LBCTR2019090245已完成3 期
A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA
Shire Human Genetic Therapies, Inc. (Shire)_Now Takeda0 个研究点目标入组 1 人开始时间: 2022年7月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 至 80（—）
- 性别
- All
入选标准
- •Ulcerative Colitis:
- •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 have been previously enrolled in study SHP647-302, or SHP647-303, and reached 1 of the following clinical trial milestones:
- •- Completed the Week 12 visit in induction study SHP647-302, and did NOT achieve a clinical response. Clinical response is defined as: 1) a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding =1 point or a subscore for rectal bleeding =1, OR 2) a decrease from the induction study (SHP647-302) baseline total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1.
- •- Completed the Week 52 visit in maintenance study SHP647-303.
- •- Withdrew early from maintenance study SHP647-303 due to treatment failure, defined by an endoscopic subscore that has increased by at least 1 point over baseline in the maintenance study or a value =2 plus an increase in clinical subscore (stool frequency + rectal bleeding score) of at least 2 points. Centrally read endoscopic subscores will be used to determine treatment failure.
- •4. Subjects receiving any treatment(s) for UC described in Section 5.2.1 are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
- •Crohn's Disease:
- •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 have been previously enrolled in study SHP647-306, or SHP647-307, and reached 1 of the following clinical trial milestones:
- •Completed the Week 16 visit in induction study SHP647-306, and did NOT meet the efficacy criteria (clinical and/or endoscopic response/remission as appropriate) for entry into maintenance study SHP647-307.
- •Completed the Week 52 visit in maintenance study SHP647-307.
- •Withdrew early from maintenance study SHP647-307 due to treatment failure (or were considered to have failed treatment, at the time of the last visit in study SHP647-307), as defined in the SHP647-307 protocol.
- •4. Subjects receiving any treatment(s) for CD described in Section 5.3.1 are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
排除标准
- •Ulcerative Colitis:
- •1. Subjects who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-302, or SHP647-303.
- •2. Subjects who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in study SHP647-302, or SHP647-303.
- •3. Subjects who are likely to require major surgery for UC.
- •4. Subjects are females who became pregnant during study SHP647-302, or SHP647-303, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue using appropriate contraception methods through the conclusion of study participation (see Section 4.3).
- •5. Subjects who do not agree to postpone donation of any organ or tissue, including male subjects who are planning to bank or donate sperm and female subjects who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
- •6. Subjects who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
- •7. Subjects who have a newly-diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
- •8. Subjects who have developed any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal [except disease under study], endocrine, cardiovascular, pulmonary, immunologic [eg, Felty’s syndrome], or local active infection/infectious illness) that, in the investigator’s judgment, will substantially increase the risk to the subject if he or she participates in the study.
- •9. Subjects with any other severe acute or chronic medical or psychiatric condition or laboratory or electrocardiogram (ECG) abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- •10. Subjects with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in study SHP647-302 and who have been advised to require treatment for latent or active disease, but who are without a generally accepted course of treatment.
- •11. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are sponsor employees directly involved in the conduct of the study.
- •12. Subjects who are participating in other investigational studies (other than SHP647-302, or SHP647-303) or plan to participate in other investigational studies during long-term extension study SHP647-304.
- •Crohn's Disease:
- •1. Subjects who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-306, or SHP647-307.
- •2. Subjects who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in study SHP647-306, or SHP647-307.
- •3. Subjects who are likely to require major surgery for CD, or developed acute severe complications of CD (with or without fulfilling the treatment failure criteria in the maintenance study) that required immediate intervention (eg, need for immediate biologic treatment with proven effect)
研究者
相似试验
已完成
3 期
A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)Ulcerative ColitisCrohn's DiseaseNL-OMON54678Shire9
进行中（未招募）
1 期
Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)EUCTR2017-000574-11-HUShire Human Genetic Therapies, Inc.2,453
进行中（未招募）
1 期
Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)EUCTR2017-000574-11-SKShire Human Genetic Therapies, Inc.2,453
进行中（未招募）
1 期
Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA)EUCTR2017-000574-11-HRShire Human Genetic Therapies, Inc.2,453
进行中（未招募）
1 期
Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)lcerative colitis or Crohn's DiseaseMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2017-000574-11-GBShire Human Genetic Therapies, Inc.2,453