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Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)

NCT03566823 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-05-11

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.

Conditions

Interventions

BIOLOGICAL

Ontamalimab

Subcutaneous injection of ontamalimab will be administered using a prefilled syringe.

OTHER

Placebo

Subcutaneous 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
2018-07-17
Primary Completion
2020-08-18
Completion
2020-08-18
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Bosnia and Herzegovina
  • Bulgaria
  • Colombia
  • Estonia
  • Greece
  • Hungary
  • Ireland
  • Japan
  • Lebanon
  • Mexico
  • New Zealand
  • Portugal
  • Slovakia
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • Ukraine

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 NCT03566823 on ClinicalTrials.gov