Psoriasis Clinical Trial
Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque Psoriasis
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.
Full Description
A 52-week multicenter, randomized, double-blind, parallel-group trial in 331 subjects with moderate to severe chronic plaque-type psoriasis of body weight 90 kg or higher at time of randomization.
This study consisted of 4 periods: screening (up to 4 weeks), treatment Period 1 (16 weeks), treatment Period 2 (36 weeks), and post-treatment follow-up (8 weeks).
Subjects were randomized using a 1:1 ratio to the following groups: Secukinumab 300 mg every 2 weeks; Secukinumab 300 mg every 4 weeks.
In addition, subjects from the 300 mg every 4 weeks group who did not achieve Psoriasis Area Severity Index (PASI) 90 response at Week 16 were reassigned using a 1:1 ratio to either remain on secukinumab 300 mg every 4 weeks or receive secukinumab 300 mg every 2 weeks starting at Week 16, until the end of treatment.
Eligibility Criteria
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., sunbathing and / or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited. Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited.
Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting Interleukin-17 (IL-17) or the IL-17 receptor.
Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 4 weeks until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
Pregnant or nursing (lactating) women
History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
History of hypersensitivity to any of the study drug constituents.
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There are 67 Locations for this study
Birmingham Alabama, 35205, United States
Phoenix Arizona, 85032, United States
Rogers Arkansas, 72758, United States
Irvine California, 92697, United States
Sacramento California, 95817, United States
Sacramento California, 95819, United States
San Diego California, 92123, United States
Santa Monica California, 90404, United States
Centennial Colorado, 80111, United States
Tampa Florida, 33612, United States
West Palm Beach Florida, 33409, United States
Alpharetta Georgia, 30022, United States
Snellville Georgia, 30078, United States
Skokie Illinois, 60077, United States
Indianapolis Indiana, 46256, United States
New Albany Indiana, 47150, United States
Louisville Kentucky, 40241, United States
Owensboro Kentucky, 42303, United States
Boston Massachusetts, 02111, United States
New Brighton Minnesota, 55112, United States
Saint Joseph Missouri, 64506, United States
East Windsor New Jersey, 08520, United States
Verona New Jersey, 07044, United States
Forest Hills New York, 11375, United States
New York New York, 10025, United States
Charlotte North Carolina, 28277, United States
Winston-Salem North Carolina, 27157, United States
Fairborn Ohio, 45324, United States
Oregon City Oregon, 97045, United States
Portland Oregon, 97210, United States
Charleston South Carolina, 29414, United States
Houston Texas, 77056, United States
Mesquite Texas, 75150, United States
Pflugerville Texas, 78660, United States
San Antonio Texas, 78218, United States
Norfolk Virginia, 23507, United States
Wenatchee Washington, 98801, United States
Madison Wisconsin, 53717, United States
Calgary Alberta, T2G 1, Canada
Red Deer Alberta, T4N 6, Canada
Etobicoke Ontario, M8X 1, Canada
Guelph Ontario, N1L 0, Canada
Hamilton Ontario, L8N 1, Canada
Quebec , G1V 4, Canada
Prague Prague 1, 11000, Czechia
Novy Jicin , 741 0, Czechia
Bochum , 44793, Germany
Frankfurt , 60590, Germany
Hamburg , 20246, Germany
Hamburg , 20537, Germany
Kiel , 24105, Germany
Leipzig , 04103, Germany
Debrecen , 4032, Hungary
Pecs , 7623, Hungary
Szeged , H 672, Hungary
Rozzano MI, 20089, Italy
Modena MO, 41124, Italy
Perugia PG, 06100, Italy
Siena SI, 53100, Italy
Napoli , 80138, Italy
Chelyabinsk , 45409, Russian Federation
Ekaterinburg , 62002, Russian Federation
Kazan , 42001, Russian Federation
Krasnodar , 35002, Russian Federation
Lipetsk , 39800, Russian Federation
Saint Petersburg , 19702, Russian Federation
Saratov , 41001, Russian Federation
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