Evaluating HS-10374 for treating moderate to severe plaque psoriasis
A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis
This study is testing a new treatment called HS-10374 to see if it can help people with moderate to severe plaque psoriasis feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Hansoh BioMedical R&D Company Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06077331 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of HS-10374 in patients with moderate to severe plaque psoriasis. It is a 12-week, multi-center, randomized, double-blind, placebo-controlled Phase 2 study that includes a 4-week screening period, a 12-week treatment period, and a 4-week follow-up. Participants will be randomly assigned to receive either HS-10374 at two different doses or a placebo. The study will also determine the optimal dosing for future clinical development of HS-10374.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a diagnosis of plaque psoriasis covering at least 10% of their body surface area.
Not a fit: Patients with non-plaque psoriasis or those who have previously not responded to targeted therapies for psoriasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from moderate to severe plaque psoriasis.
How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in treating psoriasis with novel agents, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female subjects between the ages of 18-70 years 2. Diagnosis of plaque psoriasis for at least 6 months 3. Eligible for phototherapy or systemic therapy 4. Plaque covering ≥ 10% of BSA 5. PASI ≥ 12, sPGA ≥3 Exclusion Criteria: 1. Diagnosis of non-plaque psoriasis or drug-induced psoriasis 2. Recent history of infection, history or risk of serious infection 3. Any major illness or evidence of unstable condition of major organ systems including psychiatric disease 4. Any condition possibly affecting the PK process of the study drug 5. Evidence of other skin conditions that would interfere with the evaluation of psoriasis 6. History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis 7. History of lack of response to any therapeutic agent targeted to IL-12, IL-17 or IL-23 at approved doses after at least 3 months of therapy 8. Have received the prohibited treatment during the protocol required washout period 9. Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period
Where this trial is running
Shanghai, Shanghai
- Huashan Hospital of Fudan University — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jinhua Xu — Huashan Hospital
- Study coordinator: Jinghua Xu, PhD
- Email: xjhhsyy@163.com
- Phone: 13818978539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.