A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis

Last updated: July 8, 2026
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

2

Condition

Arthritis And Arthritic Pain

Dermatomyositis (Connective Tissue Disease)

Rheumatoid Arthritis

Treatment

Placebo

Ravagalimab

Lutikizumab

Clinical Study ID

NCT06972446
M25-056
2025-520721-21-00
  • Ages > 18
  • All Genders

Study Summary

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA).

This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide.

There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At any time prior to the Screening Visit, participant must have been treated for >or = 3 months with at least 1 b/tsDMARD therapy but continued to exhibit active RA,or had to discontinue due to intolerability or toxicity, irrespective of treatmentduration. The maximum cap for prior use of b/tsDMARD is 2.

  • Participant must be on a stable dose of methotrexate (MTX)

Exclusion

Exclusion Criteria:

  • Participant is taking nonsteroidal anti-inflammatory drugs (NSAIDs),acetaminophen/paracetamol, low-potency opioids (tramadol, codeine, hydrocodone,alone or in combination with acetaminophen), oral corticosteroids (equivalent to ≤ 10 mg/day of prednisone), or inhaled corticosteroids for stable medical conditionsunless they have been on stable doses for ≥ 1 week prior to Baseline Visit.

  • History of any arthritis with onset prior to age 17 years or current diagnosis ofinflammatory joint disease other than rheumatoid arthritis.

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 20, 2025
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Care Clinic - Calgary /ID# 274405

    Calgary, Alberta T2N 4L7
    Canada

    Active - Recruiting

  • Centre Hospitalier Universite De Sherbrooke - Hotel-Dieu Hospital /ID# 273711

    Sherbrooke, Quebec J1G 2E8
    Canada

    Active - Recruiting

  • Dr. Latha Naik Medical Professional Corporation /ID# 274403

    Saskatoon, Saskatchewan S7H 0P4
    Canada

    Active - Recruiting

  • L.K.N. Arthrocentrum /ID# 271932

    Hlučín, Moravian-Silesian Region 748 01
    Czechia

    Active - Recruiting

  • MEDICAL PLUS Research s.r.o /ID# 271926

    Uherské Hradiště, 686 01
    Czechia

    Active - Recruiting

  • PV Medical Services /ID# 271934

    Zlín, 760 01
    Czechia

    Active - Recruiting

  • PV Medical Services s.r.o. /ID# 271934

    Zlín, 760 01
    Czechia

    Active - Recruiting

  • Rheumateam Lahn-Dill-Siegerland /ID# 274858

    Wetzlar, Hesse 35578
    Germany

    Active - Recruiting

  • Universitaetsklinikum Bonn /ID# 272808

    Bonn, North Rhine-Westphalia 53127
    Germany

    Active - Recruiting

  • Krankenhaus Porz Am Rhein /ID# 272903

    Cologne, North Rhine-Westphalia 51149
    Germany

    Active - Recruiting

  • MVZ Rheumatologie und Autoimmunmedizin in Hamburg /ID# 272795

    Hamburg, 20095
    Germany

    Active - Recruiting

  • Mvz Rheuma /ID# 272795

    Hamburg, 20095
    Germany

    Active - Recruiting

  • Szegedi Tudomanyegyetem /ID# 272865

    Szeged, Csongrád megye 6720
    Hungary

    Active - Recruiting

  • Complex Rendelo Med Zrt. /ID# 272859

    Székesfehérvár, Fejér 8000
    Hungary

    Active - Recruiting

  • Vital-Medicina /ID# 272858

    Veszprém, Fejér 8200
    Hungary

    Active - Recruiting

  • Vital-Medicina Kft. /ID# 272858

    Veszprém, Fejér 8200
    Hungary

    Active - Recruiting

  • Qualiclinic /ID# 281259

    Budapest, 1134
    Hungary

    Active - Recruiting

  • Revita Reumatologiai Rendelo (Revita Kft.) /ID# 281247

    Budapest, 1027
    Hungary

    Active - Recruiting

  • Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273212

    Budapest, 1023
    Hungary

    Active - Recruiting

  • Medicover Integrated Clinical Services - Bydgoszcz (SMO/Network/Consortium) /ID# 272975

