Trial Review

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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/NCT03566823




Registration number
NCT03566823
Ethics application status
Date submitted
9/05/2018
Date registered
25/06/2018
Date last updated
11/05/2021

Titles & IDs
Public title
Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)
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 Crohn's Disease (CARMEN CD 306)
Secondary ID [1] 0 0
SHP647-306
Universal Trial Number (UTN)
Trial acronym
CARMEN CD 306
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

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

Experimental: Ontamalimab 25 mg - Participants will receive 25 mg of ontamalimab subcutaneous injection using a prefilled syringe on Week 0/Day 1, Week 4, Week 8, and Week 12.

Experimental: Ontamalimab 75 mg - Participants will receive 75 mg of ontamalimab subcutaneous injection using a prefilled syringe on Week 0/Day 1, Week 4, Week 8, and Week 12.

Placebo Comparator: Placebo - Participants will receive placebo matching with ontamalimab subcutaneous injection using a prefilled syringe on Week 0/Day 1, Week 4, Week 8, and Week 12.


Other interventions: Ontamalimab
Subcutaneous injection of ontamalimab will be administered using a prefilled syringe.

Other interventions: Placebo
Subcutaneous injection of placebo matched with ontamalimab will be administered using a prefilled syringe.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Clinical Remission Based on 2-item Patient-reported Outcome (PRO) at Week 16
Timepoint [1] 0 0
At Week 16
Primary outcome [2] 0 0
Number of Participants With Endoscopic Response at Week 16
Timepoint [2] 0 0
At Week 16
Secondary outcome [1] 0 0
Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 16
Timepoint [1] 0 0
At Week 16
Secondary outcome [2] 0 0
Number of Participants With Enhanced Endoscopic Response at Week 16
Timepoint [2] 0 0
At Week 16
Secondary outcome [3] 0 0
Number of Participants With Clinical Remission Based on 2-item PRO With 4-point Scale for Abdominal Pain at Week 16
Timepoint [3] 0 0
At Week 16
Secondary outcome [4] 0 0
Number of Participants With Clinical Response Based on 2-item PRO With 2 Criteria at Week 16
Timepoint [4] 0 0
At Week 16
Secondary outcome [5] 0 0
Number of Participants With Clinical Remission Based on 2-Item PRO With Endoscopic Response at Week 16
Timepoint [5] 0 0
At Week 16
Secondary outcome [6] 0 0
Number of Participants With Complete Endoscopic Healing at Week 16
Timepoint [6] 0 0
At Week 16
Secondary outcome [7] 0 0
Number of Participants With Clinical Response as Measured by CDAI-100 at Week 16
Timepoint [7] 0 0
At Week 16
Secondary outcome [8] 0 0
Number of Participants With Clinical Response as Measured by CDAI-70 at Week 16
Timepoint [8] 0 0
At Week 16
Secondary outcome [9] 0 0
Number of Participants With Clinical Remission Over Time
Timepoint [9] 0 0
At Week 16
Secondary outcome [10] 0 0
Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily Electronic Diary (E-diary) Entries
Timepoint [10] 0 0
Baseline and at Week 16
Secondary outcome [11] 0 0
Number of Participants With Endoscopic Healing at Week 16
Timepoint [11] 0 0
At Week 16
Secondary outcome [12] 0 0
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Score at Weeks 8, 12 and 16
Timepoint [12] 0 0
Baseline, Weeks 8, 12 and 16
Secondary outcome [13] 0 0
Change From Baseline in Short Form-36 Health Survey (SF-36) Scores at Week 16
Timepoint [13] 0 0
Baseline, Week 16
Secondary outcome [14] 0 0
Number of Participants Based on Incidence of All-cause Hospitalizations
Timepoint [14] 0 0
Baseline up to Week 32
Secondary outcome [15] 0 0
Number of Participants Based on Total Inpatient Days
Timepoint [15] 0 0
Baseline up to Week 32
Secondary outcome [16] 0 0
Number of Participants Based on Incidence of CD-related Surgeries and Other Surgical Procedures
Timepoint [16] 0 0
Baseline up to Week 32

Eligibility
Key inclusion criteria
- Participants must be between greater than or equal to (> =) 16 and less than or equal
to (<=) 80 years of age; participants less than (<) 18 years of age must weigh >=40 kg
and must have body mass index >=16.5 kilogram per meter square (kg/m^2)

- Participants must have active moderate to severe ileal (terminal ileum), ileocolic, or
colonic CD at baseline (Visit 2) as defined by:

