PsoriasisPhase 2NCT06620692
A Study to Investigate the Efficacy and Safety Profile of GM-XANTHO [GM-XAN003] in Patients With Psoriasis
A Phase 2 study testing 5% GM-XANTHO [GM-XAN003] in people with Psoriasis, run by Xantho Biotechnology Co., LTD.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- 5% GM-XANTHO [GM-XAN003]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- All male patients and female patients with child-bearing potential (between puberty and 2 years after menopause) should use at least any one of the appropriate contraception methods shown below, for during and at least 4 weeks after GM-XANTHO [GM-XAN003] treatment.
- Total abstinence [when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Male sterilization. For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.
- Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or d.2+d.3):
- d.1 Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception.
- d.2 Placement of an intrauterine device (IUD) or intrauterine system (IUS). d.3 Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase IIa Study to Investigate the Efficacy and Safety Profile of GM-XANTHO [GM-XAN003] in Patients With Psoriasis
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
- Being tested
- 5% GM-XANTHO [GM-XAN003], Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% GM-XANTHO [GM-XAN003]Drug
5% GM-XANTHO [GM-XAN003]
PlaceboDrug
The placebo
| Study group | Role | What they receive |
|---|---|---|
| 5 % GM-XANTHO [GM-XAN003] group | Experimental | Patients will take the test product, 5 % GM-XANTHO [GM-XAN003]. Receives: Drug: 5% GM-XANTHO [GM-XAN003] |
| Placebo group | Placebo comparator | Patients will take the placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Psoriasis Area and Severity Index (PASI)
Measured: through study completion, an average of 7 weeks
Secondary outcomes (4)
Change from baseline in Body Surface Area (BSA) affected
Measured: through study completion, an average of 7 weeks
Change from baseline in quality of life by using the Dermatology Life Quality Index (DLQI)
Measured: 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
Measured: through study completion, up to 2 years
Number of patients achieving PGA of 0 or 1 at each visit
Measured: through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xantho Biotechnology Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Virginia Contract Research Organization Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Clinical PM, Study director, Xantho Biotechnology Co., LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620692
- Sponsor's protocol ID
- XANGMXH20211027
- Status last verified
- Aug 2026
- First submitted
- 23 Sep 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Study to Investigate the Efficacy and Safety Profile of GM-XANTHO [GM-XAN003] in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT06620692
- Acronym / sponsor ID
- XANGMXH20211027
- Conditions
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Xantho Biotechnology Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Virginia Contract Research Organization Co., Ltd.
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 % GM-XANTHO [GM-XAN003] group | Experimental | Drug: 5% GM-XANTHO [GM-XAN003]Patients will take the test product, 5 % GM-XANTHO [GM-XAN003]. |
| Placebo group | Placebo comparator | Drug: PlaceboPatients will take the placebo. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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)
Key exclusion criteria (14 listed)
- Patients with the following subtype of 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% GM-XANTHO [GM-XAN003]5% GM-XANTHO [GM-XAN003] | Drug | 5 % GM-XANTHO [GM-XAN003] group |
| PlaceboThe placebo | Drug | Placebo group |
Primary outcome
Change from baseline in Psoriasis Area and Severity Index (PASI)
Time frame: through study completion, an average of 7 weeks
4 secondary outcomes
Change from baseline in Body Surface Area (BSA) affected
Time frame: through study completion, an average of 7 weeks
Change from baseline in quality of life by using the Dermatology Life Quality Index (DLQI)
Time frame: 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
Time frame: through study completion, up to 2 years
Number of patients achieving PGA of 0 or 1 at each visit
Time frame: through study completion, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical PM study director
Xantho Biotechnology Co., LTD
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5% GM-XANTHO [GM-XAN003] in people with Psoriasis, run by Xantho Biotechnology Co., LTD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Regulatory Affairs Group Assistant Manager (886-2-26575399 ext. 4218, echo.lee@vcro.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Psoriasis Area and Severity Index (PASI) (time frame: through study completion, an average of 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.