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Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT01970488
Recruitment Status : Completed
First Posted : October 28, 2013
Results First Posted : December 13, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with plaque psoriasis.

Condition or disease Intervention/treatment Phase
Psoriasis Biological: Adalimumab Biological: ABP 501 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 501 Compared With Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
Actual Study Start Date : October 18, 2013
Actual Primary Completion Date : August 14, 2014
Actual Study Completion Date : March 18, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: ABP 501

Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16.

Participants with a PASI 50 response at week 16 continued to receive 40 mg APB 501 until week 48.

Biological: ABP 501
Administered by subcutaneous injection
Other Names:
  • Adalimumab-atto
  • AMJEVITA™

Active Comparator: Adalimumab

Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16.

At week 16 participants with a PASI 50 response were re-randomized to treatment with adalimumab or were transitioned to ABP 501 until week 48.

Biological: Adalimumab
Administered by subcutaneous injection
Other Name: HUMIRA®




Primary Outcome Measures :
  1. Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 [ Time Frame: Baseline and Week 16 ]

    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 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

    Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).



Secondary Outcome Measures :
  1. Percentage of Participants With a PASI 75 Response at Week 16 [ Time Frame: Baseline and Week 16 ]
    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 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

  2. Percentage of Participants With a PASI 75 Response at Week 32 [ Time Frame: Baseline and week 32 ]

    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 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.


  3. Percentage of Participants With a PASI 75 Response at Week 50 [ Time Frame: Baseline and week 50 ]

    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 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.


  4. Percent Improvement From Baseline in PASI at Week 32 [ Time Frame: Baseline and week 32 ]

    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 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

    Percent improvement from baseline is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).


  5. Percent Improvement From Baseline in PASI at Week 50 [ Time Frame: Baseline and week 50 ]

    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 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.

    Percent improvement from baseline is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).


  6. Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 16 [ Time Frame: Week 16 ]
    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).

  7. Percentage of Participants With a sPGA Response at Week 32 [ Time Frame: Week 32 ]
    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).

  8. Percentage of Participants With a sPGA Response at Week 50 [ Time Frame: Week 50 ]
    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).

  9. Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16 [ Time Frame: Baseline and Week 16 ]

    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 subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.

    Change from baseline is calculated as (value at post-baseline visit - value at baseline).

    A decrease from baseline (negative value) indicates improvement.


  10. Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32 [ Time Frame: Baseline and week 32 ]

    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 subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.

    Change from baseline is calculated as (value at post-baseline visit - value at baseline).

    A decrease from Baseline (negative value) indicates improvement.


  11. Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50 [ Time Frame: Baseline and week 50 ]

    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 subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.

    Change from baseline is calculated as (value at post-baseline visit - value at baseline).

    A decrease from Baseline (negative value) indicates improvement.


  12. Number of Participants With Adverse Events [ Time Frame: From first dose of study drug until 28 days after the last dose. Treatment was for 16 weeks in Part 1 and 32 weeks in Part 2. ]

    The Investigator assessed whether each adverse event (AE) was possibly related to the investigational product. AEs were graded for severity according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03.

    A serious AE is defined as an AE that meets at least 1 of the following serious criteria:

    • fatal
    • life threatening
    • requires inpatient hospitalization or prolongation of existing hospitalization
    • results in persistent or significant disability/incapacity
    • congenital anomaly/birth defect
    • other medically important serious event. Results are reported from Day 1 to week 16 for the Part 1 ABP 501 and Adalimumab groups, and from post week 16 to the end of study (week 52) for the Part 2 ABP 501/ABP 501, Adalimumab/Adalimumab and Adalimumab/ABP 501 groups.

  13. Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab [ Time Frame: For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2. ]

    Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay).

    Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Men or women ≥ 18 and ≤ 75 years of age at time of screening
  2. Stable moderate to severe plaque psoriasis for at least 6 months before baseline
  3. Moderate to severe psoriasis defined at screening and baseline by:

    Body surface area (BSA) affected by plaque psoriasis of 10% or greater, and PASI score of 12 or greater, and static physician's global assessment score of 3 or greater

  4. No known history of active tuberculosis
  5. Subject is a candidate for systemic therapy or phototherapy procedures
  6. Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy

Exclusion Criteria:

  1. Forms of psoriasis or other skin conditions at the time of the screening visit (eg, eczema)
  2. Ongoing use of prohibited treatments
  3. Prior use of 2 or more biologics for treatment of psoriasis
  4. Previous receipt of adalimumab or a biosimilar of adalimumab

Other Inclusion/Exclusion criteria may apply


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): NCT01970488


Locations
Australia, New South Wales
Research Site
Saint Leonards, New South Wales, Australia, 2065
Canada, Newfoundland and Labrador
Research Site
St. John's, Newfoundland and Labrador, Canada, A1A 5E8
Hungary
Research Site
Nyíregyháza, Szabolcs-szatmar-bereg, Hungary, 4400
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01970488     History of Changes
Other Study ID Numbers: 20120263
2013-000537-12 ( EudraCT Number )
First Posted: October 28, 2013    Key Record Dates
Results First Posted: December 13, 2016
Last Update Posted: August 31, 2018
Last Verified: August 2018

Keywords provided by Amgen:
Plaque Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents