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

NCT ID: NCT06972446

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-20

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Substudy 1: Lutikizumab Monotherapy

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

Group Type EXPERIMENTAL

Lutikizumab

Intervention Type DRUG

Subcutaneous (SC) injection

Substudy 1: Matching Placebo Monotherapy

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous (SC) injection

Substudy 2: Ravagalimab Monotherapy

Participants will be randomized to receive Ravagalimab

Group Type EXPERIMENTAL

Ravagalimab

Intervention Type DRUG

Subcutaneous (SC) injection

Substudy 2: Matching Placebo Monotherapy

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous (SC) injection

SubStudy 3: Lutikizumab and Ravagalimab Combination Therapy

Participants will be randomized to be administered Lutikizumab and Ravagalimab doses

Group Type EXPERIMENTAL

Lutikizumab

Intervention Type DRUG

Subcutaneous (SC) injection

Ravagalimab

Intervention Type DRUG

Subcutaneous (SC) injection

Substudy 3: Matching Placebo Combination Therapy

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous (SC) injection

Interventions

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Lutikizumab

Subcutaneous (SC) injection

Intervention Type DRUG

Placebo

Subcutaneous (SC) injection

Intervention Type DRUG

Ravagalimab

Subcutaneous (SC) injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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

Beverly Hills, California, United States

Site Status RECRUITING

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

Chula Vista, California, United States

Site Status RECRUITING

Newport Huntington Medical Group /ID# 272439

Huntington Beach, California, United States

Site Status RECRUITING

Inland Rheumatology & Osteoporosis Medical Group /ID# 272449

Upland, California, United States

Site Status RECRUITING

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

Fort Collins, Colorado, United States

Site Status RECRUITING

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

Avon Park, Florida, United States

Site Status RECRUITING

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

Clearwater, Florida, United States

Site Status RECRUITING

Neoclinical Research - Hialeah /ID# 272070

Hialeah, Florida, United States

Site Status RECRUITING

Life Clinical Trials /ID# 272589

Margate, Florida, United States

Site Status RECRUITING

HMD Research LLC /ID# 272432

Orlando, Florida, United States

Site Status RECRUITING

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

Tampa, Florida, United States

Site Status RECRUITING

Deerbrook Medical Associates /ID# 273439

Libertyville, Illinois, United States

Site Status RECRUITING

Willow Rheumatology and Wellness, PLLC /ID# 272691

Willowbrook, Illinois, United States

Site Status RECRUITING

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

Lake Charles, Louisiana, United States

Site Status RECRUITING

AA Medical Research Center - Grand Blanc /ID# 272496

Grand Blanc, Michigan, United States

Site Status RECRUITING

Albuquerque Center For Rheumatology /ID# 272301

Albuquerque, New Mexico, United States

Site Status RECRUITING

Joint And Muscle Research Institute /ID# 277290

Charlotte, North Carolina, United States

Site Status RECRUITING

DJL Clinical Research, PLLC /ID# 272387

Charlotte, North Carolina, United States

Site Status RECRUITING

Paramount Medical Research and Consulting /ID# 272474

Middleburg Heights, Ohio, United States

Site Status RECRUITING

Altoona Center For Clinical Research /ID# 272479

Duncansville, Pennsylvania, United States

Site Status RECRUITING

West Tennessee Research Institute /ID# 272453

Jackson, Tennessee, United States

Site Status RECRUITING

Arthritis & Rheumatology Research Institute /ID# 272299

Allen, Texas, United States

Site Status RECRUITING

Tekton Research - West Gate /ID# 272270

Austin, Texas, United States

Site Status RECRUITING

Arthritis Care Of Texas /ID# 277961

Corpus Christi, Texas, United States

Site Status RECRUITING

Accurate Clinical Research - Houston /ID# 272271

Houston, Texas, United States

Site Status RECRUITING

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

Houston, Texas, United States

Site Status RECRUITING

Texas Rheumatology Research Institute Llc /Id# 278010

Plano, Texas, United States

Site Status RECRUITING

Epic Medical Research /ID# 272656

Red Oak, Texas, United States

Site Status RECRUITING

Dynamed Clinical Research - Tomball /ID# 272452

Tomball, Texas, United States

Site Status RECRUITING

Care Clinic - Calgary /ID# 274405

Calgary, Alberta, Canada

Site Status RECRUITING

Dr. Latha Naik Medical Professional Corporation /ID# 274403

Saskatoon, Saskatchewan, Canada

Site Status RECRUITING

Rheumateam Lahn-Dill-Siegerland /ID# 274858

Wetzlar, Hesse, Germany

Site Status RECRUITING

Universitaetsklinikum Bonn /ID# 272808

Bonn, North Rhine-Westphalia, Germany

Site Status RECRUITING

MVZ Rheumatologie und Autoimmunmedizin in Hamburg /ID# 272795

Hamburg, , Germany

Site Status RECRUITING

Clinical Research Investigator Group, LLC /ID# 274821

Bayamón, , Puerto Rico

Site Status RECRUITING

Reuviva Research Center, LLC /ID# 277140

Guaynabo, , Puerto Rico

Site Status RECRUITING

Countries

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United States Canada Germany Puerto Rico

Central Contacts

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ABBVIE CALL CENTER

Role: CONTACT

Phone: 844-663-3742

Email: [email protected]

Facility Contacts

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Site Coordinator

Role: primary

Site Coordinator

Role: primary

Site Coordinator

Role: primary

Site Coordinator

Role: primary

Related Links

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https://www.abbvieclinicaltrials.com/study/?id=M25-056

Related Info

Other Identifiers

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2025-520721-21-00

Identifier Type: OTHER

Identifier Source: secondary_id

M25-056

Identifier Type: -

Identifier Source: org_study_id