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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01970488




Registration number
NCT01970488
Ethics application status
Date submitted
23/10/2013
Date registered
28/10/2013
Date last updated
3/04/2019

Titles & IDs
Public title
Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis
Scientific 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
Secondary ID [1] 0 0
2013-000537-12
Secondary ID [2] 0 0
20120263
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Adalimumab
Treatment: Other - ABP 501

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.

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.


Treatment: Other: Adalimumab
Administered by subcutaneous injection

Treatment: Other: ABP 501
Administered by subcutaneous injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [1] 0 0
Percentage of Participants With a PASI 75 Response at Week 16
Timepoint [1] 0 0
Baseline and Week 16
Secondary outcome [2] 0 0
Percentage of Participants With a PASI 75 Response at Week 32
Timepoint [2] 0 0
Baseline and week 32
Secondary outcome [3] 0 0
Percentage of Participants With a PASI 75 Response at Week 50
Timepoint [3] 0 0
Baseline and week 50
Secondary outcome [4] 0 0
Percent Improvement From Baseline in PASI at Week 32
Timepoint [4] 0 0
Baseline and week 32
Secondary outcome [5] 0 0
Percent Improvement From Baseline in PASI at Week 50
Timepoint [5] 0 0
Baseline and week 50
Secondary outcome [6] 0 0
Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 16
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Percentage of Participants With a sPGA Response at Week 32
Timepoint [7] 0 0
Week 32
Secondary outcome [8] 0 0
Percentage of Participants With a sPGA Response at Week 50
Timepoint [8] 0 0
Week 50
Secondary outcome [9] 0 0
Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16
Timepoint [9] 0 0
Baseline and Week 16
Secondary outcome [10] 0 0
Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32
Timepoint [10] 0 0
Baseline and week 32
Secondary outcome [11] 0 0
Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50
Timepoint [11] 0 0
Baseline and week 50
Secondary outcome [12] 0 0
Number of Participants With Adverse Events
Timepoint [12] 0 0
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 outcome [13] 0 0
Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab
Timepoint [13] 0 0
For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2.

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/03/2015
Sample size
Target
Accrual to date
Final
350
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Research Site - Saint Leonards
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Newfoundland and Labrador
Country [2] 0 0
Hungary
State/province [2] 0 0
Szabolcs-szatmar-bereg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01970488
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01970488