RECRUITINGPhase 2INTERVENTIONAL
A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and/or Janus Kinase (JAK Inhibitors)
A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response or Intolerance to TNF and/or JAK Inhibitors
About This Trial
This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid arthritis (RA) who have an inadequate response or intolerance to TNF and/or JAK inhibitors.
Who May Be Eligible (Plain English)
Who May Qualify:
- Has moderate to severe active RA defined by the presence of \>=6 swollen joints and \>=6 tender joints at screening and baseline (based on 66/68-joint count)
- Diagnosis of RA for \>=3 months and also fulfills the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria for RA
- Demonstrated an inadequate response or loss of response to or intolerance to \>=1 conventional synthetic disease-modifying antirheumatic drug (csDMARD)
Who Should NOT Join This Trial:
- Have failed more than two TNF inhibitors or JAK inhibitors
- Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)
- Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab
- Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy, whichever is longer, prior to initiation of study treatment.
- History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA
- Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug
- History of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of the study drug (or its excipients) and/or other products in the same class
- Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
- Any serious, chronic and/or unstable pre-existing medical, psychiatric, or other- condition
- History of malignancy, with the exception non-metastatic basal cell or cutaneous squamous cell cancer adequately treated with electrodesiccation and curettage or resection or in situ cervical cancer adequately treated and cured
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Has moderate to severe active RA defined by the presence of \>=6 swollen joints and \>=6 tender joints at screening and baseline (based on 66/68-joint count)
* Diagnosis of RA for \>=3 months and also fulfills the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria for RA
* Demonstrated an inadequate response or loss of response to or intolerance to \>=1 conventional synthetic disease-modifying antirheumatic drug (csDMARD)
Exclusion Criteria:
* Have failed more than two TNF inhibitors or JAK inhibitors
* Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)
* Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab
* Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy, whichever is longer, prior to initiation of study treatment.
* History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA
* Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug
* History of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of the study drug (or its excipients) and/or other products in the same class
* Any major surgery within 6 weeks prior to screening or a major surgery planned during the study
* Any serious, chronic and/or unstable pre-existing medical, psychiatric, or other- condition
* History of malignancy, with the exception non-metastatic basal cell or cutaneous squamous cell cancer adequately treated with electrodesiccation and curettage or resection or in situ cervical cancer adequately treated and cured
* Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections
* History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
* History of organ transplant
* Any identified confirmed congenital or acquired immunodeficiency
* Abnormal laboratory values and liver function test
Treatments Being Tested
DRUG
Afimkibart
Afimkibart will be administered as SC injection.
DRUG
Placebo
Placebo will be administered as SC injection.
Locations (20)
SunValley Arthritis Center Ltd.
Peoria, Arizona, United States
Inland Rheumatology Clinical Trials Incorporated
Upland, California, United States
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, United States
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, United States
Accurate Clinical Research Inc.
Lake Charles, Louisiana, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Accurate Clinical Management
Houston, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Tidewater Clinical Research
Chesapeake, Virginia, United States
Rheumatic Disease Center
Glendale, Wisconsin, United States
UZ Leuven
Leuven, Belgium
L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil
Bispebjerg og Frederiksberg Hospital
Frederiksberg, Denmark
Sjllands Universitetshospital
Kge, Denmark
CHU Strasbourg Hpital Hautepierre
Strasbourg, Bas Rhin, France
Hopital de la Conception
Marseille, Bouches-du-Rhne, France
Hopital Lapeyronie
Montpellier, Herault, France
Hopital Purpan
Toulouse, Lot Et Garonne, France
Hpital Cochin
Paris, France