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

NCT04075825 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: Darvadstrocel-30032019-000333-39
• Study Type: interventional
• Target: 150
• Locations: 9 countries
• Sites: 58

Brief 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.

Conditions

Crohn's Disease; Complex Perianal Fistula

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  An Adverse Event (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. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.

  Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)

• Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)

  TEAE is defined as: any adverse event emerging/manifesting at or after the initiation of treatment with a study intervention/medicinal product or any existing event that worsens in either intensity/frequency following exposure to the study intervention/medicinal product. Serious adverse event (SAE) is an untoward medical occurrence, significant hazard, contraindication, side effect/precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization/prolongation of existing hospitalization, results in persistent/significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

  Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)

• 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 require close monitoring and prompt reporting to the sponsor. Protocol pre-specified AESIs included immunogenicity/allo-immunoreactions, tumorigenicity, ectopic tissue formation and fistula/abscess. In addition, ad hoc AESIs of anaphylactic reaction, hypersensitivity, and malignancy.

  Baseline (Week 0) up to Week 104 of this study (Week 52 up to Week 156 in relation to ADMIRE-CD II)

Secondary Outcomes (7)

• Percentage of Participants Who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)

  At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)

• Percentage of Participants Who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study)

  At Weeks 52 and 104 of this study (Weeks 104 and 156 in relation to ADMIRE-CD II, respectively)

• Percentage of Participants With Relapse at Week 156 After Achieving Combined Remission at Week 52 of ADMIRE-CD II

  At Week 104 of this study (Week 156 in relation to ADMIRE-CD II)

• Percentage of Participants Who Achieve Combined Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study)

  At Week 104 of this study (Week 156 in relation to ADMIRE-CD II)

• Percentage of Participants With New Anal Abscess in Treated Fistula at Week 156

  At Week 104 of this study (Week 156 in relation to ADMIRE-CD II)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants who received darvadstrocel placebo-matching expanded adipose-derived stem cells (eASCs) intralesional injection previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.

Other: Placebo

Darvadstrocel

EXPERIMENTAL

Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally previously in the ADMIRE-CD II study were observed for efficacy and safety. No drug was administered in this study.

Biological: Darvadstrocel

Interventions

Placebo OTHER

Darvadstrocel placebo-matching eASCs intralesional injection received in previous ADMIRE-CD II study. No drug administration in this study.

Placebo

Darvadstrocel BIOLOGICAL

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.

Also known as: Cx601

Darvadstrocel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (58)

University of California San Francisco

San Francisco, California, 94115, United States

Location

Cedar-Sinai Medical Center

West Hollywood, California, 90048, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Cleveland Clinic Florida

Fort Lauderdale, Florida, 33331, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

USF Health South Tampa Center for Advanced Healthcare

Tampa, Florida, 33606, United States

Location

AdventHealth Tampa

Tampa, Florida, 33613, United States

Location

Indiana University - Colon and Rectal

Indianapolis, Indiana, 46237, United States

Location

University of Kansas Medical Center (KUMC) - University of Kansas Liver Center - Hepatology Clinic

Kansas City, Kansas, 66160, United States

Location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location

Massachussetts General Hospital - Gastroenterology

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery

Rochester, Minnesota, 55905, United States

Location

Dartmouth Hitchcock Medical Center - Cancer Center

Lebanon, New Hampshire, 03576, United States

Location

Morristown Medical Center - Gastroenterology

Morristown, New Jersey, 07960, United States

Location

Northwell Health

Manhasset, New York, 11030, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Penn State Hershey Medical Center - Surgery

Hershey, Pennsylvania, 17033, United States

Location

Brown Surgical Associates,Inc.

Providence, Rhode Island, 02904, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Mason Medical Center - Gastroenterology

Seattle, Washington, 98101, United States

Location

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

GZA Sint-Vincentius

Antwerp, 2018, Belgium

Location

NH Hospital a.s.

Hořovice, 268 31, Czechia

Location

FN Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

CHRU de Brabois Hopitaux de Brabois

Vandœuvre-lès-Nancy, Nancy, 54511, France

Location

CHRU de Lille - Hopital Claude Huriez - Gastroenterologie

Lille, Nord, 59037, France

Location

CHU de Clermont-Ferrand - Estaing

Clermont-Ferrand, 63003, France

Location

Hopital Saint Louis

Paris, 75010, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti

Rennes, 35033, France

Location

Paris St. Joseph Hospital

Paris, Île-de-France Region, 75014, France

Location

Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar

Szeged, Csongrád megye, 6720, Hungary

Location

MH Egeszsegugyi Kozpont

Budapest, Pest County, 1062, Hungary

Location

Semmelweis Egyetem Altalanos Orvostudomanyi Kar

Budapest, 1088, Hungary

Location

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus Gyermekgyogyaszati Klinika

Debrecen, H-4032, Hungary

Location

Rabin Medical Center, Beilinson Hospital -Gastroenterology

Petah Tikva, Central District, 4941492, Israel

Location

Hadassah Medical Organization, Hadassah Medical Center, Ein-

Jerusalem, Jerusalem, 9112001, Israel

Location

Rambam Medical Centre

Haifa, 31096, Israel

Location

The Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

AOU Policlinico di Modena - Gastroenterologia

Modena, 41124, Italy

Location

Complesso Integrato Columbus, Universita Cattolica del Sacro Cuore

Roma, 00168, Italy

Location

PU A. Gemelli, Universita Cattolica del Sacro Cuore

Roma, 00168, Italy

Location

Centrum Medyczne Melita Medical

Wroclaw, Lower Silesian Voivodeship, 50-449, Poland

Location

Wielospecjalistyczny Szpital Medicover

Warsaw, 02-972, Poland

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

H.U. G.Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Parc Tauli Hospital Universitari

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital Clinic De Barcelona

Barcelona, 08036, Spain

Location

Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

C.H.U. de Pontevedra

Pontevedra, 36071, Spain

Location

H.U.V. del Rocio

Seville, 21005, Spain

Location

Related Links

• To obtain more information about this study, click this link.

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: September 3, 2019
• Study Start: November 5, 2019
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: April 23, 2025
• Results First Posted: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

IT (3); HU (4); FR (7); US (22); CZ (2); ES (11); BE (3); IL (4); PL (2)