psoriasis
Conditions
Interventions
Standard dosing group:The group receiving Vunakizumab Injections every 4 weeks continued treatment until week 60
Extended dosing group:The group receiving Vunakizumab Injections every 8 weeks continued treatment until week 60
Twice-extended drug administration group:The group receiving Vunakizumab Injections every 12 weeks continued treatment until week 60
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years and less than 75 years, of either gender; 2. Diagnosed with moderate to severe plaque psoriasis; 3. The researcher determined that the study participant was eligible for treatment with Vunakizumab Injection; 4. After completing 12 weeks of treatment with Vunakizumab, the study participants achieved PASI 90.
Exclusion criteria
Exclusion criteria: 1. Study participants who have used biologics (TNF-a inhibitors, IL-23 inhibitors, IL12/23 inhibitors, IL-17 inhibitors, etc.) for the treatment of psoriasis within the first 6 months prior to baseline; 2. Non-chronic plaque psoriasis and drug-induced psoriasis; 3. The presence of other skin issues that researchers believe may interfere with the assessment of psoriasis; 4. Accompanied by active tuberculosis, active hepatitis B, or other severe infectious diseases; 5. Accompanied by active inflammatory bowel disease or other persistent autoimmune diseases; 6. Pregnant women, lactating women, or women with reproductive potential who plan to become pregnant, as well as male research participants who plan to conceive with their partners during the study period; 7. Other conditions that may weaken the efficacy of immunotherapy; 8. Patients who are allergic to Vunakizumab and its excipients, or to other biologics with the same mechanism of action; 9. Patients who, according to the researchers' judgment, are not suitable for inclusion in this study due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants in the study who maintain a PASI 75 at week 60; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of participants in the 60W study maintaining a PASI 90 score;The proportion of study participants maintaining a PASI score of 100 at Week 60;The proportion of study participants who achieved sPGA 0/1 response at Week 60;The proportion of study participants with a DLQI index of 0 or 1 at week 60;Cell subpopulation detection and omics analysis at 12W, when PASI reaches 100, or when PASI decreases by 75; | — |
Countries
China
Contacts
Public ContactJuan Du
Huashan Hospital, Fudan University
Outcome results
None listed