Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma

December 8, 2018 updated by: AB Science

A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma

The aim of the study is to evaluate, comparatively to a placebo, the activity of oral AB1010, administered at three dose levels during 4 months to patients with severe persistent corticosteroid dependent asthma, assessed on :

  • the decrease in corticosteroid therapy
  • the asthma control improvement (symptomatic scores, rescue medication intake, respiratory function)
  • the pharmacokinetic profile of AB1010
  • clinical and biological safety parameters

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind, placebo-controlled, randomized, parallel-groups, multicenter study of daily oral AB1010 at doses 3, 4.5 and 6 mg/kg/day.

The study treatment is administered for 16 weeks:

  • the first 4 weeks are a run-in period during which corticosteroids remain stable;
  • during the following 8 weeks, corticosteroids are decreased every week until weaning or an exacerbation occurs;
  • the last 4 weeks are a stabilization period. Patients have to perform a visit every 2 weeks during run-in, then every week for the following 3 months.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Known severe persistent corticosteroid dependent asthma (WHO/NHLBI workshop definition).
  • Disease duration > 1 year.
  • Stable disease with no exacerbation episode for at least one month before inclusion.
  • Daily treated with 10 to 50 mg of equivalent prednisolone, with stable dosage since at least 3 months.
  • Known reversibility of bronchial obstruction, defined as an enhancement of FEV1 ≥ 12%, 10 minutes after salbutamol administration, or 14 days after systemic treatment with 1 mg/kg/day of equivalent prednisolone.

Exclusion Criteria:

  • Asthmatic patients still exposed to allergens or to triggering factors influencing asthma control.
  • History of infection requiring hospitalization or treatment with antibiotics within 2 weeks of screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
4,5 mg/kg/day
Drug: AB1010
3 mg/kg/day
Other Names:
  • masitinib
Drug: AB1010
4,5 mg/kg/day
Other Names:
  • masitinib
Drug: AB1010
6 mg/kg/day
Other Names:
  • masitinib
Experimental: 3
6 mg/kg/day
Drug: AB1010
3 mg/kg/day
Other Names:
  • masitinib
Drug: AB1010
4,5 mg/kg/day
Other Names:
  • masitinib
Drug: AB1010
6 mg/kg/day
Other Names:
  • masitinib
Placebo Comparator: 4
matching placebo for AB1010 3, 4,5 and 6 mg/kg/day
Drug: placebo
matching placebo to AB1010 dosages
Experimental: 1
AB1010 3 mg/kg/day
Drug: AB1010
3 mg/kg/day
Other Names:
  • masitinib
Drug: AB1010
4,5 mg/kg/day
Other Names:
  • masitinib
Drug: AB1010
6 mg/kg/day
Other Names:
  • masitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
decrease in oral corticosteroid therapy (weaning extent)
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
asthma control improvement
Time Frame: 16 weeks
16 weeks
asthma exacerbation rate
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AB Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 11, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 8, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB04026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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