Study to Assess the Immunogenicity and Safety of Etanercept Produced in Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

A Single-arm Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Subjects With Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274792
• Other study ID #: 20101177
• Status: Completed
• Phase: Phase 4
• First received: October 22, 2014
• Last updated: February 8, 2016
• Start date: January 2015
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn more about the immune response to etanercept in patients with plaque psoriasis.

Description:

This is a multicenter, open-label, single-arm phase 4 study in subjects with PsO who are etanercept-naïve and who are not receiving methotrexate therapy. The study will consist of a screening period of up to 30 days, a 24-week treatment period and a 30-day follow-up period for safety. Etanercept dosing will follow the recommended label dosing for patients with PsO.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 125 Years

Eligibility

Inclusion Criteria:

• Subject is = 18 years of age at time of screening.

• Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator.

• Subject has involved body surface area (BSA) = 10%, static physician global assessment (sPGA) = 3, and Psoriasis Area and Severity Index (PASI) = 10 at screening and at baseline.

• Subject is naïve to etanercept.

• Subject is a candidate for treatment with etanercept in the opinion of the investigator in addition to the caring physician's intent to initiate treatment with etanercept, as applicable.

• Subject is able to self-inject etanercept or have a designee who can do so.

• Subject has not used methotrexate within 4-weeks from the first dose of etanercept.

• Subject has a negative test for hepatitis B surface antigen, hepatitis B core antibody and hepatitis C antibody.

• Subject has no known history of active tuberculosis.

• Subject has a negative test for tuberculosis during screening

• Subject, if female and not at least 2 years postmenopausal or history of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, has a negative serum pregnancy test = 4 weeks from starting etanercept and a negative urine pregnancy test at baseline (day 1).

Exclusion Criteria:

• Subject has active erythrodermic, pustular, guttate psoriasis, or medication induced psoriasis, or other skin conditions at the time of the screening visit (eg,eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.

• Subject has any uncontrolled, clinically significant systemic disease (eg, renal failure, heart failure, hypertension, pulmonary or liver disease, diabetes, anemia).

• Myocardial infarction or unstable angina pectoris within the last year.

• Major chronic inflammatory disease or connective tissue disease other than psoriasis and/or psoriatic arthritis.

• Multiple sclerosis or any other demyelinating disease.

• Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, Merkel cell carcinoma, or history of cancer (other than fully resected and surgically cured cutaneous basal cell and squamous cell carcinoma) within 5 years before the first dose of etanercept. If malignancy occurred more than 5 years ago, documentation of disease-free state since treatment is required.

• Known history of alcoholic hepatitis or immunodeficiency syndromes including Human Immunodeficiency virus infection.

• Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first dose of etanercept.

• Subject has a serious infection, defined as requiring hospitalization or intravenous (IV) anti-infectives within 8 weeks prior to first dose of etanercept.

• Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the subject.

• Subject has any condition that could, in the opinion of the investigator, compromise the subject's ability to give written consent and/or comply with the study procedures, such as a history of substance abuse or a psychiatric condition.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Etanercept
Etanercept 50 mg twice weekly for 12 weeks followed by 50 mg once weekly (for additional 12 weeks). During the first 12 weeks of the study, subjects will receive 2 doses of etanercept per week (eg, on Monday and Thursday). During the second 12 weeks of the study, subjects will receive 1 dose of etanercept per week (scheduled approximately 7 days apart).

Locations

Country	Name	City	State
Canada	Research Site	Barrie	Ontario
Canada	Research Site	Bathurst	New Brunswick
Canada	Research Site	Courtice	Ontario
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Markham	Ontario
Canada	Research Site	Oakville	Ontario
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Sudbury	Ontario
Canada	Research Site	Surrey	British Columbia
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Waterloo	Ontario
United States	Research Site	Andover	Massachusetts
United States	Research Site	Aventura	Florida
United States	Research Site	Bakersfield	California
United States	Research Site	Bellaire	Texas
United States	Research Site	Beverly Hills	California
United States	Research Site	Carmel	Indiana
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clarkston	Michigan
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Denver	Colorado
United States	Research Site	Denver	Colorado
United States	Research Site	Fremont	California
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Johnston	Rhode Island
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Miami	Florida
United States	Research Site	Mobile	Alabama
United States	Research Site	Nashville	Tennessee
United States	Research Site	New Albany	Indiana
United States	Research Site	Norfolk	Virginia
United States	Research Site	Omaha	Nebraska
United States	Research Site	Overland Park	Kansas
United States	Research Site	Overland Park	Kansas
United States	Research Site	Owensboro	Kentucky
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Rockville	Maryland
United States	Research Site	San Antonio	Texas
United States	Research Site	San Antonio	Texas
United States	Research Site	Verona	New Jersey
United States	Research Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-etanercept binding antibody	Positive anti-etanercept binding antibody response	At any time through Week 24	No
Secondary	Positive anti-etanercept binding antibody response	Positive anti-etanercept binding antibody response.	At Week 24	No
Secondary	Positive anti-etanercept binding antibody response	Positive anti-etanercept binding antibody response	At Week 12	No
Secondary	Positive neutralizing antibody response	Positive neutralizing antibody response in subjects with positive anti-etanercept binding antibody response.	At weeks 12 and 24	No

External Links

•   AmgenTrials clinical trials website