Health Trials

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)

ConditionRheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Afimkibart

    Drug

    Afimkibart will be administered as SC injection.

  • Placebo

    Drug

    Placebo will be administered as SC injection.

Treatment groups

160 Participants
are divided into 3 treatment groups
Group A: Afimkibart Group IExperimental treatment 1 intervention
Group B: Afimkibart Group IIExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP)

Time frame
Baseline, At Week 14

Secondary outcomes

1

Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)

Time frame
At Week 14
2

Change from Baseline Disease Activity Score-28 for Rheumatoid Arthritis with Erythrocyte Sedimentation Rate (DAS28-ESR) Score

Time frame
Baseline, At Week 14 and Week 24
3

Change From Baseline in the ACR Core Set - Swollen Joint Count (SJC)

Time frame
Baseline, At Week 14 and Week 24
4

Change From Baseline in the ACR Core Set - Tender Joint Count (TJC)

Time frame
Baseline, At Week 14 and Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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