NCT06943950Not yet recruitingPhase 3
A Phase III Study of SYHX1901 Tablets in the Treatment of Moderate to Severe Plaque Psoriasis
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SYHX1901 Tablets in the Treatment of Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov · Last updated 30 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 17 Apr 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 28 Apr 2027
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Diseases
- Psoriasis
- NCT number
- NCT06943950
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 500
- From 1 Jun 2025 to the primary completion date, 28 Apr 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- 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 ;
Other
- Any other medical and/or social reasons identified by the investigator as inappropriate for participation in the study;
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.