Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).
- Conditions
- lcerative colitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-000599-27-PL
- Lead Sponsor
- Shire Human Genetic Therapies, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 825
Subjects must meet all of the following inclusion criteria to be eligible
for enrollment into the study:
1. Subjects must be between =16 kg/m2 and =80 years of age at the time of
the signing of the informed consent/assent form.
NOTE: Subjects <18 years of age must weigh =40 kg and must have
body mass index (BMI) =16.5.
2. Subjects must have a documented diagnosis (radiologic or endoscopic with histology) of UC for =3 months before screening. The following must be available in each subject's source documentation:
• A biopsy report to confirm the histological diagnosis.
• A report documenting disease duration based upon prior colonoscopy.
NOTE: If this documentation is not available at the time of screening, a colonoscopy with biopsy to confirm the diagnosis is required during the screening period.
3. Subjects must be willing to undergo a flexible sigmoidoscopy or
colonoscopy (if preferred), including biopsy sample collection, during
screening after all other inclusion criteria have been met.
4. Subjects must have moderate to severe active UC, defined as a total Mayo score of =6, including a centrally read endoscopic subscore =2, rectal bleeding subscore =1, and stool frequency subscore =1 at baseline (Visit 2).
5. Subjects must have evidence of UC extending proximal to the rectum (ie, not limited to proctitis).
6. Subjects must have had an inadequate response to, or lost response to, at least 1 conventional treatment such as mesalamine (5
aminosalicylic acid [5-ASA]), glucocorticoids, immunosuppressants
(azathioprine [AZA], 6 mercaptopurine [6 MP], or methotrexate [MTX]), or anti-TNF.
7. Subjects must have evidence of UC extending proximal to the rectum (ie, not limited to proctitis).
8. Subjects must have had an inadequate response to, or lost response to, or had an intolerance to at least 1 conventional treatment such as mesalamine (5-aminosalicylic acid [5-ASA]), glucocorticoids, immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]), or anti-TNF.
9. Subjects receiving any treatment(s) for UC described in Section 5.2.1 of the protocol are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
10. Subjects are males or nonpregnant, nonlactating females who, if
sexually active, agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential. Males and females of reproductive potential who are sexually active must agree to use appropriate contraception (ie, highly effective methods for female and
medically appropriate methods for male study subjects) (as described in
Section 4.4 of the protocol) for the duration of the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 82
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 726
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17
Subjects are excluded from the study if any of the following exclusion
criteria are met:
1. Subjects with indeterminate colitis, microscopic colitis, non-steroidal
ani-inflammatory drug-induced colitis, ischemic colitis, infectious colitis,
or clinical/histologic findings suggestive of Crohn's disease.
2. Subjects with colonic dysplasia or neoplasia.
3. Subjects with past medical history or presence of toxic megacolon.
4. Subjects with colonic stricture, past medical history of colonic
resection, a history of bowel surgery within 6 months before screening,
or who are likely to require surgery for UC during the treatment period.
5. Subjects at risk for colorectal cancer must have a colonoscopy
performed during the screening period with results available within 10
days before the baseline visit (Visit 2), unless the subject has had a
surveillance colonoscopy performed within 1 year prior to screening, and
any adenomatous polyps found at that examination have been excised.
Colonoscopy report and pathology report (if biopsies are obtained) from
the colonoscopy performed during screening or in the prior year
confirming no evidence of dysplasia and colon cancer must be available
in the source documents.
Subjects at risk for colorectal cancer include, but are not limited to:
? Subjects with extensive colitis for =8 years or disease limited to left
side of colon (ie, distal to splenic flexure) for =10 years before
screening, regardless of age.
? Subjects =50 years of age at the time of signing of the informed
consent form.
6. Subjects have participated in other investigational studies within
either 30 days or 5 half lives of investigational product used in the study (whichever is longer) before baseline.
7. Subjects with active enteric infections (positive stool culture and
sensitivity), Clostridium difficile infection or pseudomembranous colitis
[subjects with C. difficile infection at screening may be allowed re-test
after treatment], evidence of active cytomegalovirus infection or Listeria
monocytogenes, known active invasive fungal infections such as
histoplasmosis or parasitic infections, clinically significant underlying
disease that could predispose the subjects to infections, or a history of
serious infection (requiring parenteral antibiotic and/or hospitalization)
within 4 weeks before the baseline visit (Visit 2).
8. Subjects with abnormal chest x-ray findings at screening (Visit 1),
such as presence of active tuberculosis (TB), general infections, heart
failure, or malignancy.
9. Subjects with evidence of active or latent infection with
Mycobacterium tuberculosis (TB) who have not completed a generally
accepted full course of treatment before randomization are excluded.
10. Subjects have received any nonbiologic treatment with
immunomodulatory properties (other than their current background UC
treatment) within 30 days before baseline (Visit 2).
11. Subjects have ever received anti-integrin/adhesion molecule
treatment (eg, natalizumab, vedolizumab, efalizumab, etrolizumab, or
any other investigational antiintegrin/adhesion molecule).
12. Subjects have received parenteral or rectal glucocorticoids, or rectal
5-ASA, within 14 days before screening endoscopic procedure.
13. Subjects have received leukocyte apheresis or selective lymphocyte,
monocyte, or granulocyte apheresis or
plasma exchange within 30 days before baseline (Visit 2).
14. Subjects have participated in other investigational studies within
either 30 days or 5 half-lives
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method