NL-OMON54678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) - SHP647-304
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 9
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
- 18 至 99（—）
入选标准
- •Subjects with 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 enrolled previously in Study SHP647-301 and are in
- •the treatment period of Study SHP647-303, completed the ET or Week 52 visit in
- •maintenance study SHP647 303, had responded to ontamalimab treatment (in the
- •induction and/or maintenance studies), and meet one of the following criteria:
- •Subjects are on placebo at the maintenance study ET or Week 52 visit: they
- •received ontamalimab in the induction studies and fulfilled the maintenance
- •study response criteria, OR
- •Subjects have received ontamalimab at the maintenance study ET or Week 52
- •* Clinical composite score that has decreased by >=2 points and >=30%, with an
- •accompanying decrease in the subscore for RB >=1 point or a subscore for RB <=1,
- •compared to the baseline value for induction studies, and/or
- •* Composite score that has decreased by >=30% and >=3 points compared to the
- •baseline value for induction studies.
- •4. Subjects receiving any treatment(s) for UC described in Section 5.1.2.1 are
- •eligible provided they have been, and are anticipated to be, on a stable dose
- •for the designated period of time.
- •Subjects with 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 enrolled previously in Study SHP647-305 and are in
- •the treatment period of Study SHP647-307, completed the ET or Week 52 visit in
- •maintenance study SHP647 307, had responded to ontamalimab treatment (in the
- •induction and/or maintenance studies), and meet one of the following criteria:
- •Subjects are on placebo at the maintenance study ET or Week 52 visit: they
- •received ontamalimab in the induction study and fulfilled the maintenance study
- •response criteria, OR
- •Subjects have received ontamalimab at the maintenance study ET or Week 52
- •* CDAI score that has decreased by >=100 points at EOT visit compared to the
- •baseline value for induction studies, and/or
- •* SES-CD that has decreased by >=25% compared to the baseline value for
- •induction studies.
- •4. Subjects receiving any treatment(s) for CD described in Section 5.2.2.1 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
- •Subjects with UC Entering from an Induction or Maintenance Study/Subjects with
- •1. Subjects who had major protocol deviation(s) (as determined by the sponsor)
- •in previous studies.
- •2. Subjects who permanently discontinued investigational product because of an
- •AE, regardless of relatedness to investigational product, in previous studies.
- •3. Subjects who are likely to require major surgery for UC/CD.
- •4. Subjects are females who became pregnant during the previous UC/CD studies,
- •females who are lactating, 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 (ie, highly effective methods
- •for female and medically appropriate methods for male study subjects) through
- •the conclusion of study participation.
- •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
- •8. Subjects who have developed any major illness/condition or evidence of an
- •unstable clinical condition (except disease under study) 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
- •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 *.tuberculosis (TB) since testing at
- •screening in previous UC/CD studies and who have been advised to require
- •treatment for latent or active disease, but who are without a generally
- •accepted course of treatment.
- •Subjects with UC Entering directly
- •1. Subjects with indeterminate colitis, microscopic colitis, nonsteroidal
- •anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis,
- •or clinical/histologic findings suggestive of CD.
- •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 (Eaden and
- •Mayberry, 2002) performed during the screening period with results available
- •within 10 days before the baseline visit (Visit 1), 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.
- •6. Subjects with known or suspected intolerance or hypersen
研究者
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 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
已完成
3 期
A Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s DiseaseModerate to Severe Ulcerative Colitis or Crohn DiseaseUCLBCTR2019090245Shire Human Genetic Therapies, Inc. (Shire)_Now Takeda1
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