Recruiting

Phase 2

Lutikizumab & RavagalimabA Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis

Sponsor:

AbbVie

Code:

NCT06972446

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lutikizumab

Placebo

Ravagalimab

Study Details

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

Study ID

NCT06972446

Start date

Jun 20, 2025

Status verified date

Jul, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Substudy 1: Lutikizumab Monotherapy

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

placebo comparator: Substudy 1: Matching Placebo Monotherapy

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

experimental: Substudy 2: Ravagalimab Monotherapy

Participants will be randomized to receive Ravagalimab

placebo comparator: Substudy 2: Matching Placebo Monotherapy

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

experimental: SubStudy 3: Lutikizumab and Ravagalimab Combination Therapy

Participants will be randomized to be administered Lutikizumab and Ravagalimab doses

placebo comparator: Substudy 3: Matching Placebo Combination Therapy

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

Interventions

Lutikizumab

Subcutaneous (SC) injection

Placebo

Subcutaneous (SC) injection

Ravagalimab

Subcutaneous (SC) injection

Primary outcome measure

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response [ Time Frame: At Week 12 ]
Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Approximately Week 22 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

Locations

Sun Valley Arthritis Center /ID# 278331

Recruiting

Peoria, Arizona, United States, 85381

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

Recruiting

Jonesboro, Arkansas, United States, 72401

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

Recruiting

Beverly Hills, California, United States, 90211

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

Recruiting

Chula Vista, California, United States, 91910

Contacts

Site Coordinator

619-334-4735

Newport Huntington Medical Group /ID# 272439

Recruiting

Huntington Beach, California, United States, 92648-5994

Cohen Medical Centers /ID# 278341

Recruiting

Thousand Oaks, California, United States, 91360

The Lundquist Institute /ID# 272481

Recruiting

Torrance, California, United States, 90502

Inland Rheumatology and Osteoporosis Medical Group /ID# 272449

Recruiting

Upland, California, United States, 91786

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

Recruiting

Fort Collins, Colorado, United States, 80528

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

Recruiting

Avon Park, Florida, United States, 33825

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

Recruiting

Clearwater, Florida, United States, 33765

Finlay Medical Research - Greenacres /ID# 281654

Recruiting

Greenacres City, Florida, United States, 33467

Neoclinical Research - Hialeah /ID# 272070

Recruiting

Hialeah, Florida, United States, 33016

South Florida Rheumatology /ID# 278339

Recruiting

Hollywood, Florida, United States, 33026

Swati Shah, MD Rheumatology /ID# 273624

Recruiting

Jacksonville, Florida, United States, 32257

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

Recruiting

Margate, Florida, United States, 33063

HMD Research LLC /ID# 272432

Recruiting

Orlando, Florida, United States, 32819

Vitalia Research /ID# 272478

Recruiting

Palm Beach Gardens, Florida, United States, 33410

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

Recruiting

Tampa, Florida, United States, 33606

Contacts

Site Coordinator

813-870-1292

Northwestern Medicine - Northwestern Memorial Hospital /ID# 275422

Recruiting

Chicago, Illinois, United States, 60611

Deerbrook Medical Associates /ID# 273439

Recruiting

Libertyville, Illinois, United States, 60048

Advanced Quality Medical Research /ID# 277824

Recruiting

Orland Park, Illinois, United States, 60462

Arnold Arthritis & Rheumatology /ID# 278354

Recruiting

Skokie, Illinois, United States, 60076

Willow Rheumatology and Wellness /ID# 272691

Recruiting

Willowbrook, Illinois, United States, 60527

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

Recruiting

Lake Charles, Louisiana, United States, 70605

AA Medical Research Center - Grand Blanc /ID# 272496

Recruiting

Grand Blanc, Michigan, United States, 48439

Sahni Rheumatology & Therapy /ID# 278352

Recruiting

West Long Branch, New Jersey, United States, 07764

Albuquerque Center For Rheumatology /ID# 272301

Recruiting

Albuquerque, New Mexico, United States, 87102

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

Recruiting

Great Neck, New York, United States, 11021

Joint And Muscle Research Institute /ID# 277290

Recruiting

Charlotte, North Carolina, United States, 28204

DJL Clinical Research - Charlotte /ID# 272387

Recruiting

Charlotte, North Carolina, United States, 28211-1064

Paramount Medical Research and Consulting /ID# 272474

Recruiting

Middleburg Heights, Ohio, United States, 44130

Altoona Center For Clinical Research /ID# 272479

Recruiting

Duncansville, Pennsylvania, United States, 16635

Contacts

Site Coordinator

814-693-0300

Low Country Rheumatology /ID# 277607

Recruiting

Summerville, South Carolina, United States, 29486

West Tennessee Research Institute /ID# 272453

Recruiting

Jackson, Tennessee, United States, 38305

Arthritis and Rheumatology Research Institute /ID# 272299

Recruiting

Allen, Texas, United States, 75013

Tekton Research - West Gate /ID# 272270

Recruiting

Austin, Texas, United States, 78745

Trinity Universal Research Associates - Carrollton /ID# 272577

Recruiting

Carrollton, Texas, United States, 75007

Arthritis Care Of Texas /ID# 277961

Recruiting

Corpus Christi, Texas, United States, 78415

Contacts

Site Coordinator

713-487-8680

Accurate Clinical Research - Houston /ID# 272271

Recruiting

Houston, Texas, United States, 77089-6142

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

Recruiting

Houston, Texas, United States, 77089

Care & Cure Clinic /ID# 281684

Recruiting

Houston, Texas, United States, 77909

Contacts

Site Coordinator

832-234-1023

Biopharma Informatic /ID# 279189

Recruiting

Katy, Texas, United States, 77494

Southwest Rheumatology Research /ID# 272268

Recruiting

Mesquite, Texas, United States, 75150

Contacts

Site Coordinator

972-288-2600

Texas Rheumatology Research Institute Llc /Id# 278010

Recruiting

Plano, Texas, United States, 75024

Epic Medical Research /ID# 272656

Recruiting

Red Oak, Texas, United States, 75154

Fort Bend Rheumatology Associates /ID# 280761

Recruiting

Sugar Land, Texas, United States, 77479

DM Clinical Research - Tomball /ID# 272452

Recruiting

Tomball, Texas, United States, 77375

DM Clinical Research -Tomball RCH /ID# 281787

Recruiting

Tomball, Texas, United States, 77377

Care Clinic - Calgary /ID# 274405

Recruiting

Calgary, Alberta, Canada, T2N 4L7

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

Recruiting

Sherbrooke, Quebec, Canada, J1G 2E8

Dr. Latha Naik Medical Professional Corporation /ID# 274403

Recruiting

Saskatoon, Saskatchewan, Canada, S7H 0P4

More Information

Sponsor

AbbVie

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

Rheumatoid Arthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by AbbVie on 2026-07-10.