The primary purpose of this study is to examine safety outcomes in active plaque psoriasis patients after systemic administration of dalazatide. Clinical outcome measures will also be assessed.
The primary purpose of this study is to examine safety outcomes in active plaque psoriasis patients after systemic administration of dalazatide. Clinical outcome measures will also be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
24
Subcutaneous injection twice per week for a total of 9 doses, followed by four weeks of follow-up.
placebo, Subcutaneous injection twice per week for a total of 9 doses
Innovaderm Research, Inc
Montreal, Quebec, Canada
Subjects with adverse events
Time frame: From randomization through Day 57 (12 timepoints)
Target lesion assessment
Target lesion evaluated for erythema, induration, and scaling.
Time frame: From randomization to Day 57 (4 timepoints)
Psoriasis Area Severity Index (PASI) score
Time frame: From randomization to Day 57 (4 timepoints)
Patient and Investigator Global Assessment of Psoriasis
Time frame: From randomization to Day 57 (4 timepoints)
Psoriasis Disability Index (PDI)
Time frame: From randomization to Day 57 (4 timepoints)
Skin biomarker assessments
Skin biopsy from psoriatic lesion collected for analysis of gene expression via qPCR and immune cell infiltration via histology and immunohistochemistry analysis.
Time frame: From randomaization to Day 32 (2 timepoints)
Blood biomarker assessments
Blood collected for analysis of gene and protein expression as well as immunophenotyping of T cell subsets.
Time frame: From randomizatoin to Day 57 (5 timepoints)
Dermatology Quality of Life Questionnaire (DLQI)
Time frame: From randomization to Day 57 (4 timepoints)
Presence of specific anti-drug antibodies to dalazatide
Serum evaluated for specific anti-drug antibody using ELISA-based immunoassay.
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Time frame: From randomization to Day 57 (three timepoints)
Subjects with changes in vital signs
Vital signs include temperature, respiratory rate, supine blood pressure and pulse.
Time frame: From randomization to Day 57 (12 timepoints)
Subjects with changes in symptom-directed physical examinations
Time frame: From randomization to day 5 (12 timepoints)