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

Study Purpose

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.

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:

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, informed consent form (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 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. 8. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective/effective method of contraception from signing of informed consent and until 1 year after repeat administration.

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 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. 3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3.0 × ULN. 4. Hemoglobin <10.0 g/dL. 5. Platelets <75.0 × 109/L. 6. Albumin <3.0 g/dL. 8. The participant has an increased risk for surgical procedure. 9. The participant has a known chronically active hepatopathy of any origin, including cirrhosis and participants with persistent positive hepatitis B surface antigen and quantitative hepatitis B virus polymerase chain reaction (PCR) or positive serology for hepatitis C virus (HCV) and quantitative HCV PCR within 6 months before the baseline visit. 10. If female, the participant is pregnant or breastfeeding, or intending to become pregnant before participating in this study, during the study, or intending to donate ova during such time period. 11. If male, the participant intends to donate sperm during this study. 12. The participant has a contraindication to MRI scan (e.g., due to the presence of pacemaker, hip replacement, severe claustrophobia, or renal insufficiency as defined by local clinical guidelines). 13. The participant has a contraindication to the anesthetic procedure. 14. The participant has severe rectal and/or anal stenosis that would make it impossible to follow the surgery procedure. 15. The participant has severe proctitis (rectal ulcers >0.5 cm) that would make it impossible to follow the surgery procedure. 16. The participant has any prior invasive malignancy diagnosed within the last 3 years before baseline visit. Participants with basal cell carcinoma of the skin completely resected outside the perineal region can be included. 17. The participant has a current or recent (within 6 months before the baseline visit) history of severe, progressive, and/or uncontrolled hepatic, hematologic, gastrointestinal (other than CD), renal, endocrine, pulmonary, cardiac, neurologic, or psychiatric disease that may result in participant's increased risk from study participation and/or lack of compliance with study procedures. 18. The participant has had major surgery of the gastrointestinal tract within 6 months before baseline or any minor surgery of the gastrointestinal tract 3 months before baseline. 19. The participant had local major perianal surgery, and/or treatment with darvadstrocel within 6 months before baseline. The abscess drainage, cleaning surgery, or seton placement are not considered as "local major surgery" in this protocol. 20. The participant does not wish to or cannot comply with study procedures.

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.

NCT04118088
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.

Takeda
Principal Investigator

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

Study Director
Principal Investigator Affiliation Takeda
Agency Class

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

Industry
Overall Status Recruiting
Countries Austria, Czechia, France, Germany, Israel, Spain
Conditions

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

Crohn's Disease, Complex Perianal Fistula
Additional Details

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.

Arms & Interventions

Arms

Experimental: Darvadstrocel

Participants who have previously received darvadstrocel would receive a single repeat dose of darvadstrocel 120 million cells (5 million cells/mL), by local injection into the fistula.

Interventions

Biological: - Darvadstrocel

Darvadstrocel suspension of human expanded adipose stem cells.

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

Akh Wien, Wien, Austria

Status

Recruiting

Address

Akh Wien

Wien, , 1090

NH Hospital a.s., Horovice, Beroun, Czechia

Status

Recruiting

Address

NH Hospital a.s.

Horovice, Beroun, 268 31

Site Contact

Site Contact

sercl@seznam.cz

+420 311553031

Nice cedex 03, Alpes-Maritimes, France

Status

Recruiting

Address

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

Nice cedex 03, Alpes-Maritimes, 6202

Site Contact

Site Contact

hebuterne.x@chu-nice.fr

330492036168

Rennes, Ille-et-Vilaine, France

Status

Recruiting

Address

CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti

Rennes, Ille-et-Vilaine, 35033

Lille, Nord, France

Status

Recruiting

Address

CHRU de Lille - Hopital Claude Huriez - Gastroenterologie

Lille, Nord, 59037

CHU Amiens Picardie, AMIENS cedex 1, Picardie, France

Status

Recruiting

Address

CHU Amiens Picardie

AMIENS cedex 1, Picardie, 80054

Pierre-Benite, Rhone, France

Status

Recruiting

Address

Centre Hospitalier Lyon Sud - Gastroenterology

Pierre-Benite, Rhone, 69495

Site Contact

Site Contact

stephane.nancey@chu-lyon.fr

+33478861289

Paris St. Joseph Hospital, Paris, France

Status

Recruiting

Address

Paris St. Joseph Hospital

Paris, , 75014

Site Contact

Site Contact

v.deparades@wanadoo.fr

+33 (0) 145454692

Paris, France

Status

Recruiting

Address

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, , 75020

Site Contact

Site Contact

etienney.i@orange.fr

+33 1 44 64 20 64

Dresden, Sachsen, Germany

Status

Recruiting

Address

Klinikum Dresden, University Hospital Dresden

Dresden, Sachsen, 1307

Stadtisches Klinikum Luneburg, Luneburg, Schleswig-Holstein,, Germany

Status

Not yet recruiting

Address

Stadtisches Klinikum Luneburg

Luneburg, Schleswig-Holstein,, 21339

Charite - Campus Benjamin Franklin, Berlin, Germany

Status

Recruiting

Address

Charite - Campus Benjamin Franklin

Berlin, , 12200

Site Contact

Site Contact

britta.siegmund@charite.de

493084454708

Krankenhaus Waldfriede, Berlin, Germany

Status

Recruiting

Address

Krankenhaus Waldfriede

Berlin, , 14163

Site Contact

Site Contact

c.buening@waldfriede.de

+49 30 81 810-8509

Shaare Zedek Medical Center, Jerusalem, Israel

Status

Recruiting

Address

Shaare Zedek Medical Center

Jerusalem, , 9103102

Site Contact

Site Contact

erang@szmc.org.il

+97226776848

Jerusalem, Israel

Status

Recruiting

Address

Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem

Jerusalem, , 91120

Site Contact

Site Contact

klior@hadassah.org.il

972-2-6776848

Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel

Status

Recruiting

Address

Rabin Medical Center, Beilinson Hospital

Petah Tikva, , 49100

Site Contact

Site Contact

ian.white@clalit.org.il

97239372271

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Status

Recruiting

Address

Tel Aviv Sourasky Medical Center

Tel Aviv, , 64239

Site Contact

Site Contact

hagitt@tlvmc.gov.il

9723-6973315

Chaim sheba Medical Center, Tel Hashomer, Israel

Status

Recruiting

Address

Chaim sheba Medical Center

Tel Hashomer, , 5262000

Hospital Universitario Son Espases, Palma de Mallorca, Baleares, Spain

Status

Recruiting

Address

Hospital Universitario Son Espases

Palma de Mallorca, Baleares, 331834

Site Contact

Site Contact

xavier.gonzalez@ssib.es

+34 871-205-500

Santa Cruz de Tenerife, Canarias,, Spain

Status

Recruiting

Address

Hospital Universitario Nuestra Senora de la Candelaria

Santa Cruz de Tenerife, Canarias,, 38010

Site Contact

Site Contact

milvelillas@yahoo.es

34 922 51 42 03

H. Donostia, Donostia, San Sebastian, Spain

Status

Recruiting

Address

H. Donostia

Donostia, San Sebastian, 20014

Hospital Universitario Vall d'Hebron, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitario Vall d'Hebron

Barcelona, , 8035

Site Contact

Site Contact

fcasella@vhebron.net

+34 932746222

Hospital Clinic de Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hospital Clinic de Barcelona

Barcelona, , 8036

Site Contact

Site Contact

ericart@clinic.cat

+34932275400 ext 2779

Hospital Universitario de Bellvitge, Barcelona, Spain

Status

Not yet recruiting

Address

Hospital Universitario de Bellvitge

Barcelona, , 8907

Site Contact

Site Contact

tgolda@bellvitgehospital.cat

34 93 260 76 23

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , 28040

Hospital Universitario La Paz, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario La Paz

Madrid, , 28046

C.H.U. de Pontevedra, Pontevedra, Spain

Status

Recruiting

Address

C.H.U. de Pontevedra

Pontevedra, , 36071

Site Contact

Site Contact

daniel.carpio.lopez@sergas.es

+34986800907

H.C.U. de Valencia, Valencia, Spain

Status

Recruiting

Address

H.C.U. de Valencia

Valencia, , 46010

Site Contact

Site Contact

puchades_laulan@gva.es

+34 963862600

Hospital Universitari i Politecnic La Fe, Valencia, Spain

Status

Recruiting

Address

Hospital Universitari i Politecnic La Fe

Valencia, , 46026

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