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Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD) (ADMIRE-CD-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279081
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda ( Tigenix S.A.U. )

Brief Summary:
The purpose of this study is to evaluate the combined remission of complex perianal fistulas, defined as the clinical assessment at Week 24 of closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections greater than (>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central magnetic resonance imaging (MRI) assessment at Week 24.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Cx601 Other: Placebo Phase 3

Detailed Description:

This study is to assess the efficacy and safety of Cx601, eASC, for the treatment of complex perianal fistulas in participants with Crohn's disease.

The study will enroll approximately 600 participants.

  • Cx601 eASCs intralesional injection
  • Placebo - Cx601 placebo-matching eASCs intralesional injection

Study treatments will be allocated, on a 1:1 ratio, by central randomization through interactive web response system (IWRS). The study will follow an add-on design, participants receiving any ongoing concomitant medical treatment, at stable doses at the time of screening, for the CD will be allowed to continue it throughout the study.

The primary efficacy analysis, will be conducted at Week 24 timepoint. The double blind design will be maintained up to Week 52 (both participant and investigator) by a specific blinding for study treatment administration and for evaluating its efficacy.

This multicenter trial will be conducted globally across 150 centers. The overall time to participate in this study is approximately 5 years.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase-III Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow up Period up to 52 Weeks
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cx601
Cx601 eASCs 120 million cells (5 million cells per milliliter [mL]) will be administered once by intralesional injection.
Drug: Cx601
Cx601 eASCs intralesional injection.

Placebo Comparator: Placebo
CX601 placebo-matching eASCs cells will be administered once by intralesional administration.
Other: Placebo
Cx601 placebo-matching eASCs intralesional injection.




Primary Outcome Measures :
  1. Percentage of Participants with Combined Remission at Week 24 [ Time Frame: Week 24 ]
    Combined Remission is defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression and absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by blinded central magnetic resonance imaging (MRI) assessment.


Secondary Outcome Measures :
  1. Percentage of Participants with Clinical Remission at Week 24 [ Time Frame: Week 24 ]
    Clinical remission is defined as closure of all treated external openings that were draining at baseline despite gentle finger compression.

  2. Time to Clinical Remission up to Week 24 [ Time Frame: From the treatment start to first visit with closure of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed (up to Week 24) ]
    Time to clinical remission is defined as the time from treatment start to first visit with closure of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed.

  3. Percentage of Participants with Clinical Remission at Week 24 [ Time Frame: Week 24 ]
    Clinical remission is defined as closure of at least 50 percent (%) of all treated external openings that were draining at baseline despite gentle finger compression.

  4. Time to Clinical Response up to Week 24 [ Time Frame: From treatment start to first visit with closure of at least 50% of all treated external openings that were draining at baseline, despite gentle finger compression, as clinically assessed (up to Week 24) ]
    Time to clinical response is defined as the time from treatment start to first visit with closure of at least 50% of all treated external openings that were draining at baseline, despite gentle finger compression, as clinically assessed.

  5. Percentage of Participants with Combined Remission at Week 52 [ Time Frame: Week 52 ]
    Combined Remission is defined as the closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections >2 cm (in at least 2 dimensions) confirmed by blinded central MRI assessment.

  6. Percentage of Participants with Clinical Remission at Week 52 [ Time Frame: Week 52 ]
    Clinical remission is defined as closure of all treated external openings that were draining at baseline despite gentle finger compression.

  7. Percentage of Participants with Clinical Response at Week 52 [ Time Frame: Week 52 ]
    Clinical response is defined as closure of at least 50% of all treated external openings that were draining at baseline, despite gentle finger compression.

  8. Time to Clinical Remission up to Week 52 [ Time Frame: From treatment start to first visit with closure of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed (up to Week 52) ]
    Time to clinical remission is defined as the time from treatment start to first visit with closure of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed.

  9. Time to Clinical Response up to Week 52 [ Time Frame: From treatment start to first visit with closure of at least 50% of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed (up to Week 52) ]
    Time to clinical response is defined as time from treatment start to first visit with closure of at least 50% of all treated external openings that were draining at baseline despite gentle finger compression, as clinically assessed.

  10. Percentage of Participants with Relapse at Week 24 Combined Remission response [ Time Frame: Week 24 ]
    Relapse is defined as reopening of any of the treated fistulas external openings with active drainage as clinically assessed in participants who were in combined remission, or the development of a perianal fluid collection >2 cm of the treated perianal fistula confirmed by centrally read MRI assessment.

  11. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) [ Time Frame: Week 24 ]
  12. Number of Participants With TEAEs Related to Vital Sign Parameters [ Time Frame: Week 24 ]
  13. Number of Participants With TEAEs Related to Clinical Laboratory Parameters [ Time Frame: Week 24 ]


Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent.
  2. Participants of either gender greater than or equal to (>=) 18 years and less than or equal to (<=) 75 years of age.
  3. Participants with CD diagnosed at least 6 months prior to Screening visit in accordance with accepted clinical, endoscopic, histological and/or radiological criteria.
  4. Presence of complex perianal fistula(s) with a maximum of 2 internal openings and a maximum of 3 external openings based on clinical assessment; a central reading of a locally performed contrast enhanced (gadolinium) pelvic MRI will be performed to confirm location of the fistula and potential associated perianal abscess(es). Fistula(s) must have been draining for at least 6 weeks prior to Screening visit. Actively draining simple subcutaneous fistula(s), at the time of Screening visit, are not allowed in this study. A complex perianal fistula is defined as a fistula that meets one or more of the following criteria :

    • High inter-sphincteric, high trans-sphincteric, extra-sphincteric or suprasphincteric.
    • Presence of >=2 external openings.
    • Associated perianal abscess(es). Note: Abscesses that are larger than 2 cm 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. Clinically controlled, nonactive or mildly active CD, during the last six months prior to Screening visit with:

    • A patient reported outcomes (PRO-2) score <14 at Screening, AND
    • A colonoscopy documenting the absence of ulcers larger than 0.5 cm in the colonic mucosa:

      - If colonoscopy data are not available within 6 months prior to Screening:

    • A simple endoscopic score for Crohn's Disease (SES-CD) <=6 with absence of rectal ulcers larger than 0.5 cm must be documented in a colonoscopy performed at Screening before randomization.

      - If colonoscopy data are available within 6 months prior to Screening, the following must be documented, otherwise a new colonoscopy (as above) will be mandatory:

    • The absence of ulcers larger than 0.5 cm in the colonic mucosa AND
    • the improvement or no worsening in abdominal pain and/or in the diarrhea, sustained for one week or more, since the last colonoscopy was performed in the clinical records until Screening visit.

    AND

    o No hemoglobin decrease >=2.0 gram per deciliter (g/dL) or an unexplained rising C-reactive protein (CRP), > 5.0 milligram per liter (mg/L) to a concentration above the referenced upper limit of normal (ULN) (unless the rise is due to a known process other than luminal Crohn's Disease), since the last colonoscopy was performed as compared to results during the Screening visit.

    AND

    o no initiation or intensification of treatment with corticosteroids, immunosuppressants or monoclonal antibodies (mAbs) dose regimen since the last endoscopy up to Screening visit.

  6. Participants whose perianal fistulas were previously treated and have shown an inadequate response or a loss of response while they were receiving either an immunosuppressive agent or tumour necrosis factor (TNF)-alpha antagonist or vedolizumab or ustekinumab, or having documented intolerance to any of these treatments administered at least at approved or recommended doses during the minimum period mentioned:

    • Immunosuppressive agents: at least 3 months treatment with azathioprine (2-3 milligram per kilogram per day [mg/kg/day]), 6-mercaptopurine (1-1.5 mg/kg/day), or subcutaneous/intramuscular methotrexate (25 mg/week) prior to Screening for the study.
    • TNFalpha antagonists:
    • Infliximab: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn´s disease prior to screening for the study. For induction: 1 intravenous dose of 5 milligram per kilogram (mg/kg) followed by the same dose 2 and 6 weeks after. For maintenance: 5-10 mg/kg intravenously every 8 weeks, or more frequently.
    • Adalimumab: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn's disease prior to screening for the study. For induction: 1 subcutaneous dose of 160 milligram (mg), followed by 80 mg 2 weeks after. For maintenance: 40 mg subcutaneously every other week, or weekly.
    • Certolizumab l: at least 14 weeks treatment at the approved doses for induction and/or maintenance in Crohn´s disease prior to screening for the study. For induction: 1 subcutaneous dose of 400 mg, followed by the same dose 2 and 4 weeks after. For maintenance: 400 mg subcutaneously every 2 to 4 weeks.
    • Anti-integrin: at least 14 weeks treatment of the approved dose for induction and/or maintenance in Crohn´s disease prior to screening for the study. For induction: Vedolizumab 300 mg. For maintenance: Vedolizumab 300 mg every 4 to 8 weeks.
    • Anti-interleukin (IL)-12/23: at least 16 weeks treatment of the approved dose in Crohn´s disease prior to screening for the study. For induction: Ustekinumab, approximately 6mg/kg intravenously initially then followed by 90 mg subcutaneously every 8 weeks.
  7. Women of childbearing potential (WCBP) must have negative serum pregnancy test at screening (sensitive to 25 international units [IU] human chorionic gonadotropin [hCG]). Both WCBP or male participants participating in this study, with a WCBP as partner, must agree to use an adequate method of contraception during the entire duration of the study. An adequate method of contraception is defined as complete, non-periodic sexual abstinence (refraining from heterosexual intercourse), single-barrier method, vasectomy, adequate hormonal contraception (to have started at least 7 days prior to Screening visit), or an intra-uterine device (to have been in place for at least 2 months prior to Screening visit).

Exclusion Criteria:

  1. Concomitant rectovaginal or rectovesical fistula(s).
  2. Participant naïve to prior specific medical treatment for complex perianal fistula(s) including immunosuppressant (IS) or anti-TNFs.
  3. Presence of a perianal collection >2 cm in at least two dimensions on the central reading MRI at Screening visit that was not adequately drained as confirmed by the surgeon during the preparation procedure (week -3 to day 0).
  4. Severe rectal and/or anal stenosis and/or severe proctitis (defined as the presence of large >0.5 cm diameter] ulcers in the rectum) that make impossible to follow the surgery procedure manual.
  5. Participant with diverting stomas.
  6. Active, uncontrolled infection requiring parenteral antibiotics.
  7. Participant with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to the Preparation visit.
  8. Participants with major alteration on any of the following laboratory tests or increased risk for the surgical procedure:

    • Serum creatinine levels >1.5 times the ULN
    • Total bilirubin >1.5 ULN
    • Aspartate Transaminase (AST)/ Alanine Transaminase (ALT) >3 times ULN
    • Hemoglobin <10.0 g/dL
    • Platelets <75.0*10^9/L
    • Albuminemia <3.0 g/dL
  9. Suspected or documented infectious enterocolitis within two weeks prior to Screening visit.
  10. Any prior invasive malignancy diagnosed within the last 5 years prior to Screening visit. Participants with basal-cell carcinoma of the skin completely resected outside the perineal region can be included.
  11. Current or recent (within 6 months prior to the Screening visit) history of severe, progressive, and/or uncontrolled hepatic, haematological, gastrointestinal (GI) (other than CD), renal, endocrine, pulmonary, cardiac, neurological or psychiatric disease that may result in participants increased risk from study participation and/or lack of compliance with study procedures.
  12. Participants with primary sclerosing cholangitis.
  13. Participants with known chronically active hepatopathy of any origin, including cirrhosis and participants with persistent positive Hepatitis B Virus (HBV) surface antigen (HBsAg) and quantitative HBV polymerase chain reaction (PCR), or positive serology for Hepatitis C Virus (HCV) and quantitative HCV PCR within 6 months prior to Screening.
  14. Congenital or acquired immunodeficiencies, including participants known to be HIV carriers
  15. Known allergies or hypersensitivity to penicillin or aminoglycosides; Dulbecco Modified Eagle's Medium (DMEM); bovin serum; local anaesthetics or gadolinium (MRI contrast).
  16. Contraindication to MRI scan (example, due to the presence of pacemakers, hip replacements or severe claustrophobia).
  17. Severe trauma within 6 months prior to Screening visit.
  18. Pregnant or breastfeeding women.
  19. Participants who do not wish to or cannot comply with study procedures.
  20. Participants currently receiving, or having received any investigational drug within 3 months prior to Screening visit.
  21. Participants previously treated with Cx601 or other allogeneic stem-cell therapy cannot be enrolled into this clinical study.
  22. Any major surgery of the GI tract (including one or more segments of the colon or terminal ileum) within 6 months prior the screening or any minor surgery of the GI tract within 3 months prior to screening.
  23. Participants who had local perianal surgery other than drainage for the fistula within 6 months prior to the Screening visit, or those who may need surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study.
  24. Contraindication to the anaesthetic procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279081


Contacts
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Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

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Locations
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United States, Arizona
Scottsdale Mayo Clinic Not yet recruiting
Scottsdale, Arizona, United States, 85259
United States, California
UC San Diego Health Systems Not yet recruiting
La Jolla, California, United States, 92037
University of Southern California (USC) Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Inland Empire Liver Foundation Recruiting
Rialto, California, United States, 92377
Kaiser Permamente Not yet recruiting
San Francisco, California, United States, 91115
University of California San Francisco Not yet recruiting
San Francisco, California, United States, 94115
Vallejo Hospital and Medical Offices Not yet recruiting
Vallejo, California, United States, 94589
Cedar-Sinai Medical Center Recruiting
West Hollywood, California, United States, 90048
United States, Colorado
University of Colorado Hospital Not yet recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Hartford Hospital - Gastroenterology Not yet recruiting
Farmington, Connecticut, United States, 06032
Yale University School of Medicine Not yet recruiting
New Haven, Connecticut, United States, 06519
United States, District of Columbia
MedStar Georgetown University Hospital Not yet recruiting
Washington, District of Columbia, United States, 20017
United States, Florida
Mayo Clinic - Gastroenterology Not yet recruiting
Jacksonville, Florida, United States, 32224
University of Miami Hospital Not yet recruiting
Miami, Florida, United States, 33136
Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32804
USF Health South Tampa Center for Advanced Healthcare Not yet recruiting
Tampa, Florida, United States, 33606
Florida Hospital Tampa Recruiting
Tampa, Florida, United States, 33613
Cleveland Clinic Florida Not yet recruiting
Weston, Florida, United States, 33331
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
The University of Chicago Medicine - Colon & Rectal Surgery Not yet recruiting
Chicago, Illinois, United States, 60637
Carle Foundation Hospital Not yet recruiting
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana University - Colon and Rectal Recruiting
Indianapolis, Indiana, United States, 46237
United States, Kansas
University of Kansas School of Medicine Not yet recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40292
United States, Louisiana
Digestive Health Center of Louisiana Not yet recruiting
Baton Rouge, Louisiana, United States, 70809
Colon and Rectal Surgery Associates Recruiting
Metairie, Louisiana, United States, 70001
University Medical Center - New Orleans Recruiting
New Orleans, Louisiana, United States, 71103
Louisiana Research Center - Research Not yet recruiting
Shreveport, Louisiana, United States, 71105
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University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Johns Hopkins Medicine - The Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21287
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Massachussetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Harvard Medical School-Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Lahey Hospital & Medical Center Not yet recruiting
Burlington, Massachusetts, United States, 01803
Brigham & Womens Hosp Not yet recruiting
Chestnut Hill, Massachusetts, United States, 02115
University of Massachusetts - colon & rectal surgery Recruiting
Worcester, Massachusetts, United States, 01605
United States, Minnesota
Mayo Clinic College of Medicine - Division of Colon and Rectal Surgery - Division of Colon and Rectal Surgery Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Barnes-Jewish Hospital - Gastroenterology Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nevada
University of Nevada School of Medicine Recruiting
Las Vegas, Nevada, United States, 89154
United States, New Hampshire
Dartmouth Hitchcock Medical Center - Cancer Center Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Boston Medical Center Not yet recruiting
Bridgewater, New Jersey, United States, 08807
Morristown Medical Center - Gastroenterology Recruiting
Morristown, New Jersey, United States, 07960
United States, New York
Albany Medical Center Not yet recruiting
Albany, New York, United States, 12208
North Shore University Hospital Not yet recruiting
Manhasset, New York, United States, 11030
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Stony Brook University Medical Center Not yet recruiting
New York, New York, United States, 10016
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10021
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10028
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Lenox Hill Hospital Not yet recruiting
New York, New York, United States, 10075
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Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44106
United States, Oregon
OHSU Digestive Health Center Recruiting
Portland, Oregon, United States, 97239-4501
United States, Pennsylvania
Penn State Hershey Medical Center - Surgery Recruiting
Hershey, Pennsylvania, United States, 17033
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Allegheny General Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Cancer Institute - UPMC CancerCente Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
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University Surgical Associates-Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02904
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Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
UT Southwestern Medical Center - Gastroenterology - Gastroenterology Recruiting
Dallas, Texas, United States, 75390
Baylor College of Medicine (BCM) - Gastroenterology Not yet recruiting
Houston, Texas, United States, 77030
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University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
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University of Virginia Not yet recruiting
Charlottesville, Virginia, United States, 22908
United States, Washington
Virginia Mason Medical Center - Gastroenterology Recruiting
Seattle, Washington, United States, 98101
Swedish Medical Center Not yet recruiting
Seattle, Washington, United States, 98104
University of Washington Medical Center Not yet recruiting
Seattle, Washington, United States, 98195
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Medical College of Wisconsin Hub for Collaborative Medicine - Gastroenterology and Hepatology Recruiting
Milwaukee, Wisconsin, United States, 53226
Belgium
CHwapi - Notre Dame Recruiting
Tournai, Hainaut, Belgium, 7500
UZ Leuven - Campus Gasthuisberg Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
AZ Delta vzw - Maag-darm-leverziekten Recruiting
Roeselare, West-Vlaanderen, Belgium, 8800
GZA ziekenhuizen - Campus Sint-Vincentius - Gastro-enterology Recruiting
Antwerpen, Belgium, 2018
UZ Gent - Gastroenterology Recruiting
Gent, Belgium, 9000
Clinique Saint-Joseph (CHC) Recruiting
Liege, Belgium, 4000
Canada, Alberta
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada, T6G 2X8
Canada, British Columbia
(G.I.R.I.) GI Research Institute Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Canada, Ontario
London Health Sciences Centre University Hospital Not yet recruiting
London, Ontario, Canada, N6A5A5
Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L6
Mount Sinai Hospital - Toronto - Gastroenterology Not yet recruiting
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
ED-AMR Not yet recruiting
Montreal, Quebec, Canada, H3T1E2
Czechia
NH Hospital a.s. Active, not recruiting
Horovice, Beroun, Czechia, 268 31
FN Hradec Kralove Recruiting
Hradec Kralove, Czechia, 500 05
France
CHU de Nice Recruiting
Nice Cedex 03, Alpes-Maritimes, France, 06202
CHU de Clermont-Ferrand - Estaing Recruiting
Clermont-Ferrand cedex 1, Auvergne, France, 63003
Centre Hospitalier Universitaire De Toulouse - Hopital De Ra Recruiting
Toulouse cedex 09, Haute-Garonne, France, 31059
Hopital Beaujon Active, not recruiting
Clichy, Ile-de-France, France, 92110
Hopital Saint Louis - Gastro-hepatoenterologie Recruiting
Paris, Ile-de-France, France, 75010
CHRU Hopital De Pontchaillou Recruiting
Rennes, Ille-et-Vilaine, France, 35033
CHU Saint Etienne Recruiting
St Priest en Jarez, Loire, France, 42270
CHRU de Nancy -Hopital Brabois Adultes - Service d'Hepato- Gastroenterologie Recruiting
Vandoeuvre-les-Nancy, Lorraine, France, 54511
CHRU De Lille - Hopital Claude Huriez - Hepato-Gastro-Enterologie Recruiting
Lille, Nord, France, 59000
CHU Amiens-Picardie Recruiting
AMIENS cedex 1, Picardie, France, 80054
Centre Hospitalier Lyon Sud Recruiting
Pierre-Benite, Rhone, France, 69495
Paris St. Joseph Hospital Recruiting
Paris, France, 75014
Germany
Universitatsklinikum Erlangen Not yet recruiting
Erlangen, Bayern, Germany, 91054
Klinikum der Universitat Munchen - Campus Grosshadern Not yet recruiting
Munchen, Bayern, Germany, 81377
Klinikum der Johann Wolfgang Goethe-Universitat Not yet recruiting
Frankfurt/Main, Hessen, Germany, 69590
Universitatsklinikum Dresden Recruiting
Dresden, Sachsen, Germany, 01307
Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont - I. sz. Belgyogyaszati Klinika Recruiting
Szeged, Csongrad, Hungary, 6720
Debreceni Egyetem Klinikai Kozpont Recruiting
Debrecen, Hajdu-Bihar, Hungary, H-4032
MH Egeszsegugyi Kozpont - Gasztroenterologiai Osztaly Recruiting
Budapest, Pest, Hungary, 1062
Semmelweis Egyetem Recruiting
Budapest, Pest, Hungary, H-1088
Israel
Rabin Med Ctr Beilinson Hosp Recruiting
Petah Tikva, HaMerkaz, Israel, 4941492
Rambam Medical Centre Recruiting
Haifa, HaZafon, Israel, 31096
Chaim sheba Medical Center Recruiting
Tel Hashomer, Tel-Aviv, Israel, 5262000
Shaare Zedek Medical Center - Gastroenterology Recruiting
Jerusalem, Yerushalayim, Israel, 9103102
Hadassah Medical Organization, Hadassah Medical Center, Ein- Recruiting
Jerusalem, Yerushalayim, Israel, 91120
Italy
Ospedale Santissima Annunziata Recruiting
Cento, Ferrara, Italy, 44042
Istituto Clinico Humanitas Rozzano, IRCCS - IBD Center Recruiting
Rozzano, Milano, Italy, 20089
Policlinico S. Orsola Malpighi, AOU di Bologna-U.O. di Medicina Interna. Recruiting
Bologna, Italy, 40138
AOU Policlinico di Modena - Gastroenterologia Recruiting
Modena, Italy, 41124
II Universita degli Studi di Napoli Recruiting
Napoli, Italy, 80131
Gastroenterology Section Recruiting
Palermo, Italy, 90127
Universita degli studi di Pisa Not yet recruiting
Pisa, Italy, 56126
Policlinico Universitario Campus Biomedico - UOC di Gastroenterologia Recruiting
Roma, Italy, 00128
A.O. San Camillo Forlanini Recruiting
Roma, Italy, 00152
Complesso Integrato Columbus Recruiting
Roma, Italy, 00168
Policlinico Universitario Agostino Gemelli Recruiting
Roma, Italy, 00168
Azienda Ospedaliero Universitaria S.Maria della Misericordia - Gastroenterologia Recruiting
Udine, Italy, 33100
Azienda Ospedaliera Universitaria Integrata Verona (AOUI) - Recruiting
Verona, Italy, 37134
Poland
Centrum Medyczne Melita Medical Recruiting
Wroclaw, Dolnoslaskie, Poland, 50-449
Centrum Medyczne PROMED Recruiting
Krakow, Malopolskie, Poland, 31-411
Wielospecjalistyczny Szpital Medicover Recruiting
Warszawa, Mazowieckie, Poland, 03-984
Endoskopia Sp z o.o. Recruiting
Sopot, Pomorskie, Poland, 81-756
Szpital Kliniczny im. Heliodora Swiecickiego UM im. K. Marcinkowskiego w Poznaniu Not yet recruiting
Poznan, Poland, 60-355
Puerto Rico
University of Puerto Rico School of Medicine Not yet recruiting
San Juan, Puerto Rico, 00936
Spain
Hospital Universitario Son Espases Recruiting
Palma de Mallorca, Baleares, Spain, 07120
H.U. G.Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Corporacio Sanitaria Parc Tauli Recruiting
Sabadell, Barcelona, Spain, 8208
Hospital Universitario de Fuenlabrada Recruiting
Fuenlabrada, Madrid, Spain, 28942
Hospital Universitario Puerta de Hierro Majadahonda Recruiting
Majadahonda-Madrid, Madrid, Spain, 28222
Hospital de Sagunto Recruiting
Sagunto, Valencia, Spain, 46520
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital del Mar Recruiting
Barcelona, Spain, 8003
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Hospital Universitario Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
C.H.U. de Pontevedra Recruiting
Pontevedra, Spain, 36071
H.U.V. del Rocio Recruiting
Sevilla, Spain, 21005
United Kingdom
NHS Greater Glasgow and Clyde - Glasgow Royal Infirmary (GRI) Not yet recruiting
Glasgow, Glasgow City, United Kingdom, G52 3NQ
Guys & St Thomas Not yet recruiting
London, London, City Of, United Kingdom, SE1 7EH
Nottingham University Hospitals NHS Trust - Surgery Not yet recruiting
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Addenbrooke's Hospital Not yet recruiting
Cambridge, United Kingdom, CB2 0QQ
NHS Greater Glasgow and Clyde - Glasgow Royal Infirmary (GRI) Not yet recruiting
Glasgow, United Kingdom, G4 0SF
Guys & St Thomas Not yet recruiting
London, United Kingdom, SE1 7EH
Wythenshawe Hospital - Gastroenterology Not yet recruiting
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Tigenix S.A.U.
Investigators
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Study Director: Medical Director Takeda

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Responsible Party: Tigenix S.A.U.
ClinicalTrials.gov Identifier: NCT03279081     History of Changes
Other Study ID Numbers: Cx601-0303
2017-000725-12 ( EudraCT Number )
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda ( Tigenix S.A.U. ):
Crohn's disease
complex perianal fistula(s)
Additional relevant MeSH terms:
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Crohn Disease
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical