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

NCT01045577 | Completed Phase 2

• 1 other identifier: AB04029
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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

Conditions

Psoriasis

Keywords

Severe Psoriasis; Kinase Inhibitor; Masitinib

Outcome Measures

Primary Outcomes (1)

• Change from baseline in BSA after 12 weeks of treatment

  12 weeks

Secondary Outcomes (3)

• 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

  12 weeks

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

  12 weeks

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

  12 weeks

Study Arms (2)

Masitinib (AB1010)

ACTIVE COMPARATOR

Masitinib (AB1010)

Drug: Masitinib

Placebo mactching masitinib

PLACEBO COMPARATOR

Placebo matching masitinib

Drug: Placebo

Interventions

Masitinib DRUG

6 mg/kg/day

Masitinib (AB1010)

Placebo DRUG

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

Placebo mactching masitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AB Science: lead

MeSH Terms

Conditions

Psoriasis

Interventions

masitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jean-Paul ORTONNE, MD

  CHU NICE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 11, 2010
• Study Start: September 1, 2005
• Primary Completion: January 1, 2006
• Study Completion: February 1, 2008
• Last Updated: December 10, 2018

Record last verified: 2018-12