Last updated: November 30, 2023
Sponsor: Hansoh BioMedical R&D Company
Overall Status: Active - Recruiting
Phase
2
Condition
Warts
Rosacea
Scalp Disorders
Treatment
HS-10374-matched placebo tablets
HS-10374 tablets 1mg
HS-10374 tablets 5mg
Clinical Study ID
NCT06077331
HS-10374-201
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female subjects between the ages of 18-70 years
- 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
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 includingpsychiatric disease
- Any condition possibly affecting the PK process of the study drug
- Evidence of other skin conditions that would interfere with the evaluation ofpsoriasis
- History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis
- History of lack of response to any therapeutic agent targeted to IL-12, IL-17 or IL-23at approved doses after at least 3 months of therapy
- Have received the prohibited treatment during the protocol required washout period
- Any significant laboratory or procedure abnormalities that might place the subject atunacceptable risk during this study period
Study Design
Total Participants: 120
Treatment Group(s): 3
Primary Treatment: HS-10374-matched placebo tablets
Phase: 2
Study Start date:
September 28, 2023
Estimated Completion Date:
August 31, 2024
Study Description
Connect with a study center
Huashan Hospital of Fudan University
Shanghai, Shanghai 200040
ChinaActive - Recruiting

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