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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

This study has been completed.
Information provided by:
AB Science Identifier:
First received: January 8, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
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

Condition Intervention Phase
Drug: Masitinib
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AB Science:

Primary Outcome Measures:
  • Change from baseline in BSA after 12 weeks of treatment [ Time Frame: 12 weeks ]

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 [ Time Frame: 12 weeks ]
  • Proportion of patients achieving an OLS rating of Minimal or Clear after 12 weeks [ Time Frame: 12 weeks ]
  • Percentage change from baseline in PGA and PGPA after 12 weeks of treatment [ Time Frame: 12 weeks ]

Enrollment: 25
Study Start Date: September 2005
Study Completion Date: February 2008
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Masitinib (AB1010)
Masitinib (AB1010)
Drug: Masitinib
6 mg/kg/day
Drug: Masitinib
3 mg/kg/day
Placebo Comparator: Placebo mactching masitinib
Placebo matching masitinib
Drug: Placebo
Placebo matching masitinib (3 mg/kg/day and 6 mg/kg/day)

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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01045577

Sponsors and Collaborators
AB Science
Principal Investigator: Jean-Paul ORTONNE, MD CHU Nice
  More Information

Responsible Party: Alain MOUSSY, AB Science Identifier: NCT01045577     History of Changes
Other Study ID Numbers: AB04029
Study First Received: January 8, 2010
Last Updated: January 8, 2010

Keywords provided by AB Science:
Severe Psoriasis
Kinase Inhibitor

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases processed this record on May 25, 2017