Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis (NCT06846541)
An Extension Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy, and Durability of Response to ESK-001
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Total Dermatology — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (268 Sites)
Showing the first 25 of 268 sites.
- Total Dermatology — Birmingham, Alabama
- Chandler Clinical Trials — Chandler, Arizona
- Alliance Dermatology — Pheonix, Arizona
- Scottsdale Clinical Trials — Scottsdale, Arizona
- Noble Clinical Research — Tucson, Arizona
- Northwest AR Clinical Trials Center PLLC — Rogers, Arkansas
- Zenith Research Inc. — Beverly Hills, California
- Exalt Clinical Research Inc — Chula Vista, California
- California Dermatology and Clinical Research Institute — Encinitas, California
- Raoof MD — Encino, California
- First OC Dermatology Research Inc — Fountain Valley, California
- Marvel Clinical Research LLC — Huntington Beach, California
- Long Beach Research Institute — Long Beach, California
- Olive View UCLA Education and Research Institute — Los Angeles, California
- Dermatology Research Associates — Los Angeles, California
- Wallace Medical Group Inc — Los Angeles, California
- Northridge Clinical Trials — Northridge, California
- Pasadena Clinical Trials — Pasadena, California
- Empire Clinical Research Pomona — Pomona, California
- Integrative Skin Science and Research — Sacramento, California
- Therapeutics Clinical Research — San Diego, California
- Southern California Clinical Research — Santa Ana, California
- Clinical Science Institute Dermatology Institute — Santa Monica, California
- Unison Clinical Trials — Sherman Oaks, California
- California Dermatology Institute Thousand Oaks — Thousand Oaks, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Plaque Psoriasis
- A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis — Phoenix, Arizona
- Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis — Phoenix, Arizona
- A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis — Birmingham, Alabama
- Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects — Rogers, Arkansas
- Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis — Birmingham, Alabama
- A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2) — Phoenix, Arizona
Explore by condition: All Plaque Psoriasis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.