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Study Complete
Sponsor ID
20120263

Study to compare efficacy and safety of ABP 501 and Adalimumab (HUMIRA®) in adults with moderate to severe plaque psoriasis

Sponsor ID
20120263
Clinicaltrials.gov ID
NCT01970488
EUCTIS ID
N/A
EudraCT ID
2013-000537-12
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Study Details

The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with plaque psoriasis.

Additional Study Details

Phase
Phase 3
Product
ABP 501
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
350
Additional Study Details

Protocol Summary

Primary Outcome Measures

The primary efficacy endpoint is the Psoriasis Area and Severity Index (PASI) percent improvement after 16 weeks of treatment.

Timeframe: Week 16

Secondary Outcome Measures

PASI 75 response

Timeframe: Week 50

PASI percent improvement

Timeframe: Week 50

Static Physician’s Global Assessment (sPGA) responses (with 0 or 1 being a positive result)

Timeframe: Week 50

Body Surface Area (BSA) involvement

Timeframe: Week 50

Subject incidence of adverse events and serious adverse events

Timeframe: Week 52

Clinically significant changes in laboratory values and vital signs

Timeframe: Week 52

Incidence of anti-drug antibodies

Timeframe: Week 52

Study Documents

Study Synopsis
Available Language(s): English
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Locations

Location
Status
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Location
Research Site
Nyíregyháza, SZABOLCS-SZATMAR-BEREG, Hungary, 4400
Status
Completed
Location
Research Site
Saint Leonards, NSW, Australia, 2065
Status
Completed
Location
Research Site
St. John's, NL, Canada, A1A 5E8
Status
Completed
Study Info
Age
18 - 75 Years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Oct 2013 - Aug 2014
    Inclusion and Exclusion 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