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

NCT06972446 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: M25-0562025-520721-21-00
• Study Type: interventional
• Target: 180
• Locations: 11 countries
• Sites: 94

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response

  Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)

  At Week 12

• Number of Participants with Adverse Events (AEs)

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to Approximately Week 22

Secondary Outcomes (7)

• Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response

  At Week 12

• Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response

  At Week 12

• Percentage Of Participants Achieving Low Disease Activity (LDA) per Disease Activity Score-28 With C-Reactive Protein (DAS28-CRP)

  At Week 12

• Percentage Of Participants Achieving Clinical Remission (CR) per DAS28 (CRP)

  At Week 12

• Change from Baseline in DAS28 (CRP)

  At Week 12

Study Arms (6)

Substudy 1: Lutikizumab Monotherapy

EXPERIMENTAL

Participants will be randomized to initially receive Lutikizumab Dose A followed by Lutikizumab Dose B

Drug: Lutikizumab

Substudy 1: Matching Placebo Monotherapy

PLACEBO COMPARATOR

Participants will be randomized to receive a matching placebo dose equivalent to the Lutikizumab monotherapy.

Drug: Placebo

Substudy 2: Ravagalimab Monotherapy

EXPERIMENTAL

Participants will be randomized to receive Ravagalimab

Drug: Ravagalimab

Substudy 2: Matching Placebo Monotherapy

PLACEBO COMPARATOR

Participants will be randomized to receive a matching placebo dose equivalent to the Ravagalimab monotherapy

Drug: Placebo

SubStudy 3: Lutikizumab and Ravagalimab Combination Therapy

EXPERIMENTAL

Participants will be randomized to be administered Lutikizumab and Ravagalimab doses

Drug: Lutikizumab; Drug: Ravagalimab

Substudy 3: Matching Placebo Combination Therapy

PLACEBO COMPARATOR

Participants will be randomized to receive matching placebo doses equivalent to the Lutikizumab and Ravagalimab combination therapy

Drug: Placebo

Interventions

Ravagalimab DRUG

Subcutaneous (SC) injection

SubStudy 3: Lutikizumab and Ravagalimab Combination Therapy; Substudy 2: Ravagalimab Monotherapy

Placebo DRUG

Subcutaneous (SC) injection

Substudy 1: Matching Placebo Monotherapy; Substudy 2: Matching Placebo Monotherapy; Substudy 3: Matching Placebo Combination Therapy

Lutikizumab DRUG

Subcutaneous (SC) injection

SubStudy 3: Lutikizumab and Ravagalimab Combination Therapy; Substudy 1: Lutikizumab Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (94)

