A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Shire Human Genetic Therapies, Inc.0 个研究点目标入组 825 人开始时间: 2017年12月4日最近更新: 2021年4月12日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Shire Human Genetic Therapies, Inc.
入组人数: 825

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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

排除标准

•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.
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研究者

发起方

Shire Human Genetic Therapies, Inc.

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