A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
- Conditions
- a type of IBD that may affect any part of the gastroinestinal tract from mouth to anuschronic inflammation of the mucosa of the colon and rectumCrohn's DiseaseUlcerative Colitis10017969
- Registration Number
- NL-OMON54678
- Lead Sponsor
- Shire
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
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 enrolled previously in Study SHP647-301 and are in
the treatment period of Study SHP647-303, completed the ET or Week 52 visit in
maintenance study SHP647 303, had responded to ontamalimab treatment (in the
induction and/or maintenance studies), and meet one of the following criteria:
• 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 criteria, OR
• 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 5.1.2.1 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:
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 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:
• 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
• Subjects have received ontamalimab at the maintenance study ET or Week 52
visit:
* CDAI score that has decreased by >=100 points at EOT 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 5.2.2.1 are
eligible provided they have been, and are anticipated to be, on a stable dose
for the designated period of time.
Subjects with 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 hypersen
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the safety and tolerability of long term treatment with<br /><br>ontamalimabin subjects with moderate to severe UC or CD.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Objectives - Subjects with Ulcerative Colitis<br /><br>• To evaluate the maintenance of response to long-term treatment with<br /><br>ontamalimab as measured by clinical composite score and biomarkers, with or<br /><br>without endoscopy.<br /><br><br /><br>Secondary Objective - Subjects with Crohn's Disease:<br /><br>• To evaluate the maintenance of response to long-term treatment with<br /><br>ontamalimab as measured by Crohn's Disease Activity Index (CDAI) score and<br /><br>biomarkers, with or without endoscopy </p><br>