EUCTR2017-000574-11-ES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 (AIDA) - AIDA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,114
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 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 have been previously enrolled in study SHP647-301, SHP647 302, or SHP647-303, and reached 1 of the following clinical trial milestones:
- •Completed the Week 12 visit in induction study SHP647-301 or 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 301 or 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.
- •5. 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 acceptable contraception (as described in Section 4.3) for the duration of the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 112
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 980
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •Subjects are excluded from the study if any of the following criteria are met:
- •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 AE, regardless of relatedness to investigational product, in study SHP647-301, SHP647 302, or SHP647-303.
- •3. Subjects who are likely to require major surgery for UC.
- •4. Female subjects who became pregnant during study SHP647-301, SHP647-302, or SHP647-304, or who are planning to become pregnant during the study period.
- •5. Male subjects who are planning to donate sperm must agree not to do so 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 SHP647-301 or SHP647-302 and 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 or plan to participate in other investigational studies (other than SHP647-301, SHP647 302, or SHP647-303) during long-term extension study SHP647 304.
研究者
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