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An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis

NCT03290781 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2022-01-14

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

Conditions

Interventions

DRUG

Ontamalimab

Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).

OTHER

Placebo

Participants will receive 1 mL of sterile aqueous buffered solution.

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
81 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-04
Primary Completion
2021-07-01
Completion
2021-07-01
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

More Related Trials

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 NCT03290781 on ClinicalTrials.gov