A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis

NCT00885196 | Completed Phase 2

• 2 other identifiers: CAEB071C2201EUDRACT number: 2007-007160-19
• Study Type: interventional
• Target: 336
• Locations: 9 countries
• Sites: 40

Brief Summary

This study is designed to provide efficacy and safety data of several doses of AEB071 so that the optimal dose and treatment duration can be chosen for testing in later studies in patients with plaque psoriasis (with a disease severity such that systemic treatment is justified). The treatment free Follow-up Period is designed to provide additional safety data and information on disease recurrence after the last dose of the study drug.

Conditions

Moderate and Severe Plaque Psoriasis

Keywords

Psoriasis; plaque psoriasis; inflammatory skin disease; scaly patches; AEB071

Outcome Measures

Primary Outcomes (1)

• Change from baseline in plaque psoriasis as assessed by PASI response or PASI 75 (a patient that has an improvement from baseline PASI of at least 75%)

  to 12 weeks treatment

Secondary Outcomes (3)

• ECG and laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs

  up to 12 weeks treatment

• change in PASI and Investigator's Global Assessment (IGA) of psoriasis in patients receiving AEB071 compared with placebo

  up to 12 weeks treatment

• disease recurrence (PASI, IGA) and the effect of treatment withdrawal (including AEs) in the treatment-free Follow-up Period

  in the treatment-free Follow-up Period

Study Arms (4)

AEB071 200 mg BID

EXPERIMENTAL

Drug: AEB071

AEB071 400 mg OD

EXPERIMENTAL

Drug: AEB071

AEB071 300 mg BID

EXPERIMENTAL

Drug: AEB071

Placebo BID

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Placebo BID

AEB071 DRUG

AEB071 200 mg BID; AEB071 300 mg BID; AEB071 400 mg OD

Eligibility Criteria

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

You may qualify if:

• Moderate and Severe Plaque psoriasis diagnosed for at least 12 months (with or without psoriatic arthritis as comorbidity)that requires systemic therapy
• Severity of disease meeting all of the following three criteria:
• PASI score of 10 or greater
• Total Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater
• Investigator's Global Assessment (IGA) score of 3 or greater

You may not qualify if:

• Hematological abnormalities
• Heart rate \< 50 or \> 90 bpm when resting for 5 minutes
• Family history of long QT syndrome
• History of tachyarrhythmia
• History of conduction abnormality i.e., PR \> 200 msec, 2nd or 3rd degree AV block, complete left or right branch bundle block, pre-excitation syndrome
• Uncontrolled or unstable angina pectoris; history of myocardial infarction within the previous 12 months
• Known history of congestive heart failure
• History of percutaneous coronary intervention (PCI) or cardiac ablation
• History of stroke or transient ischemic attack (TIA)
• Implanted cardiac pacemaker or defibrillator
• History of malignancy of any organ system
• Current guttate, generalized erythrodermic, or pustular psoriasis
• Current drug associated psoriasis

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (40)

Burke Pharmaceutical Research

Hot Springs, Arizona, 71913, United States

Location

Belleair Research Center, LLC

Pinellas Park, Florida, 33781, United States

Location

Kansas City Dermatology, PA

Overland Park, Kansas, 66215, United States

Location

Dermatology Specialists

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Central Dermatology

St Louis, Missouri, 63117, United States

Location

Palmetto Clinical Trial Services

Greenville, South Carolina, 29607, United States

Location

Center for Clinical Studies

Houston, Texas, 77030, United States

Location

Suzanne Bruce & Associates, PA

Houston, Texas, 77056, United States

Location

Virginia Clinical Research

Norfolk, Virginia, 23507, United States

Location

Novartis Investigative site

Buenos Aires, Argentina

Location

Novartis Investigative site

Mendoza, Argentina

Location

Novartis Investigative site

Benowa, Australia

Location

Novartis Investigative site

Carlton, Australia

Location

Novartis Investigative site

Kogarah, Australia

Location

Novartis Investigative site

Parkville, Australia

Location

Novartis Investigative site

Brussels, Belgium

Location

Novartis Investigative site

Edegem, Belgium

Location

Novartis Investigative site

Liège, Belgium

Location

Novartis Investigative site

Berlin, Germany

Location

Novartis Investigative site

Bonn, Germany

Location

Novartis Investigative site

Erlangen, Germany

Location

Novartis Investigative site

Frankfurt, Germany

Location

Novartis Investigative site

Hamburg, Germany

Location

Novartis Investigative site

Kiel, Germany

Location

Novartis Investigative site

Leipzig, Germany

Location

Novartis Investigative site

Regensburg, Germany

Location

Novartis Investigative Site

Guatemala City, Guatemala

Location

Novartis Investigative site

Milan, Italy

Location

Novartis Investigative Site

Modena, Italy

Location

Novartis Investigative Site

Rome, Italy

Location

Novartis Investigative Site

Siena, Italy

Location

Novartis Investigative Site

Verona, Italy

Location

Novartis Investigative Site

Ankara, Turkey (Türkiye)

Location

Novartis Investigative Site

Gaziantep, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, Turkey (Türkiye)

Location

Novartis Investigative Site

Manisa, Turkey (Türkiye)

Location

Novartis Investigative site

Nuneaton, United Kingdom

Location

Novartis Investigative site

Salford, United Kingdom

Location

Novartis Investigative site

Southampton, United Kingdom

Location

Related Links

• Results for CAEB071C2201 from the Novartis Clinical Trials Results Website

MeSH Terms

Conditions

Lymphoma, Follicular; Psoriasis; Dermatitis

Interventions

sotrastaurin

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 21, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2011
• Last Updated: December 22, 2020

Record last verified: 2016-04

Locations

BE (3); AU (4); AR (2); IT (5); GB (3); GU (1); US (10); TU (4); DE (8)