ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Biological: Adalimumab
Biological: ABP 501
Enrollment 350
Recruitment Details

This study was conducted at 49 centers in 6 countries (Australia, Canada, France, Germany, Hungary, and Poland).

Participants were randomized in a 1:1 ratio to receive ABP 501 or adalimumab.

Pre-assignment Details Randomization was stratified based on prior biologic use for psoriasis and geographic region. At week 16 participants with a PASI 50 response (≥ 50% improvement in Psoriasis Area and Severity Index score) continued on study; those initially randomized to adalimumab were re-randomized to receive either ABP 501 or adalimumab.
Arm/Group Title Part 1: ABP 501 Part 1: Adalimumab Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description 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 for 16 weeks. 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 for 16 weeks. Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48. Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48. Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Period Title: Part 1: Through Week 16
Started 175 175 0 0 0
Received Treatment 174 173 0 0 0
Completed 164 162 0 0 0
Not Completed 11 13 0 0 0
Reason Not Completed
Protocol-specified Criteria             1             2             0             0             0
Protocol Violation             1             2             0             0             0
Adverse Event             6             5             0             0             0
Withdrawal by Subject             3             2             0             0             0
Lost to Follow-up             0             2             0             0             0
Period Title: Part 2: Post Week 16
Started 0 0 152 [1] 79 [1] 77 [1]
Completed 0 0 135 71 69
Not Completed 0 0 17 8 8
Reason Not Completed
Physician Decision             0             0             0             0             1
Non-compliance             0             0             1             0             0
Lack of Efficacy             0             0             2             3             1
Adverse Event             0             0             5             1             1
Withdrawal by Subject             0             0             8             3             3
Lost to Follow-up             0             0             1             1             2
[1]
Only participants who completed week 16 and with a PASI 50 response continued in Part 2
Arm/Group Title Part 1: ABP 501 Part 1: Adalimumab Total
Hide Arm/Group Description 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 for 16 weeks. 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 for 16 weeks. Total of all reporting groups
Overall Number of Baseline Participants 175 175 350
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 175 participants 175 participants 350 participants
45.1  (12.95) 44.0  (13.68) 44.6  (13.31)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 175 participants 175 participants 350 participants
< 65 years 164 163 327
≥ 65 years 11 12 23
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 175 participants 350 participants
Female
63
  36.0%
59
  33.7%
122
  34.9%
Male
112
  64.0%
116
  66.3%
228
  65.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 175 participants 175 participants 350 participants
White 167 157 324
Black or African American 0 2 2
Asian 5 8 13
Native Hawaiian or Other Pacific Islander 0 1 1
Mixed Race 0 1 1
Other 1 3 4
Unknown 2 3 5
Prior Biological Use for Psoriasis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 175 participants 175 participants 350 participants
Yes 33 30 63
No 142 145 287
Geographic Region  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 175 participants 175 participants 350 participants
Eastern Europe 71 70 141
Western Europe 43 43 86
Other 61 62 123
Static Physician’s Global Assessment (sPGA)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 175 participants 175 participants 350 participants
Clear 0 0 0
Almost Clear 0 0 0
Mild 0 0 0
Moderate 106 102 208
Severe 61 61 122
Very Severe 7 10 17
Missing 1 2 3
[1]
Measure Description: 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).
Psoriasis Area and Severity Index (PASI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 175 participants 175 participants 350 participants
19.68  (8.100) 20.48  (7.880) 20.08  (7.990)
[1]
Measure Description:

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. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.

Data are reported for 174 and 173 participants in each reporting group respectively.

Body Surface Area (BSA) Affected by Psoriasis   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of BSA
Number Analyzed 175 participants 175 participants 350 participants
25.3  (15.02) 28.5  (16.82) 26.9  (16.00)
[1]
Measure Description: Data are reported for 174 and 173 participants in each reporting group respectively.
1.Primary Outcome
Title Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
Hide Description

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).

