--- title: Study to Evaluate the Efficacy of Etanercept Treatment in Adults Who Failed Therapy With Apremilast nct_id: NCT02749370 overall_status: COMPLETED phase: PHASE4 sponsor: Amgen study_type: INTERVENTIONAL primary_condition: Plaque Psoriasis countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02749370.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02749370" ct_last_update_post_date: 2020-05-13 last_seen_at: "2026-05-12T07:04:55.185Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Study to Evaluate the Efficacy of Etanercept Treatment in Adults Who Failed Therapy With Apremilast **Official Title:** Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed Therapy With Apremilast **NCT ID:** [NCT02749370](https://clinicaltrials.gov/study/NCT02749370) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE4 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 80 - **Lead Sponsor:** Amgen - **Conditions:** Plaque Psoriasis - **Start Date:** 2016-05-18 - **Completion Date:** 2017-12-06 - **CT.gov Last Update:** 2020-05-13 ## Brief Summary To evaluate the efficacy of etanercept in adults with moderate to severe plaque psoriasis who have failed therapy with apremilast (Otezla). ## Detailed 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. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **Etanercept** (EXPERIMENTAL) — Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks. ## Interventions - **Etanercept** (DRUG) — Administered subcutaneously twice weekly for 12 weeks then once weekly for an additional 12 weeks. ## Primary Outcomes - **Percentage of Participants With a PASI 75 Response at Week 12** _(time frame: Baseline and 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. ## 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** _(time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24)_ - **Percentage of Participants With a PASI 90 Response at Each Visit** _(time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24)_ - **Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)** _(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** _(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** _(time frame: Weeks 4, 8, 12, 16, 20, and 24)_ - **Static Physician Global Assessment (sPGA) at Each Visit** _(time frame: Weeks 4, 8, 12, 16, 20, and 24)_ - **Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline** _(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** _(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** _(time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24)_ - **Psoriasis Symptom Inventory (PSI) Total Score at Each Visit** _(time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)_ - **PSI "Itch From Psoriasis" Component Score at Each Visit** _(time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)_ - **PSI "Redness of Skin Lesions" Component Score at Each Visit** _(time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)_ - **PSI "Scaling of Skin Lesions" Component Score at Each Visit** _(time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)_ - **PSI "Burning of Skin Lesions" Component Score at Each Visit** _(time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)_ - **PSI "Stinging of Skin Lesions" Component Score at Each Visit** _(time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)_ - **PSI "Cracking of Skin Lesions" Component Score at Each Visit** _(time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)_ - **PSI "Flaking of Skin Lesions" Component Score at Each Visit** _(time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)_ - **PSI "Pain From Skin Lesions" Component Score at Each Visit** _(time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24)_ - **Patient Assessment of Treatment Satisfaction at Week 12** _(time frame: Week 12)_ - **Patient Assessment of Treatment Satisfaction at Week 24** _(time frame: Week 24)_ - **Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 24** _(time frame: Baseline and weeks 12 and 24)_ - **Number of Participants With Adverse Events** _(time frame: From first dose of etanercept to 30 days after last dose, up to 28 weeks.)_ ## Locations (22) - 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 ## Recent Field Changes (last 30 days) - `locations.research site|louisville|kentucky|united states` — added _(2026-05-12)_ - `locations.research site|rockville|maryland|united states` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `locations.research site|ann arbor|michigan|united states` — added _(2026-05-12)_ - `locations.research site|clarkston|michigan|united states` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - 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`locations.research site|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.research site|henderson|nevada|united states` — added _(2026-05-12)_ - `locations.research site|east windsor|new jersey|united states` — added _(2026-05-12)_ - `locations.research site|verona|new jersey|united states` — added _(2026-05-12)_ - `locations.research site|new york|new york|united states` — added _(2026-05-12)_ - `locations.research site|greenville|north carolina|united states` — added _(2026-05-12)_ - `locations.research site|houston|texas|united states` — added _(2026-05-12)_ - `locations.research site|san antonio|texas|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02749370.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02749370* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*