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)
- Conditions
- 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 disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-000574-11-GB
- Lead Sponsor
- Shire Human Genetic Therapies, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 2453
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 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 5.1.2.1 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
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 SHP647-305, SHP647-306, or SHP647-307, and reached 1 of the following clinical trial milestones:
• Completed the Week 16 visit in induction study SHP647-305 or 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 5.3.2.1 are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.
Are the trial subjects under 18? yes
Number of subjects for this age range: 247
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2158
F.1.3 Elderly (>=65 years) y
Subjects with UC Entering from an Induction or Maintenance Study/Subjects with CD
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 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 ?.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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method