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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03259334




Registration number
NCT03259334
Ethics application status
Date submitted
21/08/2017
Date registered
23/08/2017
Date last updated
14/06/2021

Titles & IDs
Public title
Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis
Scientific title
A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 301)
Secondary ID [1] 0 0
2017-000599-27
Secondary ID [2] 0 0
SHP647-301
Universal Trial Number (UTN)
Trial acronym
FIGARO UC 301
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ontamalimab
Other interventions - Placebo

Experimental: Ontamalimab 25 mg - Participants will receive 25 milligrams (mg) of ontamalimab (SHP647) subcutaneous (SC) injection using a prefilled syringe (PFS) on Week 0, Week 4 and Week 8.

Experimental: Ontamalimab 75 mg - Participants will receive 75 mg of ontamalimab (SHP647) SC injection using PFS on Week 0, Week 4 and Week 8.

Placebo Comparator: Placebo - Participants will receive placebo matched to ontamalimab (SHP647) SC injection using PFS on Week 0, Week 4 and Week 8.


Treatment: Drugs: Ontamalimab
Participants will receive 1 mL of SHP647 sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).

Other interventions: Placebo
Participants will receive 1 mL of sterile aqueous buffered solution.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Remission at Week 12
Timepoint [1] 0 0
At Week 12
Secondary outcome [1] 0 0
Number of Participants With Endoscopic Remission at Week 12
Timepoint [1] 0 0
At Week 12
Secondary outcome [2] 0 0
Number of Participants With Clinical Remission at Week 12
Timepoint [2] 0 0
At Week 12
Secondary outcome [3] 0 0
Number of Participants With Clinical Response Based on Composite Score at Week 12
Timepoint [3] 0 0
At Week 12
Secondary outcome [4] 0 0
Number of Participants With Mucosal Healing Based on Endoscopic and Histological Assessment Using the Geboes Score Grading System at Week 12
Timepoint [4] 0 0
At Week 12
Secondary outcome [5] 0 0
Number of Participants With Remission Based on Total Mayo Score at Week 12
Timepoint [5] 0 0
At Week 12
Secondary outcome [6] 0 0
Number of Participants With Clinical Response Based on Total Mayo Score at Week 12
Timepoint [6] 0 0
At Week 12
Secondary outcome [7] 0 0
Number of Participants With Partial Mayo Score <=2 With no Individual Sub-score Greater Than (>) 1 at Weeks 4, 8, and 12
Timepoint [7] 0 0
At Weeks 4, 8, and 12
Secondary outcome [8] 0 0
Number of Participants With Clinical Remission With Stool Frequency Sub-scores of 0 or 1 and Rectal Bleeding Sub-score of 0 at Weeks 4 and 8
Timepoint [8] 0 0
At Weeks 4 and 8
Secondary outcome [9] 0 0
Number of Participants With Endoscopic Remission With Sub-score of 0 at Week 12
Timepoint [9] 0 0
At Week 12
Secondary outcome [10] 0 0
Number of Participants With Clinical Remission With Both Rectal Bleeding and Stool Frequency Sub-scores of 0 at Weeks 4, 8, and 12
Timepoint [10] 0 0
At Weeks 4, 8, and 12
Secondary outcome [11] 0 0
Number of Participants With Deep Remission at Week 12
Timepoint [11] 0 0
At Week 12
Secondary outcome [12] 0 0
Change From Baseline in Average Worst Abdominal Pain Score Based on Patient Reported Outcome-ulcerative Colitis (PRO-UC) Daily e-Diary at Week 12
Timepoint [12] 0 0
Baseline, Week 12
Secondary outcome [13] 0 0
Change From Baseline in Diarrhea (Average Loose Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12
Timepoint [13] 0 0
Baseline, Week 12
Secondary outcome [14] 0 0
Change From Baseline in Average Bowel Movements With Urgency Score Based on PRO-UC Daily e-Diary at Week 12
Timepoint [14] 0 0
Baseline, Week 12
Secondary outcome [15] 0 0
Change From Baseline in Absolute Stool Frequency (Average Number of Bowel Movements) Score Based on PRO-UC Daily e-Diary at Week 12
Timepoint [15] 0 0
Baseline, Week 12
Secondary outcome [16] 0 0
Change From Baseline in Absolute Rectal Bleeding (Average Number Bowel Movements With Blood) Score Based on PRO-UC Daily e-Diary at Week 12
Timepoint [16] 0 0
Baseline, Week 12
Secondary outcome [17] 0 0
Change From Baseline in Total Sign/Symptom Score Based on PRO-UC Daily e-Diary at Week 12
Timepoint [17] 0 0
Baseline, Week 12
Secondary outcome [18] 0 0
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domains Scores at Weeks 8 and 12
Timepoint [18] 0 0
Baseline, Weeks 8 and 12
Secondary outcome [19] 0 0
Change From Baseline in IBDQ Total Scores at Weeks 8 and 12
Timepoint [19] 0 0
Baseline, Weeks 8 and 12
Secondary outcome [20] 0 0
Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Physical and Mental Component Summary Scores) at Week 12
Timepoint [20] 0 0
Baseline, Week 12
Secondary outcome [21] 0 0
Change From Baseline in Short Form-36 Health Survey (SF-36), Version 2, Acute (Individual Domain Scores) at Week 12
Timepoint [21] 0 0
Baseline, Week 12
Secondary outcome [22] 0 0
Number of Participants Based on In-patient Hospitalization
Timepoint [22] 0 0
Baseline up to Week 12
Secondary outcome [23] 0 0
Median Duration of Total In-patient Days
Timepoint [23] 0 0
Baseline up to Week 12

Eligibility
Key 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 informed
consent and/or assent, as applicable, to participate in the study.

- Participants must be between greater than or equal to (>=)16 and <=80 years of age at
the time of the signing of the informed consent/assent form.

- Participants less than (<) 18 years of age must weigh >=40 kg and must have body mass
index (BMI) >=16.5 kilogram per square meter (kg/m^2).

- Participants must have a documented diagnosis of UC for >=3 months before screening.
The following must be available in each participant's source documentation:

1. A biopsy report to confirm the histological diagnosis.

2. A report documenting disease duration based upon prior colonoscopy. Note: If this
documentation is not available at the time of screening, a colonoscopy with
biopsy to confirm the diagnosis is required during the screening period.

- Participants must be willing to undergo a flexible sigmoidoscopy or colonoscopy,
including biopsy sample collection, during screening after all other inclusion
criteria have been met.

- Participants must have moderate to severe active UC, defined as a total Mayo score of
>=6, including a centrally read endoscopic subscore >=2, rectal bleeding subscore >=1,
and stool frequency subscore >=1 at baseline.

- Participants must have evidence of UC extending proximal to the rectum (ie, not
limited to proctitis).

- Participants must have had an inadequate response to, or lost response to, or had an
intolerance to at least 1 conventional treatment such as mesalamine (5-aminosalicylate
[ASA]), glucocorticoids, immunosuppressants (azathioprine [AZA], 6-mercaptopurine
[6-MP], or methotrexate [MTX]), or anti-tumor necrosis factor (TNF).

- 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 are males or nonpregnant, nonlactating females who, if sexually active,
agree to comply with the contraceptive requirements of the protocol, or females of
nonchildbearing potential.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants with indeterminate colitis, microscopic colitis, non-steroidal
anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or
clinical/histologic findings suggestive of Crohn's disease.

- Participants with colonic dysplasia or neoplasia. (Participants with prior history of
adenomatous polyps will be eligible if the polyps have been completely removed.)

- Participants with past medical history or presence of toxic megacolon.

- Participants 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.

- Participants at risk for colorectal cancer must have a colonoscopy performed during
the screening period with results available within 10 days before the baseline visit,
unless the participant has had a surveillance colonoscopy performed within 1 year
prior to screening, and any adenomatous polyps found at that examination have been
excised. Colonoscopy report and pathology report (if biopsies are obtained) from the
colonoscopy performed during screening or in the prior year confirming no evidence of
dysplasia and colon cancer must be available in the source documents.

Participants at risk for colorectal cancer include, but are not limited to:

1. Participants with extensive colitis for >=8 years or disease limited to left side of
colon (ie, distal to splenic flexure) for >=10 years before screening, regardless of
age.

2. Participants >=50 years of age at the time of signing of the informed consent form.

- Participants have had prior treatment with SHP647.

- Participants with known or suspected intolerance or hypersensitivity to the
investigational product(s), closely related compounds, or any of the stated
ingredients.

- Participants have received anti-TNF treatment within 60 days before baseline.