Time Frame Baseline and Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed using the full analysis set which includes all participants initially randomized in the study. Last observation carried forward (LOCF) imputation was used for participants with at least one post-baseline value.
Arm/Group Title Part 1: ABP 501 Part 1: Adalimumab
Hide Arm/Group Description:
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 for 16 weeks.
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 for 16 weeks.
Overall Number of Participants Analyzed 172 173
Mean (Standard Deviation)
Unit of Measure: percent change
80.91  (24.237) 83.06  (25.195)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: ABP 501, Part 1: Adalimumab
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Clinical equivalence was evaluated by comparing the 2-sided 95% confidence interval (CI) of the difference of PASI percent improvement from baseline to Week 16 between ABP 501 and adalimumab with an equivalence margin of ± 15.
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value -2.18
Confidence Interval (2-Sided) 95%
-7.39 to 3.02
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With a PASI 75 Response at Week 16
Hide Description 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.
Time Frame Baseline and Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.
Arm/Group Title Part 1: ABP 501 Part 1: Adalimumab
Hide Arm/Group Description:
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 for 16 weeks.
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 for 16 weeks.
Overall Number of Participants Analyzed 172 173
Measure Type: Number
Unit of Measure: percentage of participants
74.4 82.7
3.Secondary Outcome
Title Percentage of Participants With a PASI 75 Response at Week 32
Hide Description

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.

Time Frame Baseline and week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed in the re-randomized analysis set which includes all participants who were re-randomized at Week 16 in the study. Only participants with available data at week 32 are included.
Arm/Group Title Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description:
Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed 143 72 71
Measure Type: Number
Unit of Measure: percentage of participants
82.5 84.7 84.5
4.Secondary Outcome
Title Percentage of Participants With a PASI 75 Response at Week 50
Hide Description

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.

Time Frame Baseline and week 50
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed in the re-randomized analysis set which includes all participants who were re-randomized at Week 16 in the study. Only participants with available data at week 50 are included.
Arm/Group Title Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description:
Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed 134 70 69
Measure Type: Number
Unit of Measure: percentage of participants
85.1 87.1 81.2
5.Secondary Outcome
Title Percent Improvement From Baseline in PASI at Week 32
Hide Description

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).

Time Frame Baseline and week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed in the re-randomized analysis set with available data
Arm/Group Title Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description:
Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed 143 72 71
Mean (Standard Deviation)
Unit of Measure: percent change
87.62  (18.387) 88.16  (18.181) 86.98  (16.637)
6.Secondary Outcome
Title Percent Improvement From Baseline in PASI at Week 50
Hide Description

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).

Time Frame Baseline and week 50
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed in the re-randomized analysis set with available data
Arm/Group Title Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description:
Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed 134 70 69
Mean (Standard Deviation)
Unit of Measure: percent change
87.16  (19.559) 88.11  (20.957) 85.82  (21.864)
7.Secondary Outcome
Title Percentage of Participants With a Static Physician’s Global Assessment (sPGA) Response at Week 16
Hide Description 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).
Time Frame Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.
Arm/Group Title Part 1: ABP 501 Part 1: Adalimumab
Hide Arm/Group Description:
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 for 16 weeks.
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 for 16 weeks.
Overall Number of Participants Analyzed 172 173
Measure Type: Number
Unit of Measure: percentage of participants
58.7 65.3
8.Secondary Outcome
Title Percentage of Participants With a sPGA Response at Week 32
Hide Description 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).
Time Frame Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed in the re-randomized analysis set with available data
Arm/Group Title Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description:
Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed 143 72 71
Measure Type: Number
Unit of Measure: percentage of participants
66.4 72.2 70.4
9.Secondary Outcome
Title Percentage of Participants With a sPGA Response at Week 50
Hide Description 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).
Time Frame Week 50
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed in the re-randomized analysis set with available data.
Arm/Group Title Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description:
Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed 134 70 69
Measure Type: Number
Unit of Measure: percentage of participants
68.7 74.3 69.6
10.Secondary Outcome
Title Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16
Hide Description

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.

Time Frame Baseline and Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.
Arm/Group Title Part 1: ABP 501 Part 1: Adalimumab
Hide Arm/Group Description:
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 for 16 weeks.
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 for 16 weeks.
Overall Number of Participants Analyzed 172 173
Mean (Standard Deviation)
Unit of Measure: percentage of BSA
-18.0  (13.57) -22.1  (17.11)
11.Secondary Outcome
Title Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32
Hide Description

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.

Time Frame Baseline and week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed in the re-randomized analysis set with available data
Arm/Group Title Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description:
Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed 143 72 71
Mean (Standard Deviation)
Unit of Measure: percentage of BSA
-20.6  (13.87) -25.3  (15.94) -23.8  (16.17)
12.Secondary Outcome
Title Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50
Hide Description

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.

Time Frame Baseline and week 50
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed in the re-randomized analysis set with available data
Arm/Group Title Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description:
Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed 134 70 69
Mean (Standard Deviation)
Unit of Measure: percentage of BSA
-20.7  (13.58) -25.5  (16.14) -25.1  (17.43)
13.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description

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.
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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set includes all randomized participants who received at least 1 dose of study drug, based on actual treatment received.
Arm/Group Title Part 1: ABP 501 Part 1: Adalimumab Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description:
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 for 16 weeks.
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 for 16 weeks.
Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed 174 173 152 79 77
Measure Type: Number
Unit of Measure: participants
Any adverse event (AE) 117 110 108 52 54
Grade ≥ 3 adverse event 8 5 7 2 3
Treatment-related adverse event (TRAE) 43 43 28 18 20
Grade ≥ 3 treatment-related adverse event 4 2 3 1 1
Serious adverse event (SAE) 6 5 4 4 4
Treatment-related serious adverse event 4 0 2 1 1
AE leading to discontinuation of study drug 7 5 7 1 3
TRAE leading to discontinuation of study drug 4 3 3 1 2
AE leading to discontinuation from study 7 5 4 1 2
TRAE leading to discontinuation from study 4 3 2 1 1
14.Secondary Outcome
Title Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab
Hide Description

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.

Time Frame For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Results are reported for the anti-drug antibody analysis set (defined as the subset of participants in the Safety Analysis Set who had at least 1 evaluable antibody test) from Baseline to Week 16 for all randomized participants, and from baseline to Week 52 for participants who were re-randomized.
Arm/Group Title Part 1: ABP 501 Part 1: Adalimumab Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description:
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 for 16 weeks.
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 for 16 weeks.
Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed 174 173 152 79 77
Measure Type: Number
Unit of Measure: percentage of participants
Binding Antibody Positive 55.2 63.6 68.4 74.7 72.7
Neutralizing Antibody Positive 9.8 13.9 13.8 20.3 24.7
15.Post-Hoc Outcome
Title Percentage of Participants With a PASI 90 Response at Week 16
Hide Description 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 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Time Frame Baseline and Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.
Arm/Group Title Part 1: ABP 501 Part 1: Adalimumab
Hide Arm/Group Description:
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 for 16 weeks.
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 for 16 weeks.
Overall Number of Participants Analyzed 172 173
Measure Type: Number
Unit of Measure: percentage of participants
47.1 47.4
16.Post-Hoc Outcome
Title Percentage of Participants With a PASI 90 Response at Week 32
Hide Description

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

Time Frame Baseline and Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed in the re-randomized analysis set with available data
Arm/Group Title Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description:
Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed 143 72 71
Measure Type: Number
Unit of Measure: percentage of participants
62.2 65.3 57.7
17.Post-Hoc Outcome
Title Percentage of Participants With a PASI 90 Response at Week 50
Hide Description

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

Time Frame Baseline and Week 50
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed in the re-randomized analysis set with available data.
Arm/Group Title Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description:
Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed 134 70 69
Measure Type: Number
Unit of Measure: percentage of participants
59.0 64.3 66.7
18.Post-Hoc Outcome
Title Percentage of Participants With a PASI 100 Response at Week 16
Hide Description A PASI 100 response is a 100% 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.
Time Frame Baseline and Week 16
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.
Arm/Group Title Part 1: ABP 501 Part 1: Adalimumab
Hide Arm/Group Description:
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 for 16 weeks.
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 for 16 weeks.
Overall Number of Participants Analyzed 172 173
Measure Type: Number
Unit of Measure: percentage of participants
16.9 19.7
19.Post-Hoc Outcome
Title Percentage of Participants With a PASI 100 Response at Week 32
Hide Description A PASI 100 response is a 100% 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.
Time Frame Baseline and Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed in the re-randomized analysis set with available data
Arm/Group Title Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description:
Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed 143 72 71
Measure Type: Number
Unit of Measure: percentage of participants
32.9 33.3 25.4
20.Post-Hoc Outcome
Title Percentage of Participants With a PASI 100 Response at Week 50
Hide Description A PASI 100 response is a 100% 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.
Time Frame Baseline and Week 50
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed in the re-randomized analysis set with available data.
Arm/Group Title Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description:
Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
Overall Number of Participants Analyzed 134 70 69
Measure Type: Number
Unit of Measure: percentage of participants
32.8 35.7 34.8
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.
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Part 1: ABP 501 Part 1: Adalimumab Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Hide Arm/Group Description 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 for 16 weeks. 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 for 16 weeks. Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48. Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48. Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
All-Cause Mortality
Part 1: ABP 501 Part 1: Adalimumab Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Part 1: ABP 501 Part 1: Adalimumab Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/174 (3.45%)   5/173 (2.89%)   4/152 (2.63%)   4/79 (5.06%)   4/77 (5.19%) 
Cardiac disorders           
Acute myocardial infarction  1  1/174 (0.57%)  0/173 (0.00%)  0/152 (0.00%)  0/79 (0.00%)  0/77 (0.00%) 
Arrhythmia  1  1/174 (0.57%)  0/173 (0.00%)  0/152 (0.00%)  0/79 (0.00%)  0/77 (0.00%) 
Coronary artery disease  1  0/174 (0.00%)  0/173 (0.00%)  1/152 (0.66%)  0/79 (0.00%)  0/77 (0.00%) 
Hepatobiliary disorders           
Drug-induced liver injury  1  0/174 (0.00%)  0/173 (0.00%)  1/152 (0.66%)  0/79 (0.00%)  0/77 (0.00%) 
Immune system disorders           
Hypersensitivity  1  1/174 (0.57%)  0/173 (0.00%)  0/152 (0.00%)  0/79 (0.00%)  0/77 (0.00%) 
Infections and infestations           
Appendicitis  1  1/174 (0.57%)  0/173 (0.00%)  0/152 (0.00%)  0/79 (0.00%)  0/77 (0.00%) 
Bronchitis  1  0/174 (0.00%)  1/173 (0.58%)  0/152 (0.00%)  0/79 (0.00%)  0/77 (0.00%) 
Diverticulitis  1  0/174 (0.00%)  0/173 (0.00%)  1/152 (0.66%)  0/79 (0.00%)  0/77 (0.00%) 
Ophthalmic herpes zoster  1  0/174 (0.00%)  0/173 (0.00%)  0/152 (0.00%)  0/79 (0.00%)  1/77 (1.30%) 
Postoperative abscess  1  1/174 (0.57%)  0/173 (0.00%)  0/152 (0.00%)  0/79 (0.00%)  0/77 (0.00%) 
Urinary tract infection  1  0/174 (0.00%)  0/173 (0.00%)  0/152 (0.00%)  0/79 (0.00%)  1/77 (1.30%) 
Metabolism and nutrition disorders           
Dyslipidaemia  1  0/174 (0.00%)  0/173 (0.00%)  1/152 (0.66%)  0/79 (0.00%)  0/77 (0.00%) 
Musculoskeletal and connective tissue disorders           
Intervertebral disc protrusion  1  0/174 (0.00%)  0/173 (0.00%)  0/152 (0.00%)  1/79 (1.27%)  0/77 (0.00%) 
Osteoarthritis  1  0/174 (0.00%)  1/173 (0.58%)  0/152 (0.00%)  0/79 (0.00%)  0/77 (0.00%) 
Patellofemoral pain syndrome  1  0/174 (0.00%)  1/173 (0.58%)  0/152 (0.00%)  0/79 (0.00%)  0/77 (0.00%) 
Rotator cuff syndrome  1  0/174 (0.00%)  0/173 (0.00%)  1/152 (0.66%)  0/79 (0.00%)  0/77 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Lentigo maligna  1  1/174 (0.57%)  0/173 (0.00%)  0/152 (0.00%)  0/79 (0.00%)  0/77 (0.00%) 
Nervous system disorders           
Cerebral ischaemia  1  0/174 (0.00%)  0/173 (0.00%)  1/152 (0.66%)  0/79 (0.00%)  0/77 (0.00%) 
Headache  1  0/174 (0.00%)  0/173 (0.00%)  0/152 (0.00%)  1/79 (1.27%)  0/77 (0.00%) 
Migraine  1  0/174 (0.00%)  0/173 (0.00%)  0/152 (0.00%)  1/79 (1.27%)  0/77 (0.00%) 
Syncope  1  0/174 (0.00%)  1/173 (0.58%)  0/152 (0.00%)  0/79 (0.00%)  0/77 (0.00%) 
Transient ischaemic attack  1  0/174 (0.00%)  0/173 (0.00%)  0/152 (0.00%)  0/79 (0.00%)  1/77 (1.30%) 
Psychiatric disorders           
Depression  1  0/174 (0.00%)  0/173 (0.00%)  0/152 (0.00%)  1/79 (1.27%)  0/77 (0.00%) 
Reproductive system and breast disorders           
Metrorrhagia  1  0/174 (0.00%)  1/173 (0.58%)  0/152 (0.00%)  0/79 (0.00%)  0/77 (0.00%) 
Ovarian cyst  1  0/174 (0.00%)  0/173 (0.00%)  0/152 (0.00%)  0/79 (0.00%)  1/77 (1.30%) 
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease  1  1/174 (0.57%)  0/173 (0.00%)  0/152 (0.00%)  0/79 (0.00%)  0/77 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: ABP 501 Part 1: Adalimumab Part 2: ABP 501/ABP 501 Part 2: Adalimumab/Adalimumab Part 2: Adalimumab/ABP 501
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   50/174 (28.74%)   60/173 (34.68%)   48/152 (31.58%)   31/79 (39.24%)   34/77 (44.16%) 
Gastrointestinal disorders           
Diarrhoea  1  2/174 (1.15%)  3/173 (1.73%)  3/152 (1.97%)  4/79 (5.06%)  8/77 (10.39%) 
Infections and infestations           
Nasopharyngitis  1  25/174 (14.37%)  27/173 (15.61%)  25/152 (16.45%)  14/79 (17.72%)  18/77 (23.38%) 
Upper respiratory tract infection  1  9/174 (5.17%)  9/173 (5.20%)  9/152 (5.92%)  6/79 (7.59%)  7/77 (9.09%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  5/174 (2.87%)  7/173 (4.05%)  4/152 (2.63%)  5/79 (6.33%)  2/77 (2.60%) 
Back pain  1  7/174 (4.02%)  1/173 (0.58%)  5/152 (3.29%)  5/79 (6.33%)  1/77 (1.30%) 
Nervous system disorders           
Headache  1  12/174 (6.90%)  18/173 (10.40%)  5/152 (3.29%)  8/79 (10.13%)  2/77 (2.60%) 
Skin and subcutaneous tissue disorders           
Psoriasis  1  2/174 (1.15%)  2/173 (1.16%)  10/152 (6.58%)  5/79 (6.33%)  4/77 (5.19%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01970488     History of Changes
Other Study ID Numbers: 20120263
2013-000537-12 ( EudraCT Number )
First Submitted: October 23, 2013
First Posted: October 28, 2013
Results First Submitted: October 20, 2016
Results First Posted: December 13, 2016
Last Update Posted: August 31, 2018