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)

Part of paid clinical trials in Peoria, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT07137598
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Afimkibart — DRUG
    Afimkibart will be administered as SC injection.
  • Placebo — DRUG
    Placebo will be administered as SC injection.

Study Details

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.

Key Dates

Start date
Dec 5, 2025
Status verified
May 2026
Primary completion
Apr 19, 2027
Completion
Oct 8, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Afimkibart Group I
    Participants will receive afimkibart via subcutaneous (SC) injection.
  • Experimental: Afimkibart Group II
    Participants will receive afimkibart via SC injection.
  • Placebo Comparator: Placebo
    Participants will receive afimkibart matched placebo via SC injection.

Primary Outcome Measure

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

Central Contacts

  • Reference Study ID Number: WA45846 https://forpatients.roche.com/
    888-662-6728 (U.S. and Canada)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (12)

FacilityCityStateZIPSite coordinators
SunValley Arthritis Center Ltd.PeoriaArizona85381-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Inland Rheumatology Clinical Trials IncorporatedUplandCalifornia91786-
West Broward Rheumatology Associates, Inc.TamaracFlorida33321-
Willow Rheumatology and Wellness PLLCWillowbrookIllinois60527-
Accurate Clinical Research Inc.Lake CharlesLouisiana70605-
Ohio State University Wexner Medical CenterColumbusOhio43203-
Altoona Center For Clinical ResearchDuncansvillePennsylvania16635-
Accurate Clinical ManagementHoustonTexas77089-
DM Clinical ResearchTomballTexas77375-
Tidewater Clinical ResearchChesapeakeVirginia23320-
Rheumatic Disease CenterGlendaleWisconsin53217-

Find similar trials in Peoria, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
SunValley Arthritis Center Ltd.· Peoria, AZCedars Sinai Medical Center· Los Angeles, CAInland Rheumatology Clinical Trials Incorporated· Upland, CAWest Broward Rheumatology Associates, Inc.· Tamarac, FLWillow Rheumatology and Wellness PLLC· Willowbrook, ILAccurate Clinical Research Inc.· Lake Charles, LA

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