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Completed

NCT Number: NCT01045577

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

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Masitinib

Drug

6 mg/kg/day

Placebo

Drug

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

Primary outcomes

  1. Change from baseline in BSA after 12 weeks of treatment

    Time frame: 12 weeks

Secondary outcomes

  1. 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

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

    Time frame: 12 weeks

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

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

AB Science

Industry

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2008
First posted
Jan 11, 2010
Registry last updated
Dec 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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