A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients

NCT02649218 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2021-10-11

Study results available
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Summary

A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4 weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study CQGE031C2201

Conditions

Interventions

BIOLOGICAL

Ligelizumab

QGE031 240 mg s.c. q4w

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-05-24
Primary Completion
2019-05-02
Completion
2019-05-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Greece
  • Japan
  • Russia
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT02649218 on ClinicalTrials.gov