1. CDAI score between 220 and 450 (inclusive) AND

2. Meeting the following subscores in the 2 item PRO:

i. Abdominal pain subscore >= 5 (average worst daily pain on the 11 point NRS) and
abdominal pain subscore >= 2 (average daily pain on the 4-point abdominal pain
variable of CDAI) over the 7 most recent days out of the 10 days before colonoscopy
preparation (may or may not be contiguous) AND/OR ii. Average of the daily stool
frequency subscore >=4 of type 6/7 (very soft stools/liquid stools) as shown in the
BSFS over the 7 most recent days out of the 10 days before colonoscopy preparation
(may or may not be contiguous) c. Presence of ulcerations that are characteristic to
CD, as determined by a colonoscopy performed during screening, and as defined by the
SES-CD >6 (SES CD >=4 for isolated ileitis) Note that the participant must be
confirmed as meeting the CDAI score and PRO subscore requirements before a colonoscopy
is done

- Participants must have a documented diagnosis (endoscopic with histology) of CD for
>=3 months before screening. Documented diagnosis is defined as:

1. A biopsy report in which the description of the histological findings is
consistent with the CD diagnosis AND

2. A report documenting disease duration based upon prior colonoscopy Note: If a
biopsy report is not available in the source document at the time of screening, a
biopsy must be performed during the screening colonoscopy and the histology
report should be consistent with the CD diagnosis. If the histology description
does not support the CD diagnosis at this time point, the participant should not
be randomized

- Participants must be willing and able to undergo a colonoscopy during screening after
all other inclusion criteria have been met

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

- 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

- 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. Males and females of reproductive potential who are
sexually active must agree to use appropriate contraception (ie, highly effective
methods for female and medically appropriate methods for male study participants, for
the duration of the study
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Participants with indeterminate colitis, microscopic colitis, nonsteroidal
anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or
clinical/histologic findings suggestive of UC

- 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 presence of enterovesical (ie, between the bowel and urinary
bladder) or enterovaginal fistulae

- Participants with current symptomatic diverticulitis or diverticulosis

- Participants with clinically significant obstructive colonic stricture, or who have a
history of bowel surgery within 6 months before screening, or who are likely to
require surgery for CD during the treatment period. Participants who have undergone
previous colonic resection or ileocolectomy more than 6 months before screening must
have at least 25 cm of colon remaining

- Participants with past medical history of multiple small bowel resections resulting in
clinically significant short bowel syndrome

- Participants requiring total parenteral nutrition

- Participants with past medical history of bowel surgery resulting in an existing or
current stoma. Participants who had a j-pouch are excluded as a j-pouch could result
in a stoma

- Participants have had prior treatment with ontamalimab (formerly PF-00547659; 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 any nonbiologic treatment with immunomodulatory properties
(other than AZA, 6-MP, or MTX) or continuous antibiotics (>2 weeks) for the treatment
of CD within 30 days before baseline (Visit 2)

- Participants have received anti-TNF treatment within 60 days before baseline (Visit 2)

- Participants have received any biologic with immunomodulatory properties (other than
anti-TNFs) within 90 days before baseline (Visit 2)

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

- Participants have received lymphocytes apheresis or selective monocyte granulocytes
apheresis within 60 days before baseline (Visit 2)

- Participants have received enteral nutrition treatment within 30 days before baseline
(Visit 2)

- Participants have received parenteral or rectal glucocorticoids or rectal 5-ASA within
14 days before screening colonoscopy

- Participants have taken >20 milligram per day(mg/day) of prednisone, >9 mg/day of
budesonide, or equivalent oral systemic corticosteroid dose within 14 days before
baseline (Visit 2) or have taken >=40 mg/day of prednisone or equivalent oral systemic
corticosteroid dose within 6 weeks before baseline (Visit 2)

- 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 screening (Visit 1)

- Participants have received a live (attenuated) vaccine within 30 days before the
baseline visit (Visit 2)

- Participants with active enteric infections (positive stool culture and sensitivity),
Clostridium difficile infection or pseudomembranous colitis (subjects with C.
difficile infection at screening may be allowed retest 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 subjects to infections, or a
history of serious infection (requiring parenteral antibiotic and/or hospitalization)
within 4 weeks before the baseline visit (Visit 2)

- Participants with abnormal chest x-ray or other imaging findings at screening (Visit
1), such as presence of active tuberculosis (TB), general infections, heart failure,
or malignancy (A chest x-ray, computed tomography scan, etc, performed up to 12 weeks
before study entry [screening, Visit 1] may be used if available; documentation of the
official reading must be located and available in the source documentation)

- 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 baseline (Visit 2) 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 TB 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 the IGRA 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-Guérin
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 TB, a positive test on repeat will exclude the
participantParticipants 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 (Visit 1)must show no
abnormalities suggestive of active TB infection as determined by a qualified medical
specialist

- 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 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 (Visit 1) or baseline (Visit 2), including, but not limited to, the
following:

a. Any major illness/condition or evidence of an unstable clinical condition (eg, renal,
hepatic, hematologic, 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 b. 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) c. Presence of acute coronary
syndrome (eg, acute myocardial infarction, unstable angina pectoris) within 24 weeks before
screening (Visit 1) d. History of significant cerebrovascular disease within 24 weeks
before screening (Visit 1)

- Participants who have had significant trauma or major surgery within 4 weeks before
the screening (Visit 1), or with any major elective surgery scheduled to occur during
the study.

