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

Sponsor
Xantho Biotechnology Co., LTD
Study ID
NCT06620692
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5% GM-XANTHO [GM-XAN003] — DRUG
    5% GM-XANTHO \[GM-XAN003\]
  • Placebo — DRUG
    The placebo

Study Details

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.

Key Dates

First listed
Oct 1, 2024
Start date
Oct 1, 2025
Status verified
Sep 2024
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
65 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 5 % GM-XANTHO [GM-XAN003] group
    Patients will take the test product, 5 % GM-XANTHO \[GM-XAN003\].
  • Placebo Comparator: Placebo group
    Patients will take the placebo.

Primary Outcome Measure

Change from baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: through study completion, an average of 7 weeks ]

Central Contacts

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