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)

Official 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

Overview

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.

Interventions

• Drug Afimkibart
  Afimkibart will be administered as SC injection.
• Drug Placebo
  Placebo will be administered as SC injection.

Primary outcome measures

• Change from Baseline in Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) [Time frame: Baseline, At Week 14]

Secondary outcome measures (12)

• Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70) [Time frame: At Week 14]
• 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]
• Change From Baseline in the ACR Core Set - Swollen Joint Count (SJC) [Time frame: Baseline, At Week 14 and Week 24]
• Change From Baseline in the ACR Core Set - Tender Joint Count (TJC) [Time frame: Baseline, At Week 14 and Week 24]
• 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]
• 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]
• 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]
• Change From Baseline in the ACR Core Set - Health Assessment Questionnaire- Disability Index (HAQ-DI) [Time frame: Baseline, At Week 14 and Week 24]
• Change From Baseline in the ACR Core Set - High-sensitivity C-reactive Protein (hsCRP) [Time frame: Baseline, At Week 14 and Week 24]
• Change from Baseline in ACR20, ACR50 and ACR70 Response Rate [Time frame: Baseline, At Week 24]
• Change from Baseline in Simplified Disease Activity Index (SDAI) Score [Time frame: Baseline, At Week 14 and Week 24]
• Change from Baseline in Clinical Disease Activity Index (CDAI) Score [Time frame: Baseline, At Week 14 and Week 24]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 13 centers

• SunValley Arthritis Center Ltd. — Peoria
• University of California Medical Center — La Jolla
• Cedars Sinai Medical Center — Los Angeles
• Inland Rheumatology Clinical Trials Incorporated — Upland
• West Broward Rheumatology Associates, Inc. — Tamarac
• Willow Rheumatology and Wellness PLLC — Willowbrook
• Accurate Clinical Research Inc. — Lake Charles
• Ohio State University Wexner Medical Center — Columbus
• … and 5 more centers

Poland · 8 centers

• Nzoz Bif-Med — Bytom
• Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne — Elbl?g
• Malopolskie Badania Kliniczne — Krakow
• Zespol Poradni Specjalistycznych REUMED — Lublin
• Twoja Przychodnia NCM — Nowa Sól
• Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher — Warsaw
• Centrum Medyczne Reuma Park — Warsaw
• Reumatop Spolka Jawna — Wroclaw

Brazil · 7 centers

• L2IP ?Instituto de Pesquisas Clínicas Ltda. — Brasília
• IPC MT Instituto de Pesquisas Clinicas do Mato Grosso — Cuiab
• Centro Mineiro de Pesquisa - CMIP — Juiz de Fora
• Centro de Estudos em Terapias Inovadoras ? CETI — Curitiba
• Hospital So Lucas da PUCRS — Porto Alegre
• Hospital das Clínicas FMRP-USP — Ribeirão Preto
• CEPIC - Centro Paulista de Investigao Clnica e Servios Mdicos — So Paulo

Argentina · 6 centers

• Centro Medico Arsema — Ciudad Autnoma de Buenos Aires
• Centro de Investigaciones Medicas Mar Del Plata — Mar del Plata
• APRILLUS Asistencia e Investigacion — Buenos Aires
• Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán
• Centro Privado de Medicina Familiar - Mind Out Research — Ciudad Autonoma Buenos Aires
• CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica — San Juan

France · 5 centers

• CHU Strasbourg Hpital Hautepierre — Strasbourg
• Hopital de la Conception — Marseille
• Hopital Lapeyronie — Montpellier
• Hopital Purpan — Toulouse
• Hpital Cochin — Paris

Spain · 4 centers

• Complejo Hospitalario Universitario A Coruña — La Corua
• Hospital Regional Universitario de Malaga — Málaga
• Hospital Universitario Virgen Macarena — Seville
• Hospital Quironsalud Infanta Luisa — Seville

United Kingdom · 4 centers

• Leicester Royal Infirmary — Leicester
• Doncaster Royal Infirmary — Doncaster
• North Tyneside General Hospital — Newcastle upon Tyne
• Barnet Hospital — Barnet

Italy · 3 centers

• Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia — Reggio Emilia
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome
• Istituto Clinico Humanitas — Rozzano

Belgium · 2 centers

• HUB Erasme — Brussels
• UZ Leuven — Leuven

Denmark · 2 centers

• Bispebjerg og Frederiksberg Hospital — Frederiksberg
• Sjllands Universitetshospital — Kge

Germany · 2 centers

• Rheumazentrum Ruhrgebiet — Herne
• Städtisches Klinik Dresden-Friedrichstadt — Dresden

Identifiers

NCT: NCT07137598 · WA45846

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