Plaque psoriasis
Conditions
Interventions
Phase II - Treatment Group 1:CMS-D001 tablet, 50 mg, taken once a day, for 12 weeks
Phase II - Treatment Group 2:CMS-D001 tablet, 100 mg, taken once a day, for 12 weeks
Phase II - placebo group:Placebo (without the active ingredient CMS-D001), taken once a day for 12 weeks
Phase III - Treatment Group 1,Phase II - Treatment Group 2,placebo group:CMS-D001 tablet, 50 mg, taken once a day
Phase III - Treatment Group 1,Phase II - Treatment Group 2,placebo group:CMS-D001 tablet, 100 mg, taken once a day
Phase III - Treatment Group 1,Phase II - Treatment Group 2,placebo group:Placebo (without the active ingredient CMS-D001), taken once a day
Sponsors
Shandong First Medical University Affiliated Dermatology Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the Informed Consent Form (ICF), be able to communicate well with the researchers, and understand and comply with the requirements and restrictions of the study; 2. The age of signing ICF was >=18 years old and =6 months of history, as assessed by the investigator at screening; Investigator-assessed plaque psoriasis at screening and baseline met the following requirements: Psoriasis area and severity index (PASI) score >=12; Physician global assessment (PGA) score >=3; Affected body surface area (BSA) >=10%; 5. Eligible for phototherapy or systemic therapy as judged by the investigator; 6. Participants of childbearing potential who had no plans to become pregnant or to donate sperm for at least 3 months after the last dose of study dose were required to follow the contraceptive guidelines and use a highly effective or acceptable method of contraception (see Appendix 1).
Exclusion criteria
Exclusion criteria: 1. Presence of nonplaque psoriasis (e.g., guttate, pustular, erythroderma, or inverse psoriasis) within 3 months before baseline; 2. A history of other skin diseases or current conditions (e.g., eczema) at screening or baseline that, in the investigator's judgment, may have affected the study assessment; 3. Previous or present history of psoriasis induced or exacerbated by drugs (e.g., ß-blockers, calcium channel blockers, antimalarials, or lithium); 4. Previous history of severe herpes zoster or severe herpes simplex (including but not limited to disseminated herpes zoster, generalized herpes zoster, central nervous system herpes zoster, herpes zoster ophthalmicus, recurrent herpes zoster (2 or more episodes within 2 years) or present history of herpes simplex or herpes zoster infection; 5. A history of severe bacterial, fungal, or viral infection requiring hospitalization or intravenous antibiotic therapy within 3 months before the first dose; 6. A history of bacterial, fungal, or viral infection requiring oral anti-infective treatment within 4 weeks before the first dose of oral anti-infective treatment; 7. Presence of active infection or acute illness (e.g., fever, nausea, vomiting, or diarrhea) within 7 days before the first dose; 8. At screening or baseline, participants with chronic or recurrent infectious conditions, including but not limited to chronic kidney infection, recurrent urinary tract infection, chronic chest infection, fungal infection (other than superficial nail fungal infection), or infectious skin wounds or ulcers, were assessed by the investigator as potentially increasing risks to the participant's safety; 9. Meeting any of the following TB screening criteria: 1) present or past history of active tuberculosis infection; 2) presence of signs or symptoms of active tuberculosis as judged by the investigator during screening; 3) chest CT showed current or previous active tuberculosis infection; 4) Ifn-? release assay results showed evidence of LTBI, defined as a positive Ifn-? release assay at screening or two consecutive indeterminate Ifn-? release assays, and no clinical symptoms. The full course of prophylaxis did not have to be completed before the first dose, unless it was recorded that the participant had completed adequate treatment for latent tuberculosis infection or had started prophylaxis at least 4 weeks before the first dose and had agreed to complete subsequent courses of prophylaxis. Note: The use of rifampin or rifapentine for tuberculosis prophylaxis was not allowed. If the tuberculosis test result was indeterminate, one repeat test could be performed. 10. Receive a live attenuated vaccine within 4 weeks before the first dose or plan to receive a live attenuated vaccine at any time during the treatment period or within 8 weeks after study completion; 11. Patients with major or unstable digestive/hepatobiliary, renal/urinary, cardiovascular, respiratory, endocrine, hematologic, immune, or central nervous system diseases within 6 months before the first dose, who are not eligible for clinical study according to the investigator's judgment, "Examples include, but are not limited to, pancreatitis, unstable angina, myocardial infarction, symptomatic congestive heart failure (New York Heart Association class III or IV), arrhythmia requiring treatment, pulmonary hypertension, respiratory failure, stroke (including transient ischemic attack), liver cirrhosis, venous thromboembolism, etc." 12. Malignant tumo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase ?:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75);Phase ?:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75);Phase ?:Number of participants achieving a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) (PGA-TS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase ?:Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75);Phase ?:Number of participants achieving a Physicians Global Assessment (PGA) score of 0 or 1.;Phase ?:Number of participants achieving at least 50%, 90%, or 100% improvement in PASI (PASI 50/90/100);Phase ?:Change and percentage change in PASI score from baseline;Phase ?:Change and percentage change in affected Body Surface Area (BSA) from baseline;Phase ?:Change in Dermatology Life Quality Index (DLQI) score from baseline;Phase ?:Number of participants achieving at least 75% improvement in PASI (PASI 75);Phase ?:Number of participants achieving at least 90% or 100% improvement in PASI (PASI 90/100);Phase ?:Number of participants achieving a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear);Phase ?:Change and percentage change in PASI score from baseline;Phase ?:Change and percentage change in affected Body Surface Area (BSA) from baseline;Phase ?:Change in Dermatology Life Quality Index (DLQI) score from baseline; | — |
Countries
China
Contacts
Public ContactFuren Zhang
Shandong First Medical University Affiliated Dermatology Hospital
Outcome results
None listed