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

NCT01479595 | Completed Phase 2 Results

• 2 other identifiers: CQBX258X22012011-003066-32
• Study Type: interventional
• Target: 65
• Locations: 3 countries
• Sites: 20

Brief Summary

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

Conditions

Asthma

Keywords

Asthma; Interleukin; QBX258; QAX576; VAK694

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Asthma Control Questionnaire (ACQ) Score

  The ACQ consists of 7 questions assessing symptoms, rescue medication use and lung function. Except for lung function (FEV1), each question was scored on a 7-point scale where 0 = no impairment and 6 = maximum impairment. Scores ranged between 0 totally controlled to 6 (severely uncontrolled). Participants with a score below 1.0 are considered to have adequately controlled asthma. Participants with a score above 1.0 were considered not to be well controlled. A negative change from baseline indicates improvement.

  Baseline and 12 weeks

Secondary Outcomes (10)

• Change in Forced Expiratory Volume in One Second (FEV1)

  Baseline and 12 weeks

• Change in Asthma Quality of Life Questionnaire (AQLQ) Score

  Baseline and 12 weeks

• Morning and Evening Peak Expiratory Flow (PEF) Rate

  Baseline and 12 weeks

• Change From Baseline in Maximum Expiratory Flow

  Baseline and 12 weeks

• Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies

  12 weeks

Study Arms (2)

QBX258

EXPERIMENTAL

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

Drug: QBX258

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

QBX258 DRUG

QBX258 infusion, a combination of VAK694 and QAX576, was supplied to the Investigator as open label bulk medication. The planned dose of VAK694 (lyophilisate in vial, 150 mg/vial), was 3 mg/kg. The planned dose of QAX576 (lyophilisate in vial, 150 mg/vial), was 6 mg/kg.

QBX258

Placebo DRUG

The placebo infusion was an equal volume of 5% dextrose for infusion and was provided by the clinical site.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (20)

Novartis Investigative Site

Anaheim, California, 92801, United States

Location

Novartis Investigative Site

Riverside, California, 92506, United States

Location

Novartis Investigative Site

Rolling Hills Estates, California, 90274, United States

Location

Novartis Investigative Site

San Marino, California, 91108, United States

Location

Novartis Investigative Site

Denver, Colorado, 80206, United States

Location

Novartis Investigative Site

Denver, Colorado, 80230, United States

Location

Novartis Investigative Site

Aventura, Florida, 33180, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02115, United States

Location

Novartis Investigative Site

Minneapolis, Minnesota, 55402, United States

Location

Novartis Investigative Site

St Louis, Missouri, 63110, United States

Location

Novartis Investigative Site

Raleigh, North Carolina, 27607, United States

Location

Novartis Investigative Site

Winston-Salem, North Carolina, 27157, United States

Location

Novartis Investigative Site

Oklahoma City, Oklahoma, 73120, United States

Location

Novartis Investigative Site

Medford, Oregon, 97504-8741, United States

Location

Novartis Investigative Site

Spartanburg, South Carolina, 29303, United States

Location

Novartis Investigative Site

Wiesbaden, Germany, 65187, Germany

Location

Novartis Investigative Site

Berlin, 10117, Germany

Location

Novartis Investigative Site

Frankfurt, 60596, Germany

Location

Novartis Investigative Site

London, United Kingdom, SE11YR, United Kingdom

Location

Novartis Investigative Site

Manchester, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Novartis Pharmaceuticals

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: February 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: August 1, 2016
• Results First Posted: August 1, 2016

Record last verified: 2016-06

Locations

GB (2); DE (3); US (15)