USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)

NCT04496063 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: GT-2019-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 20

Brief Summary

Phase IV Trial design : Multicentre, randomized, double-blind, placebo-controlled study Population : Moderate to severe Crohn's disease with at least one active perianal fistula track Investigational treatment : Group 1: Ustekinumab (UST) IntraVenous (IV) induction (6mg/kg) followed by UST SubCutaneous (SC) 90mg every 8 weeks. Group 2: Placebo IV followed by Placebo SC The trial duration for each patient will be 48 weeks. Trial objective : To evaluate the efficacy and safety of ustekinumab in fistulizing perianal Crohn's disease. Number of patients : A total of 146 patients will be included in 20 sites in France Trial duration : First patient in: Q3 2020 - Last patient first visit: Q3 2022 Last patient last visit: Q3 2023

Conditions

Crohn's Disease

Keywords

Crohn's Disease; Fistulising Perianal; Placebo; Ustekinumab; Double-blind

Outcome Measures

Primary Outcomes (1)

• Combined clinical and radiological remission

  Number of participants with 100% of the fistula tracts without any drainage by the external openings (occurring spontaneously or after gentle finger compression) \- Number of participants with absence of collections \>2 cm of the treated perianal fistulas confirmed by masked central MRI.

  Week 12

Secondary Outcomes (9)

• Combined clinical and radiological remission

  week 24 and week 48

• Clinical response

  week 12, week 24 and week 48

• MAGNIFI-CD26

  week 12, week 24 and week 48

• PDAI

  week 12, week 24 and week 48

• IBDQ scores

  week 24 and week 48

Study Arms (2)

Group 1 Ustekinumab

EXPERIMENTAL

Intravenous induction (6mg/kg) followed by Ustekinumab subcutaneous 90mg every 8 weeks

Drug: Ustekinumab

Group 2 Placebo

PLACEBO COMPARATOR

Placebo intravenous followed by Placebo subcutaneous every 8 weeks

Drug: Placebo

Interventions

Ustekinumab DRUG

Intravenous induction (6mg/kg) followed by Ustekinumab subcutaneous 90mg every 8 weeks

Also known as: Stelara

Group 1 Ustekinumab

Placebo DRUG

Placebo intravenous followed by Placebo subcutaneous every 8 weeks

Group 2 Placebo

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Adults with moderate to severe Crohn's disease for at least six months
• Patients with at least one active perianal fistula track (between the anus or low rectum and the perineum or vulva) confirmed by MRI within the previous 12 weeks
• Patients either naïve to anti-TNF therapy (50%) or refractory to anti-TNF therapy (50%).
• If female, subject is either not of child bearing potential, defined as post-menopausal for at least1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control during the study and for 150 days after the last dose:
• Condoms, sponge and foam, jellies with diaphragm or intrauterine device (IUD). IUDs may fail during azathioprine treatment. Alternative or additional contraceptive measures are advised, if azathioprine is initiated
• Oral or parenteral contraceptives for 3 months prior to study drug administration
• A vasectomized partner
• Male subjects must agree to use an acceptable form of birth control, listed above at the start of azathioprine administration and for 90 days after last dose of azathioprine. Males should also commit to inform his partner(s) about it and to report any pregnancy to the investigator.
• If female, subject is not breast-feeding throughout the study and for 150 days after last dose.
• Subjects or his/her legal representative have voluntarily signed and dated an informed consent approved by and compliant with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
• Adequate cardiac, renal and hepatic function as determined by the Principal Investigator and demonstrated by Screening laboratory evaluations, questionnaires and physical examination results that do not indicate an abnormal clinical condition which would place the subject at undue risk and thus preclude subject participation in the study
• Subject with a negative tuberculosis (TB) Screening Assessment \[(including a Purified Protein Derivative (PPD) test \< 5 mm and/or negative QuantiFERON-TB Gold test or equivalent and negative Chest X-Ray (CXR) (PA and lateral view)\] at screening

You may not qualify if:

• Absence of written consent. People unable to give their consent (because of their physical or mental state)
• Pregnancy or breastfeeding
• Rectovaginal fistulas
• Rectal and/or anal stenosis
• Diverting stomas
• Abscess or collections \>2 cm which are not properly drained ((i.e not drained at least 3 weeks before baseline and adequately treated provided that there is no anticipated need for any further surgery)
• History of colectomy.
• History of colonic mucosal dysplasia or adenomatous colonic polyps that are not removed.
• Screening stool trial positive for enteric pathogens or Clostridium difficile toxin. History of ongoing, chronic or recurrent infectious disease
• Positive HIV, Hepatitis B Virus (HBV),Hepatitis C Virus (HCV)
• Severe infection, chronic infection, history of recurrent infections, active infection including TB
• Malignancies or history of malignancies
• History of congestive heart failure (NYHA: Grade III and IV), demyelinating disease, current signs or history of severe/ progressive/uncontrolled renal, hepatic, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or systemic lupus erythematosus (SLE).
• History of transplanted organ, lymphoproliferative disease, any known malignancy
• Previous allergy immunotherapy for anaphylaxis, hypersensitivity to ustekinumab or to any excipients, or metronidazole or ciprofloxacin

Sponsors & Collaborators

• Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives: lead
• Janssen, LP: collaborator

Study Sites (20)

CHU Rennes

Rennes, Brittany Region, 35033, France

Location

Chu Amiens

Amiens, 80054, France

Location

Chu Besancon

Besançon, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

APHP- Hopital Beaujon

Clichy, 92110, France

Location

Hôpital Louis Mourier

Colombes, 92700, France

Location

Hôpital Kremlin Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

CHRU Lille

Lille, 59037, France

Location

CHU Montpellier - St Eloi

Montpellier, 34295, France

Location

Hôpital Hôtel Dieu

Nantes, 44093, France

Location

CHU Nice- Hopital l'Archet

Nice, 62002, France

Location

CHU Nîmes - Hôpital Universitaire Caremeau

Nîmes, 30029, France

Location

Hôpital St Louis

Paris, 75010, France

Location

Hôpital Saint-Antoine

Paris, 75012, France

Location

Hôpital Bichat

Paris, 75018, France

Location

CHU LYON- Hopital Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU Roubaix

Roubaix, 59056, France

Location

CHU Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

Location

CHU de Tours - Hopital Trousseau

Tours, 37044, France

Location

CHU Nancy - Hôpital de Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (1)

• Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.

  PMID: 40357993 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: August 3, 2020
• Study Start: November 16, 2020
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

FR (20)