Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of QGE031 in Japanese Atopic Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01596712
First received: March 22, 2012
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of QGE031 in Japanese atopic male subjects in order to determine the eligibility of Japanese patients in subsequent clinical studies.


Condition Intervention Phase
Allergy
Drug: QGE031
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Following Subcutaneous Injections of QGE031 in Japanese Atopic Male Subjects

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of Patients with Adverse Events [ Time Frame: Day 113 ] [ Designated as safety issue: Yes ]
    Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs and other safety assessments.


Secondary Outcome Measures:
  • QGE031 serum concentration [ Time Frame: Pre-dose, 2, 4, 12, 24, 48, and 96 h post-dose, Days 8, 15, 22, 29, 43, 57, 71, 85, 99 and 113 ] [ Designated as safety issue: No ]
    Blood will be collected for the determination of serum QGE031 concentrations. Cmax, Tmax, Area Under the curve (AUC), terminal half-life of serum QGE031. These parameters will be determined using non-compartmental methods.

  • Free and total IgE serum concentrations [ Time Frame: Pre-dose, 2, 4, 12, 24, 48, and 96 h post-dose, Days 8, 15, 22, 29, 43, 57, 71, 85, 99 and 113 ] [ Designated as safety issue: No ]
    Blood will be collected to measure serum IgE concentrations. Cmin, Tmin, and percent decrease of free IgE serum concentration will be determined. Cmax, Tmax, and percent increase of total IgE serum concentration will be determined.

  • FcεRI expression and IgE binding on basophiles [ Time Frame: Pre-dose, 2, 24, 48, 96 h post-dose; Days 8, 15, 22, 29, 43, 57, 71, 85, 99, and 113 ] [ Designated as safety issue: No ]
    Blood will be collected to measure FcεRI expression and IgE binding on basophiles. Lots of individual values and mean values over time will be provided.

  • Immunogenicity (Anti-QGE031 antibody in serum) [ Time Frame: Pre-dose, Days 29, 57 and 113 ] [ Designated as safety issue: Yes ]
    Blood will be collected to measure Immunogenicity. The number and percentage of subjects producing anti-QGE031 antibody will be presented.


Enrollment: 209
Study Start Date: March 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QGE031 Dose 1
QGE031 Dose 1: subcutaneous injection, single dose
Drug: QGE031
QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.
Experimental: QGE031 Dose 2
QGE031 Dose 2: subcutaneous injection, single dose
Drug: QGE031
QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.
Experimental: QGE031 Dose 3
QGE031 Dose 3: subcutaneous injection, single dose
Drug: QGE031
QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.
Placebo Comparator: Placebo
Placebo to QGE031 : subcutaneous injection, single dose
Drug: Placebo
Placebo was supplied as liquid in 2 mL vial for subcutaneous injection.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male Japanese subjects who are atopic as determined by an in vitro test (CAP-RAST or MAST test)
  • Serum IgE level must be equal to or greater than 30 IU/mL at screening.

Exclusion Criteria:

  • Poorly controlled asthma i.e. symptoms of asthma (daytime or night-time) or use of short-acting beta agonist for relief of asthma (except with exercise) more than once a week
  • Worsening of asthma signs and symptoms prompting a medical intervention within 1 year prior to dosing
  • Severe atopic dermatitis within 1 year prior to dosing, defined by a history of eruption with severe inflammation such as erythema, papule, erosion, infiltration and lichen
  • Severe allergic rhinitis strongly disturbing daily life within 1 year prior to dosing
  • Severe allergic conjunctivitis (e.g., episodes of giant papillary, limbal proliferation, shield ulcer) within 1 year prior to dosing
  • Prior use of Xolair® or other anti-IgE antibodies
  • Concomitant use of allergy vaccination therapy

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596712

Locations
Japan
Novartis Investigative Site
Sagamihara, Kanagawa, Japan, 228-8520
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01596712     History of Changes
Other Study ID Numbers: CQGE031A1101
Study First Received: March 22, 2012
Last Updated: November 20, 2012
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
Allergy,
Asthma,
Atopic dermatitis,
Japanese,
QGE031,
IgE

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014