A Study to Confirm Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
NCT ID: NCT06672393
Last Updated: 2024-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
375 participants
INTERVENTIONAL
2024-11-04
2026-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HS-10374
Subjects will receive HS-10374 from Week 0 through Week 52.
HS-10374 6mg tablets
Specified dose of HS-10374 tablets administered orally QD on specified days
Placebo
Subjects will receive HS-10374 matching placebo from Week 0 through Week 16, and HS-10374 from Week 16 through Week 52.
HS-10374 6mg tablets
Specified dose of HS-10374 tablets administered orally QD on specified days
HS-10374-matched placebo tablets
Specified dose of HS-10374-matched placebo tablets administered orally QD on specified days
Interventions
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HS-10374 6mg tablets
Specified dose of HS-10374 tablets administered orally QD on specified days
HS-10374-matched placebo tablets
Specified dose of HS-10374-matched placebo tablets administered orally QD on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hansoh BioMedical R&D Company
INDUSTRY
Responsible Party
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Locations
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Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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HS-10374-301
Identifier Type: -
Identifier Source: org_study_id
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