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-068
    Poland

    Active - Recruiting

  • Mics Centrum Medyczne Bydgoszcz /ID# 272975

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-068
    Poland

    Active - Recruiting

  • Szpital Uniwersytecki Nr 2 Im. Dr Jana Biziela W Bydgoszczy /ID# 281180

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-168
    Poland

    Active - Recruiting

  • Centrum Nowoczesnych Terapii Dobry Lekarz sp.z.o.o. /ID# 281209

    Krakow, Lesser Poland Voivodeship 31-011
    Poland

    Active - Recruiting

  • Malopolskie Centrum Kliniczne /ID# 272965

    Krakow, Lesser Poland Voivodeship 30-149
    Poland

    Active - Recruiting

  • Centrum Medyczne Reuma Park /ID# 272968

    Warsaw, Masovian Voivodeship 02-665
    Poland

    Active - Recruiting

  • Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 272966

    Elblag, Warmian-Masurian Voivodeship 82-300
    Poland

    Active - Recruiting

  • Etyka Osrodek Badan Klinicznych /ID# 272974

    Olsztyn, Warmian-Masurian Voivodeship 10-117
    Poland

    Active - Recruiting

  • Clinical Research Investigator Group /ID# 274821

    Bayamón, 00960
    Puerto Rico

    Active - Recruiting

  • Clinical Research Investigator Group, LLC /ID# 274821

    Bayamón, 00960
    Puerto Rico

    Active - Recruiting

  • Centro Reumatologico De Caguas /ID# 277918

    Caguas, 00725
    Puerto Rico

    Active - Recruiting

  • Reuviva Research Center /ID# 277140

    Guaynabo, 00968-8050
    Puerto Rico

    Active - Recruiting

  • Reuviva Research Center, LLC /ID# 277140

    Guaynabo, 00968-8050
    Puerto Rico

    Active - Recruiting

  • Clinical Research Puerto Rico /ID# 281346

    San Juan, 00909-1738
    Puerto Rico

    Active - Recruiting

  • GCM Medical Group, PSC /ID# 273016

    San Juan, 00917
    Puerto Rico

    Active - Recruiting

  • Mindful Medical Research /ID# 281521

    San Juan, 00918-3756
    Puerto Rico

    Active - Recruiting

  • Santurce Clinical Trials and Infusion Center /ID# 277927

    San Juan, 00909
    Puerto Rico

    Active - Recruiting

  • Santurce Clinical Trials and Infusion Center /ID# 277927

    San Juan 4568127, 00909
    Puerto Rico

    Active - Recruiting

  • Institute Of Rheumatology /ID# 280054

    Belgrade, Beograd 11000
    Serbia

    Active - Recruiting

  • Institute Of Rheumatology /ID# 280055

    Belgrade, Beograd 11000
    Serbia

    Active - Recruiting

  • Specijalna Bolnica za Reumatske bolesti Novi Sad /ID# 280057

    Novi Sad, Juznobacki Okrug 21000
    Serbia

    Active - Recruiting

  • Specijalna Bolnica za Reumatske bolesti Novi Sad /ID# 280058

    Novi Sad, Juznobacki Okrug 21000
    Serbia

    Active - Recruiting

  • MEDMAN s.r.o. /ID# 278688

    Martin, Žilina Region 036 01
    Slovakia

    Active - Recruiting

  • Excellentis Clinical Trial Consultants /ID# 282481

    George, Western Cape 6529
    South Africa

    Site Not Available

  • SoonChunHyang University Hospital Cheonan /ID# 277624

    Cheonan-si, Chungcheongnam-do 31151
    South Korea

    Active - Recruiting

  • Ajou University Hospital - Suwon-si /ID# 273647

    Suwon, Gyeonggido 16499
    South Korea

    Active - Recruiting

  • Ajou University Hospital /ID# 273647

    Suwon, Gyeonggido 16499
    South Korea

    Active - Recruiting

  • Hanyang University Seoul Hospital /ID# 273625

    Seoul, Seoul Teugbyeolsi 04763
    South Korea

    Active - Recruiting

  • SMG-SNU Boramae Medical Center /ID# 273627

    Seoul, Seoul Teugbyeolsi 07061
    South Korea

    Active - Recruiting

  • SMG-SNU Boramae Medical Center /ID# 273627

    Seoul 1835848, Seoul Teugbyeolsi 07061
    South Korea

    Active - Recruiting

  • Complejo Hospitalario Universitario A Coruña /ID# 272609

    A Coruña, A Coruna 15006
    Spain

    Active - Recruiting

  • Hospital Universitari Parc Tauli /ID# 272607

    Sabadell, Barcelona 08208
    Spain

    Active - Recruiting

  • Hospital Universitario de Valme /ID# 281266

    Seville, Sevilla 41014
    Spain

    Active - Recruiting

  • Hospital de Basurto /ID# 272610

    Bilbao, Vizcaya 48013
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofia /ID# 272613

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon /ID# 272616

    Madrid, 28007
    Spain

    Active - Recruiting

  • Consorci Hospital General Universitario de Valencia /ID# 272615

    Valencia, 46014
    Spain

    Active - Recruiting

  • Taoyuan General Hospital /ID# 280044

    Taoyuan City, 330
    Taiwan

    Active - Recruiting

  • Sun Valley Arthritis Center /ID# 278331

    Peoria, Arizona 85381
    United States

    Active - Recruiting

  • Arensia Research Clinic /ID# 280896

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • Arthritis And Rheumatism Associates (Ara) - Jonesboro /ID# 272896

    Jonesboro, Arkansas 72401
    United States

    Active - Recruiting

  • Private Practice - Dr. David S. Hallegua /ID# 277608

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 277826

    Chula Vista, California 91910
    United States

    Active - Recruiting

  • Newport Huntington Medical Group /ID# 272439

    Huntington Beach, California 92648-5994
    United States

    Active - Recruiting

  • Cohen Medical Centers /ID# 278341

    Thousand Oaks, California 91360
    United States

    Active - Recruiting

  • The Lundquist Institute /ID# 272481

    Torrance, California 90502
    United States

    Active - Recruiting

  • Inland Rheumatology & Osteoporosis Medical Group /ID# 272449

    Upland, California 91786
    United States

    Active - Recruiting

  • Inland Rheumatology and Osteoporosis Medical Group /ID# 272449

    Upland, California 91786
    United States

    Active - Recruiting

  • Tekton Research - Fort Collins - East Harmony Road /ID# 272472

    Fort Collins, Colorado 80528
    United States

    Active - Recruiting

  • Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 272298

    Avon Park, Florida 33825
    United States

    Active - Recruiting

  • Clinical Research Of West Florida - Phase I Unit /ID# 272428

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Finlay Medical Research - Greenacres /ID# 281654

    Greenacres City, Florida 33467
    United States

    Active - Recruiting

  • Neoclinical Research - Hialeah /ID# 272070

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • South Florida Rheumatology /ID# 278339

    Hollywood, Florida 33026
    United States

    Active - Recruiting

  • Swati Shah, MD Rheumatology /ID# 273624

    Jacksonville, Florida 32257
    United States

    Active - Recruiting

  • Life Clinical Trials - Colonial Drive - Margate /ID# 272589

    Margate, Florida 33063
    United States

    Active - Recruiting

  • Life Clinical Trials /ID# 272589

    Margate, Florida 33063
    United States

    Active - Recruiting

  • LeJenue Research Associates /ID# 272269

    Miami, Florida 33126
    United States

    Site Not Available

  • HMD Research LLC /ID# 272432

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • Vitalia Research /ID# 272478

    Palm Beach Gardens, Florida 33410
    United States

    Active - Recruiting

  • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 272755

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Northwestern Medicine - Northwestern Memorial Hospital /ID# 275422

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Deerbrook Medical Associates /ID# 273439

