Efficacy, Safety, Pharmacokinetics of ICP-488 in Patients With Moderate to Severe Plaque Psoriasis

Phase 3

Recruiting

• Conditions: Plaque Psoriasis Patients
• Interventions: Drug: ICP-488 Tablets; Drug: ICP-488 Placebo

• Registration Number: NCT06842199
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-21
• Study First Posted: 2025-02-24
• Status Verified: 2025-03
• Study Start: 2025-03-20
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-05
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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, dietary supplements or food (e.g., grapefruit or grapefruit juice) 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICP-488 Tablets	ICP-488 Tablets	-
ICP-488 Placebo	ICP-488 Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (50)

The First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

The Second Affiliated Hospital of Wannan Medical College; 🇨🇳 Wuhu, Anhui, China

Beijing Chao-Yang Hospital，Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Tongren Hospital,CMU; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Chongqing Traditional Chinese Medicine Hospital; 🇨🇳 Chongqing, Chongqing, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

Scroll for more (40 remaining)