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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With 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

A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis (NCT07129382) is a Phase 1 / Phase 2 interventional studying Plaque Psoriasis, sponsored by Chipscreen Biosciences, Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

" 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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Plaque Psoriasis, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 220 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Plaque Psoriasis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Voluntarily sign the willing to sign a consent form 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. Who Should NOT Join This Trial: - 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). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

CS32582 capsule(low dose) or matched placebo

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

DRUG

CS32582 capsule(high dose) or matched placebo

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

DRUG

CS32582 capsule(low dose)

CS32582 capsule(low dose),12 weeks

DRUG

CS32582 capsule(medium dose)

CS32582 capsule(medium dose),12 weeks

DRUG

CS32582 capsule(high dose)

CS32582 capsule(high dose),12 weeks

Locations (11)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Shiyan People's Hospital
Shiyan, Hubei, China
Shandong Provincial Hospital for Skin Diseases
Jinan, Shandong, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital )
Xi’an, Shanxi, China
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, China
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China
The First Affliated Hospital of Wenzhou Medical University
Wenzhou, Zhengjiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07129382), the sponsor (Chipscreen Biosciences, Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07129382 clinical trial studying?

" 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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07129382?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07129382?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07129382. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07129382. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.