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

NCT ID: NCT06943950

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-06-30

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 treatment of moderate to severe plaque psoriasis. The total duration of the study will be 60 weeks which will be comprised of: a screening period (4 weeks); a core treatment period (16 weeks), a extended treatment period（36 weeks）and a follow-up assessment period (4 weeks). Eligible subjects will be randomly assigned to SYHX1901 dose 1 , dose 2 or placebo group at a 2:2:1 ratio for continuous oral administration for 16 weeks，then placebo group will will be randomly assigned to SYHX1901 dose 1, dose 2 at a 1:1 ratio for continuous oral administration for 36 weeks, the SYHX1901 dose 1, dose 2 group will remain the same dose for 36 weeks. The presence or absence of prior treatment with biological agents will be a stratification factor. Subjects will be monitored for the efficacy and safety throughout the study.

Conditions

Moderate to Severe Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SYHX1901 dose 1

Group Type: EXPERIMENTAL

SYHX1901

Intervention Type: DRUG

Administered orally, once daily (QD)

SYHX1901 dose 2

Group Type: EXPERIMENTAL

SYHX1901

Intervention Type: DRUG

Administered orally, once daily (QD)

Placebo

Group Type: PLACEBO_COMPARATOR

SYHX1901

Intervention Type: DRUG

Administered orally, once daily (QD)

Interventions

SYHX1901

Administered orally, once daily (QD)

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Clinical Trials Information Group officer

Role: CONTACT

ctr-contact@cspc.cn

86-0311-69085587

Other Identifiers

SYHX1902-007

Identifier Type: -

Identifier Source: org_study_id