CS32582 for moderate to severe plaque psoriasis
Official title: 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
Run by Chipscreen Biosciences, Ltd. · NCT07129382 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | Chipscreen Biosciences, Ltd. Industry-sponsored |
| 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) |
| Status | Recruiting |
| Started | September 8, 2025 |
| Main results expected | September 18, 2027 |
| Study ends | September 18, 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07129382 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China 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 -
Shiyan People's Hospital
Shiyan, Hubei, China Not yet recruiting -
Shandong Provincial Hospital for Skin Diseases
Jinan, Shandong, China Not yet recruiting
Show 5 more locations
-
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
- Email: rmzjz@126.com
- Phone: 18001315877
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
How safe and well ZP9830 works in people with plaque psoriasis over 8 weeks
This study tests whether ZP9830 is safe and tolerable in adults with plaque psoriasis for 8 weeks, with a comparison to placebo.
-
Secukinumab retention in adults with plaque psoriasis and MASLD in Spain
This study tests how long people with plaque psoriasis and MASLD stay on secukinumab in real-world Spain, using EMR data from several hospitals.
-
Long-term ORKA-001 treatment for adults with plaque psoriasis
This open-label extension will try ORKA-001 long-term in adults with moderate-to-severe plaque psoriasis who completed a previous ORKA-001 study.
-
D-2570 oral treatment for adults with moderate to severe plaque psoriasis
This trial tests whether the oral medicine D-2570 helps adults with moderate to severe plaque psoriasis compared with placebo and an approved oral drug.
-
ICP-332 versus placebo for moderate-to-severe plaque psoriasis
This will test whether ICP-332 helps adults with moderate-to-severe plaque psoriasis compared with a placebo.
-
Long-term zasocitinib treatment for children and teenagers with plaque psoriasis
This long-term study will see if the medicine zasocitinib is safe and helps children and teenagers (ages 4 to under 18) with moderate-to-severe plaque psoriasis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.