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

NCT03283085 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 557

Last updated 2024-06-21

Study results available
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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)

Conditions

Interventions

DRUG

25 mg Ontamalimab

Ontamalimab SC solution for injection

DRUG

75 mg Ontamalimab

Ontamalimab SC solution for injection

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Shire

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2023-12-13
Completion
2023-12-13
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bosnia and Herzegovina
  • Bulgaria
  • Canada
  • Colombia
  • Croatia
  • Czechia
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Lebanon
  • Lithuania
  • Mexico
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03283085 on ClinicalTrials.gov