    Libertyville, Illinois 60048
    United States

    Active - Recruiting

  • Advanced Quality Medical Research /ID# 277824

    Orland Park, Illinois 60462
    United States

    Active - Recruiting

  • Arnold Arthritis & Rheumatology /ID# 278354

    Skokie, Illinois 60076
    United States

    Active - Recruiting

  • Willow Rheumatology and Wellness /ID# 272691

    Willowbrook, Illinois 60527
    United States

    Active - Recruiting

  • Willow Rheumatology and Wellness, PLLC /ID# 272691

    Willowbrook, Illinois 60527
    United States

    Active - Recruiting

  • Accurate Clinical Research (SMO/Network/Consortium) /ID# 272650

    Lake Charles, Louisiana 70605
    United States

    Active - Recruiting

  • AA Medical Research Center - Grand Blanc /ID# 272496

    Grand Blanc, Michigan 48439
    United States

    Active - Recruiting

  • Sahni Rheumatology & Therapy /ID# 278352

    West Long Branch, New Jersey 07764
    United States

    Active - Recruiting

  • Albuquerque Center For Rheumatology /ID# 272301

    Albuquerque, New Mexico 87102
    United States

    Active - Recruiting

  • Northwell Health Physician Partners Rheumatology At Great Neck /ID# 275621

    Great Neck, New York 11021
    United States

    Active - Recruiting

  • DJL Clinical Research - Charlotte /ID# 272387

    Charlotte, North Carolina 28211-1064
    United States

    Active - Recruiting

  • DJL Clinical Research, PLLC /ID# 272387

    Charlotte, North Carolina 28211-1064
    United States

    Active - Recruiting

  • Joint And Muscle Research Institute /ID# 277290

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Cape Fear Arthritis Care /ID# 272076

    Leland, North Carolina 28451
    United States

    Site Not Available

  • Joint And Muscle Research Institute /ID# 277290

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Active - Recruiting

  • Paramount Medical Research and Consulting /ID# 272474

    Middleburg Heights, Ohio 44130
    United States

    Active - Recruiting

  • Altoona Center For Clinical Research /ID# 272479

    Duncansville, Pennsylvania 16635
    United States

    Active - Recruiting

  • Low Country Rheumatology /ID# 277607

    Summerville, South Carolina 29486
    United States

    Active - Recruiting

  • West Tennessee Research Institute /ID# 272453

    Jackson, Tennessee 38305
    United States

    Active - Recruiting

  • Arthritis & Rheumatology Research Institute /ID# 272299

    Allen, Texas 75013
    United States

    Active - Recruiting

  • Arthritis and Rheumatology Research Institute /ID# 272299

    Allen, Texas 75013
    United States

    Active - Recruiting

  • Tekton Research - West Gate /ID# 272270

    Austin, Texas 78745
    United States

    Active - Recruiting

  • The University Of Texas At Austin - Ut Health Austin /ID# 283256

    Austin, Texas 78712
    United States

    Site Not Available

  • Trinity Universal Research Associates - Carrollton /ID# 272577

    Carrollton, Texas 75007
    United States

    Active - Recruiting

  • Arthritis Care Of Texas /ID# 277961

    Corpus Christi, Texas 78415
    United States

    Active - Recruiting

  • Accurate Clinical Research - Houston /ID# 272271

    Houston, Texas 77089-6142
    United States

    Active - Recruiting

  • Care & Cure Clinic /ID# 281684

    Houston, Texas 77909
    United States

    Active - Recruiting

  • Private Practice - Dr. Laila A. Hassan /ID# 272297

    Houston, Texas 77089
    United States

    Active - Recruiting

  • University Of Texas Health Science Center /ID# 283308

    Houston, Texas 77401
    United States

    Site Not Available

  • Biopharma Informatic /ID# 279189

    Katy, Texas 77494
    United States

    Active - Recruiting

  • Southwest Rheumatology Research /ID# 272268

    Mesquite, Texas 75150
    United States

    Active - Recruiting

  • Texas Rheumatology Research Institute Llc /Id# 278010

    Plano, Texas 75024
    United States

    Active - Recruiting

  • Epic Medical Research /ID# 272656

    Red Oak, Texas 75154
    United States

    Active - Recruiting

  • Texas Digestive Disease Consultants - Southlake /ID# 277652

    Southlake, Texas 76092
    United States

    Site Not Available

  • Fort Bend Rheumatology Associates /ID# 280761

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • DM Clinical Research - Tomball /ID# 272452

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • DM Clinical Research -Tomball RCH /ID# 281787

    Tomball, Texas 77377
    United States

    Active - Recruiting

  • Dynamed Clinical Research - Tomball /ID# 272452

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Private Practice - Dr. Laila A. Hassan /ID# 272297

    Houston 4699066, Texas 4736286 77089
    United States

    Active - Recruiting

  • Annapolis Rheumatology /ID# 279144

    Fairfax, Virginia 22311
    United States

    Site Not Available

  • Hoskinson Health & Wellness Clinic /ID# 281689

    Gillette, Wyoming 82718
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.