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

NCT06620692 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: XANGMXH20211027
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Psoriasis Area and Severity Index (PASI)

  through study completion, an average of 7 weeks

Secondary Outcomes (4)

• Change from baseline in Body Surface Area (BSA) affected

  through study completion, an average of 7 weeks

• Change from baseline in quality of life by using the Dermatology Life Quality Index (DLQI)

  through study completion, an average of 7 weeks

• Incidence of subjects experiencing treatment related AE with ≥ Grade 2 according to the predefined toxicity grading scale in this study

  through study completion, up to 2 years

• Number of patients achieving PGA of 0 or 1 at each visit

  through study completion, up to 2 years

Study Arms (2)

5 % GM-XANTHO [GM-XAN003] group

EXPERIMENTAL

Patients will take the test product, 5 % GM-XANTHO \[GM-XAN003\].

Drug: 5% GM-XANTHO [GM-XAN003]

Placebo group

PLACEBO COMPARATOR

Patients will take the placebo.

Drug: Placebo

Interventions

5% GM-XANTHO [GM-XAN003] DRUG

5% GM-XANTHO \[GM-XAN003\]

5 % GM-XANTHO [GM-XAN003] group

Placebo DRUG

The placebo

Placebo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male patients are ≥ 20 years old.
• Patients who are able to understand the nature of this study and accept to enter the study by signing written informed consent.
• Patients are willing or able to comply with procedures required in this protocol including self-administration of study drug.
• 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).
• 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)
• Patients who agree discontinuation of systemic corticosteroids and systemic immune modulating agents during the study period.
• 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.
• 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).
• 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
• Total WBC ≥ 3,000 cells/μL
• Platelet ≥ 55,000 counts/μL without transfusion support
• Total bilirubin ≤ 1.5× ULN and no sign of jaundice
• ALT and AST ≤ 5× ULN and no clinical significance
• Creatinine ≤ 1.5× ULN and no clinical significance

You may not qualify if:

• Patients with the following subtype of psoriasis:
• Erythrodermic psoriasis
• Generalized or localized pustular psoriasis,
• edication-induced or medication-exacerbated psoriasis,
• New onset guttate psoriasis.
• Patients who have any concurrent skin condition that will interfere with assessment of treatment.
• Patients who have systemic infection during the last 2 weeks prior to Screening Visit or active infection on the psoriasis lesion.
• Patients who have known hypersensitivity to the study medication.
• Patients with chronic condition(s) which either is not stable or not well controlled.
• Patients having positive results for HBV, HCV or HIV screens.
• Patients who are pregnant or breast feeding.
• Patients who have the medical history of malignancy of any organ system (other than cervical carcinoma in situ or successfully treated non-melanoma skin cancer) within 5 years prior to study entry.
• Patients had participated in investigational drug trials and took any investigational drugs within 30 days or within 5 half-life of the investigational drugs prior to the screening visit.
• Patients who are not suitable to participate in the trial as judged by the Investigator(s).

Sponsors & Collaborators

• Xantho Biotechnology Co., LTD: lead
• Virginia Contract Research Organization Co., Ltd.: collaborator

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clinical PM

  Xantho Biotechnology Co., LTD

  STUDY DIRECTOR

Central Study Contacts

Echo Regulatory Affairs Group Assistant Manager

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share