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

Amgen

Status and phase

Completed

Phase 4

Conditions

Plaque Psoriasis

Treatments

Drug: Etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT02749370

20150252

Details and patient eligibility

About

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

Full description

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.