Status:
COMPLETED
Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ICP-488 in Patients with Moderate to Severe Plaque Psoriasis
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Moderate to Severe Plaque Psoriasis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate ICP-488.Efficacy, safety, PK, and PD characteristics in Chinese adults with moderate to severe p...
Eligibility Criteria
Inclusion
- Subjects voluntarily participate in this study and have signed informed consent.
- Male or female subjects between the ages of 18 and 70 (including the threshold) at the time of signing the ICF.
- History of plaque psoriasis ≥6 months at baseline.
- Subjects need to receive systemic therapy and/or phototherapy.
- 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
- The diagnosis was non-plaque psoriasis.
- Presence of infection or immune-related disease.
- Subjects with a history of TB or at risk for TB.
- Received related treatment within the time window specified in the protocol.
- An interval of less than 5 half-lives or 28 days (if any available halflife data) from the last dose of a strong CYP1A2 inhibitor or inducer, or a plan to use concurrently medications, dietary supplements or food with strong CYP1A2 inhibitory or inductive effect during study participation.
- 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.
- Pregnant or lactating women, or women who plan to become pregnant during study participation.
- A history of severe drug allergies.
- Any other conditions in which the investigator considers it unsuitable for the subject to participate in this study.
Key Trial Info
Start Date :
January 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2024
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT06109818
Start Date
January 4 2024
End Date
September 18 2024
Last Update
February 28 2025
Active Locations (31)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000
2
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100000
3
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400000
4
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350000