AzTrials
AzTrials

Radiographic Axial SpondyloarthritisPhase 2NCT07133633

A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)

A Phase 2 study testing Tulisokibart in people with Radiographic Axial Spondyloarthritis, run by Merck Sharp & Dohme LLC at 107 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial summary

Researchers are looking for new ways to treat radiographic axial spondyloarthritis (r-axSpA). R-axSpA is a type of arthritis that causes pain, stiffness, and inflammation (swelling) in the spine and joints in the pelvis (hip bone). Radiographic means the damage it causes can be seen on X-rays. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Radiographic Axial Spondyloarthritis
What is being tested?
Tulisokibart
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
315 participants
Where
107 sitesin 14 countries
Study dates
26 Sep 2025to 5 Feb 2030
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The main inclusion criteria include but are not limited to the following:
  • Has a clinical diagnosis of axial spondyloarthritis (axSpA) and meets the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA including ≥3 months of back pain with age at symptom onset <45 years
  • Meets the radiographic criterion of the modified New York criteria for ankylosing spondylitis (AS) as determined by central reading at Screening
  • Has active disease at Screening and Randomization
  • Has a history of inadequate response (IR)/intolerance to nonsteroidal anti-inflammatory drugs (NSAIDs) and is biologic disease-modifying antirheumatic drug (bDMARD)-naive, or has a history of IR/intolerance to up to a maximum of 2 bDMARD classes

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • 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
  • Has a history of cancer (except fully treated non-melanoma skin cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years
  • Has any active infection
  • Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients

Trial locations and contacts

107 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

107 sites in 14 countries

United States37 sites, 36 recruiting

  • Rheumatology Associates ( Site 0055)

    Arlington, Texas, 76012

    Study Coordinator, 214-540-0700

    Recruiting

  • Arthritis and Rheumatic Disease Specialties ( Site 0016)

    Aventura, Florida, 33180

    Study Coordinator, 305-932-4295

    Recruiting

  • John Hopkins University ( Site 0052)

    Baltimore, Maryland, 21224

    Study Coordinator, 410-550-0579

    Recruiting

  • Bay Area Arthritis and Osteoporosis ( Site 0041)

    Brandon, Florida, 33511

    Study Coordinator, 813-651-4441 Ext 243

    Recruiting

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler ( Site 0036)

    Chandler, Arizona, 85225

    Study Coordinator, 480-443-8400

    Recruiting

  • Chicago Arthritis & Regenerative Medicine ( Site 0042)

    Chicago, Illinois, 60661

    Study Coordinator, 480-443-8400

    Recruiting

  • TriWest Research Associates - Chula Vista ( Site 0013)

    Chula Vista, California, 91910

    Completed

  • GNP Research - Hollywood ( Site 0020)

    Cooper City, Florida, 33024

    Study Coordinator, 754-248-3589

    Recruiting

  • Arthritis Care of Texas ( Site 0048)

    Corpus Christi, Texas, 78415

    Study Coordinator, 361-400-7700

    Recruiting

  • Denver Arthritis Clinic ( Site 0064)

    Denver, Colorado, 80230

    Study Coordinator, 303-394-2828

    Recruiting

  • Altoona Center for Clinical Research ( Site 0004)

    Duncansville, Pennsylvania, 16635

    Study Coordinator, 814-693-0300

    Recruiting

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff ( Site 0021)

    Flagstaff, Arizona, 86001

    Study Coordinator, 480-443-8400

    Recruiting

  • Lone Star Arthritis & Rheumatology Associates, P.C. ( Site 0028)

    Fort Worth, Texas, 76109

    Study Coordinator, 301-942-7600

    Recruiting

  • Providence Medical Foundation ( Site 0049)

    Fullerton, California, 92835

    Study Coordinator, 714-626-8610

    Recruiting

  • Arizona Arthritis & Rheumatology Associates, P.C. - Gilbert ( Site 0022)

    Gilbert, Arizona, 85297

    Study Coordinator, 480-443-8400

    Recruiting

  • AARA Arizona Arthritis & Rheumatology Associates, P.C. - Glendale ( Site 0056)

    Glendale, Arizona, 85306

    Study Coordinator, 480-443-8400

    Recruiting

  • Provecta Research Network LLC ( Site 0054)

    Houston, Texas, 77027

    Study Coordinator, 346-735-8990

    Recruiting

  • The University of Texas Health Science Center at Houston ( Site 0065)

    Houston, Texas, 77030

    Study Coordinator, 713-500-6597

    Recruiting

  • Newport Huntington Medical Group ( Site 0005)

    Huntington Beach, California, 92648

    Study Coordinator, 714-378-2440

    Recruiting

  • AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving ( Site 0032)

    Irving, Texas, 75039

    Study Coordinator, 301-942-7600

    Recruiting

  • Logan Health Rheumatology ( Site 0015)

    Kalispell, Montana, 59901

    Study Coordinator, 406-752-2010

    Recruiting

  • Kansas City Physician Partners ( Site 0027)

    Kansas City, Missouri, 64111

    Study Coordinator, 816-384-2827

    Recruiting

  • Physician Research Collaboration, LLC ( Site 0057)

    Lincoln, Nebraska, 68516-5497

    Study Coordinator, 402-420-3442

    Recruiting

  • AARA Clinical Research - Murfreesboro Medical Clinic ( Site 0029)

    Murfreesboro, Tennessee, 37128

    Study Coordinator, 615-236-2504

    Recruiting

  • Innovation Medical Research Center ( Site 0012)

    Palmetto Bay, Florida, 33157

    Study Coordinator, 305-300-2695

    Recruiting

  • Perelman Center for Advanced Medicine ( Site 0060)

    Philadelphia, Pennsylvania, 19104

    Study Coordinator, 215-662-2454

    Recruiting

  • Oregon Health & Science University ( Site 0059)

    Portland, Oregon, 97239

    Study Coordinator, 503-494-8637

    Recruiting

  • Epic Medical Research ( Site 0061)

    Red Oak, Texas, 75154

    Study Coordinator, 972-777-6956

    Recruiting

  • Arthritis and Rheumatism Associates - Rockville ( Site 0019)

    Rockville, Maryland, 20850

    Study Coordinator, 301-942-7600

    Recruiting

  • Inspire Santa Fe Medical Group ( Site 0011)

    Santa Fe, New Mexico, 87505

    Study Coordinator, 505-490-5984

    Recruiting

  • Velocity Clinical Research - West County Rheumatology, St. Louis ( Site 0038)

    St Louis, Missouri, 63131

    Study Coordinator, 314-987-2980

    Recruiting

  • Advanced Rheumatology of Houston ( Site 0001)

    The Woodlands, Texas, 77382

    Study Coordinator, 936-681-4882

    Recruiting

  • Cohen Medical Centers ( Site 0034)

    Thousand Oaks, California, 91360-3967

    Study Coordinator, 713-487-8680

    Recruiting

  • DM Clinical Research - TRA ( Site 0010)

    Tomball, Texas, 77375

    Study Coordinator, 346-550-9559

    Recruiting

  • Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 0025)

    Tucson, Arizona, 85704-1140

    Study Coordinator, 480-443-8400

    Recruiting

  • Inland Rheumatology Clinical Trials, Inc. ( Site 0002)

    Upland, California, 91786

    Study Coordinator, 909-296-8700

    Recruiting

  • Willow Rheumatology and Wellness, PLLC ( Site 0035)

    Willowbrook, Illinois, 60527

    Study Coordinator, 630-537-1313

    Recruiting

Other trials in United States

China9 sites, 9 recruiting

  • Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 3100)

    Beijing, Beijing Municipality, 100005

    Study Coordinator, 01069156699

    Recruiting

  • The First Afflilated Hospital of Bengbu Medical College ( Site 3119)

    Bengbu, Anhui, 233004

    Study Coordinator, 0552-3086120

    Recruiting

  • The First Hospital Of Jilin University ( Site 3103)

    Changchun, Jilin, 130021

    Study Coordinator, +8643188782222

    Recruiting

  • Guangdong Provincial People's Hospital ( Site 3110)

    Guangzhou, Guangdong, 510080

    Study Coordinator, 020-83525210

    Recruiting

  • The Third Affiliated Hospital of Sun Yat-Sen University ( Site 3114)

    Guangzhou, Guangdong, 510630

    Study Coordinator, 020-85253153

    Recruiting

  • First Affiliated Hospital of Kunming Medical University ( Site 3123)

    Kunming, Yunnan, 650032

    Study Coordinator, +86087165324888

    Recruiting

  • The First Affiliated Hospital of Henan University of Science &Technology ( Site 3121)

    Luoyang, Henan, 471003

    Study Coordinator, 0379-64830999

    Recruiting

  • Pingxiang People's Hospital ( Site 3115)

    Pingxiang, Jiangxi, 337055

    Study Coordinator, 0799-6881723

    Recruiting

  • PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 3124)

    Ürümqi, Xinjiang, 830001

    Study Coordinator, +869918565737

    Recruiting

Other trials in China

Ukraine9 sites, 3 recruiting

  • Communal Nonprofit Enterprise Cherkasy Regional Hospital of Cherkasy Oblast Council ( Site 1704)

    Cherkasy, Chernivetska Oblast, 18009

    Active, not recruiting

  • Municipal Public Non-Profit Enterprise "City Clinical Hospital №1 of the Ivano-Frankivsk City Counc ( Site 1705)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

    Active, not recruiting

  • Municipal Non-Profit Enterprise "Khmelnytskyi Regional Hospital" of Khmelnytskyi Regional Council ( Site 1713)

    Khmelnytskiy, Khmelnytskyi Oblast, 29000

    Study Coordinator, +380501664721

    Recruiting

  • Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 1715)

    Kyiv, Kyivska Oblast, 04050

    Study Coordinator, +380977694382

    Recruiting

  • Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain ( Site 1701)

    Kyiv, 03049

    Study Coordinator, +380667464061

    Recruiting

  • Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1706)

    Kyiv, 03057

    Active, not recruiting

  • Lviv Clin Hospital of Planned Treatment Rehabilitation Palliative Care ( Site 1710)

    Lviv, Lviv Oblast, 79011

    Active, not recruiting

  • ME "Ternopil Regional Clinical Hospital of Ternopil Regional Council" ( Site 1707)

    Ternopil, Ternopil Oblast, 46002

    Active, not recruiting

  • Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia ( Site 1700)

    Vinnytsa, Vinnytsia Oblast, 21018

    Active, not recruiting

Other trials in Ukraine

Germany7 sites, 7 recruiting

  • Rheumatologische Schwerpunktpraxis ( Site 0605)

    Berlin, 10777

    Study Coordinator, +493085993390

    Recruiting

  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin-Medizinische Klinik I für Gastroenterol ( Site 0601)

    Berlin, 12203

    Study Coordinator, +49 30 450 514726

    Recruiting

  • Rheuma-Research Lausitz ( Site 0609)

    Cottbus, Brandenburg, 03042

    Study Coordinator, +4935575578825

    Recruiting

  • HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 0604)

    Hamburg, 20095

    Study Coordinator, +4940323103166

    Recruiting

  • Rheumazentrum Ruhrgebiet ( Site 0600)

    Herne, North Rhine-Westphalia, 44649

    Study Coordinator, +4923255920

    Recruiting

  • Medicover München Ost MVZ ( Site 0611)

    Munich, Bavaria, 81667

    Study Coordinator, +498945855612

    Recruiting

  • Rheumazentrum Ratingen Studienambulanz ( Site 0602)

    Ratingen, North Rhine-Westphalia, 40878

    Study Coordinator, +4921025533777

    Recruiting

Other trials in Germany

Taiwan7 sites, 7 recruiting

  • Kaohsiung Veterans General Hospital ( Site 2905)

    Kaohsiung City, 813414

    Study Coordinator, +8867-3422121

    Recruiting

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 2908)

    Kaohsiung City, 833

    Study Coordinator, +88677317123x8800

    Recruiting

  • Taipei Medical University Shuang Ho Hospital ( Site 2900)

    New Taipei City, New Taipei, 235

    Study Coordinator, +886222490088

    Recruiting

  • National Cheng Kung University Hospital ( Site 2903)

    Tainan, 704

    Study Coordinator, +88662353535x3952

    Recruiting

  • Taipei Veterans General Hospital ( Site 2906)

    Taipei, 112

    Study Coordinator, +886958309632

    Recruiting

  • National Taiwan University Hospital ( Site 2902)

    Taipei City, Taipei, 100

    Study Coordinator, +886972652625

    Recruiting

  • Chang Gung Memorial Hospital - Linkou Branch ( Site 2904)

    Taoyuan, 33305

    Study Coordinator, +88633281200

    Recruiting

Other trials in Taiwan

Poland6 sites, 3 recruiting

  • MICS Centrum Medyczne Bydgoszcz ( Site 1206)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065

    Active, not recruiting

  • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy ( Site 1203)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

    Study Coordinator, +48523655531

    Recruiting

  • Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1201)

    Lublin, Lublin Voivodeship, 20-607

    Active, not recruiting

  • MICS Centrum Medyczne Torun ( Site 1202)

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

    Study Coordinator, +48563004300

    Recruiting

  • MICS Centrum Medyczne Warszawa ( Site 1204)

    Warsaw, Masovian Voivodeship, 00-874

    Study Coordinator, +48226291354

    Recruiting

  • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site 1205)

    Warsaw, Masovian Voivodeship, 02-637

    Active, not recruiting

Other trials in Poland

Turkey (Türkiye)6 sites, 6 recruiting

  • ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1600)

    Ankara, 06230

    Study Coordinator, +90312 508 3879-3819

    Recruiting

  • Hacettepe Universite Hastaneleri ( Site 1603)

    Ankara, 06230

    Study Coordinator, +90 312 305 13 48

    Recruiting

  • Istanbul University Cerrahpasa Medical School Internal Diseases Institute ( Site 1604)

    Fatih, Istanbul, 34098

    Study Coordinator, +90 212 414 30 00

    Recruiting

  • Marmara Universitesi Pendik Egitim Arastirma Hastanesi ( Site 1602)

    Istanbul, 34899

    Study Coordinator, +902166254545

    Recruiting

  • Kocaeli Üniversitesi ( Site 1605)

    Kocaeli, 41380

    Study Coordinator, +902623037575 (6716)

    Recruiting

  • Konya Necmettin Erbakan Universitesi ( Site 1606)

    Konya, 42090

    Study Coordinator, +90 332 223 40 51

    Recruiting

Other trials in Turkey (Türkiye)

Brazil5 sites, 5 recruiting

  • Complexo Hospital de Clínicas da Universidade Federal do Paraná ( Site 1991)

    Curitiba, Paraná, 80060-900

    Study Coordinator, +554133601800

    Recruiting

  • CMIP-CENTRO MINEIRO DE PESQUISA ( Site 1999)

    Juiz de Fora, Minas Gerais, 36010-570

    Study Coordinator, +553233128920

    Recruiting

  • LMK Serviços Médicos S/S ( Site 2000)

    Porto Alegre, Rio Grande do Sul, 90480-000

    Study Coordinator, +55 5130613440

    Recruiting

  • IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 1994)

    Rio de Janeiro, 20241-180

    Study Coordinator, +55 21 25277979

    Recruiting

  • Centro de Pesquisas Clínicas do Hospital das Clínicas de São Paulo ( Site 1992)

    São Paulo, 05403-000

    Study Coordinator, +551126619272

    Recruiting

Other trials in Brazil

Chile5 sites, 2 recruiting

  • Bioreuma ( Site 2109)

    Concepción, Biobio, 4070280

    Study Coordinator, +56412226855

    Recruiting

  • Clinica Alemana Osorno ( Site 2114)

    Osorno, Los Lagos Region, 5311089

    Study Coordinator, +56967603845

    Recruiting

  • Enroll SpA ( Site 2101)

    Santiago, Region M. de Santiago, 7500587

    Active, not recruiting

  • Centro de Estudios GyC ( Site 2103)

    Santiago, Region M. de Santiago, 7510079

    Active, not recruiting

  • Bradfordhill ( Site 2110)

    Santiago, Region M. de Santiago, 8420383

    Active, not recruiting

Other trials in Chile

United Kingdom4 sites, 4 recruiting

  • Barnet Hospital ( Site 1806)

    Barnet, EN5 3DJ

    Study Coordinator, +4402082165258

    Recruiting

  • Royal United Hospital Bath NHS Foundation Trust ( Site 1803)

    Bath, Somerset, BA1 3NG

    Study Coordinator, +441225821848

    Recruiting

  • St Luke's Hospital ( Site 1801)

    Bradford, BD5 0NA

    Study Coordinator, 01274365311

    Recruiting

  • Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1800)

    Norwich, Norfolk, NR4 7UY

    Study Coordinator, 01603287725

    Recruiting

Other trials in United Kingdom

Canada3 sites, 3 recruiting

  • G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. ( Site 0200)

    Québec, Quebec, G1V 4K5

    Study Coordinator, 4186502661

    Recruiting

  • Toronto Western Hospital ( Site 0205)

    Toronto, Ontario, M5T 2S8

    Study Coordinator, 4166035800x3259

    Recruiting

  • Centre de Recherche Musculo-Squelettique ( Site 0202)

    Trois-Rivières, Quebec, G9A 3Y2

    Study Coordinator, 8193701301

    Recruiting

Other trials in Canada

Colombia3 sites, 2 recruiting

  • Clinica de la Costa S.A.S. ( Site 2202)

    Barranquilla, Atlántico, 080020

    Study Coordinator, +573008096054

    Recruiting

  • CIREEM SAS ( Site 2204)

    Bogota, Cundinamarca, 110221

    Active, not recruiting

  • Fundación Valle del Lili ( Site 2201)

    Cali, Valle del Cauca Department, 760032

    Study Coordinator, +573166237452

    Recruiting

Other trials in Colombia

Netherlands3 sites, 3 recruiting

  • Amsterdam UMC ( Site 1101)

    Amsterdam, North Holland, 1081 HV

    Study Coordinator, +31 205661849

    Recruiting

  • Zuyderland Medical Centre ( Site 1100)

    Heerlen, Limburg, 6419 PC

    Study Coordinator, +31884599716

    Recruiting

  • Maasstad Ziekenhuis ( Site 1102)

    Rotterdam, South Holland, 3079DZ

    Study Coordinator, +31 102912205

    Recruiting

Other trials in Netherlands

South Korea3 sites, 3 recruiting

  • Kyung Hee University Hospital ( Site 2803)

    Seoul, 02447

    Study Coordinator, +8229588087

    Recruiting

  • Hanyang University Seoul Hospital ( Site 2800)

    Seoul, 04763

    Study Coordinator, +82222909245

    Recruiting

  • Kyung Hee University Hosptial at Gangdong ( Site 2802)

    Seoul, 05278

    Study Coordinator, +8224406128

    Recruiting

Other trials in South Korea

About this study

Official title: 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)

Researchers are looking for new ways to treat radiographic axial spondyloarthritis (r-axSpA). R-axSpA is a type of arthritis that causes pain, stiffness, and inflammation (swelling) in the spine and joints in the pelvis (hip bone). Radiographic means the damage it causes can be seen on X-rays.

This study will help find out if a study medicine called tulisokibart can treat symptoms of r-axSpA. Researchers will look at different doses of tulisokibart.

Researchers want to know if at least one of the study doses of tulisokibart works better than a placebo to improve r-axSpA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.

Read the detailed description

This study consists of a 16-week Placebo-controlled Period and a 124-week Long-term Extension (LTE), which is composed of a 40-week Main Extension and an 84-week Optional Extension.

Being tested
Tulisokibart, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TulisokibartDrug

    Also called MK-7240, PRA023

    Subcutaneous (SC) administration

  • PlaceboDrug

    SC administration

Study groups in NCT07133633
Study groupRoleWhat they receive
High-dose tulisokibartExperimentalParticipants receive a high dose of tulisokibart.
Receives: Drug: Tulisokibart
Medium-dose tulisokibartExperimentalParticipants receive a medium dose of tulisokibart.
Receives: Drug: Tulisokibart
Low-dose tulisokibartExperimentalParticipants receive a low dose of tulisokibart and are rerandomized at week 16 to a medium or high dose of tulisokibart.
Receives: Drug: Tulisokibart
PlaceboPlacebo comparatorParticipants receive a matched placebo dose and are rerandomized at week 16 to a medium or high dose of tulisokibart.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 16

    ASAS 40 is defined as a relative improvement of ≥40% and an absolute improvement of ≥2 units from baseline in ≥3 of 4 domains, with no deterioration in the fourth domain. The 4 domains include Patient Global Assessment (PtGA), total spinal pain, physical function, and morning stiffness. Each domain is measured on a 10-point numeric scale from 0 = no disease symptoms/impact to 10 = extreme disease symptoms/impact, with a higher score indicating more severe impairment.

    Measured: Week 16

Secondary outcomes (14)

  1. Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1 at Week 16

    ASDAS is a disease activity measure calculated from the assessments of total spinal pain, duration of morning stiffness, peripheral pain/swelling, PtGA, and high sensitivity C-reactive protein (hsCRP) as follows: 0.121 × total spinal pain (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] question 2) + 0.110 × PtGA + 0.073 × peripheral pain/swelling (BASDAI question 3) + 0.058 × duration of morning stiffness (BASDAI question 6) + 0.579 × natural logarithm (ln) of (hsCRP + 1). ASDAS <2.1 indicates low disease activity and a higher score indicates greater disease activity.

    Measured: Week 16

  2. Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16

    The BASFI is a validated 10-item measure assessing individual-reported function (8 items) and ability to cope with everyday life (2 items) over the past week. Responses are recorded for each item on an 11-point numeric rating scale (NRS) from 0 "easy" to 10 "impossible". A mean score of the 10 items will be calculated to reflect the overall functional impairment, with higher scores indicating greater disability.

    Measured: Baseline and Week 16

  3. Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Spine at Week 16

    The SPARCC MRI score for spine is a validated scoring system developed to assess inflammation in the spine related to axSpA. The 6 most abnormal discovertebral units are selected, and 3 consecutive sagittal slices are assessed. Each discovertebral unit is divided into 4 quadrants, scored as 1 if increased signal is present or 0 if normal, with a maximum of 12 points per discovertebral unit. Additional points are added for lesions that exhibit intense signal or deep (≥1 cm), increasing the maximum score per unit to 18. Summed over 6 slices, the maximum total score is 108. Higher scores indicate more extensive and/or intense spinal inflammation.

    Measured: Baseline and Week 16

  4. Change From Baseline in the SPARCC MRI Score for Sacroiliac Joint (SIJ) at Week 16

    The SPARCC MRI score for SIJ is a validated scoring system to assess SIJ inflammation in axSpA. Six consecutive SIJ coronal slice images are assessed by dividing into 4 quadrants and scored as 1 if increased signal is present or 0 if normal, with a maximum of 8 points per slice for both joints. Additional points are added for lesions that exhibit intense signal or deep (≥1 cm), increasing the maximum score per unit to 12. Summed over 6 slices, the maximum total score is 72. Higher scores indicate more extensive and/or intense SIJ inflammation.

    Measured: Baseline and Week 16

  5. Change From Baseline in Total Spinal Pain Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 at Week 16

    The BASDAI is a validated 6-item questionnaire used to assess disease activity in radiographic axial spondyloarthritis. It assesses individual-reported fatigue, total spinal pain, peripheral pain/swelling, tenderness, intensity of morning stiffness, and duration of morning stiffness over the past week. To access individual-reported total spinal pain experienced over the past week, participants are asked BADSAI question 2, "How would you describe the overall level of ankylosing spondylitis neck, back, or hip pain you have had?" Responses are recorded on an 11-point NRS ranging from 0 "none" to 10 "very severe." Higher score indicates more severe total spinal pain.

    Measured: Baseline and Week 16

  6. Change From Baseline in Nocturnal Spinal Pain at Week 16

    The NRS is an 11-point scale (numeric version of the visual analog scale) to assess the pain intensity in individuals who can self-report. Participants will be asked to report their average nighttime spinal pain over the past week on an 11-point NRS. The score range is from 0 "no pain" to 10 "most severe pain." Higher score indicates more severe nocturnal spinal pain.

    Measured: Baseline and Week 16

  7. Change From Baseline in Assessment of Spondyloarthritis International Society Health Index (ASAS HI) at Week 16

    The ASAS HI assesses overall functioning and health and is a validated 17-item individual-reported measure of pain, emotional functions, sleep, sexual function, mobility, self-care, and community life, with response options of "I agree" (1) or "I do not agree" (0). The ASAS HI is a total summary score ranging from 0 to 17 with a lower score indicating a better and a higher score indicating an inferior health status.

    Measured: Baseline and Week 16

  8. Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 16

    The SF-36 is a widely used general health status questionnaire that assesses 8 domains of functional health and well-being: physical functioning, role limitations due to physical health problems, bodily pain, social functioning, mental health, role limitations due to emotional problems, vitality, and general health perceptions. The PCS score is a composite score derived from the SF-36 that summarizes the physical health aspects of the survey. It combines information primarily from the physical domains (physical functioning, role limitations due to physical health problems, bodily pain, and general health perceptions). All SF-36 scores range from 0 = worst health state to 100 = best health state, with higher scores indicating a better health-related quality of life (QoL).

    Measured: Baseline and Week 16

  9. Change From Baseline in BASDAI at Week 16

    The BASDAI is a validated 6-item measure, assessing individual-reported fatigue, total spinal pain, peripheral pain/swelling, tenderness, intensity of morning stiffness, and duration of morning stiffness over the past week. Responses are recorded for each item on an 11-point NRS from 0 "none" to 10 "very severe." BASDAI is calculated by averaging the response for question 5 and question 6, adding this result to the sum of question 1 through question 4, and then dividing the result by 5. A higher score indicates greater disease activity.

    Measured: Baseline and 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

    The MASES is a validated method to assess peripheral enthesitis in axSpA. It assesses pain on palpation at the following anatomic sites: first costochondral joint (right \& left); seventh costochondral joint (right \& left); anterior superior iliac spine (right \& left); iliac crest (right \& left); posterior superior iliac spine (right \& left); fifth lumbar spinous process; Achilles tendon, proximal insertion (right \& left). Each site is scored based on participant response as either 0 (nontender) or 1 (tender), the final score ranges from 0 (absence of enthesitis) up to a score of 13 (enthesitis present at all sites). Injected enthesitis sites will be considered not assessable for 90 days from the time of the injection. Higher score indicates more tender or inflamed enthesitis sites. Resolution of enthesitis is defined as MASES score equal to zero.

    Measured: Baseline and Week 16

  11. Change From Baseline in Bath Ankylosing Spondylitis Metrology Index Linear (BASMI lin) at Week 16

    The BASMI lin is a validated tool to assess mobility in axSpA. The BASMI lin evaluates the range in centimeters of 5 components of hip and spinal mobility (components: tragus-to-wall, lateral lumbar flexion, cervical rotation angle, lumbar flexion, and maximal intermalleolar distance). For tragus to wall, lateral lumber flexion, and cervical rotation angle, the average measurements from left and right would be used as the component score. Component score range is from 0 (no mobility limitation) to 10 (very severe mobility limitation). Higher score indicates more severe mobility limitation.

    Measured: Baseline and Week 16

  12. Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) at Week 16

    The FACIT-Fatigue is a validated 13-item measure that assesses individual-reported fatigue and its impact on daily activities and function during usual activities over the past week. Responses are recorded on a 5-point Likert scale (0 = not at all to 4 = very much), individual item scores are then summed to provide the final score with range from 0 (worst score/extreme fatigue) to 52 (best score/no or minimal fatigue). Higher total scores represent lower levels of fatigue.

    Measured: Baseline and Week 16

  13. Number of Participants With One or More Adverse Events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately 154 weeks

  14. Number of Participants Who Discontinue Study Intervention Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately 140 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study start26 Sep 2025
  3. Primary completion15 Jun 2027 (estimated)
  4. Study completion5 Feb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
315 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07133633
Sponsor's protocol ID
7240-013
Other IDs
2025-521059-21-00, U1111-1318-5807, MK-7240-013, 2025
Status last verified
Oct 2026
First submitted
14 Aug 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in