CS32582 for moderate to severe plaque psoriasis

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ib/II Study to Evaluate the Efficacy and Safety of CS32582 Capsule in Adult Patients With Moderate to Severe Plaque Psoriasis

This trial will test whether the oral medicine CS32582 helps adults with moderate to severe plaque psoriasis compared with a placebo.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Chipscreen Biosciences, Ltd. (industry)
• Drugs / interventions: ustekinumab, secukinumab, tildrakizumab, ixekizumab, guselkumab, Rituximab, natalizumab, alemtuzumab, vedolizumab, adalimumab, infliximab, certolizumab, deucravacitinib, methotrexate
• Locations: 11 sites (Beijing, Beijing Municipality and 10 other locations)
• Trial ID: NCT07129382 on ClinicalTrials.gov

What this trial studies

The study has two parts: Part 1 is a randomized, double-blind, placebo-controlled dose-escalation phase enrolling about 20–30 adults treated for 4 weeks, and Part 2 is a randomized, double-blind, placebo-controlled efficacy and safety phase enrolling about 200 adults treated for 12 weeks. Participants receive one of several CS32582 dose levels or matched placebo to compare safety and clinical response. Key entry criteria include chronic plaque psoriasis of at least 6 months duration and moderate-to-severe disease defined by PASI, sPGA, and BSA thresholds. The trial will collect preliminary safety and efficacy data to inform further development of CS32582.

Who should consider this trial

Good fit: Adults aged 18–70 with chronic, stable, moderate-to-severe plaque psoriasis (PASI ≥12, sPGA ≥3, BSA ≥10%) who are candidates for phototherapy or systemic therapy and agree to required contraception are ideal candidates.

Not a fit: People with non-plaque forms of psoriasis, other skin conditions that interfere with assessments, or those excluded for immune-related or other protocol restrictions are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, CS32582 could reduce psoriasis plaques and symptoms and add a new oral treatment option for people with moderate to severe plaque psoriasis.

How similar studies have performed: Other oral small-molecule and biologic therapies have shown benefit in plaque psoriasis, but CS32582 is a novel agent that has not yet been proven in larger trials.

Eligibility criteria

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:

* 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.

Where this trial is running

Beijing, Beijing Municipality and 10 other locations

• 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)

Study contacts

• Study coordinator: Jianzhong Zhang

Conditions: Plaque Psoriasis