Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe C… (NCT03504852) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque Psoriasis
United States331 participantsStarted 2018-06-25
Plain-language summary
The purpose of this study is to assess secukinumab high dose (every 2 weeks) vs standard dose (every 4 weeks) in heavy body weight subjects with moderate to severe plaque psoriasis.
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
* Written informed consent must have been obtained before any assessment was performed. Where relevant, a legal representative will also have signed the informed study consent according to local laws and regulations.
* Subjects must have been able to understand and communicate with the investigator and comply with the requirements of the study.
* Men or women at least 18 years of age at time of screening.
* Body weight of ≥ 90 kg at the time of randomization.
* Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
* Moderate to severe psoriasis as defined at randomization by:
* Psoriasis Area and Severity Index (PASI) score of 12 or greater, and
* Investigator's Global Assessment (IGA) mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and
* Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
* Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by:
* topical treatment and/or,
* phototherapy and/or,
* previous systemic therapy.
Key Exclusion Criteria:
* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or Randomization.
* Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit ultraviolet (UV) light exposure (e.g., sun…
What they're measuring
1
Percentage of Subjects Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set)