- Participant with evidence of cirrhosis with or without decompensation (ie, esophageal
varices, hepatic encephalopathy, portal hypertension, ascites)

- Participant with primary sclerosing cholangitis

- Participant with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis
B core antibody (HBcAb) Note: if a subject tests negative for HBsAg, but positive for
HBcAb, the subject would be considered eligible if no presence of hepatitis B virus
(HBV) DNA is confirmed by HBV DNA polymerase chain reaction (PCR) reflex testing
performed in the central laboratory

- Participant with chronic hepatitis C virus (HCV) (positive HCV antibody [HCVAb] and
HCV RNA) Note: Participant who are HCVAb positive without evidence of HCV RNA 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])

- Participant with any of the following abnormalities in hematology and/or serum
chemistry profiles during screening (Visit 1) Note: Screening laboratory tests, if the
results are considered by the investigator to be transient and inconsistent with the
subject's clinical condition, may be repeated once during the screening period for
confirmation results must be reviewed for eligibility prior to the screening
colonoscopy procedure

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

2. Total bilirubin level >=1.5 × ULN or >2.0 × ULN if the subject has a known
documented history of Gilbert's syndrome

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

4. Platelet count <=100× 10^9/L (100,000 cells/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
millilter per minute (mL/min)/173 meter square (m^2) based on the abbreviated
Modification of Diet in RenalDisease Study Equation Note: if platelet count is
<150,000 cells/mm3, a further evaluation should be performed to rule out
cirrhosis, unless another etiology has already been identified

- Participant 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

- 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.

- 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 medicinal marijuana (cannabis)

NOTE: The above Inclusion/Exclusion criteria are NOT exhaustive and other Inclusion/
Exclusion criteria as defined in the protocol may apply.

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
17/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/08/2020
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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California
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Georgia
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Illinois
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Kansas
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Pennsylvania
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Argentina
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Buenos Aires
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Argentina
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Córdoba
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Belgium
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Oost-Vlaanderen
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Belgium
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West-Vlaanderen
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Belgium
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Mouscron
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Bosnia and Herzegovina
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Banja Luka
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Bulgaria
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Sofia-Grad
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Colombia
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Valle Del Cauca
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Estonia
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Parnu
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Estonia
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Tallinn
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Greece
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Attiki
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Greece
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Heraklion
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Greece
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Paliao Faliro
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Greece
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Patras
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Békéscsaba
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Debrecen
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Mohacs
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Szekszard
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Dublin
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Hokkaidô
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Hyôgo
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Asahikawa
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Japan
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Osaka-shi
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Osaka
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Sakura
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Shimotsuga-gun
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Tokyo
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Ôita
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Korea, Republic of
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Gyeonggido
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Busan
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Daegu
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Incheon
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Korea, Republic of
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Seoul
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Korea, Republic of
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Wonju-si, Gangwon-do
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Lebanon
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Beirut
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Lebanon
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Saida
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Morelos
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Mexico
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Nuevo León
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Mexico
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Yucatán
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Mexico
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Durango
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New Zealand
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South Island
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New Zealand
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Wellington
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New Zealand
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Hamilton
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Portugal
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Lisboa
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Portugal
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Guimarães
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Portugal
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Portimão
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Slovakia
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Nitra
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Slovakia
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Presov
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Spain
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Córdoba
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Spain
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Madrid, Communidad Delaware
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Spain
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Madrid
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Spain
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Pontevedra
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Spain
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Barcelona
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Spain
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Huelva
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Spain
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Sevilla
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Turkey
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Istanbul
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Turkey
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Mersin
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Ukraine
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Chernivets'ka Oblast
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Ukraine
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Kharkivs'ka Oblast
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Ukraine
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Kyïv
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Ukraine
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Dnipro
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Ukraine
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Kharkiv
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Ukraine
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Kherson
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhzhia

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 and safety of Ontamalimab in inducing
clinical remission and endoscopic response in participants with moderate to severe Crohn's
Disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03566823
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/NCT03566823