Psoriasis
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGHS-10374 tablets 1mg
Administered orally QD for 12 weeks
DRUGHS-10374 tablets 5mg
Administered orally QD for 12 weeks
Administered orally QD for 12 weeks
Sponsors
Hansoh BioMedical R&D Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with moderate to severe plaque psoriasis achieving PASI 75 response at Week 12 | Baseline to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with clinical laboratory abnormalities | Baseline to Week 16 | Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, high-sensitivity C-reactive protein, etc. |
| Number of participants with abnormalities of vital signs | Baseline to Week 16 | Vital signs measured include blood pressure, pulse rate, and temperature. |
| Number of participants with abnormalities of physical examination | Baseline to Week 16 | Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc. |
| Incidence of clinically significant changes in electrocardiogram (ECG) | Baseline to Week 16 | ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval. |
| Proportion of patients with sPGA 0/1 at specified time points | 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. |
| PASI 50 response rates at specified time points | 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. PASI 50 response is defined as 50% or greater improvement in PASI score from baseline. |
| Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation | Baseline to Week 16 | — |
| PASI 90 response rates at specified time points | 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. PASI 90 response is defined as 90% or greater improvement in PASI score from baseline. |
| PASI 100 response rates at specified time points | 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. PASI 100 response is defined as 100% improvement in PASI score from baseline. |
| Change from baseline in PASI scores at specified time points | 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. |
| Change from baseline in BSA at specified time points | 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 DLQI scores at specified time points | 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). |
| Ctrough | Baseline to Week 12 | Trough observed plasma concentration. |
| PASI 75 response rates at specified time points | 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. PASI 75 response is defined as 75% or greater improvement in PASI score from baseline. |
Countries
China
Contacts
Primary ContactJinghua Xu, PhD
Outcome results
None listed