A Study to Confirm Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HS-10374 6mg tablets, HS-10374-matched placebo tablets.
- Who it may be relevant to
- Registry conditions: Psoriasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis
Overview
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
- Drug HS-10374 6mg tablets
Specified dose of HS-10374 tablets administered orally QD on specified days - Drug HS-10374-matched placebo tablets
Specified dose of HS-10374-matched placebo tablets administered orally QD on specified days
Primary outcome measures
- Proportion of patients achieving PASI 75 response at Week 16 [Time frame: Baseline to Week 16]
- Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 16 [Time frame: Baseline to Week 16]
Secondary outcome measures (12)
- Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation [Time frame: Baseline to Week 56]
- Number of participants with clinical laboratory abnormalities [Time frame: Baseline to Week 56]
- Incidence of clinically significant changes in electrocardiogram (ECG) [Time frame: Baseline to Week 56]
- Number of participants with abnormalities of physical examination [Time frame: Baseline to Week 56]
- Number of participants with abnormalities of vital signs [Time frame: Baseline to Week 56]
- PASI 75 response rates at specified time points [Time frame: Baseline to Week 56]
- PASI 90 response rates at specified time points [Time frame: Baseline to Week 56]
- PASI 100 response rates at specified time points [Time frame: Baseline to Week 56]
- Proportion of patients with sPGA 0/1 at specified time points [Time frame: Baseline to Week 56]
- Proportion of patients with sPGA 0 at specified time points [Time frame: Baseline to Week 56]
- Proportion of patients achieving PSSD symptom score of 0 at specified time points among patients with a baseline symptom score ≥1 [Time frame: Baseline to Week 56]
- Proportion of patients achieving DLQI 0/1 at specified time points among patients with a baseline DLQI score ≥2 [Time frame: Baseline to Week 56]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Huashan Hospital affiliated to Fudan University — Shanghai
Identifiers
NCT: NCT06672393 · HS-10374-301