A Phase III Study of SYHX1901 Tablets in the Treatment of Moderate to Severe Plaque Psoriasis

Launched by CSPC OUYI PHARMACEUTICAL CO., LTD. · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called SYHX1901, which comes in tablet form, to see how well it works for treating moderate to severe plaque psoriasis. Plaque psoriasis is a skin condition that causes red, scaly patches on the skin, and this study aims to find out if different doses of the medication can help improve symptoms and ensure safety for patients.

To participate in this study, you need to be between 18 and 65 years old and have a confirmed diagnosis of stable moderate-to-severe plaque psoriasis for at least six months. Participants will need to show that a significant portion of their skin (at least 10%) is affected by the condition. If you join the study, you will be closely monitored by healthcare professionals, and they will make sure you understand the process and provide consent before starting. It's important to note that the trial is not currently recruiting participants, but it's a great opportunity for those who qualify to potentially benefit from a new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects fully understand and voluntarily participate in this study and sign informed consent; 2. Age ≥18 and ≤ 65 years old; 3. Subjects with a clinical diagnosis of stable moderate-to-severe plaque psoriasis with a history ≥6 months before randomization; Subjects with stable moderate-to-severe plaque psoriasis defined as meeting all four of the following criteria simultaneously:
• • 1. Subject must be diagnosed of chronic plaque psoriasis with no morphological changes or significant outbreaks of disease activity assessed by the investigator;
• • 2. Subject must be a candidate for systemic treatment or phototherapy assessed by the investigator;
• • 3. Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% at screening and baseline;
• • 4. PASI score of ≥10 and Static Physician's Global Assessment (sPGA) score ≥3 at screening and baseline; 4. Negative blood pregnancy results should be provided 7 days (inclusive) prior to randomization, and subjects and their partners should voluntarily take contraceptive measures considered effective by the investigator during the study period and for at least 28 days after the study; 5. Subjects must be volunteer and be able to complete study procedures and follow-up examinations.
• Exclusion Criteria:
• • 1. Forms of psoriasis other than plaque psoriasis (Guttate psoriasis、erythrodermic psoriasis、Pustular psoriasis、Drug-induced psoriasis);
• • 2. Previous or current autoimmune disease that may affect the clinical evaluation of psoriasis;
• • 3. Other active skin conditions that may affect the clinical evaluation of psoriasis;
• • 4. Active bacterial, viral, fungal, or other infection that requires medical intervention;
• • 5. With progressive or uncontrolled systemic disease, or with chronic disease identified by the investigator as inappropriate for participation in the study;
• • 6. History of malignancy ;
• • 7. Any other medical and/or social reasons identified by the investigator as inappropriate for participation in the study;