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)

Purpose

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.

Condition

  • Rheumatoid Arthritis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Has moderate to severe active RA defined by the presence of >= 6 swollen joints and >= 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Afimkibart Group I 		Participants will receive afimkibart via subcutaneous (SC) injection.
  • Drug: Afimkibart
    Afimkibart will be administered as SC injection.
    Other names:
    • PF 06480605
    • RVT-3101
    • RO7790121
Experimental
Afimkibart Group II 		Participants will receive afimkibart via SC injection.
  • Drug: Afimkibart
    Afimkibart will be administered as SC injection.
    Other names:
    • PF 06480605
    • RVT-3101
    • RO7790121
Placebo Comparator
Placebo 		Participants will receive afimkibart matched placebo via SC injection.
  • Drug: Placebo
    Placebo will be administered as SC injection.

Recruiting Locations

SunValley Arthritis Center Ltd.
Peoria 5308480, Arizona 5551752 85381

Inland Rheumatology Clinical Trials Incorporated
Upland 5404915, California 5332921 91786

West Broward Rheumatology Associates, Inc.
Tamarac 4174738, Florida 4155751 33321

Altoona Center For Clinical Research
Duncansville 5187508, Pennsylvania 6254927 16635

Accurate Clinical Management
Houston 4699066, Texas 4736286 77089

DM Clinical Research
Tomball 4737094, Texas 4736286 77375

Rheumatic Disease Center
Glendale 5254404, Wisconsin 5279468 53217

More Details

Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: WA45846 https://forpatients.roche.com/
888-662-6728 (U.S. and Canada)
global.rochegenentechtrials@roche.com