Status:
NOT_YET_RECRUITING
A Phase III Study of SYHX1901 Tablets in the Treatment of Moderate to Severe Plaque Psoriasis
Lead Sponsor:
CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions:
Moderate to Severe Plaque Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of different doses of SYHX1901 tablets in the treatment of moderate to severe plaque psoriasis.
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of three different doses of SYHX1901 tablets compared with placebo in the treatm...
Eligibility Criteria
Inclusion
- 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:
- Subject must be diagnosed of chronic plaque psoriasis with no morphological changes or significant outbreaks of disease activity assessed by the investigator;
- Subject must be a candidate for systemic treatment or phototherapy assessed by the investigator;
- Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% at screening and baseline;
- 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
- Forms of psoriasis other than plaque psoriasis (Guttate psoriasis、erythrodermic psoriasis、Pustular psoriasis、Drug-induced psoriasis);
- Previous or current autoimmune disease that may affect the clinical evaluation of psoriasis;
- Other active skin conditions that may affect the clinical evaluation of psoriasis;
- Active bacterial, viral, fungal, or other infection that requires medical intervention;
- With progressive or uncontrolled systemic disease, or with chronic disease identified by the investigator as inappropriate for participation in the study;
- History of malignancy ;
- Any other medical and/or social reasons identified by the investigator as inappropriate for participation in the study;
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06943950
Start Date
June 1 2025
End Date
June 30 2027
Last Update
April 30 2025
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