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Trial record 3 of 688 for:    ABP 501

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 : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE October 23, 2013
First Posted Date  ICMJE October 28, 2013
Results First Submitted Date  ICMJE October 20, 2016
Results First Posted Date  ICMJE December 13, 2016
Last Update Posted Date April 3, 2019
Actual Study Start Date  ICMJE October 18, 2013
Actual Primary Completion Date August 14, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2016)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2013)
The primary efficacy endpoint is the Psoriasis Area and Severity Index (PASI) percent improvement after 16 weeks of treatment. [ Time Frame: Week 16 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2016)
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2013)
  • PASI 75 response [ Time Frame: Week 50 ]
    75% or greater improvement in PASI score
  • PASI percent improvement [ Time Frame: Week 50 ]
  • Static Physician's Global Assessment (sPGA) responses (with 0 or 1 being a positive result) [ Time Frame: Week 50 ]
  • Body Surface Area (BSA) involvement [ Time Frame: Week 50 ]
  • Subject incidence of adverse events and serious adverse events [ Time Frame: Week 52 ]
  • Clinically significant changes in laboratory values and vital signs [ Time Frame: Week 52 ]
  • Incidence of anti-drug antibodies [ Time Frame: Week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Biological: Adalimumab
    Administered by subcutaneous injection
    Other Name: HUMIRA®
  • Biological: ABP 501
    Administered by subcutaneous injection
    Other Names:
    • Adalimumab-atto
    • AMJEVITA™
Study Arms  ICMJE
  • 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.

    Intervention: Biological: ABP 501
  • 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.

    Intervention: Biological: Adalimumab
Publications * Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, Philipp S, Spelman L, Zhang N, Strober B. Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2017 Dec;177(6):1562-1574. doi: 10.1111/bjd.15857. Epub 2017 Dec 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2014)
350
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2013)
340
Actual Study Completion Date  ICMJE March 18, 2015
Actual Primary Completion Date August 14, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Hungary
Removed Location Countries France,   Germany,   Poland
 
Administrative Information
NCT Number  ICMJE NCT01970488
Other Study ID Numbers  ICMJE 20120263
2013-000537-12 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP