Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis

Conditions

• Moderate Psoriasis
• Plaque Psoriasis
• Psoriasis
• Psoriasis (PsO)
• Severe Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Open-Label Envudeucitinib — DRUG
  Open-Label ESK-001
• Blinded Envudeucitinib — DRUG
  Blinded ESK-001 during Randomized Treatment Withdrawal Period
• Placebo — DRUG
  Placebo during Randomized Treatment Withdrawal Period

Study Details

The objective of the ESK-001-018 long term extension is to evaluate the safety and efficacy of ESK-001 over time. The scientific questions it aims to answer are: * How safe is taking ESK-001 long-term in people with moderate to severe plaque psoriasis? * Does taking ESK-001 long-term reduce the severity of people's plaque psoriasis? Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks. After 24 weeks, the first 200 patients meeting at least PASI-75 clinical response will be randomly assigned to receive ESK-001 or placebo. At any point during this time, the patients losing the initial clinical response may return to the open-label ESK-001 treatment. Patients who complete Week 48 will return to open-label ESK-001 treatment and they will receive ESK-001 until the end of the study or discontinuation. All the remaining patients not meeting the entry criteria for the randomized withdrawal phase will continue to receive open-label ESK-001 for the remainder of the study. Patients taking part in the study must be men or women aged at least 18 years old and have completed a previous (parent) study of ESK-001 in moderate to severe plaque psoriasis. Patients must consent and agree to: * ensure drug daily compliance until end of study or discontinuation. * visit the clinic for checkups and assessments. * provide blood and urine samples.

Key Dates

Start date

Jan 8, 2025

Status verified

Apr 2026

Primary completion

Nov 30, 2028

Completion

Nov 30, 2028

Study Design

Enrollment

1,680 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Open-Label ESK-001
  Open-Label ESK-001 administered as an oral tablet
• Experimental: Blinded ESK-001
  Blinded ESK-001 administered as an oral tablet
• Placebo Comparator: Placebo
  Matching placebo administered as an oral tablet

Primary Outcome Measure

To assess the long-term safety and tolerability of ESK-001 throughout the duration of the study [ Time Frame: Approximately 4 years ]

Locations (92)

Find similar trials in Birmingham, AL

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