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A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521059-21-00
Acronym
MK-7240-013
Enrollment
62
Registered
2025-10-30
Start date
2025-11-25
Completion date
Unknown
Last updated
2025-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiographic axial spondyloarthritis (as known as ankylosing spondylitis)

Brief summary

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

Detailed description

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

Interventions

DRUGPlacebo for MK-7240

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
Percentage of participants achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1 at Week 16., Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16., Change from baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) score for spine at Week 16., Change from baseline in the SPARCC MRI score for sacroiliac joint (SIJ) at Week 16., Change from baseline in total spinal pain Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 (Q2) at Week 16., Change from baseline in nocturnal spinal pain at Week 16., Change from baseline in Assessment of SpondyloArthritis international Society Health Index (ASAS HI) at Week 16., Change from baseline in short form-36 health survey (SF-36) physical component summary (PCS) at Week 16., Change from baseline in BASDAI at Week 16., Change from baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 16 in the subgroup of pa

Countries

Germany, Netherlands, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026