Crohn DiseasePhase 2CATS29NCT02327221
Study Evaluating Ovasave, an Autologous Cell Therapy, in Patients With Active Crohn's Disease
A Phase 2 study testing Ovasave in people with Crohn Disease, run by TxCell at 29 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Ovasave
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 29 sitesin 6 countries
- Study dates
- Dec 2014to Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- 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;
Trial locations and contacts
29 sites in 6 countries.
29 sites in 6 countries
France11 sites
CHU d'Amiens Sud
Amiens
CHU de Besançon, Hôpital Jean Minjoz
Besançon
Hôpital Beaujon
Clichy
Hôpital Henri Mondor
Créteil
CHRU de Lille, Hôpital Claude Huriez
Lille
CHU de Nancy, Hôpital de Brabois Adulte
Nancy
CHU de Nice, Hôpital de l'Archet 2
Nice
Hôpital Saint-Louis
Paris
Hôpital St-Antoine
Paris
CHU de Bordeaux, Hôpital Haut-Lévêque
Pessac
CHU de Toulouse, Hôpital Rangueil
Toulouse
Germany6 sites
Krankenhaus Waldfriede e.V.
Berlin
Markus Hospital
Frankfurt am Main
Hannover Medical School
Hanover
University Hospital Schleswig-Holstein
Kiel
Gastroenterologische Gemeinschaftpraxis
Minden
Universitätsklinik Ulm
Ulm
Belgium4 sites
Cliniques Universitaires Saint-Luc
Brussels
UZ Gent
Ghent
UZ Gasthuisberg
Leuven
CHU Liege
Liège
Italy4 sites
Azienda Ospedaliero-Universitaria Careggi
Florence
Istituto Clinico Humanitas
Milan
Complesso Integrato Columbus
Roma
Ospedale San Camillo-Forlanini
Roma
Austria2 sites
Medical University Innsbruck
Innsbruck
Medical University of Vienna
Vienna
United Kingdom2 sites
Guy's and St Thomas' NHS Foundation Trust
London
Southampton General Hospital
Southampton
About this study
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
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.
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- Ovasave, Placebo
- Keywords
- Crohn Disease, Cell therapy, Regulatory T lymphocytes, Treg, Autologous, Antigen specific T regulatory lymphocytes
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OvasaveDrug
During CATS29-Double blind phase, two intravenous administrations of study drug will be administered, one at week 0 and another one at week 8.
PlaceboDrug
During CATS29-Double blind phase, two intravenous administrations of study drug will be administered, one at week 0 and another one at week 8.
| Study group | Role | What they receive |
|---|---|---|
| Ovasave - Dose 10e4 | Active comparator | Not described Receives: Drug: Ovasave |
| Ovasave - Dose 10e6 | Active comparator | Not described Receives: Drug: Ovasave |
| Ovasave - Dose 10e7 | Active comparator | Not described Receives: Drug: Ovasave |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 weeks post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- TxCell
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Severine VERMEIRE, MD, Principal investigator, UZ Gasthuisberg, Gent (Belgium)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327221
- Sponsor's protocol ID
- TXC-CD-002-2011
- Other IDs
- 2014-001295-65, 2014
- Acronym
- CATS29
- Status last verified
- Apr 2017
- First submitted
- 23 Dec 2014
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22885333
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02327221
- Acronym / sponsor ID
- CATS29 / TXC-CD-002-2011
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease, Cell therapy, Regulatory T lymphocytes, Treg, Autologous, Antigen specific T regulatory lymphocytes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 32 participants (actual)
- Lead sponsor
- TxCellIndustry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OvasaveDuring CATS29-Double blind phase, two intravenous administrations of study drug will be administered, one at week 0 and another one at week 8. | Drug | Ovasave - Dose 10e4, Ovasave - Dose 10e6, Ovasave - Dose 10e7 |
| PlaceboDuring CATS29-Double blind phase, two intravenous administrations of study drug will be administered, one at week 0 and another one at week 8. | Drug | Placebo |
Primary outcome
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)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Background: PubMed 22885333Desreumaux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Severine VERMEIRE, MD principal investigator
UZ Gasthuisberg, Gent (Belgium)
29 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ovasave in people with Crohn Disease, run by TxCell at 29 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in France, Germany, Belgium, Italy, Austria and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
CDAI response (time frame: 6 weeks post administration). 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 NCT02327221, 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 25 Apr 2017.