Study to Evaluate the Efficacy of Etanercept Treatment in Adults Who Failed Therapy With Apremilast

Amgen80 enrolled

Overview

To evaluate the efficacy of etanercept in adults with moderate to severe plaque psoriasis who have failed therapy with apremilast (Otezla).

This is a multicenter, open-label, single-arm, phase 4, estimation study in adults with plaque psoriasis (PsO) who have failed apremilast. The study will consist of a screening period of up to 45 days, a 24-week treatment period with study visits every 4 weeks, and a 30-day follow-up period for safety. Etanercept dosing will follow the recommended label dosing for adults with plaque psoriasis.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Plaque Psoriasis

Interventions

EtanerceptDRUG

Administered subcutaneously twice weekly for 12 weeks then once weekly for an additional 12 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has provided informed consent prior to initiation of any study specific activities/procedures * Male or female 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 moderate to severe plaque psoriasis (PsO) with involved body surface area (BSA) ≥ 10%, psoriasis area and severity index (PASI) ≥ 10 and static physician's global assessment (sPGA) ≥ 3 at screening and baseline * Subject is currently receiving treatment with apremilast for moderate to severe plaque PsO or subject has discontinued treatment with apremilast for PsO within the past 3 months prior to screening * Subject has failed therapy with apremilast for moderate to severe plaque PsO defined as either (1) failure to achieve adequate clinical response in the opinion of the investigator, (2) loss of adequate clinical response in the opinion of the investigator or (3) intolerability to apremilast in the opinion of the investigator * Subject has received at least 4 weeks of apremilast treatment for moderate to severe plaque PsO (this only applies for subjects who are qualifying by failure to achieve adequate clinical response or loss of adequate clinical response, this does not apply for subjects who are qualifying by intolerability to apremilast) * Subject has not had significant known weight increase or decrease (≥ 10%) during apremilast treatment * Subject is \< 264 lbs at screening and baseline -Subject has a negative test for hepatitis B surface antigen, hepatitis B core antibody and hepatitis C antibody * Subject has no known history of tuberculosis. Exclusion Criteria: Skin disease related -Subject has active erythrodermic, pustular, guttate psoriasis, or medication induced psoriasis, or other skin conditions at the time of the screening visit (for example, eczema) that would interfere with evaluations of the effect of investigational product on PsO. Other Medical Conditions * Subject has one or more significant concurrent medical conditions per investigator judgment, including the following * Poorly controlled diabetes * Chronic kidney disease stage IIIb, IV, or V * Symptomatic heart failure (New York Heart Association class II, III, or IV) * Myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization * Uncontrolled hypertension * Severe chronic pulmonary disease (eg, requiring oxygen therapy) * Multiple sclerosis or any other demyelinating disease * Liver disease * Anemia * Major chronic inflammatory disease or connective tissue disease other than psoriasis and/or psoriatic arthritis (for example, systemic lupus erythematosus with the exception of secondary Sjogren's syndrome) * Subject has 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 investigational product.

Locations (22)

Research Site

Scottsdale, Arizona, United States

Research Site

Beverly Hills, California, United States

Outcomes

Primary Outcomes

Percentage of Participants With a PASI 75 Response at Week 12

A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.

Time frame: Baseline and week 12

Secondary Outcomes

Percentage of Participants With a PASI 75 Response at Each Visit

Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24

Percentage of Participants With a PASI 50 Response at Each Visit

A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.

Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24

Percentage of Participants With a PASI 90 Response at Each Visit

A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.

Data from ClinicalTrials.gov

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Research Site

Fountain Valley, California, United States

Research Site

Newport Beach, California, United States

Research Site

San Ramon, California, United States

Research Site

Santa Monica, California, United States

Research Site

Coral Gables, Florida, United States

Research Site

Jacksonville, Florida, United States

Research Site

Macon, Georgia, United States

Research Site

Louisville, Kentucky, United States

...and 12 more locations

Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24

Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)

The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value \* 100, hence a positive value indicates improvement.

Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24

Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit

The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).

Time frame: Weeks 4, 8, 12, 16, 20, and 24

Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit

The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.

Time frame: Weeks 4, 8, 12, 16, 20, and 24

Static Physician Global Assessment (sPGA) at Each Visit

The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).

Time frame: Weeks 4, 8, 12, 16, 20, and 24

Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline

The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.

Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24

Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline

The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.

Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24

Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit

A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value \* 100, hence a positive value indicates improvement.

Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24

Psoriasis Symptom Inventory (PSI) Total Score at Each Visit

Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). The total score is the sum of the 8 responses, and ranges from 0 to 32. Higher scores indicate more severe psoriasis.