Psoriasis
Conditions
Brief summary
This study has been designed to confirm the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis.
Detailed description
This is a 52-week, multi-center, randomized, double-blind, placebo-controlled, Phase 3 study. The study duration includes a 4-week screening period, a 16-week placebo-controlled treatment period, a 36-week study drug treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:1 ratio to receive HS-10374 or placebo QD. At Week 16, subjects receiving placebo will be switched to HS-10374 QD.
Interventions
Specified dose of HS-10374 tablets administered orally QD on specified days
Specified dose of HS-10374-matched placebo tablets administered orally QD on specified days
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects aged 18 years and older * Diagnosis of plaque psoriasis for at least 6 months * Eligible for phototherapy or systemic therapy * Plaque covering ≥ 10% of BSA * PASI ≥ 12, sPGA ≥3
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving PASI 75 response at Week 16 | 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. |
| Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of clinically significant changes in electrocardiogram (ECG) | Baseline to Week 56 | ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval. |
| Number of participants with abnormalities of physical examination | Baseline to Week 56 | 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 | Baseline to Week 56 | Vital signs measured include blood pressure, pulse rate, and temperature. |
| PASI 75 response rates at specified time points | Baseline to Week 56 | 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. |
| PASI 90 response rates at specified time points | Baseline to Week 56 | 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 56 | 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. |
| Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation | Baseline to Week 56 | — |
| Proportion of patients with sPGA 0 at specified time points | Baseline to Week 56 | 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 means clear. |
| Proportion of patients achieving PSSD symptom score of 0 at specified time points among patients with a baseline symptom score ≥1 | Baseline to Week 56 | Psoriasis symptoms and signs diary (PSSD) is an 11-item patient-reported instrument. It assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 subject-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated from 0 (absent) to 10 (worst imaginable). Two subscores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease. |
| Proportion of patients achieving DLQI 0/1 at specified time points among patients with a baseline DLQI score ≥2 | Baseline to Week 56 | 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). |
| Proportion of patients achieving ss-PGA 0/1 at Week 16 among patients with a baseline ss-PGA score ≥3 | 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. |
| Proportion of patients achieving PGA-F 0/1 at Week 16 among patients with a baseline PGA-F score ≥3 | Baseline to Week 16 | Physician's global assessment of fingernails (PGA-F) is a scale used to assess a patient's fingernail psoriasis. Ten fingernails on the hand will be globally evaluated separately for nail bed and nail matrix disease on a scale of 0 to 4. The overall global assessment of nails is the worse of the nail bed and nail matrix assessment. A PGA-F score of 0 or 1 means clear or minimal respectively. |
| Proportion of patients achieving pp-PGA 0/1 at Week 16 among patients with a baseline pp-PGA score ≥3 | Baseline to Week 16 | Palmoplantar PGA (pp-PGA) is a scale performed by investigators to assess a patient's palmoplantar psoriasis lesions on a scale of 0 to 4. A pp-PGA score of 0 or 1 means clear or almost clear respectively. |
| Proportion of patients with sPGA 0/1 at specified time points | Baseline to Week 56 | 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. |
| Number of participants with clinical laboratory abnormalities | Baseline to Week 56 | Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, high-sensitivity C-reactive protein, etc. |
Countries
China
Contacts
Primary ContactJinhua Xu, MD
Outcome results
None listed