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Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease

NCT02405442 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2019-04-23

Study results available
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Summary

This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with andecaliximab for an additional 156 weeks.

Conditions

Interventions

DRUG

Andecaliximab

Andecaliximab administered via subcutaneous (SC) injection

DRUG

Placebo

Placebo to match andecaliximab administered via SC injection

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Team · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-11-30
Completion
2016-12-22

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • New Zealand
  • Poland
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT02405442 on ClinicalTrials.gov