Stelara fOr ChRonic AntibioTic rEfractory pouchitiS

Pouchitis Clinical Trial

— SOCRATES  

Official title:

Stelara fOr ChRonic AntibioTic rEfractory pouchitiS (SOCRATES): A Belgian Open Label Multicenter Pilot-study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04089345
• Other study ID #: CNTO1275UCO2001
• Status: Recruiting
• Phase: Phase 3
• Start date: June 11, 2020
• Est. completion date: May 2023

Study information

• Verified date: April 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Ganel Schops
• Phone: +321648856
• Email: IBD_studies[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study is a Belgian prospective open label multicenter study to evaluate the efficacy and safety of ustekinumab in the treatment of relapsing or chronic antibiotic refractory pouchitis during a 48-week treatment period. Twenty subjects with a RPC and IPAA for UC who have developed relapsing or chronic antibiotic refractory pouchitis will be enrolled.

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.

Clinical and biochemical evaluation will be planned every 8 weeks. Efficacy will be assessed at Week 16 and Week 48 using mPDAI and PDAI scores, therefor a pouchoscopy with biopsy sampling will be performed. Patients who do not achieve partial response (reduction of mPDAI score by ≥2 points from baseline) at Week 16 will be discontinued.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pouchitis

Intervention

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

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	UZ Leuven	Leuven	Vlaanderen
Belgium	CHU de Liège, Sart Tilman	Liège

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Janssen, LP

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The percentage of subjects achieving clinically relevant steroid-free remission	mPDAI score <5 and a reduction by =2 points from baseline, without need for steroids	48 weeks after baseline
Secondary	The percentage of subjects achieving partial response	reduction of mPDAI score by =2 points from baseline	16 weeks after baseline
Secondary	The percentage of subjects achieving partial response	reduction of mPDAI score by =2 points from baseline	48 weeks after baseline
Secondary	Time to clinically relevant remission	Time to mPDAI score <5 and a reduction by =2 points from baseline	Within 48 weeks after baseline
Secondary	Change in mPDAI endoscopic subscore	Change in mPDAI endoscopic subscore from baseline	At Week 16 and 48 compared to baseline
Secondary	Change in mPDAI symptomatic subscore	Change in mPDAI symptomatic subscore from baseline	At Week 16 and 48 compared to baseline
Secondary	Change in total mPDAI score	Change in total mPDAI score from baseline	At Week 16 and 48 compared to baseline
Secondary	Change in European Quality of Life 5 Dimensions (EQ-5D)	Change in European Quality of Life 5 Dimensions (EQ-5D) from baseline	At Week 16, 32 and 48 compared to baseline