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

NCT00842270 | Completed Phase 2

• 1 other identifier: AB04026
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Asthma

Keywords

severe asthma; corticosteroids dependent; asthma exacerbation; weaning; tyrosine kinase inhibitor; severe persistent corticosteroid dependent asthma

Outcome Measures

Primary Outcomes (1)

• decrease in oral corticosteroid therapy (weaning extent)

  16 weeks

Secondary Outcomes (2)

• asthma control improvement

  16 weeks

• asthma exacerbation rate

  16 weeks

Study Arms (4)

2

EXPERIMENTAL

4,5 mg/kg/day

Drug: AB1010

3

EXPERIMENTAL

6 mg/kg/day

Drug: AB1010

4

PLACEBO COMPARATOR

matching placebo for AB1010 3, 4,5 and 6 mg/kg/day

Drug: placebo

1

EXPERIMENTAL

AB1010 3 mg/kg/day

Drug: AB1010

Interventions

AB1010 DRUG

3 mg/kg/day

Also known as: masitinib

1

placebo DRUG

matching placebo to AB1010 dosages

4

Eligibility Criteria

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

You may qualify if:

• Known severe persistent corticosteroid dependent asthma (WHO/NHLBI workshop definition).
• Disease duration \> 1 year.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AB Science: lead

Related Publications (2)

• Lee-Fowler TM, Guntur V, Dodam J, Cohn LA, DeClue AE, Reinero CR. The tyrosine kinase inhibitor masitinib blunts airway inflammation and improves associated lung mechanics in a feline model of chronic allergic asthma. Int Arch Allergy Immunol. 2012;158(4):369-74. doi: 10.1159/000335122. Epub 2012 Apr 4.

  PMID: 22487554 BACKGROUND

• Humbert M, de Blay F, Garcia G, Prud'homme A, Leroyer C, Magnan A, Tunon-de-Lara JM, Pison C, Aubier M, Charpin D, Vachier I, Purohit A, Gineste P, Bader T, Moussy A, Hermine O, Chanez P. Masitinib, a c-kit/PDGF receptor tyrosine kinase inhibitor, improves disease control in severe corticosteroid-dependent asthmatics. Allergy. 2009 Aug;64(8):1194-201. doi: 10.1111/j.1398-9995.2009.02122.x.

  PMID: 19614621 RESULT

MeSH Terms

Conditions

Asthma

Interventions

masitinib

Condition Hierarchy (Ancestors)

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

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: February 11, 2009
• First Posted: February 12, 2009
• Study Start: January 1, 2006
• Primary Completion: July 1, 2007
• Last Updated: December 11, 2018

Record last verified: 2018-12