MK-6194 for Ulcerative Colitis

No longer recruiting at 19 trial locations

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Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme Corp.

Must not be taking: Recombinant IL-2, Modified IL-2

Disqualifiers: Severe colitis, Crohn's, Cardiac impairment, others

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 72 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, MK-6194, for individuals with active ulcerative colitis (UC). Researchers aim to determine the drug's safety and behavior in the body. Participants will receive varying doses of MK-6194 or a placebo to identify the most effective approach. Those who have had UC for at least three months and have not responded well to previous treatments may be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on advanced therapy, you must not have taken it within a certain period before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MK-6194 is under study to determine its safety in treating ulcerative colitis. As this trial is in its early stages, researchers are testing the treatment to assess its tolerability. Limited information exists from earlier studies regarding MK-6194's safety specifically for ulcerative colitis.

However, early-stage trials like this one closely monitor for any unexpected medical issues. These trials ensure the drug's safety for human use. Prospective participants can be assured that their safety will remain a top priority. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ulcerative colitis?

Researchers are excited about MK-6194 because it offers a potentially new way to tackle ulcerative colitis. Unlike most current treatments that focus on suppressing the immune system, MK-6194 might work by addressing inflammation directly through a novel mechanism, which could mean fewer side effects. Additionally, MK-6194 is being tested in various dosing schedules, which could provide more flexibility and convenience for patients compared to standard therapies like anti-inflammatory drugs and biologics. These features have researchers hopeful that MK-6194 could become a more effective and patient-friendly option for managing ulcerative colitis.

What evidence suggests that this trial's treatments could be effective for ulcerative colitis?

Research suggests that MK-6194 might help reduce colon swelling, potentially easing ulcerative colitis symptoms. This treatment calms the immune system, which is often overactive in those with ulcerative colitis. Early studies have shown that MK-6194 works well in the body, indicating potential benefits for this condition. Although detailed information from human studies remains limited, these findings suggest effectiveness. Participants in this trial will receive varying doses and frequencies of MK-6194, or a placebo, to evaluate its effectiveness and safety. ^{1 2 3 6 7}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with active Ulcerative Colitis (UC) who haven't responded well to at least one conventional therapy and no more than two advanced therapies. They must have had a recent colonoscopy if over 50 or at risk of colorectal cancer, not be planning surgery soon, and agree to use effective contraception. Exclusions include severe colitis symptoms, certain infections or treatments, history of other significant diseases like heart or lung problems, prior UC surgery, organ transplants, malignancy within the past five years except some skin cancers.

Inclusion Criteria

Body mass index (BMI) 18 to 35 kg/m^2 inclusive and weight ≥ 50 kg

I do not have active or untreated tuberculosis.

My ulcerative colitis is active.

Exclusion Criteria

I have previously received IL-2 or similar therapy.

I do not have any serious illnesses besides ulcerative colitis.

History of abnormal pulmonary function tests

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of MK-6194 or placebo at specified intervals

Up to 72 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 13 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK-6194
• MK-6194-matching placebo

Trial Overview The study tests MK-6194's safety and effectiveness in treating UC compared to a placebo. It will look into how the body processes the drug (pharmacokinetics), its impact on the disease (pharmacodynamics), and whether it causes any immune response (immunogenicity). Participants are randomly assigned to receive either MK-6194 or a matching placebo.

How Is the Trial Designed?

Group I: MK-6194 Medium Dose- Interval 2 (More Frequent) Experimental Treatment 1 Intervention

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

Group II: MK-6194 Low Dose - Interval 1 (Less Frequent) Experimental Treatment 1 Intervention

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

Group III: MK-6194 High Dose- Interval 2 (More Frequent) Experimental Treatment 1 Intervention

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

Group IV: MK-6194 High Dose- Interval 1 (Less Frequent) Experimental Treatment 1 Intervention

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

Group V: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04924114

A Study of MK-6194 (PT101) in Participants With Active ... 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 ...

2. ctv.veeva.com ctv.veeva.com/study/a-study-of-mk-6194-pt101-in-participants-with-active-ulcerative-colitis-uc-mk6194002

A Study of MK-6194 (PT101) in Participants With Active ... The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of MK-6194 in participants with active ...

3. clinicaltrials.eu clinicaltrials.eu/inn/mk-6194/

Mk-6194 – Application in Therapy and Current Clinical ... By influencing these immune cells, MK-6194 may help to reduce inflammation in the colon, potentially alleviating symptoms of ulcerative colitis. Safety and Side ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/14/NCT04924114/Prot_000.pdf

NCT04924114 Document Date: 13-May-2022 A Phase 1b, ... Results will be tabulated by Anatomic. 08NYPB. Page 80. MK-6194-002-08. Study PT101-201 Clinical Protocol. Amendment 8; 13-May-2022. PT101.

5. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/mk-6194-merck-ulcerative-colitis-likelihood-of-approval/

MK-6194 by Merck for Ulcerative Colitis: Likelihood of ... According to GlobalData, Phase II drugs for Ulcerative Colitis have a 45% phase transition success rate (PTSR) indication benchmark for progressing into Phase ...

6. sigma.larvol.com sigma.larvol.com/product.php?e1=839035&tab=newstrac

MK-6194 News Recruiting --> Active, not recruiting This phase 2a trial will outline the efficacy, safety, and tolerability of MK-6194 compared with placebo in patients with ...

7. withpower.com withpower.com/trial/phase-1-ulcer-9-2021-9705b

MK-6194 for Ulcerative Colitis · Info for Participants This trial tests a new drug called MK-6194 for people with active Ulcerative Colitis. It checks if the drug is safe, how it works in the body, and if it causes ...