Sun Valley Arthritis Center /ID# 278331

Peoria, Arizona, 85381, United States

RECRUITING

Arensia Research Clinic /ID# 280896

Phoenix, Arizona, 85015, United States

NOT YET RECRUITING

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

Beverly Hills, California, 90211, United States

RECRUITING

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

Chula Vista, California, 91910, United States

RECRUITING

Newport Huntington Medical Group /ID# 272439

Huntington Beach, California, 92648-5994, United States

RECRUITING

Cohen Medical Centers /ID# 278341

Thousand Oaks, California, 91360, United States

RECRUITING

The Lundquist Institute /ID# 272481

Torrance, California, 90502, United States

RECRUITING

Inland Rheumatology and Osteoporosis Medical Group /ID# 272449

Upland, California, 91786, United States

RECRUITING

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

Fort Collins, Colorado, 80528, United States

RECRUITING

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

Avon Park, Florida, 33825, United States

RECRUITING

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

Clearwater, Florida, 33765, United States

RECRUITING

Neoclinical Research - Hialeah /ID# 272070

Hialeah, Florida, 33016, United States

RECRUITING

South Florida Rheumatology /ID# 278339

Hollywood, Florida, 33026, United States

RECRUITING

Swati Shah, MD Rheumatology /ID# 273624

Jacksonville, Florida, 32257, United States

RECRUITING

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

Margate, Florida, 33063, United States

RECRUITING

LeJenue Research Associates /ID# 272269

Miami, Florida, 33126, United States

NOT YET RECRUITING

HMD Research LLC /ID# 272432

Orlando, Florida, 32819, United States

RECRUITING

Vitalia Research /ID# 272478

Palm Beach Gardens, Florida, 33410, United States

RECRUITING

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

Tampa, Florida, 33606, United States

RECRUITING

Northwestern Medicine - Northwestern Memorial Hospital /ID# 275422

Chicago, Illinois, 60611, United States

RECRUITING

Deerbrook Medical Associates /ID# 273439

Libertyville, Illinois, 60048, United States

RECRUITING

Advanced Quality Medical Research /ID# 277824

Orland Park, Illinois, 60462, United States

RECRUITING

Arnold Arthritis & Rheumatology /ID# 278354

Skokie, Illinois, 60076, United States

RECRUITING

Willow Rheumatology and Wellness /ID# 272691

Willowbrook, Illinois, 60527, United States

RECRUITING

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

Lake Charles, Louisiana, 70605, United States

RECRUITING

AA Medical Research Center - Grand Blanc /ID# 272496

Grand Blanc, Michigan, 48439, United States

RECRUITING

Sahni Rheumatology & Therapy /ID# 278352

West Long Branch, New Jersey, 07764, United States

RECRUITING

Albuquerque Center For Rheumatology /ID# 272301

Albuquerque, New Mexico, 87102, United States

RECRUITING

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

Great Neck, New York, 11021, United States

RECRUITING

Joint And Muscle Research Institute /ID# 277290

Charlotte, North Carolina, 28204, United States

RECRUITING

DJL Clinical Research - Charlotte /ID# 272387

Charlotte, North Carolina, 28211-1064, United States

RECRUITING

Cape Fear Arthritis Care /ID# 272076

Leland, North Carolina, 28451, United States

NOT YET RECRUITING

Paramount Medical Research and Consulting /ID# 272474

Middleburg Heights, Ohio, 44130, United States

RECRUITING

Altoona Center For Clinical Research /ID# 272479

Duncansville, Pennsylvania, 16635, United States

RECRUITING

Low Country Rheumatology /ID# 277607

Summerville, South Carolina, 29486, United States

RECRUITING

West Tennessee Research Institute /ID# 272453

Jackson, Tennessee, 38305, United States

RECRUITING

Arthritis and Rheumatology Research Institute /ID# 272299

Allen, Texas, 75013, United States

RECRUITING

Tekton Research - West Gate /ID# 272270

Austin, Texas, 78745, United States

RECRUITING

Trinity Universal Research Associates - Carrollton /ID# 272577

Carrollton, Texas, 75007, United States

RECRUITING

Arthritis Care Of Texas /ID# 277961

Corpus Christi, Texas, 78415, United States

RECRUITING

Accurate Clinical Research - Houston /ID# 272271

Houston, Texas, 77089-6142, United States

RECRUITING

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

Houston, Texas, 77089, United States

RECRUITING

Care & Cure Clinic /ID# 281684

Houston, Texas, 77909, United States

RECRUITING

Biopharma Informatic /ID# 279189

Katy, Texas, 77494, United States

RECRUITING

Southwest Rheumatology Research /ID# 272268

Mesquite, Texas, 75150, United States

RECRUITING

Texas Rheumatology Research Institute Llc /Id# 278010

Plano, Texas, 75024, United States

RECRUITING

Epic Medical Research /ID# 272656

Red Oak, Texas, 75154, United States

RECRUITING

Texas Digestive Disease Consultants - Southlake /ID# 277652

Southlake, Texas, 76092, United States

NOT YET RECRUITING

DM Clinical Research - Tomball /ID# 272452

Tomball, Texas, 77375, United States

RECRUITING

DM Clinical Research -Tomball RCH /ID# 281787

Tomball, Texas, 77377, United States

RECRUITING

Annapolis Rheumatology /ID# 279144

Fairfax, Virginia, 22311, United States

NOT YET RECRUITING

Hoskinson Health & Wellness Clinic /ID# 281689

Gillette, Wyoming, 82718, United States

NOT YET RECRUITING

Care Clinic - Calgary /ID# 274405

Calgary, Alberta, T2N 4L7, Canada

RECRUITING

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

Sherbrooke, Quebec, J1G 2E8, Canada

RECRUITING

Dr. Latha Naik Medical Professional Corporation /ID# 274403

Saskatoon, Saskatchewan, S7H 0P4, Canada

RECRUITING

L.K.N. Arthrocentrum /ID# 271932

Hlučín, Moravian-Silesian Region, 748 01, Czechia

RECRUITING

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

Uherské Hradiště, 686 01, Czechia

RECRUITING

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

Zlín, 760 01, Czechia

RECRUITING

Rheumateam Lahn-Dill-Siegerland /ID# 274858

Wetzlar, Hesse, 35578, Germany

RECRUITING

Universitaetsklinikum Bonn /ID# 272808

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Krankenhaus Porz Am Rhein /ID# 272903

