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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03283085




Registration number
NCT03283085
Ethics application status
Date submitted
12/09/2017
Date registered
14/09/2017

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: Ulcerative Colitis (UC): Ontamalimab 25 mg - Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.

Experimental: UC: Ontamalimab 25mg then 75 mg - Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.

Experimental: UC: Ontamalimab 75 mg - Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.

Experimental: Crohn's disease (CD): Ontamalimab 25 mg - Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.

Experimental: CD: Ontamalimab 25mg then 75 mg - Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.

Experimental: CD: Ontamalimab 75 mg - Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.


Treatment: Drugs: 25 mg Ontamalimab
Ontamalimab SC solution for injection

Treatment: Drugs: 75 mg Ontamalimab
Ontamalimab SC solution for injection
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
From first dose of study drug up to end of study [EOS] (up to 5.79 years)
Primary outcome [2] 0 0
Number of Participants With Serious Infections
Timepoint [2] 0 0
From first dose of study drug up to EOS (up to 5.79 years)
Primary outcome [3] 0 0
Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time
Timepoint [3] 0 0
From first dose of study drug up to EOS (up to 5.79 years)
Primary outcome [4] 0 0
Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time
Timepoint [4] 0 0
From first dose of study drug up to EOS (up to 5.79 years)
Primary outcome [5] 0 0
Number of Participants With Discernible Changes in Vital Signs Over Time
Timepoint [5] 0 0
From first dose of study drug up to EOS (up to 5.79 years)
Secondary outcome [1] 0 0
Number of Participants With Ulcerative Colitis With Treatment Response Over Time
Timepoint [1] 0 0
Up to 5.79 years
Secondary outcome [2] 0 0
Number of Participants With Crohn's Disease With Treatment Response Over Time
Timepoint [2] 0 0
Up to 5.79 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
557
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
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Abiko
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Hakodate
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Koga
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Japan
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Onomichi
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Osaka
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Sakai
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Sendai
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Shimotsuga-gun
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Takatsuki
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Yokohama
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Ôita
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Ôsaka
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Korea, Republic of
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Daegu Gwang'yeogsi
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Gang'weondo
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Lebanon
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Durango
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03283085