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.
Sponsor:
Information provided by:
AB Science
ClinicalTrials.gov Identifier:
NCT01045577
First received: January 8, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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
Psoriasis
Drug: Masitinib
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving an OLS rating of Minimal or Clear after 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percentage change from baseline in PGA and PGPA after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045577

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

No publications provided

Responsible Party: Alain MOUSSY, AB Science
ClinicalTrials.gov Identifier: NCT01045577     History of Changes
Other Study ID Numbers: AB04029
Study First Received: January 8, 2010
Last Updated: January 8, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AB Science:
Severe Psoriasis
Kinase Inhibitor
Masitinib

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 26, 2014