psoriasis
Conditions
Interventions
Test group:Apremilast combined with Methotrexate
Control group 1:Apremilast
Control group 2:Methotrexate
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged >= 18 years old and = 12 points, at least 10% of the total body surface area being the body surface area (BSA), and the static Physician Global Assessment (sPGA) >= 3; 4. Subjects who are intolerant to systemic treatment and/or phototherapy, have contraindications, or have poor treatment control, and are judged by the investigator to require systemic treatment; 5. In the case of women of childbearing age, they should not be pregnant or breastfeeding, and the subjects and their partners should voluntarily adopt contraceptive measures deemed effective by the investigator during the treatment period and for at least 8 months after the last administration of the study drug; 6. During the study, long-term exposure to sunlight must be avoided, and the use of ultraviolet health rooms or other ultraviolet light sources should be avoided; 7. The subjects must be willing and able to complete the study procedures and follow-up examinations.
Exclusion criteria
Exclusion criteria: 1. Subjects who had other types of psoriasis other than plaque psoriasis (such as pustular psoriasis, erythrodermic psoriasis, guttate psoriasis, etc.) before screening or randomization; 2. Subjects who had any severe infection or systemic infection (bacterial, fungal or viral) within 2 months before screening; 3. Current history of active pulmonary tuberculosis; having evidence of latent tuberculosis, unless the subject has completed at least 4 weeks of anti-tuberculosis treatment before random assignment and commits to completing the subsequent treatment during the study; 4. Positive results in the confirmatory tests for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or syphilis; 5. Subjects who received local anti-psoriasis treatment (including local use of non-mild glucocorticoids, retinoids, vitamin D3 derivatives, salicylic acid, anthralin, etc.) within 2 weeks before randomization; 6. Subjects who received physical therapy within 4 weeks before randomization; 7. Subjects who received systemic anti-psoriasis treatment (including but not limited to glucocorticoids, retinoids, cyclosporine, Tripterygium wilfordii, azathioprine, mycophenolate mofetil, etc.) within 4 weeks before randomization; 8. Subjects who took antimalarial drugs, interferons, or lithium within 4 weeks before randomization; 9. Subjects who received traditional Chinese medicine treatment for psoriasis within 2 weeks before randomization; 10. Subjects who received JAK kinase inhibitor treatment within 2 weeks before randomization; 11. Subjects who had received interleukin-17 antagonist treatments such as Secukinumab and Ixekizumab; 12. Subjects who received Natalizumab or other drugs that modulate B cells or T cells within 12 months before randomization; 13. If the subject received the following biological agents before randomization, the washout period was less than the specified time: Etanercept < 28 days; Infliximab and Adalimumab < 60 days; interleukin 12/23 (IL-12/23) or IL-23 target drugs < 6 months; or other anti-psoriasis treatments not listed above and within its 5 half-lives; 14. Subjects who received other clinical trial drugs within 3 months before screening; 15. Subjects with a history of alcohol abuse or drug abuse; 16. Subjects with symptoms or signs of progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric or brain diseases, or subjects with other chronic diseases that are not suitable for participating in this clinical trial; 17. Any other situation or condition in which the investigator deems the subject unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PASI score; | — |
Secondary
| Measure | Time frame |
|---|---|
| sPGA score;The rate of change of BSA; | — |
Countries
China
Contacts
Public ContactLi Yuzhen
The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed