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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Drug: regular treatment; Drug: Intensive treatment

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Aoling Chen; Phone Number: 15950023301; Email: aoling.chen@innoventbio.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Recruiting
      • Dermatology Hospital of Shandong First Medical University (Shandong Provincial Hospitial of Dermatology)
      • Contact: Furen Zhang; Phone Number: 13608921718; Email: ZhangFuRenlcsy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Response to previous biologic therapy; Participants with sPGA0 or 1 score and the body surface area affected with psoriasis lesions <3% at baseline; or PASI-75 was achieved after treated with the previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 12, 24 and 36.	Drug: regular treatment; IBI112 200mg s.c. at week 0, 12, 24 and 36.; Other Names: Response to previous biologic therapy
Experimental: Poor response to previous biologic therapy; Participants with sPGA score ≥2 at baseline, or body surface area affected with psoriasis lesions ≥3% at baseline, o PASI-75 was not reached after treated with previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 4, 8, 20 and 32.	Drug: Intensive treatment; IBI112 200mg s.c. at week 0, 4, 8, 20 and 32.; Other Names: Poor response to previous biologic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants who achieve sPGA clean (0) or nearly clean (1) ，and BSA < 3%	Week 16

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CIBI112A202CN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No