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

NCT06943950 | Not Yet Recruiting Phase 3

• 1 other identifier: SYHX1902-007
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Moderate to Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Title: The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving SYHX1901 Compared to Placebo at Week 16 (sPGA 0/1) Description: The sPGA is a 5-point scale of an average assessment of all

  Week 16

• Title: The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving SYHX1901 Compared to Placebo at Week 16 (PASI 75) Description: PASI is a measure of th

  Baseline and Week 16

Study Arms (3)

SYHX1901 dose 1

EXPERIMENTAL

Drug: SYHX1901

SYHX1901 dose 2

EXPERIMENTAL

Drug: SYHX1901

Placebo

PLACEBO COMPARATOR

Drug: SYHX1901

Interventions

SYHX1901 DRUG

Administered orally, once daily (QD)

Placebo; SYHX1901 dose 1; SYHX1901 dose 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): April 28, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04