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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30ug dalazatide | Experimental | 12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks. |
|
| 60ug dalazatide | Experimental | 12 subjects, 10 given active agent and 2 given placebo by subcutaneous injection twice weekly for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dalazatide | Drug | Subcutaneous injection twice per week for a total of 9 doses, followed by four weeks of follow-up. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjects with adverse events | From randomization through Day 57 (12 timepoints) |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion assessment | Target lesion evaluated for erythema, induration, and scaling. | From randomization to Day 57 (4 timepoints) |
| Psoriasis Area Severity Index (PASI) score | From randomization to Day 57 (4 timepoints) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve of dalazatide (AUC) | 5 minutes pose dose, 15 minutes post dose, 30 minutes post dose, 1 hour post dose, 2 hours post dose, 4 hours post dose |
Inclusion Criteria:
Exclusion Criteria:
The following will exclude potential subjects from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Shawn Iadonato, PhD | Kineta Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovaderm Research, Inc | Montreal | Quebec | H2K 4L5 | Canada |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 14, 2016 | |
| Unrelease | Yes |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 14, 2016 | Yes |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C533637 | Shk-186 peptide |
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| placebo | Drug | placebo, Subcutaneous injection twice per week for a total of 9 doses |
|
| Patient and Investigator Global Assessment of Psoriasis | From randomization to Day 57 (4 timepoints) |
| Psoriasis Disability Index (PDI) | 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. | 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. | From randomizatoin to Day 57 (5 timepoints) |
| Dermatology Quality of Life Questionnaire (DLQI) | 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. | From randomization to Day 57 (three timepoints) |
| Subjects with changes in vital signs | Vital signs include temperature, respiratory rate, supine blood pressure and pulse. | From randomization to Day 57 (12 timepoints) |
| Subjects with changes in symptom-directed physical examinations | From randomization to day 5 (12 timepoints) |