CClinicalTrials.gg
Sign In
RecruitingNCT07129382MECAPUpdated Sep 10, 2025

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

A Phase 1/2 interventional study of CS32582 capsule（low dose） or matched placebo and CS32582 capsule（high dose） or matched placebo in Plaque Psoriasis, sponsored by Chipscreen Biosciences, Ltd.. Recruiting at 11 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-10.

Sponsored by Chipscreen Biosciences, Ltd. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Plaque Psoriasis
03

In context

Lead sponsor

Chipscreen Biosciences, Ltd. is the lead sponsor of 41 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • History of live vaccine administration within 2 months before randomization or plans to receive a live vaccine during the study period.
  • Evidence of active infection and/or febrile illness requiring systemic anti-infective therapy within 2 weeks before randomization.

  • Abnormal virology at screening:

    • HBsAg(+) or HBcAb(+) with detectable HBV-DNA
    • HCV Ab(+) with detectable HCV-RNA
    • History of HIV infection or HIV Ab(+)
    • Treponema pallidum Ab(+) with positive RPR/TRUST
  • Prior use of TYK2 inhibitors (e.g., deucravacitinib).

  • Use of any of the following therapeutic agents within 6 months before randomization:

    • IL-12/23, IL-17, or IL-23 inhibitors (ustekinumab, secukinumab, tildrakizumab, ixekizumab, guselkumab)
    • Rituximab or other B-cell depleting agents
    • Leflunomide
  • Use of any of the following therapeutic agents within 3 months before randomization: Integrin pathway modulators (natalizumab) or B/T-cell modulators (alemtuzumab, abatacept, vedolizumab).
  • Use of TNF inhibitors (etanercept, adalimumab, infliximab, certolizumab) within 2 months before randomization.
  • Any biologic psoriasis therapy within 3 months or 5 half-lives (whichever longer) before randomization.
  • Use of systemic non-biologic psoriasis agents and/or any systemic immunosuppressants within 4 weeks before randomization, including but not limited to: apremilast, methotrexate, azathioprine, cyclosporine, JAK inhibitors, 6-thioguanine, mercaptopurine, mycophenolate, hydroxyurea, tacrolimus, oral/injectable corticosteroids, retinoids, calcitriol/analogs, psoralen, sulfasalazine, fumarates).
  • Use of Lithium, antimalarials, or intramuscular gold preparations within 4 weeks before randomization.
  • Use of any botanical agents for the treatment of psoriasis or other immune disorders within 4 weeks before randomization, including herbal supplements or traditional Chinese medicines derived from plants, minerals, or animals.
  • Received phototherapy within 4 weeks before randomization.
  • Use of medicated shampoos and/or body washes within 2 weeks before randomization, including but not limited to products containing: corticosteroids, coal tar, >3% salicylic acid, vitamin D3 analogs.
  • Use of any topical agents that may affect psoriasis symptoms within 2 weeks before randomization.
  • Received any investigational therapy within 30 days or 5 half-lives (whichever is longer) before randomization, OR current participation in other trial.

  • Laboratory values meeting any of the following criteria during screening or before randomization:

    • Liver: ALT/AST ≥3×ULN; total bilirubin >2×ULN
    • Hematology: WBC \<3.0×10⁹/L (3000/mm³); ANC \<1.0×10⁹/L (1000/mm³); lymphocyte count \<0.5×10⁹/L (500/mm³); platelets \<100×10⁹/L (100,000/mm³); hemoglobin \<9.0 g/dL (90 g/L)
    • Renal: eGFR \<60 mL/min/1.73m² (CKD-EPI equation)
  • Pregnant or lactating women.
  • Any condition deemed unsuitable by the investigator.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
220 participants (estimated)

Study arms

  • Experimental
    Part 1：Low dose CS32582

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

    Drug: CS32582 capsule（low dose） or matched placebo

  • Experimental
    Part 1：Hgh dose CS32582

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

    Drug: CS32582 capsule（high dose） or matched placebo

  • Experimental
    Part 2：Low dose CS32582

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

    Drug: CS32582 capsule（low dose）

  • Experimental
    Part 2：Medium dose CS32582

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

    Drug: CS32582 capsule（medium dose）

  • Experimental
    Part 2：High dose CS32582

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

    Drug: CS32582 capsule（high dose）

Interventions

  • DrugCS32582 capsule（low dose） or matched placebo

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

  • DrugCS32582 capsule（high dose） or matched placebo

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

  • DrugCS32582 capsule（low dose）

    CS32582 capsule（low dose），12 weeks

  • DrugCS32582 capsule（medium dose）

    CS32582 capsule（medium dose），12 weeks

  • DrugCS32582 capsule（high dose）

    CS32582 capsule（high dose），12 weeks

06

What researchers measure

Primary outcomes

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

    Time frame: 5 weeks

  2. 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.

    Time frame: Week 12

Secondary outcomes

  1. Part 1： Changes from baseline in PASI

    Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity.

    Time frame: Week 4

  2. Part 1： Changes from baseline in sPGA

    Static Physician's Global Assessment (sPGA) is an average assessment of all psoriatic lesions, with scores ranging from 0 (indicating clear) to 5 (indicating severe).

    Time frame: Week 4

  3. Part 1： Changes from baseline in BSA

    Body Surface Area (BSA) scores range from 0% (indicating absence of lesions) to 100% (indicating total body surface involvement), with higher scores correlating to greater disease severity.

    Time frame: Week 4

  4. Part 1： Changes from baseline in DLQI

    Dermatology Life Quality Index（DLQI) total score ranges from 0 (indicating no impairment in quality of life) to 30 (indicating maximum impairment in quality of life).

    Time frame: Week 4

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

    Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity. PASI 50 is defined as the proportion of patients achieving ≥50% reduction in PASI score from baseline. PASI 75 is defined as the proportion of patients achieving ≥75% reduction in PASI score from baseline.PASI 90 is defined as the proportion of patients achieving ≥90% reduction in PASI score from baseline.PASI 100 is defined as the proportion of patients achieving ≥100% reduction in PASI score from baseline.

    Time frame: Week 4

  6. Part 2：Incidence and Severity of Adverse Events (AEs)

    Time frame: 16 weeks

  7. Part 2：Proportion of patients achieving PASI 75

    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.

    Time frame: Week 4 and 8

  8. Part 2：Proportion of patients achieving PASI 50/90/100

    Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity. PASI 50 is defined as the proportion of patients achieving ≥50% reduction in PASI score from baseline. PASI 90 is defined as the proportion of patients achieving ≥90% reduction in PASI score from baseline.PASI 100 is defined as the proportion of patients achieving ≥100% reduction in PASI score from baseline.

    Time frame: Week 4，8 and 12

  9. Part 2：Proportion of patients achieving: (a) sPGA score of 0 or 1 with ≥2-point reduction from baseline (b) sPGA clearance (score 0) (c) Disease remission

    Time frame: Week 4，8 and 12

  10. Part 2： Changes from baseline in PASI

    Psoriasis Area and Severity Index (PASI) scores range from 0 to 72, with higher scores indicating more severe disease activity.

    Time frame: Week 4，8 and 12

  11. Part 2： Changes from baseline in BSA

    Body Surface Area (BSA) scores range from 0% (indicating absence of lesions) to 100% (indicating total body surface involvement), with higher scores correlating to greater disease severity.

    Time frame: Week 4，8 and 12

  12. Part 2： Changes from baseline in sPGA

    Static Physician's Global Assessment (sPGA) is an average assessment of all psoriatic lesions, with scores ranging from 0 (indicating clear) to 5 (indicating severe).

    Time frame: Week 4，8 and 12

  13. Part 2： Changes from baseline in DLQI

    Dermatology Life Quality Index（DLQI) total score ranges from 0 (indicating no impairment in quality of life) to 30 (indicating maximum impairment in quality of life).

    Time frame: Week 4，8 and 12

  14. Pharmacokinetic parameters - Area Under the Curve(AUC)

    Time frame: Day 1~Day 85

  15. Pharmacokinetic parameters - Peak Plasma Concentration (Cmax)

    Time frame: Day 1~Day 85

07

Study locations

1 of 11 sites recruiting
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07129382
Lead sponsor
Chipscreen Biosciences, Ltd.
Responsible party
Sponsor
First posted
Aug 19, 2025
Start date
Sep 8, 2025
Primary completion
Sep 18, 2027 (estimated)
Completion
Sep 18, 2027 (estimated)
Last update
Sep 10, 2025

Study contacts

Jianzhong Zhang
Contact
rmzjz@126.com
18001315877

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Chipscreen Biosciences, Ltd.

Start the discussion