- Participants have received any biologic with immunomodulatory properties (other than
anti-TNFs) within 90 days before baseline.

- Participants have received any nonbiologic treatment with immunomodulatory
properties (other than their current background UC treatment) within 30 days before
baseline.

- Participants have ever received anti-integrin/adhesion molecule treatment (example
(eg): natalizumab, vedolizumab, efalizumab, etrolizumab, or any other investigational
anti-integrin/adhesion molecule).

- Participants have received parenteral or rectal glucocorticoids, or rectal 5-ASA,
within 14 days before screening endoscopic procedure.

- Participants have received leukocyte apheresis or selective lymphocyte, monocyte, or
granulocyte apheresis or plasma exchange within 30 days before baseline.

- Participants have participated in other investigational studies within either 30
days or 5 half-lives of investigational product used in the study (whichever is
longer) before baseline.

- Participants have received a live (attenuated) vaccine within 30 days before the
baseline visit.

- Participants with active enteric infections (positive stool culture and
sensitivity), Clostridium difficile infection or pseudomembranous colitis
[Participants with C. difficile infection at screening may be allowed re-test after
treatment], evidence of active cytomegalovirus infection or Listeria monocytogenes,
known active invasive fungal infections such as histoplasmosis or parasitic
infections, clinically significant underlying disease that could predispose the
participants to infections, or a history of serious infection (requiring parenteral
antibiotic and/or hospitalization) within 4 weeks before the baseline visit.

- Participants with abnormal chest x-ray findings at screening, such as presence of
active tuberculosis, general infections, heart failure, or malignancy.

- Participants with evidence of active or latent infection with Mycobacterium
tuberculosis (TB) or participants with this history who have not completed a generally
accepted full course of treatment before randomization are excluded. All other
participants must have either the Mantoux (purified protein derivative [PPD])
tuberculin skin test or interferon gamma release assay (IGRA) performed.

Participants who have no history of previously diagnosed active or latent tuberculosis are
excluded if they have a positive Mantoux (PPD) tuberculin skin test (ie >=5 millimeter [mm]
induration) or a positive IGRA (the latter to be tested at the site's local laboratory)
during screening or within 12 weeks before screening. If IGRA test cannot be performed
locally, a central laboratory may be used, with prior agreement from the sponsor.

1. An IGRA is strongly recommended for participants with a prior Bacillus Calmette-Guerin
(BCG) vaccination, but may be used for any participant. Documentation of IGRA product
used and the test result must be in the participant's source documentation if
performed locally. Acceptable IGRA products include QuantiFERON TB Gold Plus In-Tube
Test.

2. If the results of the IGRA are indeterminate, the test may be repeated, and if a
negative result is obtained, enrollment may proceed. In participants with no history
of treated active or latent tuberculosis, a positive test on repeat will exclude the
participant. Participants with a history of active or latent TB infection must follow
instructions for "participants with a prior diagnosis of active or latent TB are
excluded unless both of the following criteria are met" in this criterion.

3. Participants with repeat indeterminate IGRA results, with no prior TB history, may be
enrolled after consultation with a pulmonary or infectious disease specialist who
determines low risk of infection (ie, participant would be acceptable for
immunosuppressant [eg, anti-TNF] treatment without additional action). This
consultation must be included in source documentation.

Results from a chest x-ray, taken within the 12 weeks before or during screening must show
no abnormalities suggestive of active TB infection as determined by a qualified medical
specialist.

Participants with a prior diagnosis of active or latent TB are excluded unless both of the
following criteria are met:

1. The participant has previously received an adequate course of treatment for either
latent (eg, 9 months of isoniazid or an acceptable alternative regimen, in a locale
where rates of primary multidrug TB resistance are <5%. Participants from regions with
higher rates of primary multidrug TB resistance are excluded) or active (acceptable
multidrug regimen) TB infection. Evidence of diagnosis and treatment must be included
in source documentation. Consultation with a pulmonary or infectious disease
specialist to confirm adequate treatment (ie, participant would be acceptable for
immunosuppressant [eg, anti-TNF] treatment without additional action) must be
performed during the screening period. The consultation report must be included in
source documentation prior to enrollment.

2. A chest x-ray performed within 12 weeks before or during screening indicates no
evidence of active or recurrent disease, and documentation of interpretation by a
qualified medical specialist must be included in source documentation.

