Actively Recruiting
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Led by Chipscreen Biosciences, Ltd. · Updated on 2025-09-10
220
Participants Needed
11
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
" 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.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent voluntarily after understanding the trial
- Age between 18 and 70 years, any gender
- Diagnosed with chronic plaque psoriasis for 6 months or longer
- Stable plaque psoriasis with no major flare-ups or changes in the last 6 months
- Moderate to severe psoriasis with PASI score of 12 or higher, sPGA score of 3 or more, and body surface area involvement of 10% or more
- Suitable for phototherapy or systemic therapy as judged by the investigator
- Women of childbearing potential and male participants agree to use effective contraception from consent until 30 days after last dose
You will not qualify if you...
- Psoriasis types other than plaque psoriasis (such as erythrodermic, pustular, guttate, or drug-induced)
- Other skin conditions that could interfere with study assessments
- Immune diseases needing systemic therapy except NSAIDs
- History of severe drug allergies
- Major surgery within 2 months before randomization or planned during the study
- Drug or alcohol abuse within 6 months before screening
- Uncontrolled high blood pressure at screening (systolic >160 mmHg or diastolic >100 mmHg)
- Heart attack, unstable angina, stroke, or certain heart procedures within 6 months before screening
- Severe heart failure (NYHA Class III/IV) at screening
- History of cancer or lymphatic disorders within 5 years, except certain cured skin or cervical cancers
- Prosthetic joint infection unless the prosthesis was removed or replaced at least 2 months before randomization
- History of serious infections requiring hospitalization or intravenous treatment recently
- Active or latent tuberculosis infection
- Active herpes infections or history of severe herpes
- Recent live vaccine within 2 months before randomization or planned during the study
- Active infection or fever needing treatment within 2 weeks before randomization
- Positive tests for certain viral infections including hepatitis B or C, HIV, or syphilis
- Prior use of TYK2 inhibitors
- Use of certain biologic or immunosuppressant therapies within specified timeframes before randomization
- Use of systemic non-biologic psoriasis treatments or immunosuppressants within 4 weeks before randomization
- Use of certain other medications like lithium, antimalarials, or gold preparations within 4 weeks before randomization
- Use of herbal or botanical treatments for psoriasis or immune disorders within 4 weeks before randomization
- Phototherapy within 4 weeks before randomization
- Use of medicated shampoos or topical agents affecting psoriasis within 2 weeks before randomization
- Participation in another investigational study or use of investigational therapy within 30 days before randomization
- Abnormal liver, blood, or kidney lab results during screening
- Pregnant or breastfeeding women
- Any condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Peking University People's Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
3
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
Not Yet Recruiting
4
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
5
Shiyan People's Hospital
Shiyan, Hubei, China
Not Yet Recruiting
6
Shandong Provincial Hospital for Skin Diseases
Jinan, Shandong, China
Not Yet Recruiting
7
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Not Yet Recruiting
8
The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital )
Xi’an, Shanxi, China
Not Yet Recruiting
9
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, China
Not Yet Recruiting
10
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China
Not Yet Recruiting
11
The First Affliated Hospital of Wenzhou Medical University
Wenzhou, Zhengjiang, China
Not Yet Recruiting
Research Team
J
Jianzhong Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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