Back to Trials
NCT06972446PHASE2Recruiting

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

AbbVie

Start Date

6/20/2025

Completion Date

11/1/2027

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

Age Range: 18 years to No maximum

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 treatment duration. The maximum cap for prior use of b/tsDMARD is 2. * Participant must be on a stable dose of methotrexate (MTX) 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 conditions unless 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 of inflammatory joint disease other than rheumatoid arthritis.

Interventions

DRUG

Lutikizumab

DRUG

Placebo

DRUG

Ravagalimab

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Rheumatoid Arthritis

Locations

Sun Valley Arthritis Center /ID# 278331

Peoria, Arizona 85381

United States

Arensia Research Clinic /ID# 280896

Phoenix, Arizona 85015

United States

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

Jonesboro, Arkansas 72401

United States

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

Beverly Hills, California 90211

United States

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

Chula Vista, California 91910

United States

Newport Huntington Medical Group /ID# 272439

Huntington Beach, California 92648-5994

United States

Cohen Medical Centers /ID# 278341

Thousand Oaks, California 91360

United States

The Lundquist Institute /ID# 272481

Torrance, California 90502

United States

Inland Rheumatology and Osteoporosis Medical Group /ID# 272449

Upland, California 91786

United States

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

Fort Collins, Colorado 80528

United States

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

Avon Park, Florida 33825

United States

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

Clearwater, Florida 33765

United States

Finlay Medical Research - Greenacres /ID# 281654

Greenacres City, Florida 33467

United States

Neoclinical Research - Hialeah /ID# 272070

Hialeah, Florida 33016

United States

South Florida Rheumatology /ID# 278339

Hollywood, Florida 33026

United States

Swati Shah, MD Rheumatology /ID# 273624

Jacksonville, Florida 32257

United States

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

Margate, Florida 33063

United States

LeJenue Research Associates /ID# 272269

Miami, Florida 33126

United States

HMD Research LLC /ID# 272432

Orlando, Florida 32819

United States

Vitalia Research /ID# 272478

Palm Beach Gardens, Florida 33410

United States

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

Tampa, Florida 33606

United States

Northwestern Medicine - Northwestern Memorial Hospital /ID# 275422

Chicago, Illinois 60611

United States

Deerbrook Medical Associates /ID# 273439

Libertyville, Illinois 60048

United States

Advanced Quality Medical Research /ID# 277824

Orland Park, Illinois 60462

United States

Arnold Arthritis & Rheumatology /ID# 278354

Skokie, Illinois 60076

United States

Willow Rheumatology and Wellness /ID# 272691

Willowbrook, Illinois 60527

United States

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

Lake Charles, Louisiana 70605

United States

AA Medical Research Center - Grand Blanc /ID# 272496

Grand Blanc, Michigan 48439

United States

Sahni Rheumatology & Therapy /ID# 278352

West Long Branch, New Jersey 07764

United States

Albuquerque Center For Rheumatology /ID# 272301

Albuquerque, New Mexico 87102

United States

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

Great Neck, New York 11021

United States

Joint And Muscle Research Institute /ID# 277290

Charlotte, North Carolina 28204

United States

DJL Clinical Research - Charlotte /ID# 272387

Charlotte, North Carolina 28211-1064

United States

Cape Fear Arthritis Care /ID# 272076

Leland, North Carolina 28451

United States

Paramount Medical Research and Consulting /ID# 272474

Middleburg Heights, Ohio 44130

United States

Altoona Center For Clinical Research /ID# 272479

Duncansville, Pennsylvania 16635

United States

Low Country Rheumatology /ID# 277607

Summerville, South Carolina 29486

United States

West Tennessee Research Institute /ID# 272453

Jackson, Tennessee 38305

United States

Arthritis and Rheumatology Research Institute /ID# 272299

Allen, Texas 75013

United States

Tekton Research - West Gate /ID# 272270

Austin, Texas 78745

United States

Trinity Universal Research Associates - Carrollton /ID# 272577

Carrollton, Texas 75007

United States

Arthritis Care Of Texas /ID# 277961

Corpus Christi, Texas 78415

United States

Accurate Clinical Research - Houston /ID# 272271

Houston, Texas 77089-6142

United States

