Ulcerative ColitisPhase 2NCT01861249
Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)
A Phase 2 study testing SAR339658 in people with Ulcerative Colitis, run by Sanofi at 5 sites in United States.
Trial summary
Primary Objective: To assess the long term safety and tolerability of SAR339658 Secondary Objective: To assess the long term efficacy of SAR339658 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- SAR339658
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2013to Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Ulcerative Colitis (UC) who were previously randomized and have completed the 8-week treatment in ACT12688 study with an acceptable safety profile. Patients who for administrative reasons could not be enrolled in the LTS12593 study right after completion of the 8-week treatment in the ACT12688 study must be enrolled within 3 months from the end of the ACT12688 study
- Signed written informed consent for Study LTS12593
Who cannot join
- Patient with any adverse event leading to study drug (active or placebo) treatment discontinuation from ACT12688 study.
- Patient with any abnormalities or adverse events that per investigator judgment would adversely affect patient's participation in the long-term extension study.
- Use of any immunosuppressant (if patient is on immunosuppressant he or she must discontinue immunosuppressant before starting the LTS12593).
- If the patient started biological treatment for UC while waiting to be enrolled in the LTS12593, then he or she must stop the biological treatment and must have 8 weeks of wash out period before starting treatment with SAR339658 (only anti-tumor necrosis factors (TNFs) are allowed)
- Patients exposed to an anti-integrin or any investigational drug administered after the end of treatment in ACT12688
- Positive pregnancy test
Show all 9Show fewer
- Breast feeding woman
- Women of childbearing potential not protected by highly effective contraceptive method of birth control and/or who are unwilling and unable to be tested for pregnancy.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Investigational Site Number 840024
Mexico, Missouri, 65265
Investigational Site Number 840008
Miramar, Florida, 33025
Investigational Site Number 840059
Mission Hills, California, 91345
Investigational Site Number 840088
San Antonio, Texas, 78229
Investigational Site Number 840048
Winter Park, Florida, 32789
About this study
Official title: A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)
Primary Objective:
To assess the long term safety and tolerability of SAR339658
Secondary Objective:
To assess the long term efficacy of SAR339658
Read the detailed description
The study period per patient will include 62 weeks treatment, 6 weeks post treatment safety follow-up, followed by a long term safety follow-up performed in the form of a phone interview at 3, 6, 12, 18 and 24 months from the last administration of the study medication.
- Conditions
- Ulcerative Colitis
- Being tested
- SAR339658
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR339658Drug
Also called Vatelizumab
Pharmaceutical form: Solution for infusion
Route of administration: Intravenous
| Study group | Role | What they receive |
|---|---|---|
| SAR339658 | Experimental | SAR339658, every 2 weeks (Q2W) or every 4 weeks (Q4W) according to clinical response at Week 8 in the ACT12688 trial Receives: Drug: SAR339658 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with Adverse Events
Measured: Up to Week 68
Secondary outcomes (5)
Percentage of participants with abnormal safety parameters (laboratory data and vital signs)
Measured: Up to Week 68
Proportion of participants with Clinical Remission by Mayo Score
Measured: At Week 62
Proportion of participants with Mucosal Healing
Measured: At Week 62
Change from baseline in the partial Mayo Score
Measured: At Weeks 10, 22, 34, 46 and 58
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: At Weeks 34 and 62
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2014
- Study completionApr 2016
Why it stopped: Recruitment was early terminated due to slow recruitment. Not linked to any safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861249
- Sponsor's protocol ID
- LTS12593
- Other IDs
- 2013-001012-30, U1111-1141-4634
- Status last verified
- Jul 2016
- First submitted
- 21 May 2013
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC)
- ClinicalTrials.gov ID
- NCT01861249
- Acronym / sponsor ID
- LTS12593
- Conditions
- Ulcerative Colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was early terminated due to slow recruitment. Not linked to any safety concern.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 May 2013 (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.
Primary Objective:
To assess the long term safety and tolerability of SAR339658
Secondary Objective:
To assess the long term efficacy of SAR339658
Detailed description
The study period per patient will include 62 weeks treatment, 6 weeks post treatment safety follow-up, followed by a long term safety follow-up performed in the form of a phone interview at 3, 6, 12, 18 and 24 months from the last administration of the study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAR339658 | Experimental | Drug: SAR339658SAR339658, every 2 weeks (Q2W) or every 4 weeks (Q4W) according to clinical response at Week 8 in the ACT12688 trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Ulcerative Colitis (UC) who were previously randomized and have completed the 8-week treatment in ACT12688 study with an acceptable safety profile. Patients who for administrative reasons could not be enrolled in the LTS12593 study right after completion of the 8-week treatment in the ACT12688 study must be enrolled within 3 months from the end of the ACT12688 study
- Signed written informed consent for Study LTS12593
Key exclusion criteria (9 listed)
- Patient with any adverse event leading to study drug (active or placebo) treatment discontinuation from ACT12688 study.
- Patient with any abnormalities or adverse events that per investigator judgment would adversely affect patient's participation in the long-term extension study.
- Use of any immunosuppressant (if patient is on immunosuppressant he or she must discontinue immunosuppressant before starting the LTS12593).
- If the patient started biological treatment for UC while waiting to be enrolled in the LTS12593, then he or she must stop the biological treatment and must have 8 weeks of wash out period before starting treatment with SAR339658 (only anti-tumor necrosis factors (TNFs) are allowed)
- Patients exposed to an anti-integrin or any investigational drug administered after the end of treatment in ACT12688
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 |
|---|---|---|
| SAR339658Also: VatelizumabPharmaceutical form: Solution for infusion Route of administration: Intravenous | Drug | SAR339658 |
Primary outcome
Percentage of participants with Adverse Events
Time frame: Up to Week 68
5 secondary outcomes
Percentage of participants with abnormal safety parameters (laboratory data and vital signs)
Time frame: Up to Week 68
Proportion of participants with Clinical Remission by Mayo Score
Time frame: At Week 62
Proportion of participants with Mucosal Healing
Time frame: At Week 62
Change from baseline in the partial Mayo Score
Time frame: At Weeks 10, 22, 34, 46 and 58
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: At Weeks 34 and 62
Results and safety
The study was stopped early (reason given: Recruitment was early terminated due to slow recruitment. Not linked to any safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
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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.
Clinical Sciences & Operations study director
Sanofi
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAR339658 in people with Ulcerative Colitis, run by Sanofi at 5 sites in United States.
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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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. 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 (reason given: Recruitment was early terminated due to slow recruitment. Not linked to any safety concern.). 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?
Percentage of participants with Adverse Events (time frame: Up to Week 68). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2016.