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A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis
NCT06972446 · AbbVie
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis
About this study
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 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 target: 180 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-06-20
Estimated completion: 2027-11
Last updated: 2026-04-14
Interventions
Drug: LutikizumabDrug: PlaceboDrug: Ravagalimab
Primary outcomes
- • Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response (At Week 12)
- • Number of Participants with Adverse Events (AEs) (Up to Approximately Week 22)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (70)
Sun Valley Arthritis Center /ID# 278331Recruiting
Peoria, Arizona, United States
Private Practice - Dr. David S. Hallegua /ID# 277608Recruiting
Beverly Hills, California, United States
Advanced Clinical Research Center, LLC dba TriWest Research Associates /ID# 277826Recruiting
Chula Vista, California, United States
Newport Huntington Medical Group /ID# 272439Recruiting
Huntington Beach, California, United States
Cohen Medical Centers /ID# 278341Recruiting
Thousand Oaks, California, United States
The Lundquist Institute /ID# 272481Recruiting
Torrance, California, United States
Inland Rheumatology & Osteoporosis Medical Group /ID# 272449Recruiting
Upland, California, United States
Tekton Research - Fort Collins - East Harmony Road /ID# 272472Recruiting
Fort Collins, Colorado, United States
Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 272298Recruiting
Avon Park, Florida, United States
Clinical Research Of West Florida - Phase I Unit /ID# 272428Recruiting
Clearwater, Florida, United States
Neoclinical Research - Hialeah /ID# 272070Recruiting
Hialeah, Florida, United States
South Florida Rheumatology /ID# 278339Recruiting
Hollywood, Florida, United States
Swati Shah, MD Rheumatology /ID# 273624Recruiting
Jacksonville, Florida, United States
Life Clinical Trials /ID# 272589Recruiting
Margate, Florida, United States
HMD Research LLC /ID# 272432Recruiting
Orlando, Florida, United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 272755Recruiting
Tampa, Florida, United States
Northwestern Medicine - Northwestern Memorial Hospital /ID# 275422Recruiting
Chicago, Illinois, United States
Deerbrook Medical Associates /ID# 273439Recruiting
Libertyville, Illinois, United States
Willow Rheumatology and Wellness, PLLC /ID# 272691Recruiting
Willowbrook, Illinois, United States
Accurate Clinical Research (SMO/Network/Consortium) /ID# 272650Recruiting
Lake Charles, Louisiana, United States
AA Medical Research Center - Grand Blanc /ID# 272496Recruiting
Grand Blanc, Michigan, United States
Albuquerque Center For Rheumatology /ID# 272301Recruiting
Albuquerque, New Mexico, United States
Joint And Muscle Research Institute /ID# 277290Recruiting
Charlotte, North Carolina, United States
DJL Clinical Research, PLLC /ID# 272387Recruiting
Charlotte, North Carolina, United States
Paramount Medical Research and Consulting /ID# 272474Recruiting
Middleburg Heights, Ohio, United States
Altoona Center For Clinical Research /ID# 272479Recruiting
Duncansville, Pennsylvania, United States
Low Country Rheumatology /ID# 277607Recruiting
Summerville, South Carolina, United States
West Tennessee Research Institute /ID# 272453Recruiting
Jackson, Tennessee, United States
Arthritis & Rheumatology Research Institute /ID# 272299Recruiting
Allen, Texas, United States
Tekton Research - West Gate /ID# 272270Recruiting
Austin, Texas, United States
Trinity Universal Research Associates - Carrollton /ID# 272577Recruiting
Carrollton, Texas, United States
Arthritis Care Of Texas /ID# 277961Recruiting
Corpus Christi, Texas, United States
Accurate Clinical Research - Houston /ID# 272271Recruiting
Houston, Texas, United States
Private Practice - Dr. Laila A. Hassan /ID# 272297Recruiting
Houston, Texas, United States
Southwest Rheumatology Research /ID# 272268Recruiting
Mesquite, Texas, United States
Texas Rheumatology Research Institute Llc /Id# 278010Recruiting
Plano, Texas, United States
Epic Medical Research /ID# 272656Recruiting
Red Oak, Texas, United States
Dynamed Clinical Research - Tomball /ID# 272452Recruiting
Tomball, Texas, United States
Care Clinic - Calgary /ID# 274405Recruiting
Calgary, Alberta, Canada
Dr. Latha Naik Medical Professional Corporation /ID# 274403Recruiting
Saskatoon, Saskatchewan, Canada
L.K.N. Arthrocentrum /ID# 271932Recruiting
Hlučín, Moravian-Silesian Region, Czechia
MEDICAL PLUS Research s.r.o /ID# 271926Recruiting
Uherské Hradiště, Czechia
PV Medical Services s.r.o. /ID# 271934Recruiting
Zlín, Czechia
Rheumateam Lahn-Dill-Siegerland /ID# 274858Recruiting
Wetzlar, Hesse, Germany
Universitaetsklinikum Bonn /ID# 272808Recruiting
Bonn, North Rhine-Westphalia, Germany
Krankenhaus Porz Am Rhein /ID# 272903Recruiting
Cologne, North Rhine-Westphalia, Germany
MVZ Rheumatologie und Autoimmunmedizin in Hamburg /ID# 272795Recruiting
Hamburg, Germany
Complex Rendelo Med Zrt. /ID# 272859Recruiting
Székesfehérvár, Fejér, Hungary
Vital-Medicina Kft. /ID# 272858Recruiting
Veszprém, Fejér, Hungary
Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273212Recruiting
Budapest, Hungary
Szegedi Tudomanyegyetem /ID# 272865Recruiting
Szeged, Hungary
Mics Centrum Medyczne Bydgoszcz /ID# 272975Recruiting
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Malopolskie Centrum Kliniczne /ID# 272965Recruiting
Krakow, Lesser Poland Voivodeship, Poland
Centrum Medyczne Reuma Park /ID# 272968Recruiting
Warsaw, Masovian Voivodeship, Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 272966Recruiting
Elblag, Warmian-Masurian Voivodeship, Poland
Clinical Research Investigator Group, LLC /ID# 274821Recruiting
Bayamón, Puerto Rico
Centro Reumatologico De Caguas /ID# 277918Recruiting
Caguas, Puerto Rico
Reuviva Research Center, LLC /ID# 277140Recruiting
Guaynabo, Puerto Rico
Santurce Clinical Trials and Infusion Center /ID# 277927Recruiting
San Juan, Puerto Rico
GCM Medical Group, PSC /ID# 273016Recruiting
San Juan, Puerto Rico
MEDMAN s.r.o. /ID# 278688Recruiting
Martin, Žilina Region, Slovakia
SoonChunHyang University Hospital Cheonan /ID# 277624Recruiting
Cheonan-si, Chungcheongnam-do, South Korea
Ajou University Hospital /ID# 273647Recruiting
Suwon, Gyeonggido, South Korea
Hanyang University Seoul Hospital /ID# 273625Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
SMG-SNU Boramae Medical Center /ID# 273627Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Complejo Hospitalario Universitario A Coruña /ID# 272609Recruiting
A Coruña, A Coruna, Spain
Hospital Universitari Parc Tauli /ID# 272607Recruiting
Sabadell, Barcelona, Spain
Hospital de Basurto /ID# 272610Recruiting
Bilbao, Vizcaya, Spain
Hospital General Universitario Gregorio Maranon /ID# 272616Recruiting
Madrid, Spain
Consorci Hospital General Universitario de Valencia /ID# 272615Recruiting
Valencia, Spain