Clinical trial NCT02749370: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-04-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 criteria: 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.

Primary outcomes:
measure: Percentage of Participants With a PASI 75 Response at Week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Percentage of Participants With a PASI 75 Response at Each Visit
timeFrame: Baseline and weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants With a PASI 50 Response at Each Visit
timeFrame: Baseline and weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants With a PASI 90 Response at Each Visit
timeFrame: Baseline and weeks 4, 8, 12, 16, 20, and 24
measure: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline and weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Static Physician Global Assessment (sPGA) at Each Visit
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
timeFrame: Baseline and weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
timeFrame: Baseline and weeks 4, 8, 12, 16, 20, and 24
measure: Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit
timeFrame: Baseline and weeks 4, 8, 12, 16, 20, and 24
measure: Psoriasis Symptom Inventory (PSI) Total Score at Each Visit
timeFrame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
measure: PSI "Itch From Psoriasis" Component Score at Each Visit
timeFrame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
measure: PSI "Redness of Skin Lesions" Component Score at Each Visit
timeFrame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
measure: PSI "Scaling of Skin Lesions" Component Score at Each Visit
timeFrame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
measure: PSI "Burning of Skin Lesions" Component Score at Each Visit
timeFrame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
measure: PSI "Stinging of Skin Lesions" Component Score at Each Visit
timeFrame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
measure: PSI "Cracking of Skin Lesions" Component Score at Each Visit
timeFrame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
measure: PSI "Flaking of Skin Lesions" Component Score at Each Visit
timeFrame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
measure: PSI "Pain From Skin Lesions" Component Score at Each Visit
timeFrame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
measure: Patient Assessment of Treatment Satisfaction at Week 12
timeFrame: Week 12
measure: Patient Assessment of Treatment Satisfaction at Week 24
timeFrame: Week 24
measure: Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 24
timeFrame: Baseline and weeks 12 and 24
measure: Number of Participants With Adverse Events
timeFrame: From first dose of etanercept to 30 days after last dose, up to 28 weeks.
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Fountain Valley
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: San Ramon
country: United States
facility: Research Site
state: California
city: Santa Monica
country: United States
facility: Research Site
state: California
city: Coral Gables
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Macon
country: United States
facility: Research Site
state: Georgia
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Rockville
country: United States
facility: Research Site
state: Maryland
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Clarkston
country: United States
facility: Research Site
state: Michigan
city: Fort Gratiot
country: United States
facility: Research Site
state: Michigan
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Henderson
country: United States
facility: Research Site
state: Nevada
city: East Windsor
country: United States
facility: Research Site
state: New Jersey
city: Verona
country: United States
facility: Research Site
state: New Jersey
city: New York
country: United States
facility: Research Site
state: New York
city: Greenville
country: United States
facility: Research Site
state: North Carolina
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Bagel J, Samad AS, Stolshek BS, Aras GA, Chung JB, Kricorian G, Kircik LH. Open-Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed Therapy With Apremilast. J Drugs Dermatol. 2018 Oct 1;17(10):1078-1082.
citation: Bagel J, Stolshek BS, Yang Y, Kricorian G, Kircik LH. Evaluation of Patient-Reported Outcomes With Etanercept in Moderate to Severe Plaque Psoriasis Patients After Therapy With Apremilast. J Drugs Dermatol. 2020 Apr 1;19(4):378-383. doi: 10.36849/JDD.2020.4910.