AzTrials
AzTrials

Crohn's DiseasePhase 3ADMIRE-CD-IINCT03279081

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)

A Phase 3 study testing Cx601 in people with Crohn's Disease, run by Tigenix S.A.U. at 159 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
Cx601
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
568 participants
Where
159 sitesin 15 countries
Study dates
15 Sep 2017to 26 Jul 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent.
  • Participants of either gender greater than or equal to (>=) 18 years and less than or equal to (<=) 75 years of age.
  • Participants with CD diagnosed at least 6 months prior to Screening visit in accordance with accepted clinical, endoscopic, histological and/or radiological criteria.
  • 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.
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  • 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.
  • 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.
  • 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.
  • 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).

Who cannot join

  • Concomitant rectovaginal or rectovesical fistula(s).
  • Participant naïve to prior specific medical treatment for complex perianal fistula(s) including immunosuppressant (IS) or anti-TNFs.
  • 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).
  • Severe rectal and/or anal stenosis and/or severe proctitis (defined as the presence of large >0.5 cm ulcers in the rectum) that make impossible to follow the surgery procedure manual.
  • Participant with diverting stomas.
  • Active, uncontrolled infection requiring parenteral antibiotics.
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  • Participant with ongoing systemic or rectal steroids for CD in the last 2 weeks prior to the Preparation visit.
  • 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
  • Suspected or documented infectious enterocolitis within two weeks prior to Screening visit.
  • 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.
  • 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.
  • Participants with primary sclerosing cholangitis.
  • 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.
  • Congenital or acquired immunodeficiencies, including participants known to be HIV carriers
  • Known allergies or hypersensitivity to penicillin or aminoglycosides; Dulbecco Modified Eagle's Medium (DMEM); bovine serum; local anaesthetics or gadolinium (MRI contrast).
  • Contraindication to MRI scan (example, due to the presence of pacemakers, hip replacements or severe claustrophobia).
  • Severe trauma within 6 months prior to Screening visit.
  • Pregnant or breastfeeding women.
  • Participants who do not wish to or cannot comply with study procedures.
  • Participants currently receiving, or having received any investigational drug within 3 months prior to Screening visit.
  • Participants previously treated with Cx601 or other allogeneic stem-cell therapy cannot be enrolled into this clinical study.
  • 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.
  • 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.
  • Contraindication to the anaesthetic procedure.

Trial locations and contacts

159 sites in 15 countries.

159 sites in 15 countries

United States68 sites

  • Albany Medical Center

    Albany, New York, 12208

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins Medicine - The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Digestive Health Center of Louisiana

    Baton Rouge, Louisiana, 70809

  • Massachussetts General Hospital

    Boston, Massachusetts, 02114

  • Boston Medical Center

    Boston, Massachusetts, 08807

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01803

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The University of Chicago Medicine - Colon & Rectal Surgery

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44106

  • UT Southwestern Medical Center - Gastroenterology - Gastroenterology

    Dallas, Texas, 75390

  • Hartford Hospital - Gastroenterology

    Farmington, Connecticut, 06032

  • Harvard Medical School-Beth Israel Deaconess Medical Center

    Hershey, Pennsylvania, 17033

  • Penn State Hershey Medical Center - Surgery

    Hershey, Pennsylvania, 17033

  • Baylor College of Medicine (BCM) - Gastroenterology

    Houston, Texas, 77030

  • Indiana University - Colon and Rectal

    Indianapolis, Indiana, 46237

  • Mayo Clinic - Gastroenterology

    Jacksonville, Florida, 32224

  • University of Kansas Sxchool of Medicine

    Kansas City, Kansas, 66160

  • UC San Diego Health Systems

    La Jolla, California, 92037

  • University of Nevada School of Medicine

    Las Vegas, Nevada, 89154

  • Dartmouth Hitchcock Medical Center - Cancer Center

    Lebanon, New Hampshire, 03756

  • University of Southern California (USC) Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • University of Louisville

    Louisville, Kentucky, 40292

  • North Shore University Hospital - Gastroenterology

    Manhasset, New York, 11030

  • Colon and Rectal Surgery Associates

    Metairie, Louisiana, 70001

  • University of Miami Hospital

    Miami, Florida, 33136

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin Hub for Collaborative Medicine - Gastroenterology and Hepatology

    Milwaukee, Wisconsin, 53226

  • Morristown Medical Center - Gastroenterology

    Morristown, New Jersey, 07960

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale University School of Medicine

    New Haven, Connecticut, 06519

  • University Medical Center - New Orleans

    New Orleans, Louisiana, 71103

  • NYU Langone Medical Center

    New York, New York, 10016

  • Stony Brook University Medical Center

    New York, New York, 10016

  • Weill Medical College of Cornell University

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10028

  • Columbia University Medical Center

    New York, New York, 10032

  • Lenox Hill Hospital

    New York, New York, 10075

  • UC Irvine Medical Center - Chao Family Comprehensive Cancer

    Orange, California, 92868

  • Florida Hospital Orlando

    Orlando, Florida, 32804

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • OHSU Digestive Health Center

    Portland, Oregon, 97239

  • University Surgical Associates-Rhode Island Hospital

    Providence, Rhode Island, 02904

  • Rapid City Medical Center

    Rapid City, South Dakota, 57701

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • Carilion Clinic

    Roanoke, Virginia, 24016

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

    Rochester, Minnesota, 55905

  • University of Utah

    Salt Lake City, Utah, 84112

  • Kaiser Permamente

    San Francisco, California, 91115

  • University of California San Francisco

    San Francisco, California, 94115

  • Scottsdale Mayo Clinic

    Scottsdale, Arizona, 85259

  • Virginia Mason Medical Center - Gastroenterology

    Seattle, Washington, 98101

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Barnes-Jewish Hospital - Gastroenterology

    St Louis, Missouri, 63110

  • USF Health South Tampa Center for Advanced Healthcare

    Tampa, Florida, 33606

  • Florida Hospital Tampa

    Tampa, Florida, 33613

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Vallejo Hospital and Medical Offices

    Vallejo, California, 94589

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20017

  • Cedar-Sinai Medical Center

    West Hollywood, California, 90048

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • University of Massachusetts - colon & rectal surgery

    Worcester, Massachusetts, 01605

Other trials in United States

Spain15 sites

  • H.U. G.Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital del Mar

    Barcelona, 8003

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, 28942

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07120

  • C.H.U. de Pontevedra

    Pontevedra, 36071

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 8208

  • Hospital de Sagunto

    Sagunto, Valencia, 46520

  • H.U.V. del Rocio

    Seville, 21005

Other trials in Spain

Italy13 sites

  • Policlinico S. Orsola Malpighi, AOU di Bologna-U.O. di Medicina Interna.

    Bologna, 40138

  • Ospedale Santissima Annunziata

    Cento, Ferrara, 44042

  • AOU Policlinico di Modena - Gastroenterologia

    Modena, 41124

  • II Universita degli Studi di Napoli

    Naples, 80131

  • Gastroenterology Section

    Palermo, 90127

  • Universita degli studi di Pisa

    Pisa, 56126

  • Policlinico Universitario Campus Biomedico - UOC di Gastroenterologia

    Roma, 00128

  • A.O. San Camillo Forlanini

    Roma, 00152

  • Complesso Integrato Columbus

    Roma, 00168

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • Istituto Clinico Humanitas Rozzano, IRCCS - IBD Center

    Rozzano, Milano, 20089

  • Azienda Ospedaliero Universitaria S.Maria della Misericordia - Gastroenterologia

    Udine, 33100

  • Azienda Ospedaliera Universitaria Integrata Verona (AOUI) -

    Verona, 37134

Other trials in Italy

France12 sites

  • CHU Amiens-Picardie

    Amiens, Picardie, 80054

  • CHU de Clermont-Ferrand - Estaing

    Clermont-Ferrand, Auvergne, 63003

  • Hopital Beaujon

    Clichy, Île-de-France Region, 92110

  • CHRU De Lille - Hopital Claude Huriez - Hepato-Gastro-Enterologie

    Lille, Nord, 59000

  • CHU de Nice

    Nice, Alpes-Maritimes, 06202

  • Paris St. Joseph Hospital

    Paris, 75014

  • Hopital Saint Louis - Gastro-hepatoenterologie

    Paris, Île-de-France Region, 75010

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Rhone, 69495

  • CHRU Hopital De Pontchaillou

    Rennes, Ille-et-Vilaine, 35033

  • CHU Saint Etienne

    Saint Priest En Jarez, Pays de la Loire Region, 42270

  • Centre Hospitalier Universitaire De Toulouse - Hopital De Ra

    Toulouse, Haute-Garonne, 31059

  • CHRU de Nancy -Hopital Brabois Adultes - Service d'Hepato- Gastroenterologie

    Vandœuvre-lès-Nancy, Lorraine, 54511

Other trials in France

Belgium9 sites

  • GZA ziekenhuizen - Campus Sint-Vincentius - Gastro-enterology

    Antwerp, 2018

  • Imelda Ziekenhuis

    Antwerp, 2820

  • UZ Gent - Gastroenterology

    Ghent, 9000

  • AZ Groeninge - Campus Kennedylaan - Gastro-enterology

    Kortrijk, West-Vlaanderen, 8500

  • UZ Leuven - Campus Gasthuisberg

    Leuven, Vlaams Brabant, 3000

  • CHU de Liege - Domaine Universitaire du Sart Tilman

    Liège, 4000

  • Clinique Saint-Joseph (CHC)

    Liège, 4000

  • CHU Dinant Godinne UCL Namur

    Namur, 5530

  • AZ Delta vzw - Maag-darm-leverziekten

    Roeselare, West-Vlaanderen, 8800

Other trials in Belgium

United Kingdom8 sites

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

  • NHS Greater Glasgow and Clyde - Glasgow Royal Infirmary (GRI)

    Glasgow, Glasgow City, G52 3NQ

  • St. Mark's Hospital

    Harrow, London, City of, HA1 3UJ

  • Guys & St Thomas

    London, London, City of, SE1 7EH

  • University Colleague London Hospital (UCLH)

    London, NW1 2BU

  • Wythenshawe Hospital - Gastroenterology

    Manchester, M13 9WL

  • Nottingham University Hospitals NHS Trust - Surgery

    Nottingham, Nottinghamshire, NG7 2UH

  • Northern General Hospital

    Sheffield, S10 2JF

Other trials in United Kingdom

Canada7 sites

  • University of Alberta

    Edmonton, Alberta, T6G 2X8

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3J4

  • McGill University Health Centre - Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Mount Sinai Hospital - Toronto - Gastroenterology

    Toronto, Ontario, M5G 1X5

  • Kensington Screening Clinic - Gastroenterology

    Toronto, Ontario, M5T 3A9

  • (G.I.R.I.) GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

Poland7 sites

  • COPERNICUS Podmiot Leczniczy Sp. z o.o.

    Gdansk, 80-803

  • Centrum Medyczne PROMED

    Krakow, Lesser Poland Voivodeship, 31-411

  • Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow

    Lodz, Łódź Voivodeship, 90-647

  • Endoskopia Sp z o.o.

    Sopot, Pomeranian Voivodeship, 81-756

  • Wielospecjalistyczny Szpital Medicover

    Warsaw, Masovian Voivodeship, 03-984

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, 02-507

  • Centrum Medyczne Melita Medical

    Wroclaw, Lower Silesian Voivodeship, 50-449

Other trials in Poland

Israel5 sites

  • Rambam Medical Centre

    Haifa, Northern District, 31096

  • Shaare Zedek Medical Center - Gastroenterology

    Jerusalem, Jerusalem, 9103102

  • Hadassah Medical Organization, Hadassah Medical Center, Ein-

    Jerusalem, Jerusalem, 91120

  • Rabin Med Ctr Beilinson Hosp

    Petah Tikva, Central District, 4941492

  • Chaim sheba Medical Center

    Tel HaShomer, Tel Aviv, 5262000

Other trials in Israel

Germany4 sites

  • Universitatsklinikum Dresden

    Dresden, Saxony, 01307

  • Universitatsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • Klinikum der Johann Wolfgang Goethe-Universitat

    Frankfurt am Main, Hesse, 69590

  • Klinikum der Universitat Munchen - Campus Grosshadern

    München, Bavaria, 81377

Other trials in Germany

Hungary4 sites

  • MH Egeszsegugyi Kozpont - Gasztroenterologiai Osztaly

    Budapest, Pest County, 1062

  • Semmelweis Egyetem

    Budapest, Pest County, H-1088

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, Hajdú-Bihar, H-4032

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont - I. sz. Belgyogyaszati Klinika

    Szeged, Csongrád megye, 6720

Other trials in Hungary

Denmark3 sites

  • Aarhus University Hospital - Department of Hepatology and Gastroenterology, Lever-Mave- og Tarmsygdomme Klinik, krydspunkt C216

    Aarhus, 8200

  • Bispebjerg Hospital

    Copenhagen, Copenhague, 2400

  • Odense Universitetshospital

    Odense

Other trials in Denmark

Czechia2 sites

  • NH Hospital a.s.

    Hořovice, Beroun, 268 31

  • FN Hradec Kralove

    Hradec Králové, 500 05

Other trials in Czechia

Puerto Rico1 site

  • University of Puerto Rico School of Medicine

    San Juan, 00936

Other trials in Puerto Rico

Sweden1 site

  • Linkoping University Hospital - Department of Surgery

    Linköping, Ostergotlands Lan [se-05], 581 85

Other trials in Sweden

About this study

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

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.

Read the 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 randomize approximately 554 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.

Conditions
Crohn's Disease
Being tested
Cx601, Placebo
Keywords
Crohn's disease, complex perianal fistula(s)
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cx601Drug

    Cx601 eASCs intralesional injection.

  • PlaceboOther

    Cx601 placebo-matching eASCs intralesional injection.

Study groups in NCT03279081
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo (saline) 24 milliliters (mL) was administered once by local injection.
Receives: Other: Placebo
Cx601ExperimentalCx601 expanded adipose-derived stem cells (eASCs) 120 million cells (5 million cells per mL) was administered once by local injection.
Receives: Drug: Cx601

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Combined Remission at Week 24

    Combined remission was 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. Percentages are rounded off to whole number at the nearest decimal.

    Measured: Week 24

Secondary outcomes (13)

  1. Percentage of Participants With Clinical Remission at Week 24

    Clinical remission was defined as closure of all treated external openings that were draining at baseline despite gentle finger compression. Percentages are rounded off to whole number at the nearest decimal.

    Measured: Week 24

  2. Time to Clinical Remission at Week 24

    Time to clinical remission was 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.

    Measured: Week 24

  3. Percentage of Participants With Combined Remission at Week 52

    Combined remission was 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. Percentages are rounded off to whole number at the nearest decimal.

    Measured: Week 52

  4. Percentage of Participants With Clinical Remission at Week 52

    Clinical remission was defined as closure of all treated external openings that were draining at baseline despite gentle finger compression. Percentages are rounded off to whole number at the nearest decimal.

    Measured: Week 52

  5. Percentage of Participants With Clinical Response at Week 24

    Clinical response was defined as closure of at least 50 percent (%) of all treated external openings that were draining at baseline despite gentle finger compression. Percentages are rounded off to whole number at the nearest decimal.

    Measured: Week 24

  6. Percentage of Participants With Clinical Response at Week 52

    Clinical response was defined as closure of at least 50% of all treated external openings that were draining at baseline, despite gentle finger compression. Percentages are rounded off to whole number at the nearest decimal.

    Measured: Week 52

  7. Time to Clinical Remission at Week 52

    Time to clinical remission was 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.

    Measured: Week 52

  8. Time to Clinical Response at Week 24

    Time to clinical response was 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.

    Measured: Week 24

  9. Time to Clinical Response at Week 52

    Time to clinical response was 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.

    Measured: Week 52

  10. Percentage of Participants With Relapse by Week 52 After Achieving Combined Remission at Week 24

    Relapse was defined as reopening of any of the treated fistulas external openings with active drainage as clinically assessed, or the development of a perianal fluid collection >2 cm of the treated perianal fistula confirmed by centrally read MRI assessment in participants who were in combined remission at week 24. Percentages are rounded off to whole number at the nearest decimal.

    Measured: From Week 24 to Week 52

  11. Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESIs)

    An adverse event(AE)=any untoward medical occurrence in a clinical investigation participant receiving a medicinal product; it did not necessarily have to have a causal relationship with this treatment. Serious adverse event(SAE)=any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital abnormality/birth defect, or was a medically significant event or required intervention to prevent at least one of the outcomes listed above, or was a suspected transmission of an infectious agent. AESIs included tumorigenicity, ectopic tissue formation, hypersensitivity reactions, transmission of infectious agents, immunogenicity/alloimmune reactions, and medication errors, as reported by the investigator. TEAE=AE whose onset occurred, severity worsened, or intensity increased after receiving the study treatment.

    Measured: From first dose of study drug to end of follow up period (up to Week 52)

  12. Number of Participants With Clinically Significant Changes in Vital Sign Parameters

    Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinically significant vital signs assessment was based on investigator interpretation. Number of participants with clinically significant changes in vital signs were reported.

    Measured: From first dose of study drug to end of follow up period (up to Week 52)

  13. Number of Participants With Clinically Significant Changes in Laboratory Parameters

    Laboratory parameters included blood chemistry and hematology. Clinically significant laboratory parameters assessment was based on investigator interpretation. Number of participants with clinically significant changes in laboratory parameters (hematology and blood chemistry) were reported.

    Measured: From first dose of study drug to end of follow up period (up to Week 52)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2017
  2. Study start15 Sep 2017
  3. Primary completion23 Jan 2023
  4. Study completion26 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
568 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03279081
Sponsor's protocol ID
Cx601-0303
Other IDs
2017-000725-12, 2017
Acronym
ADMIRE-CD-II
Status last verified
Aug 2024
First submitted
21 Jul 2017
Last updated
19 Sep 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

  • Colombel JF, Garcia Olmo D, Chen ST, Serclova Z, Schwartz DA, Wexner SD, Panes J, Wu C, Zhang B, Song M, McKay C, Nazarey P, Wright E, Raffals L, Fleshner P. Darvadstrocel in Patients With Crohn's Disease With Complex Perianal Fistulas: The ADMIRE CD II Phase 3 Randomized Trial. Gastroenterology. 2026 Jun;170(7):1562-1570. doi: 10.1053/j.gastro.2025.12.033. Epub 2026 Mar 6.

    PubMed 41790076

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cx601 in people with Crohn's Disease, run by Tigenix S.A.U. at 159 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 159 sites in United States, Spain, Italy, France, Belgium and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Combined Remission at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03279081, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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ADMIRE-CD-II Clinical Trial NCT03279081 | AzTrials