Plaque Psoriasis
Conditions
Brief summary
This is a multi-center, open-label extension (OLE) study in patients with plaque psoriasis who have completed their participation in a previous plaque psoriasis study of ESK-001.
Detailed description
This study will consist of patients who have completed their participation in a previous plaque psoriasis study of ESK-001. Each patient will be assigned to receive ESK-001 at one of two open-label dose levels. Patients have the option to remain on study until ESK-001 is commercially available.
Interventions
DRUGenvudeucitinib
Oral tablet
Sponsors
Alumis Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have completed a prior ESK-001 study * Men and Women must use highly effective methods of contraception for the entirety of the study
Exclusion criteria
* Pregnancy * Received a prohibited concomitant medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety and tolerability of long-term ESK-001 treatment | Approximately 3 years | Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the long-term efficacy of ESK-001 | Approximately 3 years | Change from baseline in Psoriasis Area and Severity Index (PASI) over time |
| To assess the change in quality of life (QoL) with long-term ESK-001 administration | Approximately 3 years | Change from baseline in Dermatology Life Quality Index (DLQI) over time |
| To assess the pharmacokinetics (PK) of ESK-001 (ctrough) | 2 years | Plasma concentrations and PK parameters including steady-state trough observed plasma concentration (Ctrough) for ESK-001 |
Countries
Canada, United States
Outcome results
None listed