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A Study to Confirm Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis

ConditionPsoriasis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company

About this trial

This study has been designed to confirm the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • HS-10374 6mg tablets

    Drug

    Specified dose of HS-10374 tablets administered orally QD on specified days

  • HS-10374-matched placebo tablets

    Drug

    Specified dose of HS-10374-matched placebo tablets administered orally QD on specified days

Treatment groups

375 Participants
are divided into 2 treatment groups
Group A: HS-10374Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients achieving PASI 75 response at 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.

Time frame
Baseline to Week 16
2

Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at 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.

Time frame
Baseline to Week 16

Secondary outcomes

1

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
2

Number of participants with clinical laboratory abnormalities

Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, high-sensitivity C-reactive protein, etc.

Time frame
Baseline to Week 56
3

Incidence of clinically significant changes in electrocardiogram (ECG)

ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.

Time frame
Baseline to Week 56
4

Number of participants with abnormalities of physical examination

Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.

Time frame
Baseline to Week 56

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hansoh BioMedical R&D Company

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: