Efficacy and Safety Study of SHP647 as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)

Inclusion Criteria:

- Participants and/or their parent or legally authorized representative (LAR) 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 LAR) informed consent and/or assent, as applicable, to
participate in the study.

- Participants must have completed the 16-week induction treatment period from study
SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and met the following criteria at
baseline in maintenance study SHP647-307:

a) Meet endoscopic response criteria of a reduction in SES-CD from induction studies
SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline by greater than or equal
to >=25% at Week 16 of induction studies SHP647-305 (NCT03559517) or SHP647-306
(NCT03566823) or b) Meet at least 1 of the following 4 criteria at baseline in
maintenance study SHP647-307, in addition to no worsening of endoscopic score as
measured by SES-CD relative to induction studies SHP647-305 (NCT03559517) or
SHP647-306 (NCT03566823) baseline: i) Achieving clinical remission as determined by
meeting the criteria for clinical remission using the 2-item PRO, that is, 2-item PRO
subscores of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7
most recent days* and average daily stool type frequency <=2 of type 6/7 (very soft
stools/liquid stools) as shown in the BSFS over the 7 most recent days*.

ii) A decrease of at least 100 points in CDAI score (CDAI-100) from induction studies
baseline.

iii) A decrease of >=30% and at least 2 points from induction studies baseline in the
average daily worst abdominal pain over the 7 most recent days*, with the average daily
stool frequency of type 6/7 (very soft stools/liquid stools) either: (i) not worsening from
induction studies baseline and/or (ii) meeting the criteria for clinical remission, that
is, 2-item PRO subscore of average daily stool frequency <=2 of type 6/7 (very soft
stools/liquid stools) as shown in the BSFS over the 7 most recent days*.

iv) A decrease of >=30% from induction studies SHP647-305 (NCT03559517) or SHP647-306
(NCT03566823) baseline in the average daily stool frequency of type 6/7 (very soft
stools/liquid stools) as shown in the BSFS over the 7 most recent days*, with the average
daily worst abdominal pain either: (i) not worsening from induction studies SHP647-305
(NCT03559517) or SHP647-306 (NCT03566823) baseline and/or (ii) meeting the criteria for
clinical remission, that is, 2-item PRO subscore of average worst daily abdominal pain <=3
(based on 11-point NRS) over the 7 most recent days*.

*Note: The 7 days may or may not be contiguous during the 10 days of data collection before
colonoscopy preparation, depending on days to be excluded because of missing data. If fewer
than 7 days are available, the criterion will be calculated on all available most recent 6
or 5 days. If fewer than 5 days are available, the criterion will be treated as missing.

- Participants receiving any treatments 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 who had major protocol deviations (as determined by the sponsor) in
induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).

- Participants who permanently discontinued investigational product because of an AE,
regardless of relatedness to investigational product, in induction studies SHP647-305
(NCT03559517) or SHP647-306 (NCT03566823).

- Participants who are likely to require surgery for CD during the study period, except
minor interventions (eg, seton placement for anal fistulas).

- Participants are females who became pregnant during induction studies SHP647-305
(NCT03559517) or SHP647-306 (NCT03566823), females who are planning to become pregnant
during the study period, or males or females of childbearing potential not agreeing to
continue acceptable 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, or 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 developed obstructive colonic stricture, or enterovesical or
enterovaginal fistulae during the induction study SHP647-305 (NCT03559517) or
SHP647-306 (NCT03566823).

- 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 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 induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823)
and who have been advised to require treatment for latent or active disease but who
are without a generally accepted course of treatment.

- Participants with any of the following abnormalities in hematology and/or serum
chemistry profiles during the evaluation of the last visit in the induction studies
SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823). If the results are considered by
the investigator to be transient and inconsistent with the participant's clinical
condition, may be repeated once prior to enrolment in Study SHP647-307.

1. Alanine aminotransferase and aspartate aminotransferase levels >= 3 × the upper
limit of normal (ULN).

2. Total bilirubin level >=1.5 × ULN or >2 × ULN if the participant has a known
documented history of Gilbert's syndrome.

3. Hemoglobin level <=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]).

4. Platelet count <=100 × 10^9/L (100,000 cells per cubic millimeter [mm^3]) or
>=1000 × 10^9/L (1,000,000 cells/mm^3).

5. White blood cell count <=3.5 × 10^9/L (3500 cells/mm^3).

6. Absolute neutrophil count<2 × 10^9/L (<2000 cells/mm^3)

7. Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30
milliliter per minute (mL/min)/1.73 m^2 based on the abbreviated Modification of
Diet in Renal Disease Study Equation.

- Note: If platelet count is <150,000 cells/mm^3, a further evaluation should
be performed to rule out cirrhosis, unless another etiology has already been
identified.

- 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
induction studies SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) or plan to
participate in other investigational studies during this study.