Phase 3 Study to Evaluate the Safety and Effectiveness of PJ009 Injections in Patients 14 Years and Older With Short Bowel Syndrome Requiring Parenteral Nutrition

What this Trial Is About

Researchers are evaluating the effectiveness and safety of PJ009 in treating patients aged 14 and older with short bowel syndrome SBS who require parenteral nutrition. This randomized, double-blind, placebo-controlled Phase 3 study aims to determine if PJ009 can improve outcomes compared to a placebo. The study also assesses immunogenicity and pharmacokinetics of PJ009 in these patients. Participants will receive daily subcutaneous injections of PJ009 or a placebo based on their weight for 24 weeks. After this period, those who received placebo will switch to PJ009 for an additional 12 weeks, while those on PJ009 will continue the same treatment until the end of 36 weeks. The trial includes a screening, optimization, and stabilization period lasting up to 16 weeks before treatment begins, followed by the double-blind treatment and an open-label extension phase. During the study, participants will visit the clinic at scheduled times including weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, and 36 for assessments. They will keep a diary tracking their parenteral nutrition, enteral nutrition, and urine output. Researchers will measure the percentage of responders between weeks 20 and 24 to evaluate treatment effect. Safety follow-ups will be conducted four weeks after the last dose to monitor participants health throughout the study.

Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition