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

Primary Purpose

Psoriasis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
regular treatment
Intensive treatment
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 to 75 years old; Evaluated suitable for continuing biologic therapy for plaque psoriasis by the investigator; Received previous biologic therapy with at least 4 months. Exclusion Criteria: Previously or currently diagnosed with pustular psoriasis, erythrodermic psoriasis, or drug-induced psoriasis (e.g., psoriasis caused by beta blockers, calcium channel inhibitors, etc.); Or presenting with guttate psoriasis at screening or first dose administration; Previously treated with IBI112 or other IL-23 inhibitors; Treated with two biologics for psoriasis within 4 months prior to screening; 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; Treated with Natalizumab, or B/T cell regulators (e.g., Rituximab, Abatacept, or Visilizumab) within 12 months prior to the first dose administration; Not willing to avoid constant sunshine and other ultraviolet light sources exposure during the study; 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.

Sites / Locations

  • Dermatology Hospital of Shandong First Medical University (Shandong Provincial Hospitial of Dermatology)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Response to previous biologic therapy

Poor response to previous biologic therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of participants who achieve sPGA clean (0) or nearly clean (1) at week 16.

Secondary Outcome Measures

Percentage of participants who achieve sPGA clean (0) at Week 16.
Percentage of participants with a DLQI score of 0/1 at Week 16.
Percentage of participants with sPGA 0/1 or sPGA 0 or DLQI 0/1 at Week 44.
Percentage of participants who achieve sPGA 0 or 1 at week 16 and maintain that up to Week 44

Full Information

First Posted
July 24, 2023
Last Updated
September 15, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05970978
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Response to previous biologic therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Poor response to previous biologic therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
regular treatment
Other Intervention Name(s)
Response to previous biologic therapy
Intervention Description
IBI112 200mg s.c. at week 0, 12, 24 and 36.
Intervention Type
Drug
Intervention Name(s)
Intensive treatment
Other Intervention Name(s)
Poor response to previous biologic therapy
Intervention Description
IBI112 200mg s.c. at week 0, 4, 8, 20 and 32.
Primary Outcome Measure Information:
Title
Percentage of participants who achieve sPGA clean (0) or nearly clean (1) at week 16.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of participants who achieve sPGA clean (0) at Week 16.
Time Frame
Week 16
Title
Percentage of participants with a DLQI score of 0/1 at Week 16.
Time Frame
Week 16
Title
Percentage of participants with sPGA 0/1 or sPGA 0 or DLQI 0/1 at Week 44.
Time Frame
Week 44
Title
Percentage of participants who achieve sPGA 0 or 1 at week 16 and maintain that up to Week 44
Time Frame
Week 16 up to Week 44

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 75 years old; Evaluated suitable for continuing biologic therapy for plaque psoriasis by the investigator; Received previous biologic therapy with at least 4 months. Exclusion Criteria: Previously or currently diagnosed with pustular psoriasis, erythrodermic psoriasis, or drug-induced psoriasis (e.g., psoriasis caused by beta blockers, calcium channel inhibitors, etc.); Or presenting with guttate psoriasis at screening or first dose administration; Previously treated with IBI112 or other IL-23 inhibitors; Treated with two biologics for psoriasis within 4 months prior to screening; 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; Treated with Natalizumab, or B/T cell regulators (e.g., Rituximab, Abatacept, or Visilizumab) within 12 months prior to the first dose administration; Not willing to avoid constant sunshine and other ultraviolet light sources exposure during the study; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aoling Chen
Phone
15950023301
Email
aoling.chen@innoventbio.com
Facility Information:
Facility Name
Dermatology Hospital of Shandong First Medical University (Shandong Provincial Hospitial of Dermatology)
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Furen Zhang
Phone
13608921718
Email
ZhangFuRenlcsy@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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