Phase 2
Completed N=228
A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Plaque Psoriasis
Source: ClinicalTrials.gov NCT05600036 ↗Enrolled (actual)
228
Serious AEs
2.2%
Results posted
Jul 2024
Primary outcomePrimary: To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo — 19.4; 33.3; 56.4; 56.4 Percentage — p=0.0025
Summary
This is a multi-center, randomized, double-blind, placebo-controlled study in patients with moderate to severe plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Compare the Psoriasis Area and Severity Index (PASI-75) Between Doses of ESK-001 and Placebo |
19.4; 33.3; 56.4; 56.4; 64.1; 0 | 0.0025 sig |
| SECONDARY To Assess the Safety and Tolerability of ESK-001 Dose in Moderate to Severe Psoriasis Patients |
19; 14; 19; 18; 25; 15 | — |
| SECONDARY To Assess the Response Rate in Static Physician's Global Assessment (sPGA) Score |
6; 14; 21; 19; 23; 3 | — |
| SECONDARY To Characterize the Pharmacokinetics (PK) of ESK-001 |
11.9; 33.0; 50.7; 63.9; 174.0; 2.9 | — |
Eligibility Criteria
Inclusion Criteria
- Total body weight >40 kg (88 lb)
- Men and woman age 18-75
- Men and Women must use highly effective methods of contraception for the entirety of the study
Exclusion Criteria
- History of malignancy within the last 5 years
- Positive for HIV, Hepatitis B or C
- History of tuberculosis
- Diagnosis of non-plaque psoriasis
- Patients with QTcF >450 msec (males) or >470 msec (females) at screening
- Live vaccines
Data sourced from ClinicalTrials.gov (NCT05600036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.