Cologne, North Rhine-Westphalia, 51149, Germany

RECRUITING

Mvz Rheuma /ID# 272795

Hamburg, 20095, Germany

RECRUITING

Szegedi Tudomanyegyetem /ID# 272865

Szeged, Csongrád megye, 6720, Hungary

RECRUITING

Complex Rendelo Med Zrt. /ID# 272859

Székesfehérvár, Fejér, 8000, Hungary

RECRUITING

Vital-Medicina Kft. /ID# 272858

Veszprém, Fejér, 8200, Hungary

RECRUITING

Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273212

Budapest, 1023, Hungary

RECRUITING

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

Budapest, 1027, Hungary

RECRUITING

Qualiclinic /ID# 281259

Budapest, 1134, Hungary

RECRUITING

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-068, Poland

RECRUITING

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

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

RECRUITING

Malopolskie Centrum Kliniczne /ID# 272965

Krakow, Lesser Poland Voivodeship, 30-149, Poland

RECRUITING

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

Krakow, Lesser Poland Voivodeship, 31-011, Poland

RECRUITING

Centrum Medyczne Reuma Park /ID# 272968

Warsaw, Masovian Voivodeship, 02-665, Poland

RECRUITING

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

Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

RECRUITING

Etyka Osrodek Badan Klinicznych /ID# 272974

Olsztyn, Warmian-Masurian Voivodeship, 10-117, Poland

RECRUITING

Clinical Research Investigator Group /ID# 274821

Bayamón, 00960, Puerto Rico

RECRUITING

Centro Reumatologico De Caguas /ID# 277918

Caguas, 00725, Puerto Rico

RECRUITING

Reuviva Research Center /ID# 277140

Guaynabo, 00968-8050, Puerto Rico

RECRUITING

Clinical Research Puerto Rico /ID# 281346

San Juan, 00909-1738, Puerto Rico

RECRUITING

Santurce Clinical Trials and Infusion Center /ID# 277927

San Juan, 00909, Puerto Rico

RECRUITING

GCM Medical Group, PSC /ID# 273016

San Juan, 00917, Puerto Rico

RECRUITING

MEDMAN s.r.o. /ID# 278688

Martin, Žilina Region, 036 01, Slovakia

RECRUITING

SoonChunHyang University Hospital Cheonan /ID# 277624

Cheonan-si, Chungcheongnam-do, 31151, South Korea

RECRUITING

Ajou University Hospital - Suwon-si /ID# 273647

Suwon, Gyeonggido, 16499, South Korea

RECRUITING

Hanyang University Seoul Hospital /ID# 273625

Seoul, Seoul Teugbyeolsi, 04763, South Korea

RECRUITING

SMG-SNU Boramae Medical Center /ID# 273627

Seoul, Seoul Teugbyeolsi, 07061, South Korea

RECRUITING

Complejo Hospitalario Universitario A Coruña /ID# 272609

A Coruña, A Coruna, 15006, Spain

RECRUITING

Hospital Universitari Parc Tauli /ID# 272607

Sabadell, Barcelona, 08208, Spain

RECRUITING

Hospital Universitario de Valme /ID# 281266

Seville, Sevilla, 41014, Spain

RECRUITING

Hospital de Basurto /ID# 272610

Bilbao, Vizcaya, 48013, Spain

RECRUITING

Hospital Universitario Reina Sofia /ID# 272613

Córdoba, 14004, Spain

RECRUITING

Hospital General Universitario Gregorio Maranon /ID# 272616

Madrid, 28007, Spain

RECRUITING

Consorci Hospital General Universitario de Valencia /ID# 272615

Valencia, 46014, Spain

RECRUITING

Taoyuan General Hospital /ID# 280044

Taoyuan City, 330, Taiwan

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

lutikizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

DE (4); PL (7); CA (3); CZ (3); PR (6); SL (1); ES (7); KR (4); HU (6); TW (1); US (52)