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)

Phase 1

Conditions: lcerative 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]

Registration Number: EUCTR2017-000574-11-HU

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

Inclusion Criteria

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

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 adverse event (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.
4. Subjects are females who became pregnant during Study
SHP647-301, SHP647-302, or SHP647-303, 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 (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.
10. Subjects with known exposure to Mycobacterium tuberculosis (TB)
since testing at screening in Study SHP647-301 or 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 SHP647-301, SHP647-302, or SHP647-303) or plan to participate in
other investigational studies during long-term extension study SHP647304.

Subjects with CD:
1. Subjects who had major protocol deviation(s) (as determined by the
sponsor) in Study SHP647-305, SHP647-306, or SHP647-307.
2. Subjects who permanently discontinued investigational product
because of an AE, regardless of relatedness to investigational product, in
Study SHP647-305, SHP647-306, or SHP647-307.
3. Subjects who are likely to require major surgery for CD or developed
acute severe complications of CD (with o

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

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