Psoriasis
Conditions
Brief summary
This is a multicenter, open-label study aim to evaluate the efficacy and safety of IBI112 in Chinese participants with plaque psoriasis who were treated with biologics and switched to IBI112. The study will enroll 160 participants who were diagnosed with plaque psoriasis. The whole study consists of 4 weeks of screening, 32 or 36 weeks of treatment and a safety follow-up visit at Week 44.
Interventions
IBI112 200mg s.c. at week 0, 12, 24 and 36.
IBI112 200mg s.c. at week 0, 4, 8, 20 and 32.
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 75 years old; 2. Evaluated suitable for continuing biologic therapy for plaque psoriasis by the investigator; 3. Received previous biologic therapy with at least 4 months.
Exclusion criteria
1. Diagnosed with guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, or drug-induced psoriasis (e.g., psoriasis caused by beta blockers, calcium channel inhibitors, etc.) at screening; 2. Previously treated with IBI112 or other IL-23 inhibitors; 3. Treated with two biologics for psoriasis within 4 months prior to screening; 4. Treated with topical therapy for psoriasis within 2 weeks prior to the first dose administration, or treated with systemic non-biological agents or phototherapy within 4 weeks prior to the first dose administration; 5. Treated with Natalizumab, or B/T cell regulators (e.g., Rituximab, Abatacept, or Visilizumab) within 12 months prior to the first dose administration; 6. Not willing to avoid constant sunshine and other ultraviolet light sources exposure during the study; 7. Treated with an investigational biologic within 6 months prior to the first dose administration, or any investigational therapy within 30 days, or an investigational drug within 5 half-lives, or currently participating in a clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants who achieve sPGA clean (0) or nearly clean (1) ，and BSA < 3% | Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants who achieve sPGA clean (0) at Week 16. | Week 16 |
| Percentage of participants with a DLQI score of 0/1 at Week 16. | Week 16 |
| Percentage of participants with sPGA 0/1 or sPGA 0 or DLQI 0/1 at Week 44. | Week 44 |
| Percentage of participants who achieve sPGA 0 or 1 at week 16 and maintain that up to Week 44 | Week 16 up to Week 44 |
Countries
China
Outcome results
None listed