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

Houston, Texas 77089

United States

Care & Cure Clinic /ID# 281684

Houston, Texas 77909

United States

Biopharma Informatic /ID# 279189

Katy, Texas 77494

United States

Southwest Rheumatology Research /ID# 272268

Mesquite, Texas 75150

United States

Texas Rheumatology Research Institute Llc /Id# 278010

Plano, Texas 75024

United States

Epic Medical Research /ID# 272656

Red Oak, Texas 75154

United States

Texas Digestive Disease Consultants - Southlake /ID# 277652

Southlake, Texas 76092

United States

Fort Bend Rheumatology Associates /ID# 280761

Sugar Land, Texas 77479

United States

DM Clinical Research - Tomball /ID# 272452

Tomball, Texas 77375

United States

DM Clinical Research -Tomball RCH /ID# 281787

Tomball, Texas 77377

United States

Annapolis Rheumatology /ID# 279144

Fairfax, Virginia 22311

United States

Hoskinson Health & Wellness Clinic /ID# 281689

Gillette, Wyoming 82718

United States

Care Clinic - Calgary /ID# 274405

Calgary, Alberta T2N 4L7

Canada

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

Sherbrooke, Quebec J1G 2E8

Canada

Dr. Latha Naik Medical Professional Corporation /ID# 274403

Saskatoon, Saskatchewan S7H 0P4

Canada

L.K.N. Arthrocentrum /ID# 271932

Hlučín, Moravian-Silesian Region 748 01

Czechia

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

Uherské Hradiště, 686 01

Czechia

PV Medical Services /ID# 271934

Zlín, 760 01

Czechia

Rheumateam Lahn-Dill-Siegerland /ID# 274858

Wetzlar, Hesse 35578

Germany

Universitaetsklinikum Bonn /ID# 272808

Bonn, North Rhine-Westphalia 53127

Germany

Krankenhaus Porz Am Rhein /ID# 272903

Cologne, North Rhine-Westphalia 51149

Germany

Mvz Rheuma /ID# 272795

Hamburg, 20095

Germany

Szegedi Tudomanyegyetem /ID# 272865

Szeged, Csongrád megye 6720

Hungary

Complex Rendelo Med Zrt. /ID# 272859

Székesfehérvár, Fejér 8000

Hungary

Vital-Medicina /ID# 272858

Veszprém, Fejér 8200

Hungary

Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273212

Budapest, 1023

Hungary

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

Budapest, 1027

Hungary

Qualiclinic /ID# 281259

Budapest, 1134

Hungary

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-068

Poland

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-168

Poland

Malopolskie Centrum Kliniczne /ID# 272965

Krakow, Lesser Poland Voivodeship 30-149

Poland

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

Krakow, Lesser Poland Voivodeship 31-011

Poland

Centrum Medyczne Reuma Park /ID# 272968

Warsaw, Masovian Voivodeship 02-665

Poland

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

Elblag, Warmian-Masurian Voivodeship 82-300

Poland

Etyka Osrodek Badan Klinicznych /ID# 272974

Olsztyn, Warmian-Masurian Voivodeship 10-117

Poland

Clinical Research Investigator Group /ID# 274821

Bayamón, 00960

Puerto Rico

Centro Reumatologico De Caguas /ID# 277918

Caguas, 00725

Puerto Rico

Reuviva Research Center /ID# 277140

Guaynabo, 00968-8050

Puerto Rico

Clinical Research Puerto Rico /ID# 281346

San Juan, 00909-1738

Puerto Rico

Santurce Clinical Trials and Infusion Center /ID# 277927

San Juan, 00909

Puerto Rico

GCM Medical Group, PSC /ID# 273016

San Juan, 00917

Puerto Rico

Mindful Medical Research /ID# 281521

San Juan, 00918-3756

Puerto Rico

Institute Of Rheumatology /ID# 280055

Belgrade, Beograd 11000

Serbia

Specijalna Bolnica za Reumatske bolesti Novi Sad /ID# 280057

Novi Sad, Juznobacki Okrug 21000

Serbia

Specijalna Bolnica za Reumatske bolesti Novi Sad /ID# 280058

Novi Sad, Juznobacki Okrug 21000

Serbia

MEDMAN s.r.o. /ID# 278688

Martin, Žilina Region 036 01

Slovakia

SoonChunHyang University Hospital Cheonan /ID# 277624

Cheonan-si, Chungcheongnam-do 31151

South Korea

Ajou University Hospital - Suwon-si /ID# 273647

Suwon, Gyeonggido 16499

South Korea

Hanyang University Seoul Hospital /ID# 273625

Seoul, Seoul Teugbyeolsi 04763

South Korea

SMG-SNU Boramae Medical Center /ID# 273627

Seoul, Seoul Teugbyeolsi 07061

South Korea

Complejo Hospitalario Universitario A Coruña /ID# 272609

A Coruña, A Coruna 15006

Spain

Hospital Universitari Parc Tauli /ID# 272607

Sabadell, Barcelona 08208

Spain

Hospital Universitario de Valme /ID# 281266

Seville, Sevilla 41014

Spain

Hospital de Basurto /ID# 272610

Bilbao, Vizcaya 48013

Spain

Hospital Universitario Reina Sofia /ID# 272613

Córdoba, 14004

Spain

Hospital General Universitario Gregorio Maranon /ID# 272616

Madrid, 28007

Spain

Consorci Hospital General Universitario de Valencia /ID# 272615

Valencia, 46014

Spain

Taoyuan General Hospital /ID# 280044

Taoyuan City, 330

Taiwan