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

Crohn Disease Clinical Trial

— CATS29  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02327221
• Other study ID #: TXC-CD-002-2011
• Secondary ID: 2014-001295-65
• Status: Terminated
• Phase: Phase 2
• First received: December 23, 2014
• Last updated: April 24, 2017
• Start date: December 2014
• Est. completion date: November 2016

Study information

• Verified date: April 2017
• Source: TxCell
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck
Austria	Medical University of Vienna	Vienna
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Belgium	UZ Gent	Gent
Belgium	UZ Gasthuisberg	Leuven
Belgium	CHU Liege	Liege
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
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
Italy	Azienda Ospedaliero-Universitaria Careggi	Firenze
Italy	Istituto Clinico Humanitas	Milano
Italy	Complesso Integrato Columbus	Roma
Italy	Ospedale San Camillo-Forlanini	Roma
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Southampton General Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
TxCell

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Italy,  United Kingdom, 

References & Publications (1)

Desreumaux P, Foussat A, Allez M, Beaugerie L, Hébuterne X, Bouhnik Y, Nachury M, Brun V, Bastian H, Belmonte N, Ticchioni M, Duchange A, Morel-Mandrino P, Neveu V, Clerget-Chossat N, Forte M, Colombel JF. Safety and efficacy of antigen-specific regulatory T-cell therapy for patients with refractory Crohn's disease. Gastroenterology. 2012 Nov;143(5):1207-17.e1-2. doi: 10.1053/j.gastro.2012.07.116. Epub 2012 Aug 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CDAI response	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)	6 weeks post administration