Clinical trial NCT01970488: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Plaque Psoriasis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-10-28
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: Percentage of Participants With a PASI 75 Response at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With a PASI 75 Response at Week 32
timeFrame: Baseline and week 32
measure: Percentage of Participants With a PASI 75 Response at Week 50
timeFrame: Baseline and week 50
measure: Percent Improvement From Baseline in PASI at Week 32
timeFrame: Baseline and week 32
measure: Percent Improvement From Baseline in PASI at Week 50
timeFrame: Baseline and week 50
measure: Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 16
timeFrame: Week 16
measure: Percentage of Participants With a sPGA Response at Week 32
timeFrame: Week 32
measure: Percentage of Participants With a sPGA Response at Week 50
timeFrame: Week 50
measure: Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32
timeFrame: Baseline and week 32
measure: Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50
timeFrame: Baseline and week 50
measure: Number of Participants With Adverse Events
timeFrame: 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.
measure: Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab
timeFrame: For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2.
Other outcomes:
Locations:
city: Saint Leonards
country: Australia
facility: Research Site
state: New South Wales
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Nyíregyháza
country: Hungary
facility: Research Site
state: Szabolcs-szatmar-bereg
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.