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.0 sites2,453 target enrollmentOctober 30, 2017

Conditionslcerative colitis or Crohn's Disease MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: lcerative colitis or Crohn's Disease
Sponsor: Shire Human Genetic Therapies, Inc.
Enrollment: 2453
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 30, 2017

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Shire Human Genetic Therapies, Inc.

Eligibility Criteria

Inclusion Criteria

•Subjects with UC:
•1\. Subjects 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.

Exclusion Criteria

•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 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/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 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.