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PouchitisPhase 3SOCRATESNCT04089345

Stelara fOr ChRonic AntibioTic rEfractory pouchitiS

A Phase 3 study testing Ustekinumab in people with Pouchitis, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the efficacy and safety of ustekinumab in the treatment of chronic antibiotic refractory and relapsing pouchitis. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pouchitis
What is being tested?
Ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesBelgium
Study dates
15 Jun 2020to 1 May 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZ Leuven

    Leuven, Flanders, 3000

  • CHU de Liège, Sart Tilman

    Liège, 4000

Other trials in Belgium

About this study

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

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

Read the 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.

Conditions
Pouchitis
Being tested
Ustekinumab
Medical subject headings
Pouchitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UstekinumabDrug

    Also called Stelara

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

Study groups in NCT04089345
Study groupRoleWhat they receive
Open label ustekinumabExperimentalAll 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.
Receives: Drug: Ustekinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The percentage of subjects achieving clinically relevant steroid-free remission

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

    Measured: 16 weeks after baseline

Secondary outcomes (8)

  1. 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

    Measured: 48 weeks after baseline

  2. The percentage of subjects achieving partial response

    reduction of mPDAI score by ≥2 points from baseline

    Measured: 16 weeks after baseline

  3. The percentage of subjects achieving partial response

    reduction of mPDAI score by ≥2 points from baseline

    Measured: 48 weeks after baseline

  4. Time to clinically relevant remission

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

    Measured: Within 48 weeks after baseline

  5. Change in mPDAI endoscopic subscore

    Change in mPDAI endoscopic subscore from baseline

    Measured: At Week 16 and 48 compared to baseline

  6. Change in mPDAI symptomatic subscore

    Change in mPDAI symptomatic subscore from baseline

    Measured: At Week 16 and 48 compared to baseline

  7. Change in total mPDAI score

    Change in total mPDAI score from baseline

    Measured: At Week 16 and 48 compared to baseline

  8. Change in European Quality of Life 5 Dimensions (EQ-5D)

    Change in European Quality of Life 5 Dimensions (EQ-5D) from baseline

    Measured: At Week 16, 32 and 48 compared to baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2019
  2. Study start15 Jun 2020
  3. Primary completion1 Dec 2022
  4. Study completion1 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
open label pilot study
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04089345
Sponsor's protocol ID
CNTO1275UCO2001
Acronym
SOCRATES
Status last verified
Apr 2021
First submitted
9 Sep 2019
Last updated
11 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication

Publications

  • 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.

    PubMed 38750870

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ustekinumab in people with Pouchitis, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of subjects achieving clinically relevant steroid-free remission (time frame: 16 weeks after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04089345, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.

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