NCT01596712

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 11, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 22, 2012

Status Verified

November 1, 2012

Enrollment Period

1.4 years

First QC Date

March 22, 2012

Last Update Submit

November 20, 2012

Conditions

Allergy

Keywords

Allergy,Asthma,Atopic dermatitis,Japanese,QGE031,IgE

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with Adverse Events

    Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs and other safety assessments.

    Day 113

Secondary Outcomes (4)

  • QGE031 serum concentration

    Pre-dose, 2, 4, 12, 24, 48, and 96 h post-dose, Days 8, 15, 22, 29, 43, 57, 71, 85, 99 and 113

  • Free and total IgE serum concentrations

    Pre-dose, 2, 4, 12, 24, 48, and 96 h post-dose, Days 8, 15, 22, 29, 43, 57, 71, 85, 99 and 113

  • FcεRI expression and IgE binding on basophiles

    Pre-dose, 2, 24, 48, 96 h post-dose; Days 8, 15, 22, 29, 43, 57, 71, 85, 99, and 113

  • Immunogenicity (Anti-QGE031 antibody in serum)

    Pre-dose, Days 29, 57 and 113

Study Arms (4)

QGE031 Dose 1

EXPERIMENTAL

QGE031 Dose 1: subcutaneous injection, single dose

Drug: QGE031

QGE031 Dose 2

EXPERIMENTAL

QGE031 Dose 2: subcutaneous injection, single dose

Drug: QGE031

QGE031 Dose 3

EXPERIMENTAL

QGE031 Dose 3: subcutaneous injection, single dose

Drug: QGE031

Placebo

PLACEBO COMPARATOR

Placebo to QGE031 : subcutaneous injection, single dose

Drug: Placebo

Interventions

QGE031DRUG

QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.

QGE031 Dose 1QGE031 Dose 2QGE031 Dose 3
PlaceboDRUG

Placebo was supplied as liquid in 2 mL vial for subcutaneous injection.

Placebo

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Sagamihara, Kanagawa, 228-8520, Japan

Location

MeSH Terms

Conditions

HypersensitivityAsthmaDermatitis, Atopic

Interventions

ligelizumab

Condition Hierarchy (Ancestors)

Immune System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2012

First Posted

May 11, 2012

Study Start

March 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

November 22, 2012

Record last verified: 2012-11

Locations

JP(1)