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

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

Sponsors

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Source Takeda
Brief Summary

The purpose of this study is to evaluate the long-term safety of a single dose of darvadstrocel in participants with Crohn's disease (CD) and complex perianal fistula by evaluation of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).

Detailed Description

The drug being tested in this study is called darvadstrocel (Cx601). Darvadstrocel is being tested to treat people who have Crohn's disease (CD) and complex perianal fistula. 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 trial will be conducted worldwide. The overall time to participate in this study is 104 weeks. Participants will make multiple visits to the clinic and will be contacted by telephone every 3 months for a follow-up assessment.

Overall Status Recruiting
Start Date 2019-11-04
Completion Date 2024-02-28
Primary Completion Date 2024-02-28
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants With Adverse Events (AEs) Baseline up to Week 156 after investigational medicinal product (IMP) administration
Number of Participants With Serious Adverse Events (SAEs) Baseline up to Week 156 after IMP administration
Number of Participants With Specific Adverse Events of Special Interest (AESIs) Baseline up to Week 156 after IMP administration
Secondary Outcome
Measure Time Frame
Percentage of Participants who Achieve Clinical Remission at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) Baseline and Weeks 104 and 156
Percentage of Participants who Achieve Clinical Response at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) Baseline and Weeks 104 and 156
Percentage of Participants With Relapse Week 52 up to Week 104
Percentage of Participants who Achieve Combined Clinical Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study) Baseline and Week 156
Percentage of Participants With New Anal Abscess in Treated Fistula Week 104
Change from Baseline in Scores of Discharge Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) Weeks 104 and 156
Change from Baseline in Scores of Pain Items of Perianal Disease Activity Index (PDAI) Score at Weeks 104 and 156 (After IMP Administration in ADMIRE-CD II Study) Weeks 104 and 156
Enrollment 150
Condition
Intervention

Intervention Type: Biological

Intervention Name: Darvadstrocel

Description: Allogenic eASCs 5 million cells/ml - suspension for injection Cx601 received in previous ADMIRE-CD II study. No drug administration in this study.

Arm Group Label: Darvadstrocel

Other Name: Cx601

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Medical Director Study Director Millennium Pharmaceuticals, Inc.
Overall Contact

Last Name: Takeda Study Registration Call Center

Phone: +1-877-825-3327

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Cedar-Sinai Medical Center | West Hollywood, California, 90048, United States Recruiting Site Contact 310-289-9224 [email protected] Phillip Fleshner Principal Investigator
Hartford Hospital - Gastroenterology | Farmington, Connecticut, 06032, United States Not yet recruiting Site Contact 860-246-2571 [email protected] John D. Wysocki Principal Investigator
Florida Hospital Tampa | Tampa, Florida, 33613, United States Recruiting Site Contact 813-615-7068 [email protected] Yasser Saloum Principal Investigator
Indiana University - Colon and Rectal | Indianapolis, Indiana, 46237, United States Not yet recruiting Site Contact 317-834-2020 [email protected] Dipen Maun Principal Investigator
University of Kansas Sxchool of Medicine | Kansas City, Kansas, 66160, United States Recruiting Site Contact 209-814-3400 [email protected] Florence Aslinia Principal Investigator
Colon and Rectal Surgery Associates | Metairie, Louisiana, 70001, United States Not yet recruiting Site Contact 504-456-5108 [email protected] Jennifer Silinsky Principal Investigator
University of Maryland | Baltimore, Maryland, 21201, United States Not yet recruiting Site Contact 410-706-3387 [email protected] Raymond Cross Principal Investigator
University of Massachusetts - colon & rectal surgery | Worcester, Massachusetts, 01605, United States Not yet recruiting Site Contact 508-334-8195 [email protected] Karim Alavi Principal Investigator
Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery | Rochester, Minnesota, 55905, United States Recruiting Site Contact 507-284-2511 [email protected] Laura Raffals Principal Investigator
Barnes-Jewish Hospital - Gastroenterology | Saint Louis, Missouri, 63110, United States Not yet recruiting Site Contact 314-407-9222 [email protected] Smith Radhika Principal Investigator
Dartmouth Hitchcock Medical Center - Cancer Center | Lebanon, New Hampshire, 03756, United States Not yet recruiting Site Contact 603-650-5261 [email protected] Corey Siegel Principal Investigator
Morristown Medical Center - Gastroenterology | Morristown, New Jersey, 07960, United States Recruiting Site Contact 973-971-7507 [email protected] Razvan Arsenescu Principal Investigator
Icahn School of Medicine at Mount Sinai | New York, New York, 10028, United States Recruiting Site Contact 212-241-8100 [email protected] James Marion Principal Investigator
Lenox Hill Hospital | New York, New York, 10075, United States Recruiting Site Contact 212-434-6963 [email protected] Arum Swaminath Principal Investigator
Cleveland Clinic | Cleveland, Ohio, 44106, United States Not yet recruiting Site Contact 216-445-6063 [email protected] Amy Lightner Principal Investigator
Penn State Hershey Medical Center - Surgery | Hershey, Pennsylvania, 17033, United States Recruiting Site Contact 717-531-0003 285565 [email protected] Jeffrey Scow Principal Investigator
University Surgical Associates-Rhode Island Hospital | Providence, Rhode Island, 02904, United States Recruiting Site Contact 401-725-4888 [email protected] Adam Klipfel Principal Investigator
Vanderbilt University Medical Center | Nashville, Tennessee, 37232, United States Recruiting Site Contact 615-322-0128 [email protected] Baldeep Pabla Principal Investigator
University of Utah | Salt Lake City, Utah, 84112, United States Not yet recruiting Site Contact 801-581-7124 [email protected] Thomas PICKRON Principal Investigator
Virginia Mason Medical Center - Gastroenterology | Seattle, Washington, 98101, United States Recruiting Site Contact 206-625-7373 [email protected] Michael Chiorean Principal Investigator
Swedish Medical Center | Seattle, Washington, 98104, United States Not yet recruiting Site Contact 206-215-4250 [email protected] Karlee Ausk Principal Investigator
Medical College of Wisconsin Hub for Collaborative Medicine - Gastroenterology and Hepatology | Milwaukee, Wisconsin, 53226, United States Not yet recruiting Site Contact 414-955-6729 [email protected] Poonam Beniwal-Patel Principal Investigator
