Moderate-to-Severe Plaque Psoriasis
Conditions
Brief summary
This is study designed to investigate the efficacy and safety of Jaktinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.
Interventions
DRUGJaktinib
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18\ 65 years old (including lower limit), no gender limit； * You must have active chronic plaque psoriasis for at least 6 months prior to entry into the study； * You must have active plaque psoriasis covering at least 10% body surface area； You must have Psoriasis Area and Severity Index (PASI) score of at least 12；You must have Static Physician's Global Assessment (sPGA) score of at least 3； * The patient can communicate well with the investigator and follow the research and follow-up procedures； * Understand and voluntarily sign the informed consent form.
Exclusion criteria
* You must not have prior treatment with an oral Janus kinase (JAK) inhibitor； * You must not have received a phototherapy within 4 weeks prior to entry into the study； * You must not have a history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)； * You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Jaktinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI]) | Week 12 | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Jaktinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA]) | Week 8、12、16、20、24 | The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear |
Countries
China
Outcome results
None listed