Plaque Psoriasis Patients
Conditions
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy, safety, PK characteristics of ICP-488 in Chinese adults with moderate to severe plaque psoriasis.
Interventions
DRUGICP-488 Tablets
Eligible patients will receive ICP-488 orally as per the protocol
DRUGICP-488 Placebo
Eligible patients will receive ICP-488 Placebo orally as per the protocol
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Eligible subjects must meet all of the following criteria: 1. Subjects voluntarily participate in this study and have signed informed consent. 2. Male or female subjects between the ages of 18 and 75 (including the threshold) at the time of signing the ICF. 3. History of plaque psoriasis ≥6 months at baseline. 4. Subjects need to receive systemic therapy and/or phototherapy. 5. The following three criteria were met: a) psoriasis Area and Severity index (PASI) score ≥12; b) Psoriasis affected body surface area (BSA) ≥10%; c) Static physician overall assessment (sPGA) ≥3 scores
Exclusion criteria
1. The diagnosis was non-plaque psoriasis. 2. Subjects with concurrent skin diseases that the investigator believes would interfere with the study assessments. 3. Presence of infection or immune-related disease. 4. Subjects with a history of TB or at risk for TB. 5. Received related treatment within the time window specified in the protocol. 6. An interval of less than 5 half-lives or 28 days (if any available half-life data) from the last dose of a strong CYP1A2/CYP3A4 inhibitor or inducer, or a plan to use concurrently medications with strong CYP1A2/CYP3A4 inhibitory or inductive effect during study participation. 7. The investigator has determined that there are clinically significant test results and that participation in this trial would pose an unacceptable risk to patients; Or the laboratory values of the subjects in the screening period meet the criteria specified in the protocol. 8. Pregnant or lactating women, or women who plan to become pregnant during study participation. 9. A history of severe drug allergies. 10. Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who achieve a score of clear (0) or almost clear (1) with an improvement of at least 2 points from baseline on the static Physician's Global Assessment (sPGA) at week 16 | week 16 |
| Percentage of subjects who achieved a PASI 75 response (a reduction of minimum 75% from baseline in PASI score) at Week 16 | Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | Week 52 |
| Percentage of subjects with PASI 50/75/90/100 in each planned visit | Week 52 |
| Percentage of subjects with sPGA score of 0 (clear) or 1 (almost clear) and an improvement of at least 2 points from baseline in planned visits. | Week 52 |
| The proportion of subjects with sPGA score of 0 in each planned visit. | Week 52 |
| PK parameter: ICP-488 and its metabolite. | Week 52 |
Countries
China
Contacts
CONTACTAlexia Lu
Outcome results
None listed