RecruitingPhase 2NCT06972446

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

A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis

Sponsor

AbbVie

Enrollment

180 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different targeted therapies for people with rheumatoid arthritis (RA) — a condition where the immune system attacks the joints — to find out which treatments work best for different patients. **You may be eligible if...** - You have rheumatoid arthritis that has not responded well to at least one biologic or targeted synthetic DMARD (disease-modifying drug), or you had to stop that treatment due to side effects - You have tried no more than 2 prior biologic or targeted treatments - You are currently taking methotrexate at a stable dose **You may NOT be eligible if...** - You are taking pain medications (NSAIDs, acetaminophen, opioids) or corticosteroids that have not been at a stable dose for at least 1 week before the study begins - Your arthritis started before age 17 or you have a different type of inflammatory joint disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLutikizumab

Subcutaneous (SC) injection

DRUGPlacebo

Subcutaneous (SC) injection

DRUGRavagalimab

Subcutaneous (SC) injection

Locations(70)

Sun Valley Arthritis Center /ID# 278331

Peoria, Arizona, United States

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

Beverly Hills, California, United States

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

Chula Vista, California, United States

Newport Huntington Medical Group /ID# 272439

Huntington Beach, California, United States

Cohen Medical Centers /ID# 278341

Thousand Oaks, California, United States

The Lundquist Institute /ID# 272481

Torrance, California, United States

Inland Rheumatology & Osteoporosis Medical Group /ID# 272449

Upland, California, United States

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

Fort Collins, Colorado, United States

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

Avon Park, Florida, United States

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

Clearwater, Florida, United States

Neoclinical Research - Hialeah /ID# 272070

Hialeah, Florida, United States

South Florida Rheumatology /ID# 278339

Hollywood, Florida, United States

Swati Shah, MD Rheumatology /ID# 273624

Jacksonville, Florida, United States

Life Clinical Trials /ID# 272589

Margate, Florida, United States

HMD Research LLC /ID# 272432

Orlando, Florida, United States

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

Tampa, Florida, United States

Northwestern Medicine - Northwestern Memorial Hospital /ID# 275422

Chicago, Illinois, United States

Deerbrook Medical Associates /ID# 273439

Libertyville, Illinois, United States

Willow Rheumatology and Wellness, PLLC /ID# 272691

Willowbrook, Illinois, United States

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

Lake Charles, Louisiana, United States

AA Medical Research Center - Grand Blanc /ID# 272496

Grand Blanc, Michigan, United States

Albuquerque Center For Rheumatology /ID# 272301

Albuquerque, New Mexico, United States

Joint And Muscle Research Institute /ID# 277290

Charlotte, North Carolina, United States

DJL Clinical Research, PLLC /ID# 272387

Charlotte, North Carolina, United States

Paramount Medical Research and Consulting /ID# 272474

Middleburg Heights, Ohio, United States

Altoona Center For Clinical Research /ID# 272479

Duncansville, Pennsylvania, United States

Low Country Rheumatology /ID# 277607

Summerville, South Carolina, United States

West Tennessee Research Institute /ID# 272453

Jackson, Tennessee, United States

Arthritis & Rheumatology Research Institute /ID# 272299

Allen, Texas, United States

Tekton Research - West Gate /ID# 272270

Austin, Texas, United States

Trinity Universal Research Associates - Carrollton /ID# 272577

Carrollton, Texas, United States

Arthritis Care Of Texas /ID# 277961

Corpus Christi, Texas, United States

Accurate Clinical Research - Houston /ID# 272271

Houston, Texas, United States

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

Houston, Texas, United States

Southwest Rheumatology Research /ID# 272268

Mesquite, Texas, United States

Texas Rheumatology Research Institute Llc /Id# 278010

Plano, Texas, United States

Epic Medical Research /ID# 272656

Red Oak, Texas, United States

Dynamed Clinical Research - Tomball /ID# 272452

Tomball, Texas, United States

Care Clinic - Calgary /ID# 274405

Calgary, Alberta, Canada

Dr. Latha Naik Medical Professional Corporation /ID# 274403

Saskatoon, Saskatchewan, Canada

L.K.N. Arthrocentrum /ID# 271932

Hlučín, Moravian-Silesian Region, Czechia

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

Uherské Hradiště, Czechia

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

Zlín, Czechia

Rheumateam Lahn-Dill-Siegerland /ID# 274858

Wetzlar, Hesse, Germany

Universitaetsklinikum Bonn /ID# 272808

Bonn, North Rhine-Westphalia, Germany

Krankenhaus Porz Am Rhein /ID# 272903

Cologne, North Rhine-Westphalia, Germany

MVZ Rheumatologie und Autoimmunmedizin in Hamburg /ID# 272795

Hamburg, Germany

Complex Rendelo Med Zrt. /ID# 272859

Székesfehérvár, Fejér, Hungary

Vital-Medicina Kft. /ID# 272858

Veszprém, Fejér, Hungary

Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273212

Budapest, Hungary

Szegedi Tudomanyegyetem /ID# 272865

Szeged, Hungary

Mics Centrum Medyczne Bydgoszcz /ID# 272975

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Malopolskie Centrum Kliniczne /ID# 272965

Krakow, Lesser Poland Voivodeship, Poland

Centrum Medyczne Reuma Park /ID# 272968

Warsaw, Masovian Voivodeship, Poland

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

Elblag, Warmian-Masurian Voivodeship, Poland

Clinical Research Investigator Group, LLC /ID# 274821

Bayamón, Puerto Rico

Centro Reumatologico De Caguas /ID# 277918

Caguas, Puerto Rico

Reuviva Research Center, LLC /ID# 277140

Guaynabo, Puerto Rico

Santurce Clinical Trials and Infusion Center /ID# 277927

San Juan, Puerto Rico

GCM Medical Group, PSC /ID# 273016

San Juan, Puerto Rico

MEDMAN s.r.o. /ID# 278688

Martin, Žilina Region, Slovakia

SoonChunHyang University Hospital Cheonan /ID# 277624

Cheonan-si, Chungcheongnam-do, South Korea

Ajou University Hospital /ID# 273647

Suwon, Gyeonggido, South Korea

Hanyang University Seoul Hospital /ID# 273625

Seoul, Seoul Teugbyeolsi, South Korea

SMG-SNU Boramae Medical Center /ID# 273627

Seoul, Seoul Teugbyeolsi, South Korea

Complejo Hospitalario Universitario A Coruña /ID# 272609

A Coruña, A Coruna, Spain

Hospital Universitari Parc Tauli /ID# 272607

Sabadell, Barcelona, Spain

Hospital de Basurto /ID# 272610

Bilbao, Vizcaya, Spain

Hospital General Universitario Gregorio Maranon /ID# 272616

Madrid, Spain

Consorci Hospital General Universitario de Valencia /ID# 272615

Valencia, Spain

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NCT06972446

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