Back to resultsStelara fOr ChRonic AntibioTic rEfractory pouchitiS (SOCRATES)
Primary Purpose
Pouchitis
Status
Unknown status
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Ustekinumab
Sponsored by
About this trial
This is an interventional treatment trial for Pouchitis
Eligibility Criteria
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
Sites / Locations
- UZ LeuvenRecruiting
- Cliniques Universitaires Saint-Luc
- CHU de Liège, Sart Tilman
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open label ustekinumab
Arm Description
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.
Outcomes
Primary Outcome Measures
The percentage of subjects achieving clinically relevant steroid-free remission
mPDAI score <5 and a reduction by ≥2 points from baseline
Secondary Outcome Measures
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
The percentage of subjects achieving partial response
reduction of mPDAI score by ≥2 points from baseline
The percentage of subjects achieving partial response
reduction of mPDAI score by ≥2 points from baseline
Time to clinically relevant remission
Time to mPDAI score <5 and a reduction by ≥2 points from baseline
Change in mPDAI endoscopic subscore
Change in mPDAI endoscopic subscore from baseline
Change in mPDAI symptomatic subscore
Change in mPDAI symptomatic subscore from baseline
Change in total mPDAI score
Change in total mPDAI score from baseline
Change in European Quality of Life 5 Dimensions (EQ-5D)
Change in European Quality of Life 5 Dimensions (EQ-5D) from baseline
Full Information
NCT ID
NCT04089345
First Posted
September 9, 2019
Last Updated
April 27, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Janssen, LP
1. Study Identification
Unique Protocol Identification Number
NCT04089345
Brief Title
Stelara fOr ChRonic AntibioTic rEfractory pouchitiS
Acronym
SOCRATES
Official Title
Stelara fOr ChRonic AntibioTic rEfractory pouchitiS (SOCRATES): A Belgian Open Label Multicenter Pilot-study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Janssen, LP
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy and safety of ustekinumab in the treatment of chronic antibiotic refractory and relapsing pouchitis.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pouchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
open label pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open label ustekinumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Other Intervention Name(s)
Stelara
Intervention Description
All patients will receive intravenously (IV) ustekinumab ~6mg/kg at baseline and subcutaneously (SC) ustekinumab 90mg every 8 weeks thereafter until Week 48.
Primary Outcome Measure Information:
Title
The percentage of subjects achieving clinically relevant steroid-free remission
Description
mPDAI score <5 and a reduction by ≥2 points from baseline
Time Frame
16 weeks after baseline
Secondary Outcome Measure Information:
Title
The percentage of subjects achieving clinically relevant steroid-free remission
Description
mPDAI score <5 and a reduction by ≥2 points from baseline, without need for steroids
Time Frame
48 weeks after baseline
Title
The percentage of subjects achieving partial response
Description
reduction of mPDAI score by ≥2 points from baseline
Time Frame
16 weeks after baseline
Title
The percentage of subjects achieving partial response
Description
reduction of mPDAI score by ≥2 points from baseline
Time Frame
48 weeks after baseline
Title
Time to clinically relevant remission
Description
Time to mPDAI score <5 and a reduction by ≥2 points from baseline
Time Frame
Within 48 weeks after baseline
Title
Change in mPDAI endoscopic subscore
Description
Change in mPDAI endoscopic subscore from baseline
Time Frame
At Week 16 and 48 compared to baseline
Title
Change in mPDAI symptomatic subscore
Description
Change in mPDAI symptomatic subscore from baseline
Time Frame
At Week 16 and 48 compared to baseline
Title
Change in total mPDAI score
Description
Change in total mPDAI score from baseline
Time Frame
At Week 16 and 48 compared to baseline
Title
Change in European Quality of Life 5 Dimensions (EQ-5D)
Description
Change in European Quality of Life 5 Dimensions (EQ-5D) from baseline
Time Frame
At Week 16, 32 and 48 compared to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ganel Schops
Phone
+321648856
Email
IBD_studies@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
An Outtier, MD
Phone
+3216348856
Email
IBD_studies@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Ferrante, MD, PhD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaanderen
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Ferrante, MD, PhD
Phone
+3216342845
Email
IBD_studies@uzleuven.be
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Dewit, MD PhD
Email
olivier.dewit@uclouvain.be
Facility Name
CHU de Liège, Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard Louis, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
Learn more about this trial
Stelara fOr ChRonic AntibioTic rEfractory pouchitiS
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