A clinical study of tulisokibart in people with psoriatic arthritis (MK-7240-015)

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] - Musculoskeletal Diseases [C05]

Trial duration

8 May 2026 → ongoing

Decision date (initial)

2026-04-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2025-520997-21-00

WHO UTN

U1111-1318-4301

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

1. To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving ACR20 at Week 16.

Secondary objectives 4

1. To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving ACR50 at Week 16.
2. To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving ACR70 at Week 16.
3. To evaluate the efficacy of tulisokibart compared with placebo as assessed by the change from baseline in the HAQ-DI at Week 16.
4. To evaluate the safety and tolerability of tulisokibart.

Conditions and MedDRA coding

Psoriatic arthritis​​

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Has a clinical diagnosis of psoriatic arthritis (PsA), with symptom onset ≥6 months before Screening.
2. Has active disease, defined as ≥3 tender joints and ≥3 swollen joints.
3. Has a diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
4. Has had inadequate response or intolerance to certain disease-modifying antirheumatic drugs (DMARDs).
5. If on treatment with any protocol-specified drugs during the study, meets drug stable duration requirements, as applicable.

Exclusion criteria 13

1. Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than PsA (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, myositis, etc), or any other conditions that may interfere with the assessment of PsA.
2. Has a skin condition diagnosis, other than psoriasis that may interfere with the assessment of psoriasis.
3. Has a diagnosis of fibromyalgia that has been active within the 12 months before randomization or would have the potential to interfere with efficacy assessments.
4. Has a transplanted organ and requires continued systemic immunosuppression.
5. 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.
6. Has had a diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) and the possibility of malignancy cannot be reasonably excluded following additional clinical assessments.
7. Has a known infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus.
8. Has any active infection.
9. Has active tuberculosis.
10. Has had major surgery within 3 months before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study.
11. Has had joint surgery at joints to be assessed in the study ≤8 weeks before randomization.
12. Has had inadequate response, intolerance, or treatment with a targeted synthetic DMARD for ≥8 weeks.
13. Has received an intra-articular, trigger point, tender point, intra-bursa, or intra-tendon sheath injection <8 weeks before randomization.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 16

Secondary endpoints 5

1. Number of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 16
2. Number of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 16
3. Mean Change from Baseline in the Health Assessment of Questionnaire Disability Index (HAQ-DI) at Week 16
4. Number of Participants Who Experience One or More Adverse Events (AEs)
5. 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

Sarah Chen​

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Sarah Chen​

Third parties 7

Locations

3 EU/EEA countries · 17 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 29 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