A clinical study of tulisokibart in people with rheumatoid arthritis (MK-7240-014)

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] - Immune System Diseases [C20]

Trial duration

6 Nov 2025 → ongoing

Decision date (initial)

2025-10-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2025-521745-25-00

WHO UTN

U1111-1320-8718

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving ACR20 at Week 12.

Secondary objectives 5

1. To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving ACR50 at Week 12.
2. To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving ACR70 at Week 12.
3. To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving LDA based on DAS28-CRP score ≤3.2 at Week 12.
4. To evaluate the efficacy of tulisokibart compared with placebo as assessed by the change from baseline in HAQ-DI at Week 12.
5. To evaluate the safety and tolerability of tulisokibart.

Conditions and MedDRA coding

Rheumatoid Arthritis

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Has a clinical diagnosis of rheumatoid arthritis (RA) and fulfillment of 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria
2. Has active disease defined as ≥6 tender joints (based on 68 joints) and ≥6 swollen joints (based on 66 joints)
3. Has current treatment with oral or parenteral methotrexate (MTX) therapy
4. Has history of one of the following: a) biologic disease-modifying antirheumatic drug (bDMARD) naïve, or b) bDMARD-Inadequate Response (IR)/intolerant up to a maximum of 2 classes of bDMARDS

Exclusion criteria 4

1. Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than RA (such as, but not limited to, psoriatic arthritis, systemic lupus erythematosus, gout, systemic sclerosis, myositis, pseudogout, etc) or any other condition that may, in the judgment of the investigator, interfere with the assessment of RA
2. Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before randomization
3. Has any active infection.
4. Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 12

Secondary endpoints 6

1. Proportion of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 12
2. Proportion of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 12
3. Proportion of Participants Achieving Low Disease Activity (LDA) based on Disease Activity Score 28 Using C-Reactive Protein (DAS28-CRP)
4. Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 12
5. Number of Participants Who Experience One or More Adverse Events (AEs)
6. Number of Participants Who Discontinue Study Intervention Due to an AE

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

Erik Anderson

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Erik Anderson

Third parties 4

Locations

3 EU/EEA countries · 16 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 37 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