Long-term Follow-up Study With Darvadstrocel in the Treatment of Complex Perianal Fistula

Crohn's Disease Clinical Trial

Official title:

A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04075825
• Other study ID #: Darvadstrocel-3003
• Secondary ID: 2019-000333-39
• Status: Completed
• Phase: Phase 3
• Start date: November 4, 2019
• Est. completion date: April 2, 2024

Study information

• Verified date: May 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.

Description:

The drug being tested in this study is called darvadstrocel (Cx601). Darvadstrocel is being tested to treat people who have complex perianal fistula in CD. This study will look at the long-term safety and efficacy of darvadstrocel in the treatment of complex perianal fistula in CD.

The study will enroll approximately 150 patients. Participants who received darvadstrocel or placebo in study ADMIRE-CD II (Cx601-0303, NCT03279081) and who have completed the 52 weeks of the study will be enrolled in this long-term extension study.

This multi-center study will be conducted worldwide. The overall time to participate in this study is 104 weeks (in addition to the 52 weeks on ADMIRE-CD II study). Participants will make multiple visits to the clinic and will be contacted by telephone every 3 months for a follow-up assessment. After unblinding of the ADMIRE-CD II study, the LTE study will be conducted as an open-label study. Participants will remain in the treatment group assigned in the ADMIRE-CD II study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: April 2, 2024
• Est. primary completion date: April 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Has participated in and completed the ADMIRE-CD II (NCT03279081) study (i.e., did not discontinue).

Exclusion Criteria:

1. Has been more than 3 months since the participant completed the ADMIRE-CD II study.

Related Conditions & MeSH terms

• Complex Perianal Fistula
• Crohn Disease
• Crohn's Disease
• Fistula
• Rectal Fistula

Intervention

Biological:
• Darvadstrocel
Allogenic expanded adipose-derived stem cells (eASCs) 5 million cells/ml - suspension for injection darvadstrocel received in previous ADMIRE-CD II study. No drug administration in this study.

Locations

Country	Name	City	State
Belgium	GZA Sint-Vincentius	Antwerpen
Belgium	Universitair Ziekenhuis Gent	Gent	Oost-Vlaanderen
Belgium	UZ Leuven	Leuven	Vlaams Brabant
Czechia	NH Hospital a.s.	Horovice
Czechia	FN Hradec Kralove	Hradec Kralove
France	CHU de Clermont-Ferrand - Estaing	Clermont-Ferrand cedex 1
France	CHRU de Lille - Hopital Claude Huriez - Gastroenterologie	Lille	Nord
France	Hopital Saint Louis	Paris
France	Paris St. Joseph Hospital	Paris	Ile-de-France
France	Centre Hospitalier Lyon Sud	Pierre Benite Cedex
France	CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti	Rennes
France	CHRU de Brabois Hopitaux de Brabois	Vandoeuvre Les Nancy Cedex	Nancy
Hungary	MH Egeszsegugyi Kozpont	Budapest	Pest
Hungary	Semmelweis Egyetem Altalanos Orvostudomanyi Kar	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus Gyermekgyogyaszati Klinika	Debrecen
Hungary	Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar	Szeged	Csongrad
Israel	Rambam Medical Centre	Haifa
Israel	Hadassah Medical Organization, Hadassah Medical Center, Ein-	Jerusalem	Yerushalayim
Israel	Rabin Medical Center, Beilinson Hospital -Gastroenterology	Petah Tikva	HaMerkaz
Israel	The Chaim Sheba Medical Center	Tel Hashomer
Italy	AOU Policlinico di Modena - Gastroenterologia	Modena
Italy	Complesso Integrato Columbus, Universita Cattolica del Sacro Cuore	Roma
Italy	PU A. Gemelli, Universita Cattolica del Sacro Cuore	Roma
Poland	Wielospecjalistyczny Szpital Medicover	Warszawa
Poland	Centrum Medyczne Melita Medical	Wroclaw	Dolnoslaskie
Spain	H.U. G.Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic De Barcelona	Barcelona
Spain	Hospital Del Mar	Barcelona
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Fundacion Jimenez Diaz	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Son Espases	Palma de Mallorca	Baleares
Spain	C.H.U. de Pontevedra	Pontevedra
Spain	Parc Tauli Hospital Universitari	Sabadell	Barcelona
Spain	H.U.V. del Rocio	Sevilla
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	Massachussetts General Hospital - Gastroenterology	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Cleveland Clinic Florida	Fort Lauderdale	Florida
United States	Penn State Hershey Medical Center - Surgery	Hershey	Pennsylvania
United States	Indiana University - Colon and Rectal	Indianapolis	Indiana
United States	University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic	Kansas City	Kansas
United States	Dartmouth Hitchcock Medical Center - Cancer Center	Lebanon	New Hampshire
United States	Northwell Health	Manhasset	New York
United States	University of Miami Hospital	Miami	Florida
United States	Morristown Medical Center - Gastroenterology	Morristown	New Jersey
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	Brown Surgical Associates,Inc.	Providence	Rhode Island
United States	Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery	Rochester	Minnesota
United States	University of California San Francisco	San Francisco	California
United States	Virginia Mason Medical Center - Gastroenterology	Seattle	Washington
United States	AdventHealth Tampa	Tampa	Florida
United States	USF Health South Tampa Center for Advanced Healthcare	Tampa	Florida
United States	Cedar-Sinai Medical Center	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  France,  Hungary,  Israel,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.	Baseline (Week 52 of ADMIRE-CD II) up to Week 156 after investigational medicinal product (IMP) administration
Primary	Number of Participants With Serious Adverse Events (SAEs)	An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.	Baseline (Week 52 of ADMIRE-CD II) up to Week 156 after IMP administration
Primary	Number of Participants With Specific Adverse Events of Special Interest (AESIs)	AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESIs included protocol specified immunogenicity/alloimmune reactions, tumorgenicity and ectopic tissue formation.	Baseline (Week 52 of ADMIRE-CD II) up to Week 156 after IMP administration
Secondary	Percentage of Participants who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)	Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline of ADMIRE-CD II despite gentle finger compression.	Baseline of ADMIRE-CD II and Weeks 104 and 156
Secondary	Percentage of Participants who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)	Clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline of ADMIRE-CD II despite gentle finger compression.	Baseline of ADMIRE-CD II and Weeks 104 and 156
Secondary	Percentage of Participants With Relapse	Relapse is defined as participants who were in combined remission at Week 52 of ADMIRE-CD II and who have either reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed or, the development of a perianal fluid collection >2 cm of the treated perianal fistulas confirmed by centrally read magnetic resonance imaging (MRI) assessment.	Up to Week 156
Secondary	Percentage of Participants who Achieve Combined Clinical Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study)	Combined remission of complex perianal fistula(s) is defined as the clinical assessment of closure of all treated external openings that were draining at baseline of ADMIRE-CD II, despite gentle finger compression, and absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by centrally read blinded MRI assessment.	Baseline of ADMIRE-CD II and Week 156
Secondary	Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156		Week 156
Secondary	Change from Baseline of ADMIRE-CD II in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156	The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, discharge will be used. Each category is graded on a 5-point Likert scale ranging from no symptoms (score of 0) to severe symptoms (score of 4); a higher score indicates more severe disease.	Weeks 104 and 156
Secondary	Change from Baseline of ADMIRE-CD II in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156	The PDAI is a scoring system to evaluate the severity of perianal CD. From the 5-item instrument, pain will be used. Each category is graded on a 5-point Likert scale ranging from no symptoms (score of 0) to severe symptoms (score of 4); a higher score indicates more severe disease.	Weeks 104 and 156

External Links

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