A clinical trial of MK-8690 in people with ulcerative colitis (MK-8690-002)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

29 Jun 2026 → ongoing

Decision date (initial)

2026-06-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2025-523479-49-00

WHO UTN

U1111-1326-7763

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacogenetic, Efficacy, Safety, Pharmacogenomic, Pharmacodynamic, Pharmacokinetic

To evaluate the efficacy of MK-8690 compared to placebo as assessed by the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.

Secondary objectives 5

1. To evaluate the safety and tolerability of MK-8690.
2. To evaluate the efficacy of MK-8690 compared to placebo as assessed by the proportion of participants achieving a clinical response per Modified Mayo Score at Week 12.
3. To evaluate the efficacy of MK-8690 compared to placebo as assessed by the proportion of participants with endoscopic improvement at Week 12.
4. To evaluate the efficacy of MK-8690 compared to placebo as assessed by the proportion of participants achieving clinical remission per partial Modified Mayo Score at Week 12.
5. To evaluate the efficacy of MK-8690 compared to placebo as assessed by the proportion of participants achieving histologic-endoscopic mucosal improvement at Week 12.

Conditions and MedDRA coding

Colitis ulcerative

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before Randomization
2. Has moderately to severely active UC
3. Has a weight ≥40 kg
4. Satisfies at least 1 of the criteria: Has had an inadequate response or loss of response to 1 or more protocol-specified treatments; protocol specified corticosteroid dependence; has been intolerant to 1 or more protocol-specified UC treatments
5. Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable

Exclusion criteria 13

1. Has a diagnosis of Crohn’s Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment
2. Has a current diagnosis of fulminant colitis and/or toxic megacolon
3. Has UC limited to the rectum
4. Has a current or impending need for colostomy or ileostomy
5. Has had a total proctocolectomy or partial colectomy
6. Has UC exacerbation requiring hospitalization within 2 weeks before Screening
7. Has any active infection including but not limited to: Symptomatic infection despite adequate treatment (excluding fungal infections of the nail bed or localized oral herpes); chronic infection that requires ongoing antimicrobial treatment; recent infection with completion of parenteral or oral anti-infectives within protocol specified time frames
8. Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
9. Has evidence of active tuberculosis (TB) or meets TB exclusionary parameters
10. Has a history of cancer (except fully treated nonmelanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before Randomization or has a history of colorectal cancer at any time
11. Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed
12. Has had major surgery within 3 months before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study
13. Has received protocol-specified prohibited medications

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12

Secondary endpoints 6

1. Percentage of Participants With One or More Adverse Events (AEs)
2. Percentage of Participants Who Discontinued Study Intervention Due to an AE
3. Percentage of Participants Achieving Clinical Response Per MMS at Week 12
4. Percentage of Participants With Endoscopic Improvement at Week 12
5. Percentage of Participants Achieving Clinical Remission Per Partial Modified Mayo Score (pMMS) at Week 12
6. Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 12

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Amna Azfal

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Amna Azfal

Third parties 6

Locations

6 EU/EEA countries · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 42 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications