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NCT Number: NCT07137598

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)

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro Medico Arsema, Ciudad Autnoma de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Afimkibart

Drug

Afimkibart will be administered as SC injection.

Other names: PF 06480605, RVT-3101, RO7790121

Placebo

Drug

Placebo will be administered as SC injection.

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

  5. Change From Baseline in the ACR Core Set - Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGADA-VAS)

    Time frame: Baseline, At Week 14 and Week 24

  6. Change From Baseline in the ACR Core Set - Patient's Global Assessment of Arthritis Pain-Visual Analog Scale (PGA Arthritis Pain-VAS)

    Time frame: Baseline, At Week 14 and Week 24

  7. Change From Baseline in the ACR Core Set - Patient's Global Assessment of Disease Activity-Visual Analog Scale (PaGADA-VAS)

    Time frame: Baseline, At Week 14 and Week 24

  8. Change From Baseline in the ACR Core Set - Health Assessment Questionnaire- Disability Index (HAQ-DI)

    Time frame: Baseline, At Week 14 and Week 24

  9. Change From Baseline in the ACR Core Set - High-sensitivity C-reactive Protein (hsCRP)

    Time frame: Baseline, At Week 14 and Week 24

  10. Change from Baseline in ACR20, ACR50 and ACR70 Response Rate

    Time frame: Baseline, At Week 24

  11. Change from Baseline in Simplified Disease Activity Index (SDAI) Score

    Time frame: Baseline, At Week 14 and Week 24

  12. Change from Baseline in Clinical Disease Activity Index (CDAI) Score

    Time frame: Baseline, At Week 14 and Week 24

  13. Change from Baseline in Short Form-36 Health Survey (SF-36) Score

    Time frame: Baseline, At Week 14 and Week 24

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

    Time frame: Baseline, At Week 24

  15. Percentage of Participants With Adverse Events (AEs)

    Time frame: Up to Week 38

  16. Serum Concentration of RO7790121 at Specified Timepoints

    Time frame: Up to Week 38

  17. Percentage of Participants With Anti-Drug Antibodies

    Time frame: Baseline, Up to Week 38

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: WA45846 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. and Canada)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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