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Crohn's DiseasePhase 4USTAPNCT04496063

USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)

A Phase 4 study testing Ustekinumab in people with Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 20 sites in France.

Completed

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

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
Ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
20 sitesFrance
Study dates
16 Nov 2020to 30 Dec 2025
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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 locations and contacts

20 sites in 1 country.

20 sites in 1 country

France20 sites

  • Chu Amiens

    Amiens, 80054

  • Chu Besancon

    Besançon

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63003

  • APHP- Hopital Beaujon

    Clichy, 92110

  • Hôpital Louis Mourier

    Colombes, 92700

  • Hôpital Kremlin Bicêtre

    Le Kremlin-Bicêtre, 94270

  • CHRU Lille

    Lille, 59037

  • CHU Montpellier - St Eloi

    Montpellier, 34295

  • Hôpital Hôtel Dieu

    Nantes, 44093

  • CHU Nice- Hopital l'Archet

    Nice, 62002

  • CHU Nîmes - Hôpital Universitaire Caremeau

    Nîmes, 30029

  • Hôpital St Louis

    Paris, 75010

  • Hôpital Saint-Antoine

    Paris, 75012

  • Hôpital Bichat

    Paris, 75018

  • CHU LYON- Hopital Lyon Sud

    Pierre-Bénite, 69495

  • CHU Rennes

    Rennes, Brittany Region, 35033

  • CHU Roubaix

    Roubaix, 59056

  • CHU Saint-Etienne

    Saint-Priest-en-Jarez, 42270

  • CHU de Tours - Hopital Trousseau

    Tours, 37044

  • CHU Nancy - Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

Official title: USTekinumab in Fistulising Perianal Crohn's Disease (CD): The USTAP CD Study

Phase IV

Trial design : Multicentre, randomized, double-blind, placebo-controlled study

Read more

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

Read the detailed description

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
Conditions
Crohn's Disease
Being tested
Ustekinumab, Placebo
Keywords
Crohn's Disease, Fistulising Perianal, Placebo, Ustekinumab, Double-blind
Medical subject headings
Crohn Disease

What participants receive

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

  • UstekinumabDrug

    Also called Stelara

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

  • PlaceboDrug

    Placebo intravenous followed by Placebo subcutaneous every 8 weeks

Study groups in NCT04496063
Study groupRoleWhat they receive
Group 1 UstekinumabExperimentalIntravenous induction (6mg/kg) followed by Ustekinumab subcutaneous 90mg every 8 weeks
Receives: Drug: Ustekinumab
Group 2 PlaceboPlacebo comparatorPlacebo intravenous followed by Placebo subcutaneous every 8 weeks
Receives: Drug: Placebo

What is being measured

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

  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.

    Measured: Week 12

Secondary outcomes (9)

  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.

    Measured: week 24 and week 48

  2. Clinical response

    Number of participants with closure of at least 50% of all treated external openings that were draining at baseline

    Measured: week 12, week 24 and week 48

  3. MAGNIFI-CD26

    Evaluation of the magnetic resonance novel index for fistula imaging in CD (MAGNIFI-CD26)

    Measured: week 12, week 24 and week 48

  4. PDAI

    Perineal Disease Activity Index

    Measured: week 12, week 24 and week 48

  5. IBDQ scores

    Quality of life will be assessed with the Inflammatory Bowel Disease questionnaire scores

    Measured: week 24 and week 48

  6. UST trough levels and antidrug

    Correlation between response and remission and UST trough levels and antidrug (UST) antibodies

    Measured: week 12 and week 24

  7. Clinical response of UST optimization

    Number of participants with closure of at least 50% of all treated external openings that were draining at week 12

    Measured: week 24 and week 48

  8. Clinical response of UST introduction at week 12

    Number of participants with closure of at least 50% of all treated external openings that were draining at week 12

    Measured: week 24 and week 48

  9. CDAI

    Crohn Disease Activity Index

    Measured: week 12, week 24 and week 48

Timeline

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

  1. First posted3 Aug 2020
  2. Study start16 Nov 2020
  3. Primary completion30 Jun 2025
  4. Study completion30 Dec 2025

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04496063
Sponsor's protocol ID
GT-2019-01
Acronym
USTAP
Status last verified
Oct 2026
First submitted
29 Jun 2020
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wils P, Nancey S, Messmer E, Bourreille A, Buisson A, Caillo L, Vuitton L, Altwegg R, Hebuterne X, Ernst O, Meunier P, Laurent V, Paul S, Laharie D, Vicaut E, Peyrin-Biroulet L; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Ustekinumab for fistulising perianal Crohn's disease: a randomised placebo-controlled trial from the GETAID. Gut. 2026 Jul 24:gutjnl-2026-339158. doi: 10.1136/gutjnl-2026-339158. Online ahead of print.

    PubMed 42498622

  • 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.

    PubMed 40357993

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ustekinumab in people with Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 20 sites in France.

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 13 inclusion and 22 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Combined clinical and radiological remission (time frame: Week 12). 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 NCT04496063, which also lists 2 linked publications.

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 28 Oct 2026.

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USTAP Clinical Trial NCT04496063 | AzTrials