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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970488
• Other study ID #: 20120263
• Secondary ID: 2013-000537-12
• Status: Completed
• Phase: Phase 3
• Start date: October 18, 2013
• Est. completion date: March 18, 2015

Study information

• Verified date: April 2019
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: March 18, 2015
• Est. primary completion date: August 14, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• Adalimumab
Administered by subcutaneous injection
• ABP 501
Administered by subcutaneous injection

Locations

Country	Name	City	State
Australia	Research Site	Saint Leonards	New South Wales
Canada	Research Site	St. John's	Newfoundland and Labrador
Hungary	Research Site	Nyíregyháza	Szabolcs-szatmar-bereg

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Australia,  Canada,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at 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).	Baseline and Week 16
Secondary	Percentage of Participants With a PASI 75 Response at 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.	Baseline and Week 16
Secondary	Percentage of Participants With a PASI 75 Response at 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.	Baseline and week 32
Secondary	Percentage of Participants With a PASI 75 Response at 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.	Baseline and week 50
Secondary	Percent Improvement From Baseline in PASI at 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).	Baseline and week 32
Secondary	Percent Improvement From Baseline in PASI at 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).	Baseline and week 50
Secondary	Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at 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).	Week 16
Secondary	Percentage of Participants With a sPGA Response at 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).	Week 32
Secondary	Percentage of Participants With a sPGA Response at 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).	Week 50
Secondary	Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at 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.	Baseline and Week 16
Secondary	Change From Baseline in the Percentage of BSA Involved With Psoriasis at 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.	Baseline and week 32
Secondary	Change From Baseline in the Percentage of BSA Involved With Psoriasis at 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.	Baseline and week 50
Secondary	Number of Participants With Adverse Events	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.	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.
Secondary	Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab	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.	For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2.

External Links

•   AmgenTrials clinical trials website