Afimkibart (RO7790121) for the Treatment of Moderate to Severe Active Crohn's Disease
NCT ID: NCT05910528
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
21 participants
INTERVENTIONAL
2023-07-24
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment Sequence A; Drug: Afimkibart (RO7790121) Induction dose A, Maintenance dose and OLE dose
Afimkibart
Afimkibart will be administered during the Induction, Maintenance and OLE period.
Treatment Sequence B; Drug: Afimkibart (RO7790121) Induction dose B, Maintenance dose and OLE dose
Afimkibart
Afimkibart will be administered during the Induction, Maintenance and OLE period.
Interventions
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Afimkibart
Afimkibart will be administered during the Induction, Maintenance and OLE period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Elevated very soft or liquid stool frequency and/or abdominal pain
* Must have no response, insufficient response, loss of response and/or intolerance to at least 1 conventional therapy (e.g. corticosteroids) or advanced therapy
Exclusion Criteria
* Short gut syndrome
* Presence of an ostomy or ileoanal pouch
* Bowel resection or diversion with \~6-months
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Digestive Health Specialists
Dothan, Alabama, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States
I.H.S Health Northwell Health
Kissimmee, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Clinical Research Institute of Michigan
Chesterfield, Michigan, United States
AZ Delta
Roeselare, , Belgium
CHU de Nantes
Nantes, , France
Institut des MICI, Clinique Ambroise Paré
Neuilly-sur-Seine, , France
CHRU de Nancy Brabois
Vandœuvre-lès-Nancy, , France
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, , Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Countries
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Other Identifiers
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2023-504265-23-00
Identifier Type: CTIS
Identifier Source: secondary_id
GA45392
Identifier Type: -
Identifier Source: org_study_id
NCT06370858
Identifier Type: -
Identifier Source: nct_alias