Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma

NCT02336425 | Terminated Phase 2 Results DMC

• 2 other identifiers: CQGE031B22042014-003155-57
• Study Type: interventional
• Target: 10
• Locations: 10 countries
• Sites: 37

Brief Summary

This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations

  Week 52

Secondary Outcomes (10)

• QGE031 Compared to Placebo in All Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations

  Week 52

• QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations

  Week 52

• QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on the Reduction in Rate of Asthma Exacerbations (by Severity)

  Week 52

• QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Time to First Asthma Exacerbations (by Severity)

  Week 52

• QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Questionnaire (ACQ)

  Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)

Study Arms (4)

QGE031 240 mg

EXPERIMENTAL

QGE031 240 mg subcutaneous injection every 4 weeks

Drug: QGE031

QGE031 72 mg

EXPERIMENTAL

QGE031 72 mg subcutaneous injection every 4 weeks

Drug: QGE031

QGE031 24 mg

EXPERIMENTAL

QGE031 24 mg subcutaneous injection every 4 weeks

Drug: QGE031

Placebo to QGE031

PLACEBO COMPARATOR

Placebo subcutaneous injection every 4 weeks

Drug: Placebo

Interventions

QGE031 DRUG

QGE031 120 mg per 1 mL liquid in vial

QGE031 24 mg; QGE031 240 mg; QGE031 72 mg

Placebo DRUG

Placebo to QGE031 0 mg per 1 mL liquid in vial

Placebo to QGE031

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of allergic asthma, uncontrolled on current medication.
• History of at least 2 asthma exacerbations during the last 1 year
• Forced Expiratory Volume in one second (FEV1) of ≥ 40% and ≤ 80% of the predicted normal value; reversibility following administration of bronchodilator.

You may not qualify if:

• Use of tobacco products within the previous 6 months (Social occasional smokers may be included).
• Recent asthma attack/exacerbation or asthma worsening/ respiratory infection.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (37)

Novartis Investigative Site

Birmingham, Alabama, 35209, United States

Location

Novartis Investigative Site

Kingwood, Texas, 77339, United States

Location

Novartis Investigative Site

Plano, Texas, 75093, United States

Location

Novartis Investigative Site

Erpent, 5100, Belgium

Location

Novartis Investigative Site

Toronto, Ontario, M5T 3A9, Canada

Location

Novartis Investigative Site

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

Novartis Investigative Site

Le Kremlin-Bicêtre, 94275, France

Location

Novartis Investigative Site

Cottbus, Saxony, 03050, Germany

Location

Novartis Investigative Site

Berlin, 12099, Germany

Location

Novartis Investigative Site

Frankfurt, 60596, Germany

Location

Novartis Investigative Site

Hamburg, 20354, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Marburg, 35037, Germany

Location

Novartis Investigative Site

Münster, 48145, Germany

Location

Novartis Investigative Site

Miskolc, HUN, 3529, Hungary

Location

Novartis Investigative Site

Balassagyarmat, 2660, Hungary

Location

Novartis Investigative Site

Pisa, PI, 56124, Italy

Location

Novartis Investigative Site

Sapporo, Hokkaido, 064-0804, Japan

Location

Novartis Investigative Site

Sakaidechō, Kagawa-ken, 762-8550, Japan

Location

Novartis Investigative Site

Sagamihara, Kanagawa, 228-8522, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 232-0024, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 234-8503, Japan

Location

Novartis Investigative Site

Habikino, Osaka, 583-8588, Japan

Location

Novartis Investigative Site

Kishiwada, Osaka, 596-8501, Japan

Location

Novartis Investigative Site

Chuo-ku, Tokyo, 103-0027, Japan

Location

Novartis Investigative Site

Edogawa-ku, Tokyo, 134-0083, Japan

Location

Novartis Investigative Site

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Novartis Investigative Site

Ōta-ku, Tokyo, 140-0063, Japan

Location

Novartis Investigative Site

Ōta-ku, Tokyo, 143-0023, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 142-8666, Japan

Location

Novartis Investigative Site

Toshima-ku, Tokyo, 171-0014, Japan

Location

Novartis Investigative Site

Harderwijk, 3840 AC, Netherlands

Location

Novartis Investigative Site

Leiden, 2333 ZA, Netherlands

Location

Novartis Investigative Site

Bojnice, Slovak Republic, 972 01, Slovakia

Location

Novartis Investigative Site

Liptovský Hrádok, Slovak Republic, 033 01, Slovakia

Location

Novartis Investigative Site

Nitra, Slovak Republic, 949 01, Slovakia

Location

Novartis Investigative Site

Zvolen, 960 01, Slovakia

Location

MeSH Terms

Conditions

Asthma

Interventions

ligelizumab

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study was terminated due to the efficacy results from the Phase II study CQGE031B2201 (NCT01716754). Data analyses were not performed due to the very limited dataset (only 10 participants received study medication of the 440 participants planned).

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 13, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 11, 2017
• Results First Posted: April 7, 2017

Record last verified: 2017-08

Locations

CA (2); DE (7); IT (1); BE (1); NL (2); HU (2); FR (1); US (3); SL (4); JP (14)