An Investigational Study to Evaluate Experimental Medication SYHX1901 Tablets With Moderate to Severe Plaque Psoriasis

NCT05858047 | Completed Phase 2

• 1 other identifier: SYHX1902-002
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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 in order to select doses for further clinical trials.

Conditions

Effects, Drug Side

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a Psoriasis Area and Severity Index Score ≥75% (PASI 75) response

  Week 12

Secondary Outcomes (4)

• Percentage of Participants Achieving a Psoriasis Area and Severity Index Score ≥50% (PASI 50) response

  Week 12

• Percentage of Participants Achieving a Physician Global Assessment (PGA) of 0 or 1

  Week 12

• Change from Baseline in Body Surface Area (BSA) affected with Psoriasis to Week 12

  Week 12

• Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1

  Week 12

Other Outcomes (1)

• Incidence of AEs and SAEs

  Time Frame:Week 16

Study Arms (4)

Group I (Placebo)

PLACEBO COMPARATOR

Placebo will be administered orally (PO) for 12 weeks.

Drug: Placebo

Group Ⅱ (SYHX1901 60 mg)

EXPERIMENTAL

SYHX1901 will be administered orally (PO) for 12 weeks.

Drug: SYHX1901

Group III (SYHX1901 90 mg)

EXPERIMENTAL

SYHX1901 will be administered orally (PO) for 12 weeks.

Drug: SYHX1901

Group Ⅳ (SYHX1901 180 mg)

EXPERIMENTAL

SYHX1901 will be administered orally (PO) for 12 weeks.

Drug: SYHX1901

Interventions

Placebo DRUG

Administered orally, once daily (QD)

Group I (Placebo)

SYHX1901 DRUG

Administered orally, once daily (QD)

Group III (SYHX1901 90 mg); Group Ⅱ (SYHX1901 60 mg); Group Ⅳ (SYHX1901 180 mg)

Eligibility Criteria

• Age: 18 Years - 75 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;
• Age ≥18 and ≤ 75 years old;
• 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 ≥12 and Physician's Global Assessment (PGA) score ≥3 at screening and baseline;
• Negative blood pregnancy results should be provided 14 days (inclusive) and 3 days (inclusive) prior to initial dosing, 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;
• 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;
• Other active skin conditions that may affect the clinical evaluation of psoriasis;
• Active infection or fever at randomization;
• Severe bacterial, fungal, or viral infection requiring hospitalization/intravenous drug treatment within 60 days prior to randomization;
• Any proven history of untreated bacterial infection within 60 days prior to randomization;
• Any existing evidence of chronic infection;
• Any proven history of infection of a joint prosthesis or receiving antibiotics for a suspected joint prosthesis infection;
• Received live vaccine within 60 days before randomization or scheduled to receive live vaccine within 60 days after the end of the study;
• History of severe herpes zoster or sever herpes simplex infection;
• Abnormal hepatitis B virus (HBV) related check during screening;
• Hepatitis C virus (HCV) antibody positive at screening;
• HIV antibody or treponema pallidum antibody positive;
• Any known or suspected condition of congenital or acquired immunodeficiency;
• Tuberculosis (TB);

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: May 15, 2023
• Study Start: April 11, 2023
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)