NCT06374979

Efficacy and Safety of Ixekizumab in Patients with Refractory Guttate Psoriasis

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to analyse efficacy and safety of ixekizumab in participants with refractory guttate psoriasis. The main question it aims to answer is: What percentage of participants achieved more than 90% reduction from baseline in Psoriasis Area Index （PASI 90） after 12 weeks of ixekizumab treatment? Participants will receive a 12-week treatment of ixekizumab, with follow-up visits every 2 weeks during the treatment period. Keep a diary of their symptoms and Psoriasis Area Index.

Detailed description

This study was a single-arm, open-label, single-center multi-dose trial. Approximately 50 participants are scheduled to receive subcutaneous injection of ixekizumab for 12 weeks, with follow-up every 2 weeks during the treatment period. After the treatment period, the primary endpoint was assessed at week 16, and patients who achieved PASI 90 response were followed up at week 34 and week 52 to the medical center to assess disease recurrence or progression. To evaluate the efficacy of ixekizumab in the treatment of refractory guttate psoriasis.

Conditions

• Guttate Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	Ixekizumab	Participants will receive an initial dose of 160 mg (two injections of 80 mg) ixekizumab subcutaneously at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2024-04-19
• Last updated: 2025-02-10