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

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ClinicalTrials.gov Identifier: NCT02749370
Recruitment Status : Completed
First Posted : April 25, 2016
Results First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

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

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Etanercept Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 18, 2016
Actual Primary Completion Date : August 14, 2017
Actual Study Completion Date : December 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Etanercept
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
Drug: Etanercept
Administered subcutaneously twice weekly for 12 weeks then once weekly for an additional 12 weeks.
Other Name: Enbrel




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Percentage of Participants With a PASI 75 Response at Each Visit [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
    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.

  2. Percentage of Participants With a PASI 50 Response at Each Visit [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
    A PASI 50 response is a 50% 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.

  3. Percentage of Participants With a PASI 90 Response at Each Visit [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]
    A PASI 90 response is a 90% 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.

  4. Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20, and 24 ]

    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.

    Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.


  5. 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 ]
    The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).

  6. 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 ]
    The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.

  7. Static Physician Global Assessment (sPGA) at Each Visit [ Time Frame: Weeks 4, 8, 12, 16, 20, and 24 ]
    The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).

  8. 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 ]
    The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.

  9. 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 ]
    The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.

  10. 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 ]
    A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.

  11. Psoriasis Symptom Inventory (PSI) Total Score at Each Visit [ Time Frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 ]
    Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). The total score is the sum of the 8 responses, and ranges from 0 to 32. Higher scores indicate more severe psoriasis.

  12. PSI "Itch From Psoriasis" Component Score at Each Visit [ Time Frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 ]
    Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).

  13. PSI "Redness of Skin Lesions" Component Score at Each Visit [ Time Frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 ]
    Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).

  14. PSI "Scaling of Skin Lesions" Component Score at Each Visit [ Time Frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 ]
    Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).

  15. PSI "Burning of Skin Lesions" Component Score at Each Visit [ Time Frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 ]
    Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).

  16. PSI "Stinging of Skin Lesions" Component Score at Each Visit [ Time Frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 ]
    Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).

  17. PSI "Cracking of Skin Lesions" Component Score at Each Visit [ Time Frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 ]
    Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).

  18. PSI "Flaking of Skin Lesions" Component Score at Each Visit [ Time Frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 ]
    Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).

  19. PSI "Pain From Skin Lesions" Component Score at Each Visit [ Time Frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 ]
    Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).

  20. Patient Assessment of Treatment Satisfaction at Week 12 [ Time Frame: Week 12 ]
    Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied".

  21. Patient Assessment of Treatment Satisfaction at Week 24 [ Time Frame: Week 24 ]
    Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied".

  22. 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 ]
    The dermatology life quality index (DLQI) is a skin disease-specific instrument to evaluate health-related quality of life. The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answered 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is from 0 (best possible score) to 30 (worst possible score). Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.

  23. Number of Participants With Adverse Events [ Time Frame: From first dose of etanercept to 30 days after last dose, up to 28 weeks. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749370


Locations
United States, Arizona
Research Site
Scottsdale, Arizona, United States, 85254
United States, California
Research Site
Beverly Hills, California, United States, 90211
Research Site
Fountain Valley, California, United States, 92708
Research Site
Newport Beach, California, United States, 92663
Research Site
San Ramon, California, United States, 94583
Research Site
Santa Monica, California, United States, 90404
United States, Florida
Research Site
Coral Gables, Florida, United States, 33134
Research Site
Jacksonville, Florida, United States, 32204
United States, Georgia
Research Site
Macon, Georgia, United States, 31217
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40217
United States, Maryland
Research Site
Rockville, Maryland, United States, 20850
United States, Michigan
Research Site
Ann Arbor, Michigan, United States, 48103
Research Site
Clarkston, Michigan, United States, 48346
Research Site
Fort Gratiot, Michigan, United States, 48059
United States, Missouri
Research Site
Saint Louis, Missouri, United States, 63117
United States, Nevada
Research Site
Henderson, Nevada, United States, 89052
United States, New Jersey
Research Site
East Windsor, New Jersey, United States, 08520
Research Site
Verona, New Jersey, United States, 07044
United States, New York
Research Site
New York, New York, United States, 10075
United States, North Carolina
Research Site
Greenville, North Carolina, United States, 27834
United States, Texas
Research Site
Houston, Texas, United States, 77082
Research Site
San Antonio, Texas, United States, 78218
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] February 5, 2016
Statistical Analysis Plan  [PDF] April 11, 2016


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02749370     History of Changes
Other Study ID Numbers: 20150252
First Posted: April 25, 2016    Key Record Dates
Results First Posted: August 27, 2018
Last Update Posted: August 27, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors