A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma

Novartis

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: QBX258

Study type: Interventional

Funder types: Industry

Identifiers

NCT01479595

2011-003066-32 (EudraCT Number)

CQBX258X2201

Details and patient eligibility

About

This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma.

Enrollment: 65 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with atopic asthma >1 year duration diagnosed according to the GINA guidelines.
• Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 39 kg/m2.
• Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of > 1.5.
• FEV1 40 to 90% of predicted.

Exclusion criteria

• Diagnosed with COPD as defined by the GOLD guidelines
• Subjects who have had a respiratory tract infection within 4 weeks prior to screening.
• Women of child-bearing potential must use highly effective methods of contraception during dosing and for at least 18 weeks after last study drug administration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

QBX258

Experimental group

Description:

Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.

Treatment:

Drug: QBX258

Placebo

Placebo Comparator group

Description:

Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.

Treatment:

Drug: Placebo