Long-term Safety Study of QGE031 in Patients With Allergic Asthma Who Completed Study CQGE031B2201

Phase 2TerminatedNCT02075008

Novartis Pharmaceuticals270 enrolled

Overview

This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma patients who completed study CQGE031B2201.

This study planned to assess long-term safety and tolerability of QGE031 administered every 4 weeks for an additional 12 months in patients with allergic asthma who previously completed study CQGE031B2201. The study was terminated early due to the efficacy results from an interim analysis of the Phase II study CQGE031B2201.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

270

Conditions

Asthma

Interventions

QGE031DRUG

QGE031 120 mg/mL solution for subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 76 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * forced Expiratory Volume in one second ( FEV1) \>= 40% predicted * patients who completed CQGE031B2201 study Key Exclusion Criteria: * life-threatening asthma attack, intubation, respiratory arrest during or after completion of CQGE031B2201 study * new malignancy * ongoing SAE from CQGE031B2201 that was assessed as related to study drug * patient experienced platelets drop to \< 75,000/uL * patient experienced one unexpected grade 4 or two unexpected grade 3 hypersensitivity reactions * patient is pregnant

Locations (84)

Outcomes

Primary Outcomes

Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability

Safety was monitored throughout the study.

Time frame: 52 weeks

Data from ClinicalTrials.gov

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Novartis Investigative Site

Evansville, Indiana, United States

Novartis Investigative Site

Owensboro, Kentucky, United States

Novartis Investigative Site

Waldorf, Maryland, United States

Novartis Investigative Site

Minneapolis, Minnesota, United States

Novartis Investigative Site

Fairfax, Virginia, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Mar del Plata, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires F.D., Argentina

Novartis Investigative Site

Santa Fe, Rosario, Argentina

...and 74 more locations