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Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

NCT02477332 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2021-01-05

Study results available
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Summary

This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic Spontaneous Urticaria.

Conditions

Interventions

BIOLOGICAL

QGE031

BIOLOGICAL

Omalizumab

OTHER

Placebo

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-07-15
Primary Completion
2016-11-02
Completion
2017-06-12
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

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 NCT02477332 on ClinicalTrials.gov