Stelara fOr ChRonic AntibioTic rEfractory pouchitiS

NCT04089345 | Completed Phase 3

• 1 other identifier: CNTO1275UCO2001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

To evaluate the efficacy and safety of ustekinumab in the treatment of chronic antibiotic refractory and relapsing pouchitis.

Conditions

Pouchitis

Outcome Measures

Primary Outcomes (1)

• The percentage of subjects achieving clinically relevant steroid-free remission

  mPDAI score \<5 and a reduction by ≥2 points from baseline

  16 weeks after baseline

Secondary Outcomes (8)

• The percentage of subjects achieving clinically relevant steroid-free remission

  48 weeks after baseline

• The percentage of subjects achieving partial response

  16 weeks after baseline

• The percentage of subjects achieving partial response

  48 weeks after baseline

• Time to clinically relevant remission

  Within 48 weeks after baseline

• Change in mPDAI endoscopic subscore

  At Week 16 and 48 compared to baseline

Study Arms (1)

Open label ustekinumab

EXPERIMENTAL

All patients will receive intravenously (IV) ustekinumab \~6mg/kg at baseline and subcutaneously (SC) ustekinumab 90mg every 8 weeks thereafter until Week 48. All subjects will receive concomitant antibiotic treatment with ciprofloxacin or metronidazole from baseline through Week 4. Intravenous induction doses will be 260mg for patients \<55kg, 390mg for patients between 55 and 85kg, and 520mg for patients with a body weight \>85 kg.

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

All patients will receive intravenously (IV) ustekinumab \~6mg/kg at baseline and subcutaneously (SC) ustekinumab 90mg every 8 weeks thereafter until Week 48.

Also known as: Stelara

Open label ustekinumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has a history of ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC)
• The subject has pouchitis that is (a) relapsing or (b) chronic antibiotic refractory, defined by an mPDAI score ≥5 assessed as the average from 3 days immediately prior to the baseline endoscopy visit and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either (a) ≥3 recurrent episodes within the last year, each treated with ≥2 weeks of antibiotic or other prescription therapy, or (b) requiring maintenance antibiotic therapy taken continuously for ≥4 weeks immediately prior to the baseline endoscopy visit

You may not qualify if:

• Crohn's disease (CD), CD-related complications of the pouch (pouch fistula, pouch strictures, ulcerations in the pre-pouch ileum without pouchitis), irritable pouch syndrome (IPS), isolated or predominant cuffitis, infectiouw pouchitis, diverting ostomy or mechanical complications of the pouch
• Previous treatment with an anti-IL12/23 or an anti-IL23 antibody
• Any investigational or approved biologic agent within 30 days of baseline
• Nonbiologic investigational therapy or tofacitinib within 30 days prior to baseline
• Active or untreated latent tuberculosis (TB)
• Chronic hepatitis B virus (HBV) infection, chronic hepatitis C virus (HCV) infection, a known history of human immunodeficiency virus (HIV) infection (or is found to be seropositive at screening) or subject is immunodeficient
• Active severe infection (e.g. sepsis, cytomegalovirus, listeriosis or C. difficile)
• History of malignancy or current malignancy

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Janssen Pharmaceuticals: collaborator

Study Sites (3)

UZ Leuven

Leuven, Flanders, 3000, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

CHU de Liège, Sart Tilman

Liège, 4000, Belgium

Location

Related Publications (1)

• Outtier A, Louis E, Dewit O, Reenaers C, Schops G, Lenfant M, Pontus E, De Hertogh G, Verstockt B, Sabino J, Vermeire S, Ferrante M. Efficacy and Safety of Ustekinumab for Chronic Pouchitis: A Prospective Open-label Multicenter Study. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2468-2474.e1. doi: 10.1016/j.cgh.2024.04.030. Epub 2024 May 14.

  PMID: 38750870 DERIVED

MeSH Terms

Conditions

Pouchitis

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Marc Ferrante, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open label pilot study

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 13, 2019
• Study Start: June 15, 2020
• Primary Completion: December 1, 2022
• Study Completion: May 1, 2023
• Last Updated: December 11, 2024

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (3)