TULISOKIBART for Ankylosing spondylitis | Radiographic axial spondyloarthritis

Inclusion criteria

• {"criterion_text":"- 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

• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Has active tuberculosis (TB) or meets TB exclusionary parameters"}

Primary endpoints

• {"endpoint_text":"- Percentage of participants achieving Assessment of SpondyloArthritis international Society (ASAS) 40 response at Week 16.","definition_or_measurement_approach":"ASAS 40 response assessed at Week 16 (proportion of participants achieving ASAS 40 at Week 16)."}

Secondary endpoints

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

Methods

• Germany: Recruitment arrangements documents include Digital Ad Pack, Flyer, Patient Brochure, Dear Patient Letter, Dear Advocacy Letter (documents titled K2_Recruitment Doc Digital Ad Pack_DEU..., K2_Recruitment Doc Flyer_DEU..., K2_Recruitment Doc Brochure_DEU..., K2_Recruitment Doc Dear Patient Letter_DEU..., K2_Recruitment Doc Dear Advocacy Letter_DEU...). Channels: digital ads, printed flyers/brochures, direct letters to patients and advocacy outreach.
• Netherlands: Materials include Patient Banner Ad and Patient Brochure (K2_Recruitment Doc Patient Banner Ad_NLD..., K2_Recruitment Doc Patient Brochure_NLD...). Channels: web banner ads and brochures targeted at patients via participating centres.
• Poland: Materials include Poster, Patient Flyer, Patient Letter, Summary PIS, Brochure (K2_Recruitment Doc Poster_POL..., K2_Recruitment Doc Patient Flyer_POL..., K2_Recruitment Doc Patent Letter_POL..., K2_Recruitment Doc Summary PIS_POL..., K2_Recruitment Doc Brochure_POL...). Channels: posters, flyers, patient letters, printed summaries distributed in Poland sites.

Germany

Earliest CTIS Part Ii Submission Date

29-09-2025

Latest Decision Or Authorization Date

27-02-2026

Processing Time Days

151

Number Of Sites

7

Number Of Participants

25

Netherlands

Earliest CTIS Part Ii Submission Date

07-10-2025

Latest Decision Or Authorization Date

27-02-2026

Processing Time Days

143

Number Of Sites

3

Number Of Participants

7

Poland

Earliest CTIS Part Ii Submission Date

23-10-2025

Latest Decision Or Authorization Date

26-02-2026

Processing Time Days

126

Number Of Sites

7

Number Of Participants

30

Primary sponsor

Full Name

Merck Sharp & Dohme LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Parexel International Corp.

Responsibilities

EUB services (call center and medical services)

Name

Infinity Biologix LLC

Responsibilities

Genetic Analysis

Name

Icon Clinical Research Limited

Name

Syneos Health Clinique Inc.

Name

Q2 Solutions LLC

Responsibilities

Antibody testing

Third parties

• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"Genetic Analysis","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"Antibody testing","organisation_type":"Laboratory/Research/Testing facility"}