- Participants with a pre-existing demyelinating disorder such as multiple
sclerosis or new onset seizures, unexplained sensory motor, or cognitive
behavioral, neurological deficits, or significant abnormalities noted during
screening.

- Participants with any unexplained symptoms suggestive of progressive multifocal
leukoencephalopathy (PML) based on the targeted neurological assessment during
the screening period.

- Participants with a transplanted organ. Skin grafts to treat pyoderma gangrenosum
are allowed.

- Participants with a significant concurrent medical condition at the time of
screening or baseline, including, but not limited to, the following:

1. 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.

2. Cancer or history of cancer or lymphoproliferative disease within the previous 5 years
(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).

3. Presence of acute coronary syndrome (eg, acute myocardial infarction, unstable angina
pectoris) within 24 weeks before screening.

4. History of significant cerebrovascular disease within 24 weeks before screening.

- Participants who have had significant trauma or major surgery within 4 weeks
before the screening visit, or with any major elective surgery scheduled to occur
during the study.

- Participants with evidence of cirrhosis with or without decompensation.

- Participants with primary sclerosing cholangitis.

- Participants with evidence of positive hepatitis B surface antigen (HBsAg) or
hepatitis B core antibody (HBcAb).

Note: If a participant tests negative for HBsAg, but positive for hepatitis B virus
(HBcAb), the participant would be considered eligible if no presence of HBV DNA is
confirmed by HBV DNA polymerasechainreaction(PCR) reflex testing performed in the central
laboratory.

- Participants with chronic hepatitis C (HCV) (positive HCVAb and HCVRNA). Note:
Participants who are HCVAb positive without evidence of HCVRNA may be considered eligible
(spontaneous viral clearance or previously treated and cured [defined as no evidence of HCV
RNA at least 12 weeks prior to baseline]).

- Participants with any of the following abnormalities in hematology and/or serum chemistry
profiles during screening.

Note: Screening laboratory tests, if the results are considered by the investigator to be
transient and inconsistent with the participant's clinical condition, may be repeated once
during the screening period for confirmation. Results must be reviewed for eligibility
prior to the screening endoscopy procedure.

1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >=3.0×upper
limit of normal (ULN).

2. Total bilirubin level >=1.5×ULN or >2.0×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 per liter (/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). - Absolute neutrophil count
(ANC)<2×10^9/L (2000 cells/mm^3).

- Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30
ml/min/1.73m^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 with known human immunodeficiency virus (HIV) infection based on documented
history, with positive serological test, or positive HIV serologic test at screening,
tested at the site's local laboratory in accordance with country requirements or tested at
the central laboratory.

Note: A documented negative HIV test within 6 months of screening is acceptable and does
not need to be repeated.

- Participants who have, or who have a history of (within 2 years before screening),
serious psychiatric disease, alcohol dependency, or substance/drug abuse or dependency of
any kind, including abuse of medical marijuana (cannabis).

- 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.

- Female participants who are planning to become pregnant during study period.

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/10/2020
Sample size
Target
Accrual to date
Final
380
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [4] 0 0
Mater Hospital Brisbane - South Brisbane
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
St Vincents Hospital Melbourne - PPDS - Fitzroy
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Arkansas
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California
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Colorado
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Georgia
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Indiana
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Louisiana
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Mississippi
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West Virginia
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Austria
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Kärnten
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Klagenfurt am Wörthersee
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Wien
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Goiás
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São Paulo
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Grad Zagreb
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Karlovacka Županija
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Zadar
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Praha 4
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Praha 7
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Usti nad Labem
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Usti nad Orlici
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Thüringen
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Berlin-Zehlendorf
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Berlin
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Frankfurt
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Hamburg
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Köln
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Jerusalem
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Israel
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Nahariya
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Israel
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Nazareth
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Israel
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Tel Aviv
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Israel
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Tiberias
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Italy
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Calabria
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Lazio
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Puglia
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Toscana
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Veneto
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Bologna
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Novara
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Pavia
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Italy
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Roma
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Italy
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Rozzano (MI)
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Italy
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Torino
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Kanagawa
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Tokyo
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Abiko-shi, Chiba
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Hakodate
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Koga
Country [79] 0 0
Japan
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shire
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based
on composite score of participant-reported symptoms and centrally read endoscopy, in
participants with moderate to severe ulcerative colitis (UC).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03259334
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Shire
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03259334