EUCTR2017-000574-11-HU进行中（未招募）1 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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,453
研究概览
简要总结
暂无简介。
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 with UC:
- •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 or
- •SHP647-302 and are in the treatment period of Study SHP647-303,
- •completed the ET or Week 52 visit in the maintenance study SHP647-303,
- •had responded to ontamalimab treatment (in the induction and/or
- •maintenance studies), and meet one of the following criteria:
- •o 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 entry criteria, OR
- •o Subjects have received ontamalimab at the maintenance study ET or
- •Week 52 visit:
- •? 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 5.2.1
- •are eligible provided they have been 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 or
- •SHP647-306 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:
- •o 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
- •o Subjects have received ontamalimab at the maintenance study ET or
- •Week 52 visit:
- •CDAI score that has decreased by =100 points at the end of treatment
- •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 5.3.1
- •are eligible provided they have been on a
- •stable dose for the designated period of time.
- 另有 6 项未显示
排除标准
- •Subjects with UC:
- •1. Subjects who had major protocol deviation(s) (as determined by the
- •sponsor) in Study SHP647-301, SHP647-302, or SHP647-303.
- •2. Subjects who permanently discontinued investigational product
- •because of an adverse event (AE), regardless of relatedness to
- •investigational product, in Study SHP647-301, SHP647-302, or SHP647303.
- •3. Subjects who are likely to require major surgery for UC.
- •4. Subjects are females who became pregnant during Study
- •SHP647-301, SHP647-302, or SHP647-303, 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 (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 [GI] [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 SHP647-301 or 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 SHP647-301, SHP647-302, or SHP647-303) or plan to participate in
- •other investigational studies during long-term extension study SHP647304.
- •Subjects with CD:
- •1. Subjects who had major protocol deviation(s) (as determined by the
- 另有 6 项未显示
研究者
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