NCT06904872

Safety and Efficacy of Crofelemer in Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)

A Phase 2, Placebo-Controlled, Randomized, Double-Blind Study of 2 Doses of Crofelemer for the Treatment of Adult Patients With Short Bowel Syndrome and Intestinal Failure (SBS-IF) Without Colon-in-continuity (CIC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Napo Therapeutics, S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A 24-week, randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety and tolerability of crofelemer in patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF) without colon-in-continuity (CIC) requiring parenteral support (PS). Blinded study drug will be administered orally (or enterally) three times daily (TID) as a novel crofelemer formulation, Crofelemer Powder for Oral Solution, or a matching placebo powder formulation for oral solution. Patients will be randomized in a 1:1:1 ratio to crofelemer 3 mg/kg/dose TID, crofelemer 10 mg/kg/dose TID or placebo and randomization will be stratified by baseline PS volume (≤4 or \>4 L/week).

Detailed description

This is a 24-week, randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety and tolerability of crofelemer in patients with Short Bowel Syndrome and Intestinal Failure (SBS-IF) without colon-in-continuity (CIC) requiring parenteral support (PS). After an up to 4-week screening period and a PS stabilization period that will last from 2 to 12 weeks, eligible patients who have meet the stabilization requirements will be randomized 1:1:1 to the following treatment groups and entered into the 24-week double-blind treatment period: * Crofelemer 3 mg/kg/dose TID, morning, midday and evening; * Crofelemer 10 mg/kg/dose TID, morning, midday and evening; * Matched placebo TID, morning, midday and evening. Visits during the 24-week treatment period will be performed at baseline (Day 0) and after 1, 2, 4, 8, 12, 16, 20 and 24 weeks of treatments. At the end of the 24-week treatment period, patients will be followed up for 4 weeks for safety. For the primary and secondary objectives, changes between the two crofelemer and placebo arms will be assessed over the 24-week treatment period versus baseline.

Conditions

• Short Bowel Syndrome
• Malabsorption Syndromes
• Short Gut Syndrome
• Post-Op Complication
• Functional Gastrointestinal Disorders

Interventions

Type	Name	Description
DRUG	Crofelemer Powder for Oral Solution	Crofelemer Powder for Oral Solution
DRUG	Matched Placebo Powder for Oral Solution	Matched Placebo Powder for Oral Solution

Timeline

• Start date: 2025-05-29
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2025-04-01
• Last updated: 2025-06-12

Locations

8 sites across 2 countries: Germany, Italy