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

Psoriasis Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06049810
• Other study ID #: CIBI112A302CN
• Status: Recruiting
• Phase: Phase 3
• Start date: October 12, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Bingjing Feng
• Phone: +86 18361923769
• Email: bingjing.feng[@]innoventbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: December 31, 2025
• Est. primary completion date: July 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Have a diagnosis of plaque-type psoriasis for at least 6 months;

2. 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;

3. Must be a candidate for either systemic therapy or phototherapy for psoriasis.

Exclusion Criteria:

1. 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

2. Participants who have ever received IBI112 or IL-23 inhibitor

3. 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

4. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the participant

5. Is pregnant, nursing, or planning a pregnancy (both men and women) within 6 months following the last administration of the study drug

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• IBI112
Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44
• IBI112/placebo
Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44 by subcutaneous injection
• IBI112/placebo
Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & placebo through week 44
• IBI112
Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44
• IBI112
Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44
• IBI112
Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44 by subcutaneous injection

Locations

Country	Name	City	State
China	Shanghai Skin Disease Hospital	Shanghai	Shanghai

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