UZ Leuven - Campus Gasthuisberg | Leuven, Vlaams Brabant, 3000, Belgium Recruiting Site Contact +32 16 344225 [email protected] Ferrante Ferrante Principal Investigator
AZ Delta vzw - Maag-darm-leverziekten | Roeselare, West-Vlaanderen, 8800, Belgium Not yet recruiting Site Contact +32 5 123 72 15 [email protected] Filip Baert Principal Investigator
GZA ziekenhuizen - Campus Sint-Vincentius - Gastro-enterology | Antwerpen, 2018, Belgium Not yet recruiting Site Contact +32 3 285 28 15 [email protected] Dirk Staessen Principal Investigator
UZ Gent - Gastroenterology | Gent, 9000, Belgium Recruiting Site Contact 3292402371 [email protected] Danny De Looze Principal Investigator
NH Hospital a.s. | Horovice, Beroun, 268 31, Czechia Recruiting Site Contact +420 311553031 [email protected] Zuzana Serclova Principal Investigator
FN Hradec Kralove | Hradec Kralove, 500 05, Czechia Recruiting Site Contact +420 495 833 818 [email protected] Tomas Douda Principal Investigator
CHU de Nice | Nice Cedex 03, Alpes-Maritimes, 06202, France Not yet recruiting Site Contact 330492036168 [email protected] Hebuterne Hebuterne Principal Investigator
CHU de Clermont-Ferrand - Estaing | Clermont-Ferrand cedex 1, Auvergne, 63003, France Recruiting Site Contact +33 (0) 4 73 75 05 04 [email protected] Anthony Buisson Principal Investigator
Hopital Saint Louis - Gastro-hepatoenterologie | Paris, Ile-de-France, 75010, France Recruiting Site Contact 33142 49 95 97 [email protected] M Allez Allez Principal Investigator
CHRU Hopital De Pontchaillou | Rennes, Ille-et-Vilaine, 35033, France Recruiting Site Contact 02 99 28 43 11 [email protected] Charlene BROCHARD Principal Investigator
CHRU de Nancy -Hopital Brabois Adultes - Service d'Hepato- Gastroenterologie | Vandoeuvre-les-Nancy, Lorraine, 54511, France Recruiting Site Contact +33 3 83 15 33 54 [email protected] Laurent PEYRIN-BIROULET Principal Investigator
CHRU De Lille - Hopital Claude Huriez - Hepato-Gastro-Enterologie | Lille, Nord, 59000, France Recruiting Site Contact +33 3 20 44 47 14 [email protected] Maria Nachury Principal Investigator
CHU Amiens-Picardie | AMIENS cedex 1, Picardie, 80054, France Not yet recruiting Site Contact +33 3 22 08 88 50 [email protected] Fumery FUMERY Principal Investigator
Centre Hospitalier Lyon Sud | Pierre-Benite, Rhone, 69495, France Recruiting Site Contact +33478861289 [email protected] Nancey Nancey Principal Investigator
Paris St. Joseph Hospital | Paris, 75014, France Recruiting Site Contact 33 1 44 12 80 00 [email protected] Vincent De Parades Principal Investigator
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont - I. sz. Belgyogyaszati Klinika | Szeged, Csongrad, 6720, Hungary Recruiting Site Contact 3662545186 [email protected] Tamas Molnar Principal Investigator
Debreceni Egyetem Klinikai Kozpont | Debrecen, Hajdu-Bihar, H-4032, Hungary Recruiting Site Contact +3652255601 [email protected] Istvan Altorjay Principal Investigator
MH Egeszsegugyi Kozpont - Gasztroenterologiai Osztaly | Budapest, Pest, 1062, Hungary Recruiting Site Contact +36 (1) 3020841 [email protected] Laszlo Herszenyi Principal Investigator
Semmelweis Egyetem | Budapest, Pest, H-1088, Hungary Recruiting Site Contact +3612660926 ext.5569 [email protected] P Miheller Miheller Principal Investigator
Rabin Med Ctr Beilinson Hosp | Petah Tikva, HaMerkaz, 4941492, Israel Recruiting Site Contact +97239377237 [email protected] Irit Avni-Biron Principal Investigator
Rambam Medical Centre | Haifa, HaZafon, 31096, Israel Recruiting Site Contact +97248541777 [email protected] Waterman Waterman Principal Investigator
Chaim sheba Medical Center | Tel Hashomer, Tel-Aviv, 5262000, Israel Recruiting Site Contact 972-3-5302679 [email protected] Adi Lahat-Zok Principal Investigator
Shaare Zedek Medical Center - Gastroenterology | Jerusalem, Yerushalayim, 9103102, Israel Recruiting Site Contact +97226776848 [email protected] Goldin Goldin Principal Investigator
Hadassah Medical Organization, Hadassah Medical Center, Ein- | Jerusalem, Yerushalayim, 91120, Israel Recruiting Site Contact 972-2-6776848 [email protected] Katz Katz Principal Investigator
Istituto Clinico Humanitas Rozzano, IRCCS - IBD Center | Rozzano, Milano, 20089, Italy Not yet recruiting Site Contact +390282245555 [email protected] Silvio Danese Principal Investigator
AOU Policlinico di Modena - Gastroenterologia | Modena, 41124, Italy Recruiting Site Contact +39 0594225308 [email protected] Erica Villa Principal Investigator
Complesso Integrato Columbus | Roma, 00168, Italy Recruiting Site Contact +39 06-30159310 [email protected] Alfredo Papa Principal Investigator
Policlinico Universitario Agostino Gemelli | Roma, 00168, Italy Recruiting Site Contact +39 0630155923 [email protected] Franco Scaldaferri Principal Investigator
Azienda Ospedaliero Universitaria S.Maria della Misericordia - Gastroenterologia | Udine, 33100, Italy Not yet recruiting Site Contact +39 3337697364 [email protected] Marco Marino Principal Investigator
Centrum Medyczne Melita Medical | Wroclaw, Dolnoslaskie, 50-449, Poland Not yet recruiting Site Contact +48660551155 [email protected] J Leszczyszyn Leszczyszyn Principal Investigator
Wielospecjalistyczny Szpital Medicover | Warszawa, Mazowieckie, 03-984, Poland Recruiting Site Contact +48 664 454 040 [email protected] Katarzyna Borycka-Kiciak Principal Investigator
Endoskopia Sp z o.o. | Sopot, Pomorskie, 81-756, Poland Not yet recruiting Site Contact 48 58 555 26 31 [email protected] Dariusz Kleczkowski Principal Investigator
Hospital Universitario Son Espases | Palma de Mallorca, Baleares, 07120, Spain Recruiting Site Contact +34 871-205-500 [email protected] Xavier Gonzalez Argente Principal Investigator
H.U. G.Trias i Pujol | Badalona, Barcelona, 08916, Spain Recruiting Site Contact 00034934978909 [email protected] Eugeni Domenech Principal Investigator
Corporacio Sanitaria Parc Tauli | Sabadell, Barcelona, 8208, Spain Recruiting Site Contact +34937231010 (ext 20111) [email protected] Xavier Calvet Calvo Principal Investigator
Hospital Universitario de Fuenlabrada | Fuenlabrada, Madrid, 28942, Spain Recruiting Site Contact +34 91-6006175 [email protected] Fernando Bermejo San Jose Principal Investigator
Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda, Madrid, 28222, Spain Not yet recruiting Site Contact +34 91 191 73 34 [email protected] Isabel Vera Mendoza Principal Investigator
Hospital Clinic de Barcelona | Barcelona, 08036, Spain Recruiting Site Contact +34 93 227 54 00 ext.2779 [email protected] Julian Panes Principal Investigator
Hospital del Mar | Barcelona, 8003, Spain Recruiting Site Contact +34 932483217 [email protected] Lucia Marquez Mosquera Principal Investigator
Hospital Clinico San Carlos | Madrid, 28040, Spain Recruiting Site Contact +3491330 3049 [email protected] Carlos Taxonera Principal Investigator
Hospital Universitario Fundacion Jimenez Diaz | Madrid, 28040, Spain Recruiting Site Contact 34 91 550 4800 [email protected] Maria Dolores Herreros Marcos Principal Investigator
Hospital Universitario 12 de Octubre | Madrid, 28041, Spain Recruiting Site Contact 34 91-390-80-00 [email protected] Jesus Gonzalo Gomez Gomez Principal Investigator
Hospital Universitario La Paz | Madrid, 28046, Spain Recruiting Site Contact +34 91 727 7467 [email protected] Maria Dolores Martin Arranz Principal Investigator
C.H.U. de Pontevedra | Pontevedra, 36071, Spain Recruiting Site Contact +34986800907 [email protected] Daniel Carpio Lopez Principal Investigator
H.U.V. del Rocio | Sevilla, 21005, Spain Recruiting Site Contact 34 955 01 20 00 [email protected] Fernando de la Portilla de Juan Principal Investigator
Location Countries

Belgium

Czechia

France

Hungary

Israel

Italy

Poland

Spain

United States

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Darvadstrocel

Type: Experimental

Description: Participants who received a single dose of darvadstrocel, 120 million cells, intralesionally or darvadstrocel matching placebo previously in the ADMIRE-CD II study will be observed for efficacy and safety. No drug administration in this study.

Patient Data Yes
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)

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