A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis
- Summary
- This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of mild-to-moderate plaque psoriasis.
- Short title
- A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate Clinical Efficacy and Safety of HS-10374 in Adult Patients With Mild-to-moderate Plaque Psoriasis
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-12-09
- First posted
- 2025-04-13
- Registry last updated
- 2025-04-13
- Primary completion date
- 2026-07-09
- Start date
- 2025-04-09
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Randomisation ratio
- 2:2:1
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Hansoh BioMedical R&D Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06926582
- ClinicalTrials.gov ID
- NCT06926582
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 12
Timeframe: Baseline to Week 12
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.
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Timeframe: Baseline to Week 16
Number of participants with clinical laboratory abnormalities
Timeframe: Baseline to Week 16
Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, C-reactive protein, etc.
Incidence of clinically significant changes in electrocardiogram (ECG)
Timeframe: Baseline to Week 16
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
Number of participants with abnormalities of physical examination
Timeframe: Baseline to Week 16
Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
Number of participants with abnormalities of vital signs
Timeframe: Baseline to Week 16
Vital signs measured include blood pressure, pulse rate, and temperature.
Proportion of patients with sPGA 0/1 at specified time points
Timeframe: Baseline to Week 16
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.
Proportion of patients achieving BSA 75 response at specified time points
Timeframe: Baseline to Week 16
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. BSA 75 response is defined as 75% or greater improvement in BSA score from baseline.
Change from baseline in BSA at specified time points
Timeframe: Baseline to Week 16
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.
Proportion of patients who achieved BSA ≤ 1% at specified time points
Timeframe: Baseline to Week 16
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.
Change from baseline in PASI at specified time points
Timeframe: Baseline to Week 16
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.
Proportion of patients who achieved BSA ≤ 3% for patients with baseline BSA > 3% at specified time points
Timeframe: Baseline to Week 16
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.
Proportion of patients achieving ss-PGA 0/1 for patients with a baseline ss-PGA score ≥2 at specified time points
Timeframe: Baseline to Week 16
Scalp specific physician's global assessment (sPGA) of psoriasis is an assessment of the disease severity of scalp psoriasis based on erythema, thickness, and scale. It's a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "absence of disease" or "very mild disease" respectively.
Change from baseline in DLQI scores at specified time points
Timeframe: Baseline to Week 16
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).
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Healthy volunteers
- No
- Male or female subjects between the ages of 18-70 years
- Diagnosis of plaque psoriasis for at least 6 months
- sPGA score of 2-3, BSA 2-15%, PASI score 2-15
- Subject must be inadequately controlled with, or intolerant of at least one topical therapy
- Diagnosis of non-plaque psoriasis or drug-induced psoriasis
- Recent history of infection, history or risk of serious infection
- Any major illness or evidence of unstable condition of major organ systems including psychiatric disease
- Any condition possibly affecting the PK process of the study drug
- Evidence of other skin conditions that would interfere with the evaluation of psoriasis
- History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis
- Prior exposure to TYK2 inhibitors
- Have received the prohibited treatment during the protocol required washout period
- Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period
- Shanghai Dermatology HospitalShanghai, China
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Psoriasis Primary condition