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A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula | Clinical Trials | Clareo Health

TERMINATEDPHASE4

A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula

Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistula

NCT04118088•Takeda

View on ClinicalTrials.gov

Summary

The main aim is to check the long term side effects of a repeat treatment of darvadstrocel and to see if that treatment improves symptoms of Crohn's disease and complex perianal fistula. Participants will attend 8 clinic visits and will receive 1 treatment of darvadstrocel at the third visit. A magnetic resonance imaging (MRI) will be performed several times during the study.

Detailed Description

The biological being tested in this study is called darvadstrocel (Alofisel). This study is examining the long-term safety and efficacy of a repeat dose of darvadstrocel in people who have Crohn's disease and complex perianal fistula. The study will enroll approximately 50 patients. Participants will be assigned to one treatment group to receive: • Darvadstrocel 120 million cells All participants would be allowed to receive one repeat dose of darvadstrocel in the whole study. This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 3 years. Participants will make multiple visits to the clinic.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
•2. The participant signs and dates a written, ICF and any required privacy authorization before the initiation of any study procedures.
•3. The participant is male or female and aged 18 years or older.
•4. The participant has complex perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment and a reading of a locally-performed contrast enhanced (gadolinium) pelvic MRI. Fistula(s) must have been draining for at least 6 weeks prior to baseline visit. A complex perianal fistula is defined as a fistula that meets 1 or more of the following criteria:
•1. High inter-sphincteric, high trans-sphincteric, extra-sphincteric or suprasphincteric.
•2. Presence of ≥2 external openings.
•3. Associated perianal abscess(es). Note: Abscesses that are larger than 2 cm in at least 2 dimensions on MRI must be confirmed to have been drained adequately by the surgeon during the preparation curettage in order to be eligible.
•5. The participant has already received treatment with darvadstrocel for a complex perianal fistula at least 6 months prior to baseline visit for retreatment, and their physician has planned a repeat treatment administration for the original tract (full remission not obtained or relapse of fistula draining) or for a new complex perianal fistula tract.
•6. The participant has controlled or mildly active Crohn's disease (CD) (defined as patient reported outcomes measure derived from CDAI patient reported outcome score-2 \[PRO-2\] score \<14).
•7. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use barrier method of contraception (e.g. condom with or without spermicide) from signing of informed consent and until 1 year after repeat administration.
+1 more criteria

Exclusion Criteria

•1. The participant has lack of clinical response to prior treatment with darvadstrocel, where clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline despite gentle finger compression or in the case of a unique fistula, a partial closure of the fistula.
•2. The participant has a history of hypersensitivity or allergies to darvadstrocel or related compounds.
•3. The participant has a history of hypersensitivity or allergies to penicillin or to aminoglycosides; Dulbecco modified eagle medium; bovine serum; local anesthetics or gadolinium.
•4. The participant is currently participating in a double-blind clinical study with darvadstrocel. Participants participating in the ongoing INSPIRE registry (Alofisel-5003) study would need to withdraw from that study in order to enroll in this study.
•5. The participant is currently receiving or has received any other investigational medicinal product (IMP) within the last 3 months or at least 5 times the respective elimination half-life time, whichever is longer, before signing the ICF.
•6. The participant has known or suspected COVID-19 by the investigator within the past 2 months (additional testing may be performed at the discretion of the investigator). Positive antibody testing for COVID without other evidence of current or recent active infection does not exclude participation.
•a) Participants who were in screening at the time that COVID 19-related factors resulted in discontinuation may also be rescreened with approval of the sponsor or designee.
•7. The participant has major alterations in any of the following laboratory tests:
•1. Serum creatinine levels \>1.5 times the upper limit of normal (ULN).
•2. Total bilirubin \>1.5 × ULN.
+17 more criteria

Locations (30)

Akh Wien

Vienna, Austria

NH Hospital a.s.

Hořovice, Czechia

ISCARE a.s.

Prague, Czechia

CHU de Nice - Hopital de l'Archet II - Gastro-Enterologie, Hepatologi

Nice, Alpes-Maritimes, France

CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti

Rennes, Ille-et-Vilaine, France

CHRU de Lille - Hopital Claude Huriez - Gastroenterologie

Lille, Nord, France

CHU AMIENS PICARDIE Site SUD Hepato-Gastroenterology

Amiens, Picardie, France

Centre Hospitalier Lyon Sud - Gastroenterology

Pierre-Bénite, Rhone, France

Paris St. Joseph Hospital

Paris, France

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, France

Key Dates

Start Date

December 22, 2020

Primary Completion Date

February 14, 2025

Completion Date

February 14, 2025

Last Updated

January 22, 2026

Enrollment

ACTUAL participants

Conditions

Crohn's DiseaseComplex Perianal Fistula

Interventions

Darvadstrocel

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Darvadstrocel in Adults With Crohn's Disease and Complex Perianal Fistula

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

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