A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
California
Newport Huntington Medical Group /ID# 272439
RECRUITING
Huntington Beach
Inland Rheumatology & Osteoporosis Medical Group /ID# 272449
RECRUITING
Upland
Colorado
Tekton Research - Fort Collins - East Harmony Road /ID# 272472
RECRUITING
Fort Collins
Florida
Clinical Research Of West Florida - Phase I Unit /ID# 272428
RECRUITING
Clearwater
Neoclinical Research - Hialeah /ID# 272070
RECRUITING
Hialeah
Life Clinical Trials /ID# 272589
RECRUITING
Margate
HMD Research LLC /ID# 272432
RECRUITING
Orlando
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 272755
RECRUITING
Tampa
Illinois
Willow Rheumatology and Wellness, PLLC /ID# 272691
RECRUITING
Willowbrook
Louisiana
Accurate Clinical Research (SMO/Network/Consortium) /ID# 272650
RECRUITING
Lake Charles
Michigan
AA Medical Research Center - Grand Blanc /ID# 272496
RECRUITING
Grand Blanc
North Carolina
DJL Clinical Research, PLLC /ID# 272387
RECRUITING
Charlotte
Joint And Muscle Research Institute /ID# 277290
RECRUITING
Charlotte
New Mexico
Albuquerque Center For Rheumatology /ID# 272301
RECRUITING
Albuquerque
Ohio
Paramount Medical Research and Consulting /ID# 272474
RECRUITING
Middleburg Heights
Texas
Arthritis & Rheumatology Research Institute /ID# 272299
RECRUITING
Allen
Tekton Research - West Gate /ID# 272270
RECRUITING
Austin
Accurate Clinical Research - Houston /ID# 272271
RECRUITING
Houston
Private Practice - Dr. Laila A. Hassan /ID# 272297
RECRUITING
Houston
Epic Medical Research /ID# 272656
RECRUITING
Red Oak
Dynamed Clinical Research - Tomball /ID# 272452
RECRUITING
Tomball
Other Locations
Canada
Dr. Latha Naik Medical Professional Corporation /ID# 274403
RECRUITING
Saskatoon
Puerto Rico
Clinical Research Investigator Group, LLC /ID# 274821
RECRUITING
Bayamón
Reuviva Research Center, LLC /ID# 277140
RECRUITING
Guaynabo
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-06-20
Estimated Completion Date: 2027-11
Participants
Target number of participants: 180
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov