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

Sponsor
Takeda (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04075825
Collaborator
(none)
151
Enrollment
78
Locations
1
Arm
52.8
Anticipated Duration (Months)
1.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Darvadstrocel
 Phase 3

Detailed Description

The drug being tested in this study is called darvadstrocel (Cx601). Darvadstrocel is being tested to treat people who have 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
151 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Nov 4, 2019
Anticipated Primary Completion Date :
Mar 28, 2024
Anticipated Study Completion Date :
Mar 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Darvadstrocel

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.

Biological: Darvadstrocel
Allogenic expanded adipose-derived stem cells (eASCs) 5 million cells/ml - suspension for injection Cx601 received in previous ADMIRE-CD II study. No drug administration in this study.
Other Names:
  • Cx601

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Events (AEs) [Baseline up to Week 156 after investigational medicinal product (IMP) administration]

      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.

    2. Number of Participants With Serious Adverse Events (SAEs) [Baseline up to Week 156 after IMP administration]

      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.

    3. Number of Participants With Specific Adverse Events of Special Interest (AESIs) [Baseline up to Week 156 after IMP administration]

      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.

    Secondary Outcome Measures

    1. 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]

      Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline despite gentle finger compression.

    2. 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]

      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.

    3. Percentage of Participants With Relapse [Week 52 up to Week 104]

      Relapse is defined as reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed in participants who were in clinical remission at Week 52. Or, the development of a perianal fluid collection >2 cm of the treated perianal fistulas confirmed by centrally read magnetic resonance imaging (MRI) assessment.

    4. Percentage of Participants who Achieve Combined Clinical Remission at Week 156 (After IMP Administration in ADMIRE-CD II Study) [Baseline and Week 156]

      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 (ie, screening visit), 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.

    5. Percentage of Participants With New Anal Abscess in Treated Fistula [Week 104]

    6. 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]

      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.

    7. 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]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California San Francisco San Francisco California United States 94115
    2 Cedar-Sinai Medical Center West Hollywood California United States 90048
    3 Hartford Hospital - Gastroenterology Farmington Connecticut United States 06032
    4 Yale University School of Medicine New Haven Connecticut United States 06519
    5 Mayo Clinic - Gastroenterology Jacksonville Florida United States 32224
    6 University of Miami Hospital Miami Florida United States 33136
    7 USF Health South Tampa Center for Advanced Healthcare Tampa Florida United States 33606
    8 Florida Hospital Tampa Tampa Florida United States 33613
    9 Cleveland Clinic Florida Weston Florida United States 33331
    10 Indiana University - Colon and Rectal Indianapolis Indiana United States 46237
    11 University of Kansas Sxchool of Medicine Kansas City Kansas United States 66160
    12 Colon and Rectal Surgery Associates Metairie Louisiana United States 70001
    13 University of Maryland Baltimore Maryland United States 21201
    14 Johns Hopkins Medicine - The Johns Hopkins Hospital Baltimore Maryland United States 21287
    15 Massachussetts General Hospital Boston Massachusetts United States 02114
    16 University of Massachusetts - colon & rectal surgery Worcester Massachusetts United States 01605
    17 Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery Rochester Minnesota United States 55905
    18 Barnes-Jewish Hospital - Gastroenterology Saint Louis Missouri United States 63110
    19 Dartmouth Hitchcock Medical Center - Cancer Center Lebanon New Hampshire United States 03756
    20 Morristown Medical Center - Gastroenterology Morristown New Jersey United States 07960
    21 North Shore University Hospital - Gastroenterology Manhasset New York United States 11030
    22 Icahn School of Medicine at Mount Sinai New York New York United States 10028
    23 Lenox Hill Hospital New York New York United States 10075
    24 Cleveland Clinic Cleveland Ohio United States 44106
    25 Penn State Hershey Medical Center - Surgery Hershey Pennsylvania United States 17033
    26 University Surgical Associates-Rhode Island Hospital Providence Rhode Island United States 02904
    27 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    28 University of Utah Salt Lake City Utah United States 84112
    29 University of Virginia Charlottesville Virginia United States 22908
    30 Virginia Mason Medical Center - Gastroenterology Seattle Washington United States 98101
    31 Swedish Medical Center Seattle Washington United States 98104
    32 Medical College of Wisconsin Hub for Collaborative Medicine - Gastroenterology and Hepatology Milwaukee Wisconsin United States 53226
    33 UZ Leuven - Campus Gasthuisberg Leuven Vlaams Brabant Belgium 3000
    34 AZ Delta vzw - Maag-darm-leverziekten Roeselare West-Vlaanderen Belgium 8800
    35 GZA ziekenhuizen - Campus Sint-Vincentius - Gastro-enterology Antwerpen Belgium 2018
    36 UZ Gent - Gastroenterology Gent Belgium 9000
    37 NH Hospital a.s. Horovice Beroun Czechia 268 31
    38 FN Hradec Kralove Hradec Kralove Czechia 500 05
    39 CHU de Nice Nice Cedex 03 Alpes-Maritimes France 06202
    40 CHU de Clermont-Ferrand - Estaing Clermont-Ferrand cedex 1 Auvergne France 63003
    41 Hopital Saint Louis - Gastro-hepatoenterologie Paris Ile-de-France France 75010
    42 CHRU Hopital De Pontchaillou Rennes Ille-et-Vilaine France 35033
    43 CHRU de Nancy -Hopital Brabois Adultes - Service d'Hepato- Gastroenterologie Vandoeuvre-les-Nancy Lorraine France 54511
    44 CHRU De Lille - Hopital Claude Huriez - Hepato-Gastro-Enterologie Lille Nord France 59000
    45 CHU Amiens-Picardie AMIENS cedex 1 Picardie France 80054
    46 Centre Hospitalier Lyon Sud Pierre-Benite Rhone France 69495
    47 Paris St. Joseph Hospital Paris France 75014
    48 Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont - I. sz. Belgyogyaszati Klinika Szeged Csongrad Hungary 6720
    49 Debreceni Egyetem Klinikai Kozpont Debrecen Hajdu-Bihar Hungary H-4032
    50 MH Egeszsegugyi Kozpont - Gasztroenterologiai Osztaly Budapest Pest Hungary 1062
    51 Semmelweis Egyetem Budapest Pest Hungary H-1088
    52 Rabin Med Ctr Beilinson Hosp Petah Tikva HaMerkaz Israel 4941492
    53 Rambam Medical Centre Haifa HaZafon Israel 31096
    54 Chaim sheba Medical Center Tel Hashomer Tel-Aviv Israel 5262000
    55 Shaare Zedek Medical Center - Gastroenterology Jerusalem Yerushalayim Israel 9103102
    56 Hadassah Medical Organization, Hadassah Medical Center, Ein- Jerusalem Yerushalayim Israel 91120
    57 Istituto Clinico Humanitas Rozzano, IRCCS - IBD Center Rozzano Milano Italy 20089
    58 AOU Policlinico di Modena - Gastroenterologia Modena Italy 41124
    59 A.O. San Camillo Forlanini Roma Italy 00152
    60 Complesso Integrato Columbus Roma Italy 00168
    61 Policlinico Universitario Agostino Gemelli Roma Italy 00168
    62 Azienda Ospedaliero Universitaria S.Maria della Misericordia - Gastroenterologia Udine Italy 33100
    63 Centrum Medyczne Melita Medical Wroclaw Dolnoslaskie Poland 50-449
    64 Wielospecjalistyczny Szpital Medicover Warszawa Mazowieckie Poland 03-984
    65 Endoskopia Sp z o.o. Sopot Pomorskie Poland 81-756
    66 Hospital Universitario Son Espases Palma de Mallorca Baleares Spain 07120
    67 H.U. G.Trias i Pujol Badalona Barcelona Spain 08916
    68 Corporacio Sanitaria Parc Tauli Sabadell Barcelona Spain 8208
    69 Hospital Universitario de Fuenlabrada Fuenlabrada Madrid Spain 28942
    70 Hospital Universitario Puerta de Hierro Majadahonda Majadahonda Madrid Spain 28222
    71 Hospital Clinic de Barcelona Barcelona Spain 08036
    72 Hospital del Mar Barcelona Spain 8003
    73 Hospital Clinico San Carlos Madrid Spain 28040
    74 Hospital Universitario Fundacion Jimenez Diaz Madrid Spain 28040
    75 Hospital Universitario 12 de Octubre Madrid Spain 28041
    76 Hospital Universitario La Paz Madrid Spain 28046
    77 C.H.U. de Pontevedra Pontevedra Spain 36071
    78 H.U.V. del Rocio Sevilla Spain 21005

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT04075825
    Other Study ID Numbers:
    • Darvadstrocel-3003
    • 2019-000333-39
    First Posted:
    Sep 3, 2019
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Takeda
    Drug therapy
    Additional relevant MeSH terms:
    Crohn Disease
    Rectal Fistula
    Fistula

    Study Results

    No Results Posted as of Apr 12, 2022