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Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)

NCT03627091 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-03-31

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).

Conditions

Interventions

DRUG

Ontamalimab

SC injection of 25 mg or 75 mg ontamalimab will be administered using a prefilled syringe.

OTHER

Placebo

SC injection of placebo matched with ontamalimab will be administered using a prefilled syringe.

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
2019-02-06
Primary Completion
2021-06-21
Completion
2021-09-13
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bosnia and Herzegovina
  • Bulgaria
  • Colombia
  • Croatia
  • 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
  • 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 NCT03627091 on ClinicalTrials.gov