Ulcerative ColitisPhase 2FUSCIANCT01659138
Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis
A Phase 2 study testing SAR339658 in people with Ulcerative Colitis, run by Sanofi at 41 sites in 7 countries.
Trial summary
Primary Objective: To assess the efficacy of SAR339658 Secondary Objective: To assess the safety of SAR339658 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- SAR339658
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 41 sitesin 7 countries
- Study dates
- Aug 2012to 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female ≥18 and ≤70 years old
- History of active ulcerative colitis of at least 3 months duration
- Active UC should be confirmed by colonoscopy or flexible sigmoidoscopy during the screening period within 7 days prior to randomization.
- Moderate to severe ulcerative colitis at time of screening, confirmed by Mayo score ≥6 to 12 and endoscopy subscore of ≥2 despite treatment with immunosuppressants and/or anti-tumor necrosis factors (TNFs):
- Immunosuppressants: Patient must be on concurrent treatment with or have had an inadequate response to (did not respond to or lost response to) or be intolerant to immunosuppressants such as azathioprine, 6-mercaptopurine, or methotrexate.
- AND/OR
Show all 13Show fewer
- TNF-alpha antagonists: Patient must have had an inadequate response or lost response or be intolerant to TNF-alpha antagonists
- Fecal calprotectin ≥200mg/kg
- Patients on corticosteroids must be on a stable dose ≥2 weeks prior to screening
- Patients on azathioprine, 6- mercaptopurine or methotrexate must be on treatment for at least 12 weeks prior to screening; and on a stable dose ≥4 weeks prior to screening
- Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥4 weeks prior to screening
- Patients naïve to anti-TNF alpha or non-responder (primary or secondary) or intolerant to anti-TNF alpha
- Signed written informed consent
Who cannot join
- Patients with Crohn's Disease
- Diagnosis of indeterminate colitis
- Patients with stool sample positive for ova, parasites, or positive culture for aerobic pathogens including: Aeromonas, Plesiomonas, Shigella, Yersinia, Campylobacter and E. Coli spp. or positive for Clostridium difficile B toxin in stools.
- Patients with prior colectomy or anticipated colectomy during their participation in the study
- Presence of ileal pouch or ostomy
- Fulminant disease or toxic megacolon
Show all 36Show fewer
- Colonic dysplasia except for adenoma
- Total Parenteral Nutrition
- Cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide or tacrolimus within 2 months prior to screening
- Previous exposure to natalizumab (Tysabri®) or vedolizumab
- Antidiarrheals within 2 weeks prior to screening
- Prednisone >40 mg/day (or equivalent)
- Budesonide >9 mg/day
- Received intravenous corticosteroids within 2 weeks prior to screening or during screening
- Rectally administered topical 5-aminosalicylate or corticosteroids within 4 weeks prior to screening
- Received therapeutic enema or suppository, other than required for colonoscopy or flexible sigmoidoscopy within 4 weeks prior to screening or during screening
- Antibiotics for ulcerative colitis or gastrointestinal infection within 4 weeks prior to screening
- Patient who has previously participated in any clinical trial of GBR500 / SAR339658
- Patient who has taken other investigational medications within 2 months or 5 half lives, (whichever is longer) prior to screening
- Use of any biologics for the treatment of ulcerative colitis in the previous 8 weeks before screening
- Requirement for concomitant treatment that could bias primary evaluation
- Pregnant or breast-feeding women
- Women of childbearing potential not protected by highly effective contraceptive method of birth control
- Patient with latent or active tuberculosis (TB) defined as:
- Any signs or symptoms suggestive of active TB upon medical history or clinical examination
- Patients with a positive QuantiFERON TB Gold Test
- Chest radiograph within 3 months prior to the inclusion visit consistent with prior tuberculosis infection including, but not limited to, apical scarring, apical fibrosis, or multiple calcified granulomasa. This does not include non-caseating granulomasa
- Patients with close contact with a person with active tuberculosis
- Patient with a history of listeriosis or tuberculosis (unless it is documented that they were adequately treated)
- Administration of any live (attenuated) vaccine within 3 months prior to the screening Visit (eg, varicella-zoster vaccine, oral polio, rabies)
- Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening Visit
- Prior opportunistic infections within 6 months prior to screening or while receiving anti-TNF treatment
- History of a hypersensitivity reaction, other than localized injection site reaction, to any biological molecule
- History or any current signs of demyelinating disease or any neurological disease that can by the opinion of Investigator interfere with study safety assessments including assessment for progressive multifocal leukoencephalopathy
- Patients with bleeding disorders or known platelet dysfunction
- 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
41 sites in 7 countries.
41 sites in 7 countries
United States25 sites
Investigational Site Number 840068
Charlottesville, Virginia, 22908
Investigational Site Number 840001
Chicago, Illinois, 60637
Investigational Site Number 840046
Cincinnati, Ohio, 45219
Investigational Site Number 840051
Great Neck, New York, 11021
Investigational Site Number 840078
Hammond, Louisiana, 70403
Investigational Site Number 840061
Littleton, Colorado, 80120
Investigational Site Number 840024
Mexico, Missouri, 65265
Investigational Site Number 840003
Miami, Florida, 33136
Investigational Site Number 840008
Miramar, Florida, 33025
Investigational Site Number 840059
Mission Hills, California, 91345
Investigational Site Number 840005
Oak Lawn, Illinois, 60453
Investigational Site Number 840060
Ocean Springs, Mississippi, 39564
Investigational Site Number 840019
Pasadena, Texas, 77505
Investigational Site Number 840045
Phoenixville, Pennsylvania, 19460
Investigational Site Number 840071
Rochester, New York, 14642
Investigational Site Number 840070
Rochester Hills, Michigan, 48098
Investigational Site Number 840088
San Antonio, Texas, 78229
Investigational Site Number 840074
San Diego, California, 92114
Investigational Site Number 840053
Savannah, Georgia, 31405
Investigational Site Number 840034
Seattle, Washington, 98104-2499
Investigational Site Number 840038
Sugar Land, Texas, 77479
Investigational Site Number 840065
Sun City, Arizona, 85351
Investigational Site Number 840064
Wauwatosa, Wisconsin, 53226
Investigational Site Number 840089
Winston-Salem, North Carolina, 27157-1071
Investigational Site Number 840048
Winter Park, Florida, 32789
Poland7 sites
Investigational Site Number 616001
Gdynia, 81-969
Investigational Site Number 616004
Lodz, 90-242
Investigational Site Number 616005
Lodz, 90-302
Investigational Site Number 616002
Lodz, 90302
Investigational Site Number 616007
Poznan, 60539
Investigational Site Number 616006
Środa Wielkopolska, 63-000
Investigational Site Number 616008
Warsaw, 03-580
Germany3 sites
Investigational Site Number 276001
Berlin, 14163
Investigational Site Number 276007
Hamburg, 20246
Investigational Site Number 276005
Hamburg, 79106
France2 sites
Investigational Site Number 250003
Grenoble, 38043
Investigational Site Number 250006
Vandœuvre-lès-Nancy, 54511
Italy2 sites
Investigational Site Number 380003
Florence, 50141
Investigational Site Number 380006
San Giovanni Rotondo, 71013
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Efficacy and Safety of SAR339658 in Patients With Active Moderate to Severe Ulcerative Colitis (UC)
Primary Objective:
To assess the efficacy of SAR339658
Secondary Objective:
To assess the safety of SAR339658
Read the detailed description
The study period per patient will include up to 4 weeks screening, 8 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.
After completion of the 8-week treatment phase, patients may be eligible to enter a long term safety study (LTS12593) for active treatment with SAR339658.
