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This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Cryopyrin-Associated Period Syndrome (CAPS). Approximately 10 patients will take VTX2735 Dose A or VTX2735 Dose B.
The study consists of a screening/washout period of up to 28 weeks, a 2 week treatment period, a treatment withdrawal period of up to 2 weeks, another 2 week treatment period, and a 4 week follow up period. The maximum length of treatment is 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
| |
| Cohort 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VTX2735 | Drug | Dose A |
| |
| VTX2735 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of VTX2735 | Incidence and severity of treatment-emergent adverse events (TEAE), serious adverse events (SAE), and discontinuation due to adverse events | From the initial administration of VTX2735 through study completion, up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in the mean key symptom score (KSS) derived from the Daily Health Assessment Form, Second Generation (DHAF2) from baseline | Assess the change from baseline in disease activity using DHAF2 and KSS. | From Day 1 to completion of treatment with VTX2735, up to Day 28 |
| Achievement of 30%, 50%, or 75% improvement in mean KSS from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henrik Sonnergren, MD, PhD | Ventyx Biosciences, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Site # 222 | San Diego | California | 92123 | United States | ||
| Local Site # 223 |
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| ID | Term |
|---|---|
| D056587 | Cryopyrin-Associated Periodic Syndromes |
| ID | Term |
|---|---|
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
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| Drug |
Dose B |
|
Proportion of patients achieving 30%, 50%, or 75% improvement from baseline in disease activity using DHAF2 and KSS. |
| From Day 1 to completion of treatment with VTX2735, up to Day 28 |
| Number of days when the daily KSS is >3 | Number of multi-system disease flare days as defined by KSS | From Day 1 to completion of treatment with VTX2735, up to Day 28 |
| Number of days when any single DHAF2 symptom score is >3 | Number of single system disease flare days as defined by KSS | From Day 1 to completion of treatment with VTX2735, up to Day 28 |
| Maximum severity of any symptom score on DHAF2 | Maximum single DHAF2 symptom score | From Day 1 to completion of treatment with VTX2735, up to Day 28 |
| Columbus |
| Georgia |
| 31904 |
| United States |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000094482 | Chronic Inducible Urticaria |
| D000080223 | Chronic Urticaria |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D000096703 | Cold Urticaria |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |