Phase 3
N=557
A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)
Crohn's Disease · Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT03283085 ↗Enrolled (actual)
557
Serious AEs
16.2%
Results posted
Jun 2024
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 67; 122; 203; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 25 mg Ontamalimab (Drug); 75 mg Ontamalimab (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
67; 122; 203; 4; 8; 17 | — |
| PRIMARY Number of Participants With Serious Infections |
5; 4; 17; 0; 0; 0 | — |
| PRIMARY Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Discernible Changes in Vital Signs Over Time |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Ulcerative Colitis With Treatment Response Over Time |
116; 129 | — |
| SECONDARY Number of Participants With Crohn's Disease With Treatment Response Over Time |
6; 12 | — |
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)
Eligibility 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 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:
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT03283085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.