- Conditions
- Ulcerative Colitis
- Being tested
- SAR339658, Placebo
- 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
PlaceboOther
Pharmaceutical form: solution for infusion
Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| SAR339658 | Experimental | SAR339658 at Weeks 0, 2, 4, and 6 Receives: Drug: SAR339658 |
| Placebo | Placebo comparator | Placebo at Weeks 0, 2, 4, and 6 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Clinical Response by Mayo Score
Measured: At Week 8
Secondary outcomes (6)
Proportion of Participants with Clinical Remission by Mayo Score
Measured: At Week 8
Proportion of Participants with Mucosal Healing
Measured: At Week 8
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: At Weeks 4 and 8
Change from Baseline in Quality of Life (QoL) SF-36
Measured: At Weeks 4 and 8
Change from Baseline in the partial Mayo Score
Measured: At Weeks 4 and 6
Number of Participants with adverse events
Measured: Up to Week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 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
- NCT01659138
- Sponsor's protocol ID
- ACT12688
- Other IDs
- 2012-002013-19, U1111-1124-1076
- Acronym
- FUSCIA
- Status last verified
- Jul 2016
- First submitted
- 3 Aug 2012
- 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 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Efficacy and Safety of SAR339658 in Patients With Active Moderate to Severe Ulcerative Colitis (UC)
- ClinicalTrials.gov ID
- NCT01659138
- Acronym / sponsor ID
- FUSCIA / ACT12688
- 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
- 28 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 7 Aug 2012 (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 efficacy of SAR339658
Secondary Objective:
To assess the safety of SAR339658
Detailed description
The study period per patient will include up to 4 weeks screening, 8 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.
After completion of the 8-week treatment phase, patients may be eligible to enter a long term safety study (LTS12593) for active treatment with SAR339658.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAR339658 | Experimental | Drug: SAR339658SAR339658 at Weeks 0, 2, 4, and 6 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo at Weeks 0, 2, 4, and 6 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or Female ≥18 and ≤70 years old
- History of active ulcerative colitis of at least 3 months duration
- Active UC should be confirmed by colonoscopy or flexible sigmoidoscopy during the screening period within 7 days prior to randomization.
- Moderate to severe ulcerative colitis at time of screening, confirmed by Mayo score ≥6 to 12 and endoscopy subscore of ≥2 despite treatment with immunosuppressants and/or anti-tumor necrosis factors (TNFs):
- Fecal calprotectin ≥200mg/kg
Key exclusion criteria (36 listed)
- Patients with Crohn's Disease
- Diagnosis of indeterminate colitis
- Patients with stool sample positive for ova, parasites, or positive culture for aerobic pathogens including: Aeromonas, Plesiomonas, Shigella, Yersinia, Campylobacter and E. Coli spp. or positive for Clostridium difficile B toxin in stools.
- Patients with prior colectomy or anticipated colectomy during their participation in the study
- Presence of ileal pouch or ostomy
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 |
| PlaceboPharmaceutical form: solution for infusion Route of administration: intravenous | Other | Placebo |
Primary outcome
Proportion of Participants with Clinical Response by Mayo Score
Time frame: At Week 8
6 secondary outcomes
Proportion of Participants with Clinical Remission by Mayo Score
Time frame: At Week 8
Proportion of Participants with Mucosal Healing
Time frame: At Week 8
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: At Weeks 4 and 8
Change from Baseline in Quality of Life (QoL) SF-36
Time frame: At Weeks 4 and 8
Change from Baseline in the partial Mayo Score
Time frame: At Weeks 4 and 6
Number of Participants with adverse events
Time frame: Up to Week 17
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
41 sites in 7 countries: 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 41 sites in 7 countries.
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 13 inclusion and 36 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 41 sites in United States, Poland, Germany, France, Italy and 2 more countries. 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 (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?
Proportion of Participants with Clinical Response by Mayo Score (time frame: At Week 8). 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.