A Study of IBI112 in Chinese Patients With Psoriasis Who Were Previously Treated With Biologics

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970978
• Other study ID #: CIBI112A202CN
• Status: Recruiting
• Phase: Phase 2
• Start date: August 28, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: January 2024
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Aoling Chen
• Phone: 15950023301
• Email: aoling.chen[@]innoventbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: February 28, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• regular treatment
IBI112 200mg s.c. at week 0, 12, 24 and 36.
• Intensive treatment
IBI112 200mg s.c. at week 0, 4, 8, 20 and 32.

Locations

Country	Name	City	State
China	Dermatology Hospital of Shandong First Medical University (Shandong Provincial Hospitial of Dermatology)	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants who achieve sPGA clean (0) or nearly clean (1) ,and BSA < 3%		Week 16
Secondary	Percentage of participants who achieve sPGA clean (0) at Week 16.		Week 16
Secondary	Percentage of participants with a DLQI score of 0/1 at Week 16.		Week 16
Secondary	Percentage of participants with sPGA 0/1 or sPGA 0 or DLQI 0/1 at Week 44.		Week 44
Secondary	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