Afimkibart (RO7790121) for the Treatment of Moderate to Severe Active Crohn's Disease

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT05910528
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Afimkibart — DRUG
    Afimkibart will be administered during the Induction, Maintenance and OLE period.

Study Details

This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of Afimkibart (RO7790121, RVT-3101) in adult participants with moderate to severe active Crohn's disease.

Key Dates

Start date
Jul 24, 2023
Status verified
Mar 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Sequence A; Drug: Afimkibart (RO7790121) Induction dose A, Maintenance dose and OLE dose
  • Experimental: Treatment Sequence B; Drug: Afimkibart (RO7790121) Induction dose B, Maintenance dose and OLE dose

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE) and AE Leading to Discontinuation [ Time Frame: Until end of study, approximately 5 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
Digestive Health SpecialistsDothanAlabama36305-
Medical Research Center of Connecticut, LLCHamdenConnecticut06518-
I.H.S Health Northwell HealthKissimmeeFlorida34741-
Brigham and Women's HospitalBostonMassachusetts02115-
Clinical Research Institute of MichiganChesterfieldMichigan48047-

Find similar trials in Dothan, AL

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Digestive Health Specialists· Dothan, ALMedical Research Center of Connecticut, LLC· Hamden, CTI.H.S Health Northwell Health· Kissimmee, FLBrigham and Women's Hospital· Boston, MAClinical Research Institute of Michigan· Chesterfield, MI

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