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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/NCT03283085




Registration number
NCT03283085
Ethics application status
Date submitted
12/09/2017
Date registered
14/09/2017
Date last updated
26/01/2024

Titles & IDs
Public title
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
Scientific title
A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
Secondary ID [1] 0 0
2017-000574-11
Secondary ID [2] 0 0
SHP647-304
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Ulcerative Colitis 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
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 25 mg Ontamalimab
Treatment: Drugs - 75 mg Ontamalimab

Experimental: 25 mg Ontamalimab - Participants will be receiving 25 milligram (mg) of ontamalimab solution for injection subcutaneously (SC) every 4 weeks until the participant withdraws from the study, or the investigator or sponsor decide to withdraw the participant, or the sponsor decides to close the study, or the program is stopped.

Experimental: 75 mg Ontamalimab - Participants will be receiving 75 mg of ontamalimab solution for injection SC every 4 weeks until the participant withdraws from the study, or the investigator or sponsor decide to withdraw the participant, or the sponsor decides to close the study, or the program is stopped.


Treatment: Drugs: 25 mg Ontamalimab
Ontamalimab sterile aqueous buffered solution will be administered in dose of 25 mg subcutaneously.

Treatment: Drugs: 75 mg Ontamalimab
Ontamalimab sterile aqueous buffered solution will be administered in dose of 75 mg subcutaneously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Baseline upto 12 weeks post end of treatment (EOT) (upto a maximum of 3 years)
Primary outcome [2] 0 0
Number of Participants With Serious Infections
Timepoint [2] 0 0
Baseline upto 12 weeks post EOT (upto a maximum of 3 years)
Primary outcome [3] 0 0
Number of Participants With Clinically Significant Change in Clinical Laboratory Tests Reported as an Adverse Event
Timepoint [3] 0 0
Baseline upto 12 weeks post EOT (upto a maximum of 3 years)
Primary outcome [4] 0 0
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event
Timepoint [4] 0 0
Baseline upto EOT (upto a maximum of 3 years)
Primary outcome [5] 0 0
Number of Participants With Clinically Significant Change in Vital Signs Reported as an Adverse Event
Timepoint [5] 0 0
Baseline upto 12 weeks post EOT (upto a maximum of 3 years)
Secondary outcome [1] 0 0
Number of Participants with Ulcerative Colitis with Treatment Response Over Time
Timepoint [1] 0 0
Baseline upto 12 weeks post end of treatment (EOT) (upto a maximum of 3 years)
Secondary outcome [2] 0 0
Number of Participants with Crohn's Disease with Treatment Response Over Time
Timepoint [2] 0 0
Baseline upto 12 weeks post EOT (upto a maximum of 3 years)

Eligibility
Key inclusion criteria
Participants with Ulcerative Colitis (UC):

- 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 must have been enrolled previously in study SHP647-301 (NCT03259334),
SHP647-302 (NCT03259308), and are in the treatment period of Study SHP647-303,
completed the early termination (ET) or Week 52 visit in maintenance study SHP647-303
(NCT03290781), had responded to ontamalimab treatment (in the induction and/or
maintenance studies), and meet one of the following criteria:

a. Participants are on placebo at the maintenance study ET or Week 52 visit: they
received ontamalimab in the induction studies and fulfilled the maintenance study
response criteria, OR b. Participants have received ontamalimab at the maintenance
study ET or Week 52 visit: i) Clinical composite score that has decreased by >or=2
points and >or=30%, with an accompanying decrease in the subscore for RB >or=1 point
or a subscore for RB <or=1, compared to the baseline value for induction studies,
and/or ii) Composite score that has decreased by >or=30% and >or=3 points compared to
the baseline value for induction studies.

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

Participants with Crohn's Disease:

- 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 must have been enrolled previously in Study SHP647-305 (NCT03559517) or
SHP647-306 (NCT03566823) and are in the treament period of Study SHP647-307
(NCT03627091), completed the ET or Week 52 visit in maintenance study SHP647-307, had
responded to ontamalimab treatment (in the induction or maintenance studies) and meet
one of the following criteria:

1. Participants are on placebo at the maintenance study ET or Week 52 visit: they
received ontamalimab in the induction study and fulfilled the maintenance study
response criteria, OR

2. Participants have received ontamalimab at the maintenance study ET or Week 52
visit:

i) CDAI score that has decreased by >or=100 points at EOT visit compared to the
baseline value for induction studies, and/or ii) SES-CD that has decreased by >or=25%
compared to the baseline value for induction studies.

- Participants receiving any treatment(s) for CD are eligible provided they have been on
a stable dose for the designated period of time.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with UC:

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

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

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

- Participants are females who became pregnant during study SHP647-301, SHP647-302, or
SHP647-303, females who are lactating, 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 (i.e. highly effective methods for
female and medically appropriate methods for male study participants) 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 [e.g.], renal, hepatic, hematologic, gastrointestinal
[except disease under study], endocrine, cardiovascular, pulmonary, immunologic [e.g.
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 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, SHP647-302, or SHP647-303) 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 (e.g. 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 lactating, 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 (i.e. highly effective methods for female
and medically appropriate methods for male study participants) 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.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/12/2023
Sample size
Target
Accrual to date
Final
556
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
The Alfred Hospital - Box Hill
Recruitment hospital [7] 0 0
St Vincents Hospital Melbourne - PPDS - 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
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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Arkansas
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Colorado
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Santander
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Cali
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Grad Zagreb
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Karlovacka Županija
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Bjelovar
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Osijek
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Split
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Virovitica
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Vukovar
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Croatia
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Zadar
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Czechia
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Královéhradecký Kraj
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Czechia
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Olomoucký Kraj
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Czechia
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Praha 4
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Czechia
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Praha 7
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Czechia
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Usti nad Labem
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Czechia
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Usti nad Orlici
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Estonia
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Pärnumaa
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Estonia
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Kohta-Järve
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Estonia
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Tallinn
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Germany
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Baden-Württemberg
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Germany
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Nordrhein-Westfalen
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Germany
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Schleswig-Holstein
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Germany
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Thüringen
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Germany
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Berlin-Zehlendorf
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Germany
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Berlin
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Germany
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Biberach an der Riss
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Munich
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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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Hungary
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Debrecen
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Hungary
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Gyula
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Hungary
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Mohacs
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Hungary
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Szekszard
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Hungary
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Szentes
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Hungary
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Székesfehérvár
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Hungary
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Veszprém
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Hungary
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Vác
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Ireland
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Dublin
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Israel
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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
Country [105] 0 0
Israel
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Tiberias
Country [106] 0 0
Italy
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Calabria
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Italy
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Emilia-Romagna
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Italy
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Lazio
Country [109] 0 0
Italy
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Puglia
Country [110] 0 0
Italy
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Toscana
Country [111] 0 0
Italy
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Veneto
Country [112] 0 0
Italy
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Novara
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Italy
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Pavia
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Italy
State/province [114] 0 0
Roma
Country [115] 0 0
Italy
State/province [115] 0 0
Rozzano (MI)
Country [116] 0 0
Italy
State/province [116] 0 0
Torino
Country [117] 0 0
Japan
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Hokkaidô
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Japan
State/province [118] 0 0
Hyôgo
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Japan
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Kanagawa
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Japan
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Saitama
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Japan
State/province [121] 0 0
Tokyo
Country [122] 0 0
Japan
State/province [122] 0 0
Abiko
Country [123] 0 0
Japan
State/province [123] 0 0
Asahikawa
Country [124] 0 0
Japan
State/province [124] 0 0
Chikushino
Country [125] 0 0
Japan
State/province [125] 0 0
Hakodate
Country [126] 0 0
Japan
State/province [126] 0 0
Koganei
Country [127] 0 0
Japan
State/province [127] 0 0
Koga
Country [128] 0 0
Japan
State/province [128] 0 0
Kurume-shi
Country [129] 0 0
Japan
State/province [129] 0 0
Matsumoto-shi
Country [130] 0 0
Japan
State/province [130] 0 0
Nagakute
Country [131] 0 0
Japan
State/province [131] 0 0
Nishinomiya
Country [132] 0 0
Japan
State/province [132] 0 0
Onomichi
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Japan
State/province [133] 0 0
Osaka-shi
Country [134] 0 0
Japan
State/province [134] 0 0
Osaka
Country [135] 0 0
Japan
State/province [135] 0 0
Otsu-Shi
Country [136] 0 0
Japan
State/province [136] 0 0
Sakai
Country [137] 0 0
Japan
State/province [137] 0 0
Sakura
Country [138] 0 0
Japan
State/province [138] 0 0
Sapporo
Country [139] 0 0
Japan
State/province [139] 0 0
Sendai
Country [140] 0 0
Japan
State/province [140] 0 0
Shimotsuga-gun
Country [141] 0 0
Japan
State/province [141] 0 0
Takatsuki
Country [142] 0 0
Japan
State/province [142] 0 0
Yokohama
Country [143] 0 0
Japan
State/province [143] 0 0
Ôita
Country [144] 0 0
Japan
State/province [144] 0 0
Ôsaka
Country [145] 0 0
Korea, Republic of
State/province [145] 0 0
Daegu Gwang'yeogsi
Country [146] 0 0
Korea, Republic of
State/province [146] 0 0
Gang'weondo
Country [147] 0 0
Korea, Republic of
State/province [147] 0 0
Gyeonggido
Country [148] 0 0
Korea, Republic of
State/province [148] 0 0
Busan
Country [149] 0 0
Korea, Republic of
State/province [149] 0 0
Daegu
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Korea, Republic of
State/province [150] 0 0
Incheon
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Korea, Republic of
State/province [151] 0 0
Seoul
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Lebanon
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Beirut
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Lebanon
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Saida
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Lithuania
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Kaunas
Country [155] 0 0
Lithuania
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Vilnius
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Mexico
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Distrito Federal
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Mexico
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Jalisco
Country [158] 0 0
Mexico
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Morelos
Country [159] 0 0
Mexico
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Nuevo León
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Mexico
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Yucatán
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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 safety and tolerability of long-term treatment
with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's
disease (CD)
Trial website
https://clinicaltrials.gov/ct2/show/NCT03283085
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/NCT03283085