STekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD study

Phase 1

Conditions: patient with moderate to severe Crohn’s diseasewith at least one active perianal fistula track
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2019-001337-13-FR

Lead Sponsor: GETAID

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 146

Inclusion Criteria

oAge =18 years
oAdults with moderate to severe Crohn’s disease for at least six months
oPatients 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
oPatients either naïve to anti-TNF therapy (50%) or refractory to anti-TNF therapy (50%).
oIf 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
oMale 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.
oIf female, subject is not breast-feeding throughout the study and for 150 days after last dose.
oSubjects 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)
oAdequate 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
oSubject with a negative TB Screening Assessment [(including a PPD test < 5 mm and/or negative QuantiFERON-TB Gold test or equivalent and negative CXR (PA and lateral view)] at Screening

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 146
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

oAbsence of written consent. People unable to give their consent (because of their physical or mental state)
oPregnancy or breastfeeding
oRectovaginal fistulas
oRectal and/or anal stenosis
oDiverting stomas
oAbscess 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)
oHistory of colectomy.
oHistory of colonic mucosal dysplasia or adenomatous colonic polyps that are not removed.
oScreening stool trial positive for enteric pathogens or Clostridium difficile toxin. History of ongoing, chronic or recurrent infectious disease
oPositive HIV, HBV, HCV
oSevere infection, chronic infection, history of recurrent infections, active infection including TB
oMalignancies or history of malignancies
oHistory 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).
oHistory of transplanted organ, lymphoproliterative disease, any known malignancy
oPrevious allergy immunotherapy for anaphylaxis, hypersensitivity to ustekinumab or components, or metronidazole or ciprofloxacin
oPrevious use of a biologic agent targeting IL12 and/or IL 23, including but not limited to ustekinumab
oOral 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)
oAny 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 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
oNon-autologous stem cell therapy or biologic agents that deplete B or T cells <12 months prior to baseline
oCurrent or recent (less than 4 weeks) vaccination with attenuated live vaccines
oPatients using a prohibited medication
oPatients participating in another trial or being in a follow-up period for another trial