NCT06620692

A Study to Investigate the Efficacy and Safety Profile of GM-XANTHO [GM-XAN003] in Patients with Psoriasis

A Phase IIa Study to Investigate the Efficacy and Safety Profile of GM-XANTHO [GM-XAN003] in Patients with Psoriasis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Xantho Biotechnology Co., LTD · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This trial is a Phase IIa clinical trial. Around 65 subjects will be enrolled into this study to primarily assess the treatment efficacy of 5% GM-XANTHO in patients with psoriasis, as well as the safety and tolerability of 5% GM-XANTHO. Two third of the total subjects will be given the investigational product, 5% GM-XANTHO, and the other third will take placebo. The treatment period will last for 28 consecutive days, followed by a safety follow-up for 2 weeks. During the study, there will be 8 scheduled visits to the clinical center.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	5% GM-XANTHO [GM-XAN003]	5% GM-XANTHO \[GM-XAN003\]
DRUG	Placebo	The placebo

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2024-10-01
• Last updated: 2024-10-01

Regulatory

• FDA-regulated drug study