK-6194 High Dose- Interval 1 (Less Frequent); MK-6194 High Dose- Interval 2 (More Frequent); MK-6194 Low Dose - Interval 1 (Less Frequent); MK-6194 Medium Dose- Interval 2 (More Frequent)

MK-6194-matching placebo DRUG

Subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (17)

Inland Empire Clinical Trials, LLC ( Site 0102)

Rialto, California, 92377, United States

Location

IHS. Health, LLC ( Site 0104)

Kissimmee, Florida, 34741, United States

Location

Carolina's GI Research, LLC ( Site 0105)

Raleigh, North Carolina, 27607, United States

Location

Pinnacle Clinical Research ( Site 0103)

San Antonio, Texas, 78229, United States

Location

Southern Star Research Institute ( Site 0101)

San Antonio, Texas, 78229, United States

Location

ARENSIA Exploratory Medicine Georgia ( Site 0801)

Tbilisi, 0112, Georgia

Location

Charite Research Organisation GmbH ( Site 0201)

Berlin, 10117, Germany

Location

PRA Magyarorszag Kutatasi es Fejlesztesi Kft. ( Site 0302)

Budapest, 1007, Hungary

Location

ARENSIA Exploratory Medicine ( Site 0401)

Chisinau, 2025, Moldova

Location

Allmedica Badania Kliniczne Sp z o. o. Sp. K. ( Site 0502)

Nowy Targ, Lesser Poland Voivodeship, 34-400, Poland

Location

WIP Warsaw IBD Point Professor Kierkus ( Site 0501)

Warsaw, Masovian Voivodeship, 00-728, Poland

Location

Arensia Exploratory Medicine GmbH Ukraine ( Site 0701)

Kyiv, Kyivska Oblast, 01135, Ukraine

Location

MAC Clinical Research Prescot ( Site 0604)

Prescot, Knowsley, L34 1BH, United Kingdom

Location

Memory Assessment Clinics Ltd ( Site 0601)

Blackpool, Lancashire, FY2 0JH, United Kingdom

Location

MAC Clinical Research ( Site 0602)

Barnsley, S75 3DL, United Kingdom

Location

MAC Clinical Research Centre Leeds ( Site 0603)

Leeds, LS10 1DU, United Kingdom

Location

MAC Clinical Research Ltd. ( Site 0605)

Manchester, M13 9NQ, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: June 11, 2021
• Study Start: October 14, 2021
• Primary Completion: January 8, 2024
• Study Completion: July 15, 2024
• Last Updated: August 29, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (5); HU (1); PL (2); DE (1); MO (1); GE (1); UA (1); GB (5)