A Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease
- Conditions
- Moderate to Severe Ulcerative Colitis or Crohn DiseaseUC
- Registration Number
- LBCTR2019090245
- Lead Sponsor
- Shire Human Genetic Therapies, Inc. (Shire)_Now Takeda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1
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.
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: The primary objective of the study is to evaluate the safety and tolerability of long-term treatment with SHP647 in subjects with moderate to severe UC or CD.;Timepoints: weeks 12, 24, 36, 60, 72, 84...;Measure: Safety will be measured by: incidence and severity of adverse events (AEs); incidence and nature of serious infections; actual values and change from baseline, as well as the incidence of abnormalities, in laboratory tests, ECGs, and vital signs; and antidrug antibodies.
- Secondary Outcome Measures
Name Time Method