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

• 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: Amgen
• Information provided by (Responsible Party): Amgen

Tracking Information

• First Submitted Date: October 23, 2013
• First Posted Date: October 28, 2013
• Results First Submitted Date: October 20, 2016
• Results First Posted Date: December 13, 2016
• Last Update Posted Date: April 3, 2019
• Actual Study Start Date: October 18, 2013
• Actual Primary Completion Date: August 14, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Psoriasis

Intervention

• Biological: Adalimumab
  Administered by subcutaneous injection
  Other Name: HUMIRA®
• Biological: ABP 501
  Administered by subcutaneous injection
  Other Names:

  • Adalimumab-atto
  • AMJEVITA™

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 16, 2014): 350
• Original Estimated Enrollment (submitted: October 23, 2013): 340
• Actual Study Completion Date: March 18, 2015
• Actual Primary Completion Date: August 14, 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Canada, Hungary
• Removed Location Countries: France, Germany, Poland

Administrative Information

• NCT Number: NCT01970488
• Other Study ID Numbers: 20120263; 2013-000537-12 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Amgen
• Original Responsible Party: Same as current
• Current Study Sponsor: Amgen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: MD; Amgen

• PRS Account: Amgen
• Verification Date: April 2019