Clinical trial NCT06672393: A Study to Confirm Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Hansoh BioMedical R&D Company
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of patients achieving PASI 75 response at Week 16
timeFrame: Baseline to Week 16
measure: Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 16
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
timeFrame: Baseline to Week 56
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Baseline to Week 56
measure: Incidence of clinically significant changes in electrocardiogram (ECG)
timeFrame: Baseline to Week 56
measure: Number of participants with abnormalities of physical examination
timeFrame: Baseline to Week 56
measure: Number of participants with abnormalities of vital signs
timeFrame: Baseline to Week 56
measure: PASI 75 response rates at specified time points
timeFrame: Baseline to Week 56
measure: PASI 90 response rates at specified time points
timeFrame: Baseline to Week 56
measure: PASI 100 response rates at specified time points
timeFrame: Baseline to Week 56
measure: Proportion of patients with sPGA 0/1 at specified time points
timeFrame: Baseline to Week 56
measure: Proportion of patients with sPGA 0 at specified time points
timeFrame: Baseline to Week 56
measure: Proportion of patients achieving PSSD symptom score of 0 at specified time points among patients with a baseline symptom score ≥1
timeFrame: Baseline to Week 56
measure: Proportion of patients achieving DLQI 0/1 at specified time points among patients with a baseline DLQI score ≥2
timeFrame: Baseline to Week 56
measure: Proportion of patients achieving ss-PGA 0/1 at Week 16 among patients with a baseline ss-PGA score ≥3
timeFrame: Baseline to Week 16
measure: Proportion of patients achieving PGA-F 0/1 at Week 16 among patients with a baseline PGA-F score ≥3
timeFrame: Baseline to Week 16
measure: Proportion of patients achieving pp-PGA 0/1 at Week 16 among patients with a baseline pp-PGA score ≥3
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital affiliated to Fudan University
state: Shanghai
Study officials:
References: