USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)

• Register: ClinicalTrials.gov
• Last refreshed on: 29 July 2024
• Main ID: NCT04496063
• Date of registration: 29/06/2020
• Prospective Registration: Yes
• Primary sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Public title: USTekinumab in Fistulising Perianal Crohn's Disease (USTAP) USTAP
• Scientific title: USTekinumab in Fistulising Perianal Crohn's Disease (CD): The USTAP CD Study
• Date of first enrolment: November 16, 2020
• Target sample size: 33
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04496063
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 4

Countries of recruitment

France

Key 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


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Ustekinumab

Drug: Placebo

Primary Outcome(s)

Combined clinical and radiological remission [Time Frame: Week 12]

Secondary Outcome(s)

Clinical response [Time Frame: week 12, week 24 and week 48]

MAGNIFI-CD26 [Time Frame: week 12, week 24 and week 48]

PDAI [Time Frame: week 12, week 24 and week 48]

CDAI [Time Frame: week 12, week 24 and week 48]

Combined clinical and radiological remission [Time Frame: week 24 and week 48]

Clinical response of UST optimization [Time Frame: week 24 and week 48]

UST trough levels and antidrug [Time Frame: week 12 and week 24]

Clinical response of UST introduction at week 12 [Time Frame: week 24 and week 48]

IBDQ scores [Time Frame: week 24 and week 48]

Secondary ID(s)

GT-2019-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Janssen, LP