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-PT
- Lead Sponsor
- Shire Human Genetic Therapies, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2453
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.
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) yes
F.1.3.1 Number of subjects for this age range 48
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.
Subjects with UC Entering directly
1. Subjects with indeterminate colitis, microscopic colitis, nonsteroidal
anti-inflammatory drug-induced colitis,
ischemic colitis, infectious colitis, or clinical/histologic findings
suggestive of CD.
2. Subjects with colonic dysplasia or neoplasia.
3. Subjects with past medical history or presence of toxic megacolon.
4. Subjects with colonic stricture, past medical history of colonic
resection, a history of bowel surgery within 6
months before screening, or who are likely to require surgery for UC
during the treatment period.
5. Subjects at risk for colorectal cancer must have a colonoscopy (Eaden
and Mayberry, 2002) performed during the
screening period with results available within 10 days before the
baseline visit (Visit 1), unless the subject has
had a surveillance colonoscopy performed within 1 year prior to
screening, and any adenomatous polyps found at
that examination have been excised. 6. Subjects with known or
suspected intolerance or hypersensitivity to the investigational
product(s), closely related compounds, or any of the stated ingredients.
7. Subjects have re
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