A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis

NCT07129382 | Recruiting Phase 1

• 1 other identifier: CS32582-201
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 11

Brief Summary

" This study consists of two parts: Part 1 (Dose Escalation): A randomized, double-blind, placebo-controlled phase in which approximately 20 to 30 adult patients with plaque psoriasis will receive the investigational treatment for 4 weeks. Part 2 (Efficacy and Safety Assessment): A randomized, double-blind, placebo-controlled evaluation where approximately 200 adult patients with plaque psoriasis will undergo 12 weeks of treatment. The resulting data will provide preliminary evidence on the safety and efficacy profile of CS32582, informing its subsequent development strategy.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Part 1：Incidence and Severity of Adverse Events (AEs)

  5 weeks

• Part 2：Proportion of patients achieved Psoriasis Area Severity Index (PASI) 75 at Week 12

  Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity. PASI 75 is defined as the proportion of patients achieving ≥75% reduction in PASI score from baseline.

  Week 12

Secondary Outcomes (15)

• Part 1： Changes from baseline in PASI

  Week 4

• Part 1： Changes from baseline in sPGA

  Week 4

• Part 1： Changes from baseline in BSA

  Week 4

• Part 1： Changes from baseline in DLQI

  Week 4

• Part 1：Proportion of patients achieving PASI 50/75/90/100

  Week 4

Study Arms (5)

Part 1：Low dose CS32582

EXPERIMENTAL

The patient received low-dose CS32582 capsules BID or placebo for 4 weeks

Drug: CS32582 capsule（low dose） or matched placebo

Part 1：Hgh dose CS32582

EXPERIMENTAL

The patient received high-dose CS32582 capsules BID or placebo for 4 weeks

Drug: CS32582 capsule（high dose） or matched placebo

Part 2：Low dose CS32582

EXPERIMENTAL

The patient received low-dose CS32582 capsules BID or placebo for 12 weeks

Drug: CS32582 capsule（low dose）

Part 2：Medium dose CS32582

EXPERIMENTAL

The patient received medium-dose CS32582 capsules BID or placebo for 12 weeks

Drug: CS32582 capsule（medium dose）

Part 2：High dose CS32582

EXPERIMENTAL

The patient received high-dose CS32582 capsules BID or placebo for 12 weeks

Drug: CS32582 capsule（high dose）

Interventions

CS32582 capsule（low dose） or matched placebo DRUG

CS32582 capsule（low dose） or matched placebo，4 weeks

Part 1：Low dose CS32582

CS32582 capsule（high dose） or matched placebo DRUG

CS32582 capsule（high dose） or matched placebo，4 weeks

Part 1：Hgh dose CS32582

CS32582 capsule（low dose） DRUG

CS32582 capsule（low dose），12 weeks

Part 2：Low dose CS32582

CS32582 capsule（medium dose） DRUG

CS32582 capsule（medium dose），12 weeks

Part 2：Medium dose CS32582

CS32582 capsule（high dose） DRUG

CS32582 capsule（high dose），12 weeks

Part 2：High dose CS32582

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form (ICF) after fully understanding the trial.
• Age 18-70 years (inclusive) at consent, any gender
• Clinically diagnosed with chronic plaque psoriasis, defined as disease duration ≥ 6 months at screening.
• Stable plaque psoriasis at screening, defined as no significant flare-ups or morphological changes during the 6 months prior to screening (investigator-assessed).
• Moderate-to-severe disease at screening/randomization: PASI≥12, sPGA≥3, and BSA≥10%;
• Candidate for phototherapy or systemic therapy per investigator's judgment.
• Women of childbearing potential and males: Agreement to use highly effective contraception from consent until 30 days post-last dose.

You may not qualify if:

• Forms of psoriasis other than plaque-type (e.g., erythrodermic, pustular, guttate, or drug-induced psoriasis) .
• Presence of other skin conditions that in the judgement of the Investigator could interfere with study assessment.
• Immune-mediated diseases requiring systemic therapy (e.g., inflammatory bowel disease), except NSAIDs.
• History of severe drug allergies.
• Major surgery within 2 months before randomization or planned during the study.
• Drug/alcohol abuse within 6 months before screening.
• Uncontrolled hypertension at screening (SBP \>160 mmHg or DBP \>100 mmHg).
• Myocardial infarction, unstable angina, TIA, stroke, PCI, or CABG within 6 months before screening.
• NYHA Class III/IV heart failure at screening.
• History of malignancy or lymphoproliferative disorders within 5 years (exceptions: basal cell carcinoma, localized squamous cell carcinoma, or cervical carcinoma in situ cured ≥1 year).
• Prosthetic joint infection (unless prosthesis removed/replaced ≥2 months before randomization).
• History of opportunistic infections (e.g., PJP, histoplasmosis, coccidioidomycosis).
• Active/latent TB infection (positive IGRA without clinical manifestations).
• Herpes infection:a) Active herpes zoster/simplex (HSV-1/2) at screening;b) History of severe herpes (disseminated disease, multidermatomal HSV, encephalitis, ophthalmic herpes, or recurrent zoster \[≥2 episodes in 2 years\]).
• History of severe bacterial, fungal, or viral infection requiring hospitalization for IV antibiotic or antiviral administration within 2 months before randomization.

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (11)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Affiliated Hospital of Chengde Medical University

Chengde, Hebei, China

NOT YET RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Shiyan People's Hospital

Shiyan, Hubei, China

NOT YET RECRUITING

Shandong Provincial Hospital for Skin Diseases

Jinan, Shandong, China

NOT YET RECRUITING

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

NOT YET RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital )

Xi’an, Shanxi, China

NOT YET RECRUITING

Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University

Hangzhou, Zhejiang, China

NOT YET RECRUITING

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, China

NOT YET RECRUITING

The First Affliated Hospital of Wenzhou Medical University

Wenzhou, Zhengjiang, China

NOT YET RECRUITING

Central Study Contacts

Jianzhong Zhang

CONTACT

18001315877; rmzjz@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 19, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): September 18, 2027
• Study Completion (Estimated): September 18, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)