NCT05522816

KX01 Ointment Phase 1 Study in Patients With Plaque Type Psoriasis

A Phase 1, Dose Escalation Trial to Evaluate the Safety, Tolerability and Activity of Topical Administrations of Three Different Strengths of KX01 Ointment in Patients With Plaque Type Psoriasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: PharmaEssentia · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I dose escalation study to assess the safety, tolerability and activity of three different strengths of topical KX01 in the treatment of patients with plaque-type psoriasis.

Detailed description

This is a Phase I dose escalation study to assess the safety, tolerability and activity of three different strengths of topical KX01 (Tirbanibulin Ointment) in the treatment of patients with plaque-type psoriasis. The study will be performed in four stages as below. Stage I: 6 patients (KX01 0.01% \[0.1 mg/g\]) + 2 patients (placebo); Stage II: 6 patients (KX01 0.1% \[1.0 mg/g\] + 2 patients (placebo); Stage III: 6 patients (KX01 1% \[10 mg/g\]) for 5 days; Stage IV: 6 patients (KX01 1% \[10 mg/g\]), duration escalation for up to 4 cycles. If there's no major safety concern in the previous stage with an unanimous consent by the sponsor and the principle investigator, the study proceeded to the next stage. The primary objective is to evaluate the safety and tolerability of three different strengths of KX01 ointment in patients with plaque-type psoriasis. The secondary objective is to gain evidence regarding the activity of three different strengths of KX01 ointment in patients with plaque-type psoriasis.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	KX01 0.01% (0.1 mg/g)	Stage 1: 6 patients (KX01 0.01% \[0.1 mg/g\])
DRUG	Placebo	Contains same excipients with KX01 but do not contain Tirbanibulin
DRUG	KX01 0.1% (1.0 mg/g)	Stage 2: 6 patients (KX01 0.1% \[1.0 mg/g\])
DRUG	KX01 1% (10 mg/g) for 5 days	Stage 3: 6 patients (KX01 1% \[10 mg/g\]) for 5 days
DRUG	KX01 1% (10 mg/g) for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles	Stage 4: 6 patients (KX01 1% \[10 mg/g\])for consecutive 5 days and 2 days rest for 1 cycle, and repeat up to 4 cycles

Timeline

• Start date: 2015-10-27
• Primary completion: 2021-03-10
• Completion: 2021-03-10
• First posted: 2022-08-31
• Last updated: 2025-07-02