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Tests treatment safety and results for Plaque Psoriasis
Official title A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT07129382
What this study is testing
What is CS32582 capsule（low dose）?
CS32582 capsule（low dose） is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for plaque psoriasis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- " 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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...
- Moderate-to-severe disease at screening/randomization: PASI≥12, sPGA≥3, and BSA≥10%;
You likely can't join 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chengde, Hebei, China
- Shijiazhuang, Hebei, China
- Shiyan, Hubei, China
- Jinan, Shandong, China
- Taiyuan, Shanxi, China
- Xi’an, Shanxi, China
- Hangzhou, Zhejiang, China
- Yiwu, Zhejiang, China
- Wenzhou, Zhengjiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chengde, Hebei, China; Shijiazhuang, Hebei, China; Shiyan, Hubei, China; Jinan, Shandong, China; Taiyuan, Shanxi, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.