A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)

Phase 3

Completed

Conditions: 10017969
chronic inflammation of the mucosa of the colon and rectum
Ulcerative Colitis

Registration Number: NL-OMON50472

Lead Sponsor: Shire

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 14

Inclusion Criteria

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 to participate in the study.,
3. Subjects must have completed the 12-week induction treatment period from
study SHP647-301 or SHP647-302. ,
4. Subjects must have achieved clinical response in induction study SHP647-301
or SHP647-302. Clinical response is defined as:
1) A decrease from the induction study (SHP647-301 or SHP647-302) 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 in
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.
For eligibility assessment, clinical response will be determined based on the
centrally read endoscopy performed during screening and at Week 12 of induction
study SHP647-301 or SHP647-302.,
5. Subjects receiving any treatment(s) for UC described in Section 5.2.1 of the
protocol are eligible provided they have been, and are anticipated to be, on a
stable dose for the designated period of time.

Exclusion Criteria

Subjects are excluded from the study if any of the following criteria are met:,
1. Subjects who had major protocol deviation(s) (as determined by the sponsor)
in induction study SHP647-301 or SHP647-302.
2. Subjects who permanently discontinued investigational product because of an
adverse event, regardless of relatedness to investigational product, in
induction study SHP647-301 or SHP647-302.
3. Subjects who are likely to require surgery for UC during the study period.
4. Subjects are females who became pregnant during induction study SHP647-301
or SHP647-302, females who are planning to become pregnant during the study
period, or males or females of childbearing potential not agreeing to continue
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
(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 induction study SHP647-301 or SHP647-302 and 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 or plan to participate in other
investigational studies (other than induction study SHP647-301 or SHP647-302)
during study SHP647-303.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the efficacy of ontamalimab as maintenance treatment of remission,<br /><br>based on composite score of patient reported symptoms and centrally read<br /><br>endoscopy, in subjects with moderate to severe ulcerative colitis (UC).</p><br>

Secondary Outcome Measures