A clinical study of tulisokibart in people with Crohn’s disease or ulcerative colitis (MK-7240-011)

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

25 Feb 2025 → ongoing

Decision date (initial)

2025-01-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-513533-20-00

WHO UTN

U1111-1306-6970

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To evaluate the long-term safety and tolerability of tulisokibart

Secondary objectives 4

1. To evaluate the long-term efficacy of tulisokibart as assessed by the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 364
2. To evaluate the long-term efficacy of tulisokibart in participants with CD as assessed by the proportion of participants achieving PRO-2 remission at Week 364
3. To evaluate the long-term efficacy of tulisokibart as assessed by the proportion of participants with endoscopic remission per Simplified Endoscopic Score for Crohn’s disease at Week 364
4. To evaluate the long-term efficacy of tulisokibart as assessed by the proportion of participants with UC achieving clinical remission per Modified Mayo Score at Week 364

Conditions and MedDRA coding

Crohn’s Disease or Ulcerative Colitis

Regulatory references

Scientific advice from competent authorities

Swedish Medical Products Agency, European Medicines Agency, Paul-Ehrlich-Institut

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Has participated in a qualifying MSD-sponsored tulisokibart Phase 2 or Phase 3 parent study for Crohn’s Disease or Ulcerative Colitis
2. The participant is judged to derive clinical benefit from continued study intervention as determined by the investigator based upon clinical evaluations performed during their parent study.
3. Assigned female sex at birth is eligible to participate if not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention
4. A participant of childbearing potential is eligible if not pregnant and uses an acceptable form of contraception or abstinence

Exclusion criteria 5

1. Has prematurely discontinued from study intervention in the parent study
2. Has met any of the protocol-specified mandatory study intervention discontinuation criteria during the LTE Screening Period; or has an ongoing SAE from the parent study; or if in the opinion of the investigator, continued study participation poses unacceptable risk to the participant
3. Has received any protocol-defined prohibited concomitant medications
4. Is currently participating in an interventional clinical study other than a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC
5. Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Percentage of participants with ≥1 adverse event (AE)
2. Percentage of participants discontinuing from study therapy due to AE

Secondary endpoints 4

1. Percentage of participants achieving clinical remission per Crohn’s Disease Activity Index score at Week 364
2. Percentage of participants achieving 2-patient-reported outcomes (PRO-2) remission per Crohn’s Disease Activity Index score at Week 364
3. Percentage of participants achieving endoscopic remission per Simplified Endoscopic Score for Crohn’s Disease at Week 364
4. Percentage of participants with UC achieving clinical remission per Modified Mayo Score at Week 364

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

Jeremy Shao

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Jeremy Shao

Third parties 7

Locations

4 EU/EEA countries · 22 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

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

Documents 23 files

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

Application history

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