A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077331
• Other study ID #: HS-10374-201
• Status: Recruiting
• Phase: Phase 2
• Start date: September 28, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: Hansoh BioMedical R&D Company
• Contact: Jinghua Xu, PhD
• Phone: 13818978539
• Email: xjhhsyy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis. Additionally, this study is to find the optimal dosing for the future clinical development of HS-10374.

Description:

This is a 12-week, multi-center, randomized, double blind, placebo-controlled, Phase 2 study. The study duration includes a 4-week screening period, a 12-week treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned to 1 of 3 treatment arms (HS-10374 Dose 1, HS-10374 Dose 2, and placebo) in an equal ratio.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects between the ages of 18-70 years

2. Diagnosis of plaque psoriasis for at least 6 months

3. Eligible for phototherapy or systemic therapy

4. Plaque covering = 10% of BSA

5. PASI = 12, sPGA =3

Exclusion Criteria:

1. Diagnosis of non-plaque psoriasis or drug-induced psoriasis

2. Recent history of infection, history or risk of serious infection

3. Any major illness or evidence of unstable condition of major organ systems including psychiatric disease

4. Any condition possibly affecting the PK process of the study drug

5. Evidence of other skin conditions that would interfere with the evaluation of psoriasis

6. History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis

7. History of lack of response to any therapeutic agent targeted to IL-12, IL-17 or IL-23 at approved doses after at least 3 months of therapy

8. Have received the prohibited treatment during the protocol required washout period

9. Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• HS-10374 tablets 1mg
Administered orally QD for 12 weeks
• HS-10374 tablets 5mg
Administered orally QD for 12 weeks
• HS-10374-matched placebo tablets
Administered orally QD for 12 weeks

Locations

Country	Name	City	State
China	Huashan Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Hansoh BioMedical R&D Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with moderate to severe plaque psoriasis achieving PASI 75 response at Week 12	Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 response is defined as 75% or greater improvement in PASI score from baseline.	Baseline to Week 12
Secondary	Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation		Baseline to Week 16
Secondary	Number of participants with clinical laboratory abnormalities	Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, high-sensitivity C-reactive protein, etc.	Baseline to Week 16
Secondary	Number of participants with abnormalities of vital signs	Vital signs measured include blood pressure, pulse rate, and temperature.	Baseline to Week 16
Secondary	Number of participants with abnormalities of physical examination	Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.	Baseline to Week 16
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG)	ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.	Baseline to Week 16
Secondary	Proportion of patients with sPGA 0/1 at specified time points	Static physician's global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively.	Baseline to Week 16
Secondary	PASI 50 response rates at specified time points	Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 50 response is defined as 50% or greater improvement in PASI score from baseline.	Baseline to Week 16
Secondary	PASI 75 response rates at specified time points	Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 response is defined as 75% or greater improvement in PASI score from baseline.	Baseline to Week 16
Secondary	PASI 90 response rates at specified time points	Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 response is defined as 90% or greater improvement in PASI score from baseline.	Baseline to Week 16
Secondary	PASI 100 response rates at specified time points	Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 response is defined as 100% improvement in PASI score from baseline.	Baseline to Week 16
Secondary	Change from baseline in PASI scores at specified time points	Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity.	Baseline to Week 16
Secondary	Change from baseline in BSA at specified time points	Psoriasis body surface area (BSA) involvement is measured using the handprint method with the size of a patient's handprint representing ~1% of body surface area involved.	Baseline to Week 16
Secondary	Change from baseline in DLQI scores at specified time points	The dermatology life quality index (DLQI) is a patient reported outcome measurement. It's a questionnaire consisting of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. Each question is scored on a scale of 0 to 3, and the sum of each scores range from 0 (no impairment of life quality) to 30 (maximum impairment).	Baseline to Week 16
Secondary	Ctrough	Trough observed plasma concentration.	Baseline to Week 12