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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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Masitinib

Placebo

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Severe Psoriasis, Kinase Inhibitor, Masitinib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Masitinib (AB1010)

Placebo mactching masitinib

Arm Description

Masitinib (AB1010)

Placebo matching masitinib

Outcomes

Primary Outcome Measures

Change from baseline in BSA after 12 weeks of treatment

Secondary Outcome Measures

Percentage change from baseline in PASI score, proportion of patients reaching a 90%, 75% or 50% improvement in PASI score after 12 weeks of treatment; time to and duration of first occurrence in PASI 50, 75 and 90

Proportion of patients achieving an OLS rating of Minimal or Clear after 12 weeks

Percentage change from baseline in PGA and PGPA after 12 weeks of treatment

Full Information

NCT ID

NCT01045577

First Posted

January 8, 2010

Last Updated

December 6, 2018

Sponsor

AB Science

1. Study Identification

Unique Protocol Identification Number

NCT01045577

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

January 2006 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AB Science

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Severe Psoriasis, Kinase Inhibitor, Masitinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Masitinib (AB1010)

Arm Type

Active Comparator

Arm Description

Masitinib (AB1010)

Arm Title

Placebo mactching masitinib

Arm Type

Placebo Comparator

Arm Description

Placebo matching masitinib

Intervention Type

Drug

Intervention Name(s)

Masitinib

Intervention Description

6 mg/kg/day

Intervention Type

Drug

Intervention Name(s)

Masitinib

Intervention Description

3 mg/kg/day

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in BSA after 12 weeks of treatment

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Time Frame

12 weeks

Title

Proportion of patients achieving an OLS rating of Minimal or Clear after 12 weeks

Time Frame

12 weeks

Title

Percentage change from baseline in PGA and PGPA after 12 weeks of treatment

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Paul ORTONNE, MD

Organizational Affiliation

CHU Nice

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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