Clinical trial NCT05970978: A Study of IBI112 in Chinese Patients With Psoriasis Who Were Previously Treated With Biologics
Official title: A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IBI112 in Participants With Psoriasis Who Were Treated With Biologics and Switched to IBI112
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants who achieve sPGA clean (0) or nearly clean (1) ，and BSA < 3%
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of participants who achieve sPGA clean (0) at Week 16.
timeFrame: Week 16
measure: Percentage of participants with a DLQI score of 0/1 at Week 16.
timeFrame: Week 16
measure: Percentage of participants with sPGA 0/1 or sPGA 0 or DLQI 0/1 at Week 44.
timeFrame: Week 44
measure: Percentage of participants who achieve sPGA 0 or 1 at week 16 and maintain that up to Week 44
timeFrame: Week 16 up to Week 44
Other outcomes:
Locations:
city: Jinan
country: China
facility: Dermatology Hospital of Shandong First Medical University (Shandong Provincial Hospitial of Dermatology)
state: Shandong
Study officials:
References: