NCT06842199 Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis
| NCT ID | NCT06842199 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Beijing InnoCare Pharma Tech Co., Ltd. |
| Condition | Plaque Psoriasis Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 383 participants |
| Start Date | 2025-03-20 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 383 participants in total. It began in 2025-03-20 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06842199 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Plaque Psoriasis Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06842199 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 383 participants.
Is NCT06842199 currently recruiting?
Yes, NCT06842199 is actively recruiting participants. Contact the research team at CO_HGRAC@innocarepharma.com for enrollment information.
Where is the NCT06842199 trial being conducted?
This trial is being conducted at Hefei, China, Wuhu, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT06842199 clinical trial?
NCT06842199 is sponsored by Beijing InnoCare Pharma Tech Co., Ltd.. The trial plans to enroll 383 participants.
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