This is a multi-center phase 2b study in subjects with moderate to severe chronic plaque-type psoriasis. Approximately 300 subjects will be enrolled at approximately 60 investigator sites in North America and Europe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
313
M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
Placebo contains no active drug.
Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1
The primary endpoint is achievement of an IGA score of 0 or 1 at Week 12, with an IGA reduction of at least 2 points from baseline. The percentage of subjects in the Intent to Treat (ITT) Analysis Set with an IGA score of 0 or 1 at Week 12 will be used to compare treatment arms. IGA is the Investigator's Global Assessment of the extent of psoriasis, with 0 = clear of psoriasis, 1 = almost clear, 2 = mild psoriasis, 3 = moderate psoriasis, and 4 = severe psoriasis (the worst assessment on this scale). Higher scores in the IGA indicate a worse outcome.
Time frame: Week 12, as compared to Week 0 (baseline)
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)
PASI 100, i.e. a subject's psoriasis has completely cleared at Week 12, compared to baseline.
Time frame: Week 12, as compared to Week 0 (baseline)
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)
PASI 90, i.e. a subject's psoriasis has cleared by 90% at Week 12, compared to baseline
Time frame: Week 12, as compared to baseline
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)
PASI 75, i.e. a subject's psoriasis has cleared by 75% at Week 12, compared to baseline
Time frame: Week 12, as compared to Week 0 (baseline)
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Investigative Site
Birmingham, Alabama, United States
Investigative Site
San Diego, California, United States
Investigative Site
DeLand, Florida, United States
Investigative Site
Sandy Springs, Georgia, United States
Investigative Site
St Louis, Missouri, United States
Investigative Site
Albuquerque, New Mexico, United States
Investigative Site
New York, New York, United States
Investigative Site
Bexley, Ohio, United States
Investigative Site
Dallas, Texas, United States
Investigative Site
Houston, Texas, United States
...and 50 more locations