USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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

    Exclusion Criteria:

    - 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 - Previous use of a biologic agent targeting Interleukin 12 (IL12) and/or Interleukin 23 (IL 23), including but not limited to ustekinumab - Oral corticosteroids at a dose > 40 mg prednisone or its equivalent per day at inclusion (oral steroids should be at stable dose at least 7 days before inclusion) - Any current or previous use of the following within 8 weeks before the first trial agent injection : cyclosporine, tacrolimus, anti-TNF biologic agents or other agents intended to suppress or eliminate Tumor Necrosing Factor (TNF), and other biologics, including anti-integrin antibodies (approved or investigational), Janus Kinase (JAK) inhibitors (approved or investigational), or any current or previous use of an investigational agent - Non-autologous stem cell therapy or biologic agents that deplete B or T cells <12 months prior to baseline - Current or recent (less than 4 weeks) vaccination with attenuated live vaccines - Patients using a prohibited medication - Patients participating in another trial or being in a follow-up period for another trial

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04496063
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease
Additional Details

Main endpoint: The primary endpoint will be combined remission at week 12 defined as:

  • - 100% of the fistula tracts without any drainage by the external openings (occurring spontaneously or after gentle finger compression) And - absence of collections >2 cm of the treated perianal fistulas confirmed by masked central MRI Patient requiring UST optimization will be considered in failure but will be followed until week 48 Secondary endpoints: Definition - Clinical remission: 100% of the fistula tracts without any drainage by the external openings (i.
e, absence of any drainage by all fistula openings occurring spontaneously or after gentle finger compression)
  • - Clinical response (closure of at least 50% of all treated external openings that were draining at baseline) - Radiological remission: absence of collections >2 cm of the treated perianal fistulas confirmed by masked central MRI - Combined clinical and radiological remission at week 24 and 48.
  • - Clinical remission (i.
e, absence of any drainage by all fistula openings occurring spontaneously or after gentle finger compression) at week 12, 24 and 48 - Absence of collections >2 cm of the treated perianal fistulas confirmed by masked central MRI at week 12, 24 and 48 - Evaluation of the magnetic resonance novel index for fistula imaging in CD at week 12, 24 and 48 - Clinical response (closure of at least 50% of all treated external openings that were draining at baseline) at week 12, 24 and 48 - Combined clinical response and radiological remission at week 48 - Perineal Disease Activity Index (PDAI), Crohn Disease Activity Index (CDAI) at week 12, 24 and 48 - Quality of life will be assessed with the Inflammatory Bowel Disease questionnaire (IBDQ) scores at week 24 and 48 - Correlation between response and remission and UST trough levels and antidrug (UST) antibodies at week 12, 24, 48 - Clinical response of UST optimization at week 48 (closure of at least 50% of all treated external openings that were draining at week 12) - Clinical response at week 48 of UST introduction at W12 (closure of at least 50% of all treated external

Arms & Interventions

Arms

Experimental: Group 1 Ustekinumab

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

Placebo Comparator: Group 2 Placebo

Placebo intravenous followed by Placebo subcutaneous every 8 weeks

Interventions

Drug: - Ustekinumab

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

Drug: - Placebo

Placebo intravenous followed by Placebo subcutaneous every 8 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Rennes, Rennes, Bretagne, France

Status

Address

CHU Rennes

Rennes, Bretagne, 35033

Site Contact

Guillaume BOUGUEN, MD PhD

guillaume.bouguen@chu-rennes.fr

+33299284347

Chu Amiens, Amiens, France

Status

Address

Chu Amiens

Amiens, , 80054

Site Contact

Mathurin FUMERY

Fumery.Mathurin@chu-amiens.fr

+ 33 20 44 47 97

Chu Besancon, Besançon, France

Status

Address

Chu Besancon

Besançon, ,

CHU de Caen- Hopital de la Cote de Nacre, Caen, France

Status

Address

CHU de Caen- Hopital de la Cote de Nacre

Caen, , 14033

Site Contact

Stéphanie VIENNOT, MD

viennot-s@chu-caen.fr

+ 33 20 44 47 97

CHU Clermont Ferrand, Clermont-Ferrand, France

Status

Address

CHU Clermont Ferrand

Clermont-Ferrand, , 63003

APHP- Hopital Beaujon, Clichy, France

Status

Address

APHP- Hopital Beaujon

Clichy, , 92110

Site Contact

Yoram BOUHNIK, MD

yoram.bouhnik@aphp.fr

+ 33 20 44 47 97

Hôpital Louis Mourier, Colombes, France

Status

Address

Hôpital Louis Mourier

Colombes, , 92700

Site Contact

Benoit COFFIN, MD PhD

benoit.coffin@lmr.ap-hop-paris.fr

+33 1 47 60 60 61

Hôpital Kremlin Bicêtre, Le Kremlin Bicêtre, France

Status

Address

Hôpital Kremlin Bicêtre

Le Kremlin Bicêtre, , 94270

Site Contact

Franck CARBONNEL, MD PhD

franck.carbonnel@bct.aphp.fr

+33 1 45 21 37 22

CHRU Lille, Lille, France

Status

Address

CHRU Lille

Lille, , 59037

Site Contact

Benjamin PARIENTE, MD, PhD

Benjamin.PARIENTE@CHRU-LILLE.FR

+ 33 20 44 47 97

CHU Montpellier - St Eloi, Montpellier, France

Status

Address

CHU Montpellier - St Eloi

Montpellier, , 34295

Site Contact

Romain ALTWEGG, MD

r-altwegg@chu-montpellier.fr

+ 33 20 44 47 97

Hôpital Hôtel Dieu, Nantes, France

Status

Address

Hôpital Hôtel Dieu

Nantes, , 44093

Site Contact

Arnaud BOUREILLE, MD PhD

arnaud.boureille@chu-nantes.fr

+33 2 40 41 29 74

CHU Nice- Hopital l'Archet, Nice, France

Status

Address

CHU Nice- Hopital l'Archet

Nice, , 62002

Site Contact

Xavier HEBUTERNE

hebuterne.x@chu-nice.fr

+33 4 92 03 61 68

Nîmes, France

Status

Address

CHU Nîmes - Hôpital Universitaire Caremeau

Nîmes, , 30029

Hôpital St Louis, Paris, France

Status

Address

Hôpital St Louis

Paris, , 75010

Site Contact

Joëlle BONNET, MD

joelle.bonnet@aphp.fr

+ 33 20 44 47 97

Hôpital Saint-Antoine, Paris, France

Status

Address

Hôpital Saint-Antoine

Paris, , 75012

Site Contact

Philippe SEKSIK, MD PhD

philippe.seksik@sat.aphp.fr

+33 1 49 28 31 70

Hôpital Bichat, Paris, France

Status

Address

Hôpital Bichat

Paris, , 75018

Site Contact

Anne-Laure PELLETIER, MD

anne-laure.pelletier@bch.aphp.fr

+ 33 20 44 47 97

CHU LYON- Hopital Lyon Sud, Pierre-Bénite, France

Status

Address

CHU LYON- Hopital Lyon Sud

Pierre-Bénite, , 69495

Site Contact

Stéphane NANCEY, MD

stephane.nancey@chu-lyon.fr

+ 33 20 44 47 97

CHU Roubaix, Roubaix, France

Status

Address

CHU Roubaix

Roubaix, , 59056

Site Contact

Nicolas DUVEAUX, MD

nicolas.duveau@ch-roubaix.fr

+33 3 20 99 32 01

CHU Saint-Etienne, Saint-Priest-en-Jarez, France

Status

Address

CHU Saint-Etienne

Saint-Priest-en-Jarez, , 42270

Site Contact

Xavier ROBLIN, MD PhD

xavier.roblin@chu-st-etienne.fr

+33 4 77 82 83 20

CHU de Tours - Hopital Trousseau, Tours, France

Status

Address

CHU de Tours - Hopital Trousseau

Tours, , 37044

CHU Nancy - Hôpital de Brabois, Vandœuvre-lès-Nancy, France

Status

Address

CHU Nancy - Hôpital de Brabois

Vandœuvre-lès-Nancy, , 54500

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