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A Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Activity of Oral AB1010 in Adults Patients With Moderate to Severe Chronic Plaque Psoriasis

NCT ID: NCT01045577

Last Updated: 2018-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-02-29

Brief Summary

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A double-blind, placebo-controlled, randomized, parallel-group study to evaluate the activity of oral AB1010 in adults patients with moderate to severe chronic plaque psoriasis

Detailed Description

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To evaluate the activity of oral AB1010, administered at two dose levels during 12 weeks to patients with moderate to severe chronic plaque psoriasis, assessed on :

i)Body Surface Area (BSA), Psoriasis Area and Severity Index (PASI), Overall Lesion Severity (OLS), Physician's Global Assessment (PGA) and Patient's Global Psoriasis Assessment (PGPA) ii)clinical and biological safety parameters iii) pharmacokinetic profile of AB1010

Conditions

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Psoriasis

Keywords

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Severe Psoriasis Kinase Inhibitor Masitinib

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Masitinib (AB1010)

Masitinib (AB1010)

Group Type ACTIVE_COMPARATOR

Masitinib

Intervention Type DRUG

6 mg/kg/day

Masitinib

Intervention Type DRUG

3 mg/kg/day

Placebo mactching masitinib

Placebo matching masitinib

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching masitinib (3 mg/kg/day and 6 mg/kg/day)

Interventions

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Masitinib

6 mg/kg/day

Intervention Type DRUG

Masitinib

3 mg/kg/day

Intervention Type DRUG

Placebo

Placebo matching masitinib (3 mg/kg/day and 6 mg/kg/day)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female outpatients aged 18 to 75 years with chronic plaque psoriasis
* Plaque psoriasis covering ≥ 10% BSA
* Disease duration ≥ 6 months
* PASI ≥ 12.0 at screening

Exclusion Criteria

* Guttate, erythrodermic or pustular psoriasis as sole or predominant form of the disease
* Clinically significant psoriasis flare during screening or at time of enrollment
* Systemic therapy for psoriasis or systemic immunosuppressive therapy for other indications within 28 days prior to enrollment
* Topical treatment for psoriasis within 14 days prior to enrollment
* Use of CYP3A4 moderate and strong inhibitors within 4 weeks prior to randomization
* Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AB Science

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Paul ORTONNE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU NICE

Other Identifiers

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AB04029

Identifier Type: -

Identifier Source: org_study_id