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)

Roche

Status and phase: Begins enrollment in 2 months; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Afimkibart

Study type: Interventional

Funder types: Industry

Identifiers

NCT07137598

WA45846

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 3 patient groups, including a placebo group

Afimkibart Group I

Experimental group

Description:

Participants will receive afimkibart via subcutaneous (SC) injection.

Treatment:

Drug: Afimkibart

Afimkibart Group II

Experimental group

Description:

Participants will receive afimkibart via SC injection.

Treatment:

Drug: Afimkibart

Placebo

Placebo Comparator group

Description:

Participants will receive afimkibart matched placebo via SC injection.

Treatment:

Drug: Placebo