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

NCT02327221 | Terminated Phase 2 DMC

• 2 other identifiers: TXC-CD-002-20112014-001295-65
• Study Type: interventional
• Target: 32
• Locations: 6 countries
• Sites: 29

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.

Conditions

Crohn Disease

Keywords

Crohn Disease; Cell therapy; Regulatory T lymphocytes; Treg; Autologous; Antigen specific T regulatory lymphocytes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Ovasave - Dose 10e4

ACTIVE COMPARATOR

Drug: Ovasave

Ovasave - Dose 10e6

ACTIVE COMPARATOR

Drug: Ovasave

Ovasave - Dose 10e7

ACTIVE COMPARATOR

Drug: Ovasave

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ovasave DRUG

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

Ovasave - Dose 10e4; Ovasave - Dose 10e6; Ovasave - Dose 10e7

Placebo DRUG

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• Documented CDAI (Crohn's Disease Activity Index) above 250 points (CDAI ≥ 250) at screening or within the past 3 months;

Sponsors & Collaborators

• TxCell: lead

Study Sites (29)

Medical University Innsbruck

Innsbruck, Austria

Location

Medical University of Vienna

Vienna, Austria

Location

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

UZ Gent

Ghent, Belgium

Location

UZ Gasthuisberg

Leuven, Belgium

Location

CHU Liege

Liège, Belgium

Location

CHU d'Amiens Sud

Amiens, France

Location

CHU de Besançon, Hôpital Jean Minjoz

Besançon, France

Location

Hôpital Beaujon

Clichy, France

Location

Hôpital Henri Mondor

Créteil, France

Location

CHRU de Lille, Hôpital Claude Huriez

Lille, France

Location

CHU de Nancy, Hôpital de Brabois Adulte

Nancy, France

Location

CHU de Nice, Hôpital de l'Archet 2

Nice, France

Location

Hôpital Saint-Louis

Paris, France

Location

Hôpital St-Antoine

Paris, France

Location

CHU de Bordeaux, Hôpital Haut-Lévêque

Pessac, France

Location

CHU de Toulouse, Hôpital Rangueil

Toulouse, France

Location

Krankenhaus Waldfriede e.V.

Berlin, Germany

Location

Markus Hospital

Frankfurt am Main, Germany

Location

Hannover Medical School

Hanover, Germany

Location

University Hospital Schleswig-Holstein

Kiel, Germany

Location

Gastroenterologische Gemeinschaftpraxis

Minden, Germany

Location

Universitätsklinik Ulm

Ulm, Germany

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Location

Istituto Clinico Humanitas

Milan, Italy

Location

Complesso Integrato Columbus

Roma, Italy

Location

Ospedale San Camillo-Forlanini

Roma, Italy

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

Related Publications (1)

• Desreumaux P, Foussat A, Allez M, Beaugerie L, Hebuterne 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):1207-1217.e2. doi: 10.1053/j.gastro.2012.07.116. Epub 2012 Aug 8.

  PMID: 22885333 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Severine VERMEIRE, MD

  UZ Gasthuisberg, Gent (Belgium)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: December 30, 2014
• Study Start: December 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

GB (2); IT (4); DE (6); FR (11); AU (2); BE (4)