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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06972446
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

ABBVIE INC.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Study Website: View Trial Website
Arms & Interventions

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

Drug: - Lutikizumab

Subcutaneous (SC) injection

Drug: - Placebo

Subcutaneous (SC) injection

Drug: - Ravagalimab

Subcutaneous (SC) injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Fort Collins, Colorado

Status

Recruiting

Address

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

Fort Collins, Colorado, 80528

Clearwater, Florida

Status

Recruiting

Address

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

Clearwater, Florida, 33765

Hialeah, Florida

Status

Recruiting

Address

Neoclinical Research - Hialeah /ID# 272070

Hialeah, Florida, 33016

Life Clinical Trials /ID# 272589, Margate, Florida

Status

Recruiting

Address

Life Clinical Trials /ID# 272589

Margate, Florida, 33063

Tampa, Florida

Status

Recruiting

Address

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

Tampa, Florida, 33606

Site Contact

Site Coordinator

[email protected]

813-870-1292

Grand Blanc, Michigan

Status

Recruiting

Address

AA Medical Research Center - Grand Blanc /ID# 272496

Grand Blanc, Michigan, 48439

Albuquerque, New Mexico

Status

Recruiting

Address

Albuquerque Center For Rheumatology /ID# 272301

Albuquerque, New Mexico, 87102

Middleburg Heights, Ohio

Status

Recruiting

Address

Paramount Medical Research and Consulting /ID# 272474

Middleburg Heights, Ohio, 44130

Tekton Research - West Gate /ID# 272270, Austin, Texas

Status

Recruiting

Address

Tekton Research - West Gate /ID# 272270

Austin, Texas, 78745

Houston, Texas

Status

Recruiting

Address

Accurate Clinical Research - Houston /ID# 272271

Houston, Texas, 77089-6142

Houston, Texas

Status

Recruiting

Address

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

Houston, Texas, 77089

Tomball, Texas

Status

Recruiting

Address

Dynamed Clinical Research - Tomball /ID# 272452

Tomball, Texas, 77375