for Pediatric Crohn's disease (ages 2 and older)
FDA approved ustekinumab (Stelara) for patients aged two years and older with moderately to severely active Crohn's disease — pediatric label expansion of an already-marketed biologic.
Crohn's disease is a chronic inflammatory bowel disorder that causes abdominal pain, diarrhea, and malnutrition by attacking the digestive tract. Stelara (ustekinumab) is an antibody that blocks two immune proteins (IL-12 and IL-23) involved in driving gut inflammation. By quieting this immune overactivity, the drug may help reduce symptoms and flare-ups in children as young as two who struggle with the condition.
The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.
Source: ClinicalTrials.gov