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)

August 21, 2026 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

  • Name: Reference Study ID Number: WA45846 https://forpatients.roche.com/ No attachments to email below.
  • Phone Number: 888-662-6728 (U.S. and Canada)
  • Email: global.rochegenentechtrials@roche.com

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1417EYH
        • Recruiting
        • Centro Privado de Medicina Familiar - Mind Out Research
      • San Juan, Argentina, J5402DIL
        • Recruiting
        • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
    • Buenos Aires
      • Ciudad Autnoma de Buenos Aires, Buenos Aires, Argentina, C1427
        • Recruiting
        • Centro Medico Arsema
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Recruiting
        • Centro de Investigaciones Medicas Mar del Plata
    • Ciudad Autonoma Buenos Aires
      • Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina, C1406AGA
        • Recruiting
        • APRILLUS Asistencia e Investigacion
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Recruiting
        • Centro de Investigaciones Médicas Tucuman
  • Belgium
      • Brussels, Belgium, 1070
        • Recruiting
        • HUB Erasme
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven
  • Brazil
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • Recruiting
        • L2IP ?Instituto de Pesquisas Clínicas Ltda.
    • Mato Grosso
      • Cuiab, Mato Grosso, Brazil, 78020-500
        • Recruiting
        • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Recruiting
        • Centro Mineiro de Pesquisa - CMiP
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-110
        • Recruiting
        • Centro de Estudos em Terapias Inovadoras ? CETI
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Recruiting
        • Hospital So Lucas da PUCRS
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14048-900
        • Recruiting
        • Hospital das Clínicas FMRP-USP
      • So Paulo, São Paulo, Brazil, 04266-010
        • Recruiting
        • CEPIC - Centro Paulista de Investigao Clnica e Servios Mdicos
  • Denmark
      • Frederiksberg, Denmark, 2000
        • Recruiting
        • Bispebjerg og Frederiksberg Hospital
      • Kge, Denmark, 4600
        • Recruiting
        • Sjllands Universitetshospital
  • France
      • Paris, France, 75014
        • Recruiting
        • Hpital Cochin
    • Bas Rhin
      • Strasbourg, Bas Rhin, France, 67091
        • Recruiting
        • CHU Strasbourg Hpital Hautepierre
    • Bouches-du-Rhne
      • Marseille, Bouches-du-Rhne, France, 13005
        • Recruiting
        • Hopital de la Conception
    • Herault
      • Montpellier, Herault, France, 34295
        • Recruiting
        • Hopital Lapeyronie
    • Lot Et Garonne
      • Toulouse, Lot Et Garonne, France, 31059
        • Recruiting
        • Hopital Purpan
  • Germany
    • North Rhine-Westphalia
      • Herne, North Rhine-Westphalia, Germany, 44649
        • Recruiting
        • Rheumazentrum Ruhrgebiet
    • Saxony
      • Dresden, Saxony, Germany, 01067
        • Recruiting
        • Städtisches Klinik Dresden-Friedrichstadt
  • Italy
    • Emilia-Romagna
      • Reggio Emilia, Emilia-Romagna, Italy, 42123
        • Recruiting
        • Arcispedale S. Maria Nuova Azienda Ospedaliera Di Reggio Emilia
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Lombardy
      • Rozzano, Lombardy, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Recruiting
        • Investigacion y Biomedicina de Chihuahua, Sociedad Civil
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80000
        • Recruiting
        • Centro de Investigacion de Tratam Innovadores de Sin SC
    • Yucatán
      • Mérida, Yucatán, Mexico, 97070
        • Recruiting
        • Medical Care & Research SA de CV
  • Poland
      • Bytom, Poland, 41-902
        • Recruiting
        • Nzoz Bif-Med
      • Elbl?g, Poland, 82-300
        • Recruiting
        • Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne
      • Krakow, Poland, 30-002
        • Recruiting
        • Malopolskie Badania Kliniczne
      • Lublin, Poland, 20-607
        • Recruiting
        • Zespol Poradni Specjalistycznych REUMED
      • Nowa Sól, Poland, 67-100
        • Recruiting
        • Twoja Przychodnia NCM
      • Warsaw, Poland, 02-665
        • Recruiting
        • Centrum Medyczne Reuma Park
      • Warsaw, Poland, 02-637
        • Recruiting
        • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
      • Wroclaw, Poland, 52-210
        • Recruiting
        • Reumatop Spolka Jawna
  • Spain
      • Málaga, Spain, 29009
        • Recruiting
        • Hospital Regional Universitario de Málaga
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
      • Seville, Spain, 41010
        • Recruiting
        • Hospital Quironsalud Infanta Luisa
    • LA Coruna
      • La Corua, LA Coruna, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario A Coruña
      • Santiago de Compostela, LA Coruna, Spain, 15706
        • Recruiting
        • Complejo Hospitalario Universitario de Santiago.
  • United Kingdom
      • Barnet, United Kingdom, EN5 3DJ
        • Recruiting
        • Barnet Hospital
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • Recruiting
        • Leicester Royal Infirmary
    • South Yorkshire
      • Doncaster, South Yorkshire, United Kingdom, DN2 5LT
        • Recruiting
        • Doncaster Royal Infirmary
    • Tyne & Wear
      • Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE29 8NH
        • Recruiting
        • North Tyneside General Hospital
  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Recruiting
        • SunValley Arthritis Center Ltd.
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California Medical Center
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
      • Upland, California, United States, 91786
        • Recruiting
        • Inland Rheumatology Clinical Trials Incorporated
    • Florida
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • West Broward Rheumatology Associates, Inc.
    • Illinois
      • Willowbrook, Illinois, United States, 60527
        • Recruiting
        • Willow Rheumatology and Wellness PLLC
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
        • Recruiting
        • Accurate Clinical Research Inc.
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Medical Center- New Center One
    • New York
      • The Bronx, New York, United States, 10455
        • Recruiting
        • Equity Medical
    • Ohio
      • Columbus, Ohio, United States, 43203
        • Recruiting
        • Ohio State University Wexner Medical Center
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Recruiting
        • Altoona Center for Clinical Research
    • Texas
      • Colleyville, Texas, United States, 76034
        • Recruiting
        • Precision Comprehensive Clinical Research Solutions
      • Houston, Texas, United States, 77089
        • Recruiting
        • Accurate Clinical Management
      • Tomball, Texas, United States, 77375
        • Recruiting
        • DM Clinical Research
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Recruiting
        • Tidewater Clinical Research
    • Wisconsin
      • Glendale, Wisconsin, United States, 53217
        • Recruiting
        • Rheumatic Disease Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Afimkibart Group I
Participants will receive afimkibart via subcutaneous (SC) injection.
Drug: Afimkibart
Afimkibart will be administered as SC injection.
Other Names:
  • RVT-3101
  • RO7790121
  • PF 06480605
Experimental: Afimkibart Group II
Participants will receive afimkibart via SC injection.
Drug: Afimkibart
Afimkibart will be administered as SC injection.
Other Names:
  • RVT-3101
  • RO7790121
  • PF 06480605
Placebo Comparator: Placebo
Participants will receive afimkibart matched placebo via SC injection.
Drug: Placebo
Placebo will be administered as SC injection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP)
Time Frame: Baseline, At Week 14
Baseline, At Week 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)
Time Frame: At Week 14
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
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
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
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
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
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
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
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
Baseline, At Week 14 and Week 24
Change from Baseline in ACR20, ACR50 and ACR70 Response Rate
Time Frame: Baseline, At Week 24
Baseline, At Week 24
Change from Baseline in Simplified Disease Activity Index (SDAI) Score
Time Frame: Baseline, At Week 14 and Week 24
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
Baseline, At Week 14 and Week 24
Change from Baseline in Short Form-36 Health Survey (SF-36) Score
Time Frame: Baseline, At Week 14 and Week 24
Baseline, At Week 14 and Week 24
Change from Baseline Disease Activity Score-28 for Rheumatoid Arthritis with C-Reactive Protein (DAS28-CRP) Score
Time Frame: Baseline, At Week 24
Baseline, At Week 24
Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to Week 38
Up to Week 38
Serum Concentration of RO7790121 at Specified Timepoints
Time Frame: Up to Week 38
Up to Week 38
Percentage of Participants With Anti-Drug Antibodies
Time Frame: Baseline, Up to Week 38
Baseline, Up to Week 38

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 2, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WA45846

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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