A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

• Register: ClinicalTrials.gov
• Last refreshed on: 5 February 2024
• Main ID: NCT03283085
• Date of registration: 12/09/2017
• Prospective Registration: Yes
• Primary sponsor: Shire
• 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)
• Date of first enrolment: February 27, 2018
• Target sample size: 556
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03283085
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Colombia, Croatia, Czechia, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Lebanon, Lithuania, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Study Director
• Affiliation: Shire

Key inclusion & exclusion criteria

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 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.

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.



Age minimum: 16 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Crohn's Disease

Intervention(s)

Drug: 75 mg Ontamalimab

Drug: 25 mg Ontamalimab

Primary Outcome(s)

Number of Participants With Clinically Significant Change in Clinical Laboratory Tests Reported as an Adverse Event [Time Frame: Baseline upto 12 weeks post EOT (upto a maximum of 3 years)]

Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event [Time Frame: Baseline upto EOT (upto a maximum of 3 years)]

Number of Participants With Clinically Significant Change in Vital Signs Reported as an Adverse Event [Time Frame: Baseline upto 12 weeks post EOT (upto a maximum of 3 years)]

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time Frame: Baseline upto 12 weeks post end of treatment (EOT) (upto a maximum of 3 years)]

Number of Participants With Serious Infections [Time Frame: Baseline upto 12 weeks post EOT (upto a maximum of 3 years)]

Secondary Outcome(s)

Number of Participants with Ulcerative Colitis with Treatment Response Over Time [Time Frame: Baseline upto 12 weeks post end of treatment (EOT) (upto a maximum of 3 years)]

Number of Participants with Crohn's Disease with Treatment Response Over Time [Time Frame: Baseline upto 12 weeks post EOT (upto a maximum of 3 years)]

Secondary ID(s)

2017-000574-11

SHP647-304

Source(s) of Monetary Support

Please refer to primary and secondary sponsors