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Ulcerative ColitisPhase 1NCT04924114

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

A Phase 1 study testing MK-6194 in people with Ulcerative Colitis, run by Merck Sharp & Dohme LLC at 17 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
MK-6194
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
57 participants
Where
17 sitesin 8 countries
Study dates
14 Oct 2021to 15 Jul 2024
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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 locations and contacts

17 sites in 8 countries.

17 sites in 8 countries

United States5 sites

  • IHS. Health, LLC ( Site 0104)

    Kissimmee, Florida, 34741

  • Carolina's GI Research, LLC ( Site 0105)

    Raleigh, North Carolina, 27607

  • Inland Empire Clinical Trials, LLC ( Site 0102)

    Rialto, California, 92377

  • Pinnacle Clinical Research ( Site 0103)

    San Antonio, Texas, 78229

  • Southern Star Research Institute ( Site 0101)

    San Antonio, Texas, 78229

Other trials in United States

United Kingdom5 sites

  • MAC Clinical Research ( Site 0602)

    Barnsley, S75 3DL

  • Memory Assessment Clinics Ltd ( Site 0601)

    Blackpool, Lancashire, FY2 0JH

  • MAC Clinical Research Centre Leeds ( Site 0603)

    Leeds, LS10 1DU

  • MAC Clinical Research Ltd. ( Site 0605)

    Manchester, M13 9NQ

  • MAC Clinical Research Prescot ( Site 0604)

    Prescot, Knowsley, L34 1BH

Other trials in United Kingdom

Poland2 sites

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

    Nowy Targ, Lesser Poland Voivodeship, 34-400

  • WIP Warsaw IBD Point Professor Kierkus ( Site 0501)

    Warsaw, Masovian Voivodeship, 00-728

Other trials in Poland

Georgia1 site

  • ARENSIA Exploratory Medicine Georgia ( Site 0801)

    Tbilisi, 0112

Other trials in Georgia

Germany1 site

  • Charite Research Organisation GmbH ( Site 0201)

    Berlin, 10117

Other trials in Germany

Hungary1 site

  • PRA Magyarorszag Kutatasi es Fejlesztesi Kft. ( Site 0302)

    Budapest, 1007

Other trials in Hungary

Moldova1 site

  • ARENSIA Exploratory Medicine ( Site 0401)

    Chisinau, 2025

Other trials in Moldova

Ukraine1 site

  • Arensia Exploratory Medicine GmbH Ukraine ( Site 0701)

    Kyiv, Kyivska Oblast, 01135

Other trials in Ukraine

About this study

Official title: A Phase 1b, Randomized, Adaptive, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of PT101 in Subjects With Active Ulcerative Colitis

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

Being tested
MK-6194, MK-6194-matching placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-6194Drug

    Also called PT101

    Subcutaneous injection

  • MK-6194-matching placeboDrug

    Subcutaneous injection

Study groups in NCT04924114
Study groupRoleWhat they receive
MK-6194 Low Dose - Interval 1 (Less Frequent)ExperimentalParticipants received low dose of MK-6194 at specified less frequent intervals
Receives: Drug: MK-6194
MK-6194 Medium Dose- Interval 2 (More Frequent)ExperimentalParticipants received medium dose of MK-6194 at specified more frequent intervals
Receives: Drug: MK-6194
MK-6194 High Dose- Interval 2 (More Frequent)ExperimentalParticipants received high dose of MK-6194 at specified more frequent intervals
Receives: Drug: MK-6194
MK-6194 High Dose- Interval 1 (Less Frequent)ExperimentalParticipants received high dose MK-6194 at specified less frequent intervals
Receives: Drug: MK-6194
PlaceboPlacebo comparatorParticipants received MK- 6194-matching placebo via subcutaneous injection, administered either at interval 1 or interval 2
Receives: Drug: MK-6194-matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 85 days

  2. 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

    Measured: Up to approximately 72 days

Secondary outcomes (12)

  1. Maximum Concentration (Cmax) of MK-6194

    Blood samples were collected at pre-specified time points to determine each participant's maximum concentration (Cmax). A participant's Cmax was defined as the maximum concentration of MK-6194 observed in serum over the entire course of the study for that individual and was calculated by taking the maximum over all observed MK-6194 serum concentrations. Geometric mean and geometric coefficient of variation of Cmax were calculated for each dosing group.

    Measured: 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.

  2. Time to Cmax (Tmax) of MK-6194

    Blood samples were collected at pre-specified time points to determine maximum concentration (Cmax) of MK-6194 in each participant's serum and corresponding time of maximum concentration (Tmax). A participant's Tmax was defined as the time post-dose that the maximum concentration of MK-6194 was observed in serum. The median and range of Tmax were calculated for each dosing group.

    Measured: 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

  3. Minimum Concentration (Cmin) of MK-6194

    Blood samples were collected at pre-specified time points to determine the minimum concentration (Cmin) of MK-6194 present in each participant's serum. A participant's Cmin was defined as the minimum concentration of MK-6194 observed in serum over the entire course of the study for that individual and was calculated by taking the minimum over all observed MK-6194 serum concentrations. Geometric mean and geometric coefficient of variation of Cmin were calculated for each dosing group.

    Measured: 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

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

    Blood samples were collected at pre-specified time points to determine the apparent half-life (t1/2) of MK-6194. Noncompartmental analysis was used to calculate t1/2 for each participant using the terminal elimination phase after the final dose. Geometric mean and geometric coefficient of variation of t1/2 were calculated for each dosing group.

    Measured: 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

  5. Apparent Clearance (CL/F) of MK-6194

    Blood samples were collected at pre-specified time points to determine the apparent clearance (CL/F) of MK-6194 observed in serum. Noncompartmental analysis was used to calculate CL/F for each participant using the terminal elimination phase after the final dose. Geometric mean and geometric coefficient of variation of CL/F were calculated for each dosing group.

    Measured: 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

  6. Apparent Volume of Distribution (Vd/F) of MK-6194

    Blood samples were collected at pre-specified time points to determine the apparent volume of distribution (Vd/F) of MK-6194 observed in serum. Noncompartmental analysis was used to calculate Vd/F for each participant using the terminal elimination phase after the final dose. Geometric mean and geometric coefficient of variation of Vd/F were calculated for each dosing group.

    Measured: 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

  7. Area Under the Concentration Time-curve From Time 0 to the Last Quantifiable Concentration (AUC0-t)

    Blood samples were collected at pre-specified timepoints to determine the AUC0-t of MK-6194. AUC0-t is defined as the area under the concentration-time curve from time=0 (Day 1 predose) to the last quantifiable concentration. Noncompartmental analysis was used to calculate AUC0-t for each participant. Geometric mean and geometric coefficient of variation of AUC0-t were calculated for each dosing group.

    Measured: 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

  8. Area Under the Curve From Time 0 to Infinity (AUC0-inf) of MK-6194

    Blood samples were collected at pre-specified timepoints to determine the AUC0-inf of MK-6194. AUC0-inf is defined as the area under the concentration-time curve from time=0 (Day 1 predose) to time=infinity. Noncompartmental analysis was used to calculate AUC0-inf for each participant; the portion of the AUC following the last observed concentration was assumed to follow an exponential elimination. Geometric mean and geometric coefficient of variation of AUC0-inf were calculated for each dosing group.

    Measured: 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

  9. Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood

    Blood samples were collected at pre-specified time points and analyzed by flow cytometry. The absolute change in the number of peripheral Tregs in whole blood was assessed.

    Measured: Pre-dose (baseline) and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

  10. Change in Number of Natural Killer (NK) Cells in Whole Blood

    Blood samples were collected at pre-specified time points and analyzed by flow cytometry. The change in the number of NK cells in whole blood is presented.

    Measured: Pre-dose (baseline) and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

  11. Change in Number of Conventional T Cells (Tcons) in Whole Blood

    Blood samples were collected at pre-specified time points and analyzed by flow cytometry. The change in the number of Tcons in whole blood is presented.

    Measured: Pre-dose (baseline) and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

  12. Titer of Anti-drug Antibody (ADA) to MK-6194

    Blood samples were collected for the determination of ADA to MK-6194 using a screening assay, ADA titer using a confirmatory assay, and neutralizing antibody to MK-6194 in participants with confirmed positive titers

    Measured: Pre dose (week 0) and Weeks 4, 8, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2021
  2. Study start14 Oct 2021
  3. Primary completion8 Jan 2024
  4. Study completion15 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04924114
Sponsor's protocol ID
6194-002
Other IDs
PT101-201, 2021-000093-28
Status last verified
Aug 2025
First submitted
26 Feb 2021
Last updated
29 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-6194 in people with Ulcerative Colitis, run by Merck Sharp & Dohme LLC at 17 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, United Kingdom, Poland, Georgia, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experienced an Adverse Event (AE) (time frame: Up to approximately 85 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04924114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.

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