Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 12:55 AM
NCT ID:
NCT05078567
Eligibility Criteria:
Inclusion Criteria:
1. Male and female subjects ages 20 to 65 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 6 months prior to the study.
2. Capable of giving written informed consent
3. BSA involvement ≥ 5% and ≤ 10%
4. A PGA score of 3 (moderate) at screening and baseline
5. One target plaque located on the trunk or proximal parts of extremities (excluding knees, elbows, and intertriginous areas) that is at least 3 (centimeter) cm х 3 cm in size at Screening and Baseline with a severity representative of the subject's overall disease.
6. Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study, including screening, during the treatment period, and for at least 4 weeks after the last exposure to study treatment
Exclusion Criteria:
1. Psoriasis other than plaque variant
2. Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection within 1 week prior to the Baseline visit; chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the Baseline visit
3. Significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
4. Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's psoriasis
5. Use of any prohibited medication within the indicated period before the first dose of study drug:
* Within a minimum of 5 half lives for biologic agents
* Within 4 weeks for systemic immunosuppressive or immunomodulating agents, fumaric acid derivatives, vitamin D3 and analogs, retinoids, psolarens, corticosteroids, adrenocorticotropic hormone analogs, and tazarotene
* 2 weeks for immunizations with a live viral component
* Drugs known to possibly worsen psoriasis, unless on a stable dose for \> 12 weeks
* With the exception of non medicated emollients, 1 week for topical treatments including corticosteroids, immunomodulators, anthralin (dithranol), vitamin D derivatives or coal tar
* Any investigational product within 30 days, 5 half lives, or twice the duration of the biological effect of the study drug (whichever is longer) prior to first dose of study drug
6. Pregnant females or lactating females
7. Subjects have an allergic history of soybean and soybean derivatives.
8. History of sensitivity to the study drugs, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates the subject's participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT05078567
Study Brief:
Protocol Section:
NCT05078567