A clinical study of MK-7240 for the treatment of Crohn’s disease (MK-7240-008)

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 Sep 2025 → ongoing

Decision date (initial)

2025-09-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-518296-56-00

WHO UTN

U1111-1313-5244

ClinicalTrials.gov

NCT06430801

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacodynamic, Efficacy, Pharmacokinetic, Safety, Dose response

1.Study 2: US/FDA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 12
2.Study 2: EU/EMA: Evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per stool frequency and abdominal pain score at Week 12
3.Study 2: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving endoscopic response at Week 12

Secondary objectives 11

1. Study 2: To evaluate the efficacy of tulisokibart compared with placebo in the Dx+ subpopulation as assessed by the proportion of participants with Crohn’s Disease Activity Index clinical remission at Week 12
2. Study 2: To evaluate the efficacy of tulisokibart compared with placebo in the Dx+ subpopulation as assessed by the proportion of participants endoscopic response at Week 12
3. Study 2: To evaluate the safety and tolerability of tulisokibart
4. Study 2: US/FDA: To evaluate the efficacy of tulisokibart compared to placebo as assessed by the proportion of participants achieving clinical remission per stool frequency and abdominal pain score at Week 12
5. Study 2: EU/EMA: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 12
6. Study 2: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants with a decrease of at least 100 points in per Crohn’s Disease Activity Index score from baseline at Week 12.
7. Study 2: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the mean change from baseline in the Functional Assessment of Chronic Illness Therapy – Fatigue at Week 12
8. Study 2: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants with endoscopic remission at Week 12
9. Study 2: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the mean change from baseline in IBDQ at Week 12
10. Study 2: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants with a decrease of at least 100 points in Crohn’s Disease Activity Index from baseline at Week 6
11. Study 2: To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants with ulcer-free endoscopy at Week 12

Conditions and MedDRA coding

Crohn’s Disease

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Has had a diagnosis of Crohn’s Disease (CD) at least 3 months before study.
2. Has moderately to severely active CD.
3. Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.
4. Adolescent participants ≥16 and <18 years of age can participate if approved by the country or regulatory/health authority.

Exclusion criteria 14

1. Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.
2. Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
3. Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
4. Has current stoma or need for colostomy or ileostomy.
5. Is missing >2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.
6. Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn’s disease.
7. Has surgical bowel resection within 3 months of study.
8. Has prior or current gastrointestinal dysplasia.
9. Has chronic infection requiring ongoing antimicrobial treatment.
10. Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years.
11. Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
12. Has active tuberculosis.
13. Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.
14. Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Study 2: [US/FDA Only] Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
2. Study 2: [EU/EMA Only] Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
3. Study 2: Percentage of Participants Achieving Endoscopic Response at Week 12

Secondary endpoints 12

1. Study 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Clinical Remission per CDAI at Week 12
2. Study 2: Percentage of Participants in Diagnostic Assay Positive (Dx+) Subpopulation Achieving Endoscopic Response at Week 12
3. Study 2: Number of Participants Who Experienced an Adverse Event (AE)
4. Study 2: Number of Participants who Discontinue Study Intervention due to an AE
5. Study 2 [US/FDA Only]: Percentage of Participants Achieving Clinical Remission per Stool Frequency and Abdominal Pain Score at Week 12
6. Study 2 [EU/EMA Only]: Percentage of Participants Achieving Clinical Remission per CDAI Score at Week 12
7. Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 12
8. Study 2: Mean Change from Baseline in FACIT-Fatigue Score at Week 12
9. Study 2: Percentage of Participants Achieving Endoscopic Remission at Week 12
10. Study 2: Mean Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 12
11. Study 2: Percentage of Participants with Decrease of ≥100 Points in CDAI Score from Baseline to Week 6
12. Study 2: Percentage of Participants with Ulcer-Free Endoscopy at Week 12

Investigational products

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

Test 2

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

Paulette Chandler

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Paulette Chandler

Third parties 7

Locations

21 EU/EEA countries · 163 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 237 files

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

Application history

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