Study to Evaluate the Efficacy of Etanercept Treatment in Adults Who Failed Therapy With Apremilast
Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed Therapy With Apremilast
1 other identifier
interventional
80
1 country
22
Brief Summary
To evaluate the efficacy of etanercept in adults with moderate to severe plaque psoriasis who have failed therapy with apremilast (Otezla).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2016
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2016
CompletedFirst Posted
Study publicly available on registry
April 25, 2016
CompletedStudy Start
First participant enrolled
May 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2017
CompletedResults Posted
Study results publicly available
August 27, 2018
CompletedMay 13, 2020
May 1, 2020
1.2 years
March 14, 2016
July 24, 2018
May 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline and week 12
Secondary Outcomes (23)
Percentage of Participants With a PASI 75 Response at Each Visit
Baseline and weeks 4, 8, 12, 16, 20, and 24
Percentage of Participants With a PASI 50 Response at Each Visit
Baseline and weeks 4, 8, 12, 16, 20, and 24
Percentage of Participants With a PASI 90 Response at Each Visit
Baseline and weeks 4, 8, 12, 16, 20, and 24
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
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
Weeks 4, 8, 12, 16, 20, and 24
- +18 more secondary outcomes
Study Arms (1)
Etanercept
EXPERIMENTALParticipants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
Interventions
Administered subcutaneously twice weekly for 12 weeks then once weekly for an additional 12 weeks.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (22)
Research Site
Scottsdale, Arizona, 85254, United States
Research Site
Beverly Hills, California, 90211, United States
Research Site
Fountain Valley, California, 92708, United States
Research Site
Newport Beach, California, 92663, United States
Research Site
San Ramon, California, 94583, United States
Research Site
Santa Monica, California, 90404, United States
Research Site
Coral Gables, Florida, 33134, United States
Research Site
Jacksonville, Florida, 32204, United States
Research Site
Macon, Georgia, 31217, United States
Research Site
Louisville, Kentucky, 40217, United States
Research Site
Rockville, Maryland, 20850, United States
Research Site
Ann Arbor, Michigan, 48103, United States
Research Site
Clarkston, Michigan, 48346, United States
Research Site
Fort Gratiot, Michigan, 48059, United States
Research Site
St Louis, Missouri, 63117, United States
Research Site
Henderson, Nevada, 89052, United States
Research Site
East Windsor, New Jersey, 08520, United States
Research Site
Verona, New Jersey, 07044, United States
Research Site
New York, New York, 10075, United States
Research Site
Greenville, North Carolina, 27834, United States
Research Site
Houston, Texas, 77082, United States
Research Site
San Antonio, Texas, 78218, United States
Related Publications (2)
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.
PMID: 30365588BACKGROUNDBagel 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.
PMID: 32272514BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2016
First Posted
April 25, 2016
Study Start
May 18, 2016
Primary Completion
August 14, 2017
Study Completion
December 6, 2017
Last Updated
May 13, 2020
Results First Posted
August 27, 2018
Record last verified: 2020-05