A clinical study of tulisokibart to treat radiographic axial spondyloarthritis (MK-7240-013)

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

25 Nov 2025 → ongoing

Decision date (initial)

2025-10-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2025-521059-21-00

WHO UTN

U1111-1318-5807

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving ASAS 40 response at Week 16.

Secondary objectives 11

1. To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving ASDAS <2.1 at Week 16.
2. To evaluate the efficacy of tulisokibart compared with placebo as assessed by the change from baseline in BASFI at Week 16.
3. To evaluate the efficacy of tulisokibart compared with placebo as assessed by change from baseline in the SPARCC MRI score for spine at Week 16.
4. To evaluate the efficacy of tulisokibart compared with placebo as assessed by change from baseline in the SPARCC MRI score for SIJ at Week 16.
5. To evaluate the efficacy of tulisokibart compared with placebo as assessed by the change from baseline in total spinal pain (BASDAI Q2) and nocturnal spinal pain at Week 16.
6. To evaluate the effect of tulisokibart compared with placebo on QoL as assessed by the change from baseline in the following at Week 16: ASAS HI, SF-36 PCS.
7. To evaluate the effect of tulisokibart compared with placebo as assessed by the change from baseline in BASDAI at Week 16.
8. To evaluate the efficacy of tulisokibart compared with placebo as assessed by change from baseline in MASES in the subgroup of participants with enthesitis (MASES >0) at baseline, at Week 16.
9. To evaluate the efficacy of tulisokibart compared with placebo as assessed by the change from baseline in BASMIlin at Week 16.
10. To evaluate the effect of tulisokibart compared with placebo as assessed by the change from baseline in FACIT-Fatigue at Week 16.
11. To evaluate the safety and tolerability of tulisokibart.

Conditions and MedDRA coding

Radiographic axial spondyloarthritis (as known as ankylosing spondylitis)

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Has a clinical diagnosis of axial spondyloarthritis (axSpA) and meets the ASAS classification criteria for axSpA including ≥3 months of back pain with age at symptom onset <45 years.

Exclusion criteria 5

1. Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than radiographic axial spondyloarthritis (r-axSpA) (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis (PsA), systemic sclerosis, myositis, etc,), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of r-axSpA.
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. Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
4. Has any active infection including but not limited to: A). Symptomatic infection despite adequate treatment (excluding fungal infections of the nail bed or localized oral herpes). B). Chronic infection requiring ongoing antimicrobial treatment. C). Recent infection with completion of parenteral anti-infectives or oral anti-infectives.
5. Has active tuberculosis (TB) or meets TB exclusionary parameters

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of participants achieving Assessment of SpondyloArthritis international Society (ASAS) 40 response at Week 16.

Secondary endpoints 14

1. Percentage of participants achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1 at Week 16.
2. Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16.
3. Change from baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) score for spine at Week 16.
4. Change from baseline in the SPARCC MRI score for sacroiliac joint (SIJ) at Week 16.
5. Change from baseline in total spinal pain Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 (Q2) at Week 16.
6. Change from baseline in nocturnal spinal pain at Week 16.
7. Change from baseline in Assessment of SpondyloArthritis international Society Health Index (ASAS HI) at Week 16.
8. Change from baseline in short form-36 health survey (SF-36) physical component summary (PCS) at Week 16.
9. Change from baseline in BASDAI at Week 16.
10. Change from baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 16 in the subgroup of participants with enthesitis (MASES>0) at baseline.
11. Change from baseline in Bath Ankylosing Spondylitis Metrology Index Linear (BASMIlin) at Week 16.
12. Change from baseline in Functional Assessment of Chronic Illness Therapy – Fatigue Scale (FACIT-Fatigue) at Week 16.
13. Number of Participants With One or More adverse events (AEs).
14. Number of Participants Who Discontinued 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

Sara Penn

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Sara Penn

Third parties 5

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 30 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