A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of an Investigational Drug with Open-Label Induction, Randomized Double-Blind Maintenance, and Long-Term Extension Periods in Pediatric Patients (2 to < 18 Years of Age)
Published: 10/01/2024
General Information:
The objective of this study is to assess the PK, efficacy, and safety of the investigational drug in pediatric patients with moderately to severely active CD aged 2 to < 18 years old who have had intolerance or inadequate response to aminosalicylates, oral locally acting corticosteroids, systemic corticosteroids, immunosuppressants, and/or biologic therapies.
Eligibility:
Patients aged 2 to less than 18 years old at time of the Baseline visit.
Confirmed diagnosis of Crohn’s disease for at least 3 months (90 days) prior to Baseline.
Moderately to severely active Crohn’ disease.
Weight at time of Screening and Baseline of 10 kg or higher.
Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: aminosalicylates, oral locally acting corticosteroids, systemic corticosteroids, immunosuppressants, and/or biologics therapies.
Endoscopic evidence of mucosal inflammation.
Study Details:
This study is to see if the study drug is safe and effective to treat Crohn’s disease in participants from 2 to 17 years of age.
All participants will receive study drug (no placebo). Participants are in the study for a total of 64 weeks and can continue on the study drug for 4 years in the long term follow up period.
Description of treatment or intervention (mechanism of action):
In this study an investigational drug will be tested to see if it is safe and effective to treat Crohn’s disease in children and adolescents.
Study drug will be given intravenously (through a vein) during the induction part and subcutaneously (through the skin) during the maintenance and open-label extension parts.
The study drug blocks key immune pathways that have been associated with the inflammation found in Crohn’s disease.
Patient Participation Requirements:
•Attend all study visits.
•Follow the directions of the study doctor and research team.
•Carry the study patient card and show it to any medical staff that may be involved in your healthcare.
•If you are 13 years or older at the start of the study, fill out the electronic daily diary, completely and honestly and bring it to the study doctor's office at each visit.
Possible risks and side effects:
The study drug is being investigated to treat pediatric Crohn’s disease. The study drug has been tested for different inflammatory diseases but is not approved to treat pediatric Crohn’s disease. Therefore, the use of the study drug is investigational (experimental) for the purposes of this study. The study doctor will review with you all the known risks and side effects with you to help you determine if you would like to participate in the trial.