A Safety Extension Study of SHP647 in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

Inclusion Criteria:

- Participants and/or their parent or legally authorized representative must have an
understanding, ability, and willingness to fully comply with study procedures and
restrictions.

- Participants 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.

Participants with Ulcerative Colitis:

- Participants must have been previously enrolled in study SHP647-301 (NCT03259334),
SHP647-302 (NCT03259308), or SHP647-303 (NCT03290781), and reached 1 of the following
clinical trial milestones:

1. Completed the Week 12 visit in induction study SHP647-301 (NCT03259334) or
SHP647-302 (NCT03259308), 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 percent (%), with an accompanying decrease in the
subscore for rectal bleeding greater than or equal to (>=) 1 point or a subscore
for rectal bleeding less than or equal to (<=) 1, or 2. a decrease from the
induction study (SHP647-301 [NCT03259334] or SHP647-302 [NCT03259308]) 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.

2. Completed the Week 52 visit in maintenance study SHP647-303 (NCT03290781).

3. Withdrew early from maintenance study SHP647-303 (NCT03290781) 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.

- Participants receiving any treatment(s) for UC are eligible provided they have been,
and are anticipated to be, on a stable dose for the designated period of time.

Participants with Crohn's Disease:

- Participants must have been previously enrolled in study SHP647-305, SHP647-306, or
SHP647-307, and reached 1 of the following clinical trial milestones:

1. 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.

2. Completed the Week 52 visit in maintenance study SHP647-307.

3. 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.

- Participants receiving any treatment(s) for CD are eligible provided they have been,
and are anticipated to be, on a stable dose for the designated period of time.

Exclusion Criteria:

Participants with Ulcerative Colitis:

- Participants who had major protocol deviation(s) (as determined by the sponsor) in
study SHP647-301 (NCT03259334), SHP647-302 (NCT03259308), or SHP647-303 (NCT03290781).

- Participants who permanently discontinued investigational product because of an AE,
regardless of relatedness to investigational product, in study SHP647-301
(NCT03259334), SHP647-302 (NCT03259308), or SHP647-303 (NCT03290781).

- Participants who are likely to require major surgery for UC.

- Participants are females who became pregnant during study SHP647-301 (NCT03259334),
SHP647-302 (NCT03259308), or SHP647-303 (NCT03290781), 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 through the
conclusion of study participation.

- Participants who do not agree to postpone donation of any organ or tissue, including
male participants who are planning to bank or donate sperm and female participants who
are planning to harvest or donate eggs, for the duration of the study and through 16
weeks after last dose of investigational product.

- Participants who, in the opinion of the investigator or the sponsor, will be
uncooperative or unable to comply with study procedures.

- Participants 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).

- Participants who have developed any major illness/condition or evidence of an unstable
clinical condition (example [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 participant if he
or she participates in the study.

- Participants 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 participant inappropriate for entry into this study.

- Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at
screening in study SHP647-301 (NCT03259334) or SHP647-302 (NCT03259308) and who have
been advised to require treatment for latent or active disease, but who are without a
generally accepted course of treatment.

- Participants who are investigational site staff members or relatives of those site
staff members or participants who are sponsor employees directly involved in the
conduct of the study.

- Participants who are participating in other investigational studies (other than
SHP647-301 [NCT03259334], SHP647-302 (NCT03259308), or SHP647-303 [NCT03290781]) or
plan to participate in other investigational studies during long-term extension study
SHP647-304.

Participants with Crohn's Disease:

- Participants who had major protocol deviation(s) (as determined by the sponsor) in
study SHP647-305, SHP647-306, or SHP647-307.

- Participants who permanently discontinued investigational product because of an
adverse events (AE), regardless of relatedness to investigational product, in study
SHP647-305, SHP647-306, or SHP647-307.

- Participants who are likely to require major surgery for CD or developed acute severe
complications of CD (with or without fulfilling the treatment failure criteria in the
maintenance study) that required immediate intervention (eg, need for immediate
biologic treatment with proven effect) and/or Crohn's Disease Activity Index (CDAI)
score more than (>) 450.

- Participants are females who became pregnant during study SHP647-305, SHP647-306, or
SHP647-307, 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 through the conclusion of study participation.

- Participants who do not agree to postpone donation of any organ or tissue, including
male participants who are planning to bank or donate sperm and female participants who
are planning to harvest or donate eggs, for the duration of the study and through 16
weeks after last dose of investigational product.

- Participants who, in the opinion of the investigator or the sponsor, will be
uncooperative or unable to comply with study procedures.

- Participants 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).

- Participants 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 participant if he or she
participates in the study.

- Participants 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 participant inappropriate for entry into this study.

- Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at
screening in study SHP647-305 or SHP647-306 and who have been advised to require
treatment for latent or active disease, but who are without a generally accepted
course of treatment.

- Participants who are investigational site staff members or relatives of those site
staff members or participants who are sponsor employees directly involved in the
conduct of the study.

- Participants who are participating in other investigational studies (other than
SHP647-305, SHP647-306, or SHP647-307) or plan to participate in other investigational
studies during long-term extension study SHP647-304.