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) - SHP647-301

Shire0 个研究点目标入组 29 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Shire
入组人数: 29

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

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 12 至 99（—）

入选标准

•Subjects must meet all of the following inclusion criteria to be eligible for
•enrollment into the study.
•1. Subjects and/or their parent or legally authorized representative must have
•an understanding, ability, and willingness to fully comply with study
•procedures and restrictions.
•2. Subjects must be able to voluntarily provide written, signed, and dated
•(personally or via a legally authorized representative) informed consent and/or
•assent, as applicable, to participate in the study.
•3. Subjects must be between *16 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 kg/m2.
•4. 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.
•5. 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.
•6. 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).
•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.

排除标准

•Subjects are excluded from the study if any of the following exclusion criteria
•1. Subjects with indeterminate colitis, microscopic colitis, non-steroidal
•anti-inflammatory drug-induced colitis, ischemic ischemic colitis, infectious
•colitis, or clinical/histologic findings suggestive of Crohn*s disease.
•2. Subjects with colonic dysplasia or neoplasia. (Subjects with prior history
•of adenomatous polyps will be eligible if the polyps have been completely
•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 evidance of dysplasia and colon colon 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 had prior treatment with ontamalimab (formerly PF-00547659;
•7. Subjects with known or suspected intolerance or hypersensitivity to the
•investigational product(s), closely related compounds, or any of the stated
•ingredients.
•8. Subjects have received anti-TNF treatment within 60 days before baseline
•(Visit 2).
•9. Subjects have received any biologic with immunomodulatory properties (other
•than anti TNFs) within 90 days before baseline (Visit 2).
•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
•anti-integrin/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 of investigational product used in the study (whichever
•is longer) before baseline (Visit 2).
•15. Subjects have received a live (attenuated) vaccine within 30 days before
•the baseline visit (Visit 2).
•16. Subjects with active enteric infections (positive stool culture and
•sensitivity), Clostridium difficile infection or pseudomembranous colitis
•[subjects with C. difficile infection at scree

研究者

发起方

Shire

相似试验

进行中（未招募）

1 期

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).

EUCTR2017-000599-27-ATShire Human Genetic Therapies, Inc.825

进行中（未招募）

1 期

EUCTR2017-000599-27-NLShire Human Genetic Therapies, Inc.825

进行中（未招募）

1 期

EUCTR2017-000599-27-LTShire Human Genetic Therapies, Inc.825

进行中（未招募）

1 期

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients with Metastatic Castration-Resistant Prostate Cancer.Asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer.MedDRA version: 14.1Level: LLTClassification code 10029101Term: Neoplasm urogenitalSystem Organ Class: 100000004864

EUCTR2008-008004-41-ITJANSSEN-CILAG INTERNATIONAL N.V.1,000

进行中（未招募）

不适用

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based ChemotherapyMetastatic Castration-Resistant Prostate Cancer in Patients who have Failed Docetaxel-Based Chemotherapy.MedDRA version: 9.1Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancer

EUCTR2007-005837-13-IECougar Biotechnology, Inc1,158