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

Completed · Phase 4

Conditions studied: Plaque Psoriasis

In brief

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

Key facts

Study ID

NCT02749370

Run by

Amgen

People needed

80

Starts

2016-05-18

Expected to finish

2017-12-06

Last updated by the study team

2020-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Scottsdale, Arizona, United States
• Research Site — Beverly Hills, California, United States
• 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
• Research Site — Rockville, Maryland, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Clarkston, Michigan, United States
• Research Site — Fort Gratiot, Michigan, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Henderson, Nevada, United States
• Research Site — East Windsor, New Jersey, United States
• Research Site — Verona, New Jersey, United States
• Research Site — New York, New York, United States
• Research Site — Greenville, North Carolina, United States
• Research Site — Houston, Texas, United States
• Research Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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