This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
NYU Langone Health
New York, New York, United States
RECRUITINGRoyal Children's Hospital
Parkville, Victoria, Australia
Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI)
Time frame: At Week 52
Percentage of Participants With Endoscopic Response
Time frame: At Week 52
Percentage of Participants With Clinical Remission
Time frame: At Week 12 and Week 52
Percentage of Participants With Clinical Response
Time frame: At Week 12 and Week 52
Percentage of Participants With CDAI Remission
Time frame: At Week 12 and Week 52
Change From Baseline in Fecal Calprotectin
Time frame: Baseline, Week 12 and Week 52
Change From Baseline in Mucosal Inflammation Noninvasive Index (MINI) Score
Time frame: Baseline, Week 12 and Week 52
Percentage of Participants With Endoscopic Remission
Time frame: At Week 52
Percentage of Participants With Corticosteroid-Free Clinical Remission
Time frame: At Week 52
Percentage of Participants with Maintenance of Remission
Time frame: At Week 12 and Week 52
Percentage of Participants With Histologic Improvement
Time frame: At Week 52
Reference Study ID Number: CP45906 https://forpatients.roche.com/ No attachments to email below.
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Perth Children's Hospital
Nedlands, Western Australia, Australia
RECRUITINGCECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, Brazil
RECRUITINGBR Trials - Pesquisa Clínica
São Paulo, São Paulo, Brazil
RECRUITINGCentro de Investigación Clínica Acelerada, S.C
Mexico City, Mexico CITY (federal District), Mexico
RECRUITINGFAICIC Clinical Research
Veracruz, Mexico
RECRUITINGEmmed Research
Pretoria, Gauteng, South Africa
RECRUITINGIATROS International
Bloemfontein, South Africa
RECRUITINGNational Taiwan University Hospital
Taipei, Taiwan
RECRUITING...and 4 more locations
Percentage of Participants With Ulcer-Free Endoscopy
Time frame: At Week 52
Incidence and Severity of Adverse Events (AEs)
Time frame: Up to Approximately 5.5 Years
Serum Concentration of Afimkibart
Time frame: Up to Approximately 5.5 Years