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IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment

Primary Purpose

Psoriasis

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
IBI112
IBI112/placebo
IBI112/placebo
IBI112
IBI112
IBI112
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: Have a diagnosis of plaque-type psoriasis for at least 6 months; Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND static Physician's Global Assessment (sPGA) score of 3 (moderate) or greater; Psoriasis covering at least 10% of body surface area; Must be a candidate for either systemic therapy or phototherapy for psoriasis. Exclusion Criteria: Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments Participants who have ever received IBI112 or IL-23 inhibitor History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the participant Is pregnant, nursing, or planning a pregnancy (both men and women) within 6 months following the last administration of the study drug

Sites / Locations

  • Shanghai Skin Disease HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Group 3

Group 4

Group 6

Group 5

Group 1

Group 2

Arm Description

Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44

Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44

Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44

Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & placebo through week 44

Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44

Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44

Outcomes

Primary Outcome Measures

Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response

Secondary Outcome Measures

Percentage of participants with a PASI75 Response
Percentage of participants with a PASI100 Response
Percentage of participants with a static Investigator's Global Assessment (sIGA) score of 0 or 1
Percentage of participants with Dermatology Life Quality Index (DLQI) Score
Percentage of participants with a sIGA score of 0
Cumulative Maintenance Rate of PASI 90 Response Through Week 56 to Evaluate Loss of a PASI 90 Response
Changes of PASI Scores participants who relapse and retreatment
Changes of sIGA score in participants who relapse and retreatment

Full Information

First Posted
September 13, 2023
Last Updated
October 18, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06049810
Brief Title
IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Randomized Withdrawal and Retreatment Phase III Clinical Trial Evaluating the Efficacy and Safety of Subcutaneous Injection of IBI112 in the Treatment of Moderate to Severe Plaque Psoriasis.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2023 (Actual)
Primary Completion Date
July 3, 2025 (Anticipated)
Study Completion Date
December 31, 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
The purpose of this study is to evaluate the efficacy, safety, and tolerability of IBI112 in the treatment of participants with moderate to severe psoriasis

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Participant, Care Provider, Investigator
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 3
Arm Type
Experimental
Arm Description
Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44
Arm Title
Group 6
Arm Type
Experimental
Arm Description
Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44
Arm Title
Group 5
Arm Type
Placebo Comparator
Arm Description
Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & placebo through week 44
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44
Intervention Type
Drug
Intervention Name(s)
IBI112
Intervention Description
Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44
Intervention Type
Drug
Intervention Name(s)
IBI112/placebo
Intervention Description
Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44 by subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
IBI112/placebo
Intervention Description
Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & placebo through week 44
Intervention Type
Drug
Intervention Name(s)
IBI112
Intervention Description
Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44
Intervention Type
Drug
Intervention Name(s)
IBI112
Intervention Description
Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44
Intervention Type
Drug
Intervention Name(s)
IBI112
Intervention Description
Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44 by subcutaneous injection
Primary Outcome Measure Information:
Title
Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response
Time Frame
Week 56
Secondary Outcome Measure Information:
Title
Percentage of participants with a PASI75 Response
Time Frame
Week 56
Title
Percentage of participants with a PASI100 Response
Time Frame
Week 56
Title
Percentage of participants with a static Investigator's Global Assessment (sIGA) score of 0 or 1
Time Frame
Week 56
Title
Percentage of participants with Dermatology Life Quality Index (DLQI) Score
Time Frame
Week 56
Title
Percentage of participants with a sIGA score of 0
Time Frame
Week 56
Title
Cumulative Maintenance Rate of PASI 90 Response Through Week 56 to Evaluate Loss of a PASI 90 Response
Time Frame
Week 56
Title
Changes of PASI Scores participants who relapse and retreatment
Time Frame
Week 56
Title
Changes of sIGA score in participants who relapse and retreatment
Time Frame
Week 56

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: Have a diagnosis of plaque-type psoriasis for at least 6 months; Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND static Physician's Global Assessment (sPGA) score of 3 (moderate) or greater; Psoriasis covering at least 10% of body surface area; Must be a candidate for either systemic therapy or phototherapy for psoriasis. Exclusion Criteria: Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments Participants who have ever received IBI112 or IL-23 inhibitor History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the participant Is pregnant, nursing, or planning a pregnancy (both men and women) within 6 months following the last administration of the study drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bingjing Feng
Phone
+86 18361923769
Email
bingjing.feng@innoventbio.com
Facility Information:
Facility Name
Shanghai Skin Disease Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200443
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuling Shi
Phone
021-36803156
Email
shiyuling1973@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment

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