Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Evaluating Ovasave, an Autologous Cell Therapy, in Patients With Active Crohn's Disease (CATS29)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02327221
Recruitment Status : Terminated
First Posted : December 30, 2014
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
TxCell

Brief Summary:

The investigational product, named Ovasave (Ova-Treg), is a cell-based therapy, consisting of an autologous antigen-specific regulatory type 1 T lymphocyte expanded population administered via the intravenous route as an infusion.

The study is a multicenter, randomised, double-blinded, placebo-controlled, multi-dose and multi-injection study; followed with a 16-week phase with either the possibility for an open-label treatment part or a safety follow-up part with no injection.

Then, the patients will be followed in an additional long-term safety follow-up, of maximum duration of 3 years from the first administration.


Condition or disease Intervention/treatment Phase
Crohn Disease Drug: Ovasave Drug: Placebo Phase 2

Detailed Description:

During double-blinded phase, the treatment consists of 2 intravenous (i.v.) administrations of antigen-specific autologous T regulatory cells or placebo:

  • Group A: 1.10e4 cells and 1.10e4 cells
  • Group B: 1.10e6 cells and 1.10e6 cells
  • Group C: 1.10e7 cells and 1.10e7 cells
  • Group D: Placebo and Placebo

During double-blinded phase, two i.v. administrations of study drug (Ova-Treg) will be administered, one at week 0 and another one at week 8 for the group A, B and C. Two injections of Placebo will be administered, one at week 0 (V4) and another one at week 8 for the group D. During double-blinded phase, all the patients will be followed during 16 weeks. This will be followed by an additional period of 16 weeks when the patient is expected to receive two additional administrations of Ovasave at 10e6 cells dose (Open-label phase), except if refused by the patient or not recommended by the Investigator, representing the follow-up phase. These third and fourth administrations will be performed for all groups (A, B, C and D) with an injection of Ovasave at 1.10e6 cells administered at week 16 and week 24. A patient who didn't receive the 2 first administrations during the double-blinded phase cannot receive the third and the fourth administration during Open-label phase.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIb, Multicentre, Randomised, Double-blinded, Placebo-controlled, Multi-dose and Multi-injection, Parallel Groups Study to Evaluate the Efficacy and the Safety of Ovasave in Patients With Active Refractory Crohn's Disease
Actual Study Start Date : December 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Active Comparator: Ovasave - Dose 10e4 Drug: Ovasave
During CATS29-Double blind phase, two intravenous administrations of study drug will be administered, one at week 0 and another one at week 8.

Active Comparator: Ovasave - Dose 10e6 Drug: Ovasave
During CATS29-Double blind phase, two intravenous administrations of study drug will be administered, one at week 0 and another one at week 8.

Active Comparator: Ovasave - Dose 10e7 Drug: Ovasave
During CATS29-Double blind phase, two intravenous administrations of study drug will be administered, one at week 0 and another one at week 8.

Placebo Comparator: Placebo Drug: Placebo
During CATS29-Double blind phase, two intravenous administrations of study drug will be administered, one at week 0 and another one at week 8.




Primary Outcome Measures :
  1. CDAI response [ Time Frame: 6 weeks post administration ]
    Controlled versus placebo confirmation of the ability of a single intravenous (i.v.) injection of 1.10e6 cells dose of Ovasave (Ova-Treg cells) to induce a CDAI response (CDAI decrease ≥ 100 points)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Active Crohn's Disease diagnosis defined as patients with medical history of signs, symptoms and biological evidence of active bowel inflammation:

    • Documented endoscopic evidence of inflammatory bowel disease (IBD), compatible with Crohn's diagnosis at least 1 year prior to screening and
    • High sensitive C-reactive protein (hs-CRP) > 10 mg/L at V1.
  2. Failure or intolerance to conventional treatments including corticosteroid, immunosuppressant and at least one biologics; and had not responded (primarily failure) or responded and then lost response completely (no response or need to increase the dose / secondary failure) or were intolerant to this therapy at a dose indicated for CD
  3. Documented CDAI (Crohn's Disease Activity Index) above 250 points (CDAI ≥ 250) at screening or within the past 3 months;

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): NCT02327221


Locations
Layout table for location information
Austria
Medical University Innsbruck
Innsbruck, Austria
Medical University of Vienna
Vienna, Austria
Belgium
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium
UZ Gent
Gent, Belgium
UZ Gasthuisberg
Leuven, Belgium
CHU Liege
Liege, Belgium
France
CHU d'Amiens Sud
Amiens, France
CHU de Besançon, Hôpital Jean Minjoz
Besançon, France
Hôpital Beaujon
Clichy, France
Hôpital Henri Mondor
Créteil, France
CHRU de Lille, Hôpital Claude Huriez
Lille, France
CHU de Nancy, Hôpital de Brabois Adulte
Nancy, France
CHU de Nice, Hôpital de l'Archet 2
Nice, France
Hôpital Saint-Louis
Paris, France
Hôpital St-Antoine
Paris, France
CHU de Bordeaux, Hôpital Haut-Lévêque
Pessac, France
CHU de Toulouse, Hôpital Rangueil
Toulouse, France
Germany
Krankenhaus Waldfriede e.V.
Berlin, Germany
Markus Hospital
Frankfurt am Main, Germany
Hannover Medical School
Hannover, Germany
University Hospital Schleswig-Holstein
Kiel, Germany
Gastroenterologische Gemeinschaftpraxis
Minden, Germany
Universitätsklinik Ulm
Ulm, Germany
Italy
Azienda Ospedaliero-Universitaria Careggi
Firenze, Italy
Istituto Clinico Humanitas
Milano, Italy
Complesso Integrato Columbus
Roma, Italy
Ospedale San Camillo-Forlanini
Roma, Italy
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Sponsors and Collaborators
TxCell
Investigators
Layout table for investigator information
Principal Investigator: Severine VERMEIRE, MD UZ Gasthuisberg, Gent (Belgium)

Publications:
Layout table for additonal information
Responsible Party: TxCell
ClinicalTrials.gov Identifier: NCT02327221     History of Changes
Other Study ID Numbers: TXC-CD-002-2011
2014-001295-65 ( EudraCT Number )
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by TxCell:
Crohn Disease
Cell therapy
Regulatory T lymphocytes
Treg
Autologous
Antigen specific T regulatory lymphocytes

Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases