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

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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

NCT06620692•Xantho Biotechnology Co., LTD

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Female or male patients are ≥ 20 years old.
•2. Patients who are able to understand the nature of this study and accept to enter the study by signing written informed consent.
•3. Patients are willing or able to comply with procedures required in this protocol including self-administration of study drug.
•4. Patients who have well diagnosed chronic plaque psoriasis for at least 6 months before the Screening Visit (according to Am Fam Physician. 2013 May 1;87(9):626-633).
•5. The severity of plaque psoriasis is stable mild to moderate which meets the following disease activity criteria at both Screening and Baseline Visit (according to Joint AAD-NPF Guidelines)
•6. Patients who agree discontinuation of systemic corticosteroids and systemic immune modulating agents during the study period.
•7. Patients who agree discontinuation of all local treatment modalities, including but not limited to topical corticosteroid or light treatments during the study period for/on the affected regions.
•8. Patients are required to stop using treatment modalities listed in Criteria #6 and #7 at least 14 days (or longer if the treatment half-life requires so; 7 half-life should have elapsed).
•9. Patients have adequate hematopoietic, hepatic function, and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
•* Hemoglobin ≥ 10 g/dL
+12 more criteria

Exclusion Criteria

•1. Patients with the following subtype of psoriasis:
•* Erythrodermic psoriasis
•* Generalized or localized pustular psoriasis,
•* edication-induced or medication-exacerbated psoriasis,
•* New onset guttate psoriasis.
•2. Patients who have any concurrent skin condition that will interfere with assessment of treatment.
•3. Patients who have systemic infection during the last 2 weeks prior to Screening Visit or active infection on the psoriasis lesion.
•4. Patients who have known hypersensitivity to the study medication.
•5. Patients with chronic condition(s) which either is not stable or not well controlled.
•6. Patients having positive results for HBV, HCV or HIV screens.
+4 more criteria

Key Dates

Start Date

October 1, 2025

Primary Completion Date

December 31, 2027

Completion Date

June 30, 2028

Last Updated

October 1, 2024

Enrollment

ESTIMATED participants

Conditions

Psoriasis

Interventions

5% GM-XANTHO [GM-XAN003]

DRUG

Placebo

DRUG

Contacts

Echo Regulatory Affairs Group Assistant Manager

CONTACT

886-2-26575399 echo.lee@vcro.com.tw

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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