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

Phase 3

Active, not recruiting

• Conditions: Psoriasis
• Interventions: Drug: IBI112/placebo; Drug: IBI112

• Registration Number: NCT06049810
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-22
• Study Start: 2023-10-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-07-03
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 5	IBI112/placebo	Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& placebo through week 44
Group 1	IBI112	Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 through week 44
Group 2	IBI112/placebo	Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& placebo through week 44
Group 3	IBI112	Participants receive Dose 1 IBI112 through week 8 \& Dose 2 IBI112 on week 20 \& Dose 1 IBI112 through week 44
Group 4	IBI112	Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 through week 44
Group 6	IBI112	Participants receive Dose 1 IBI112 through week 8 \& Dose 3 IBI112 on week 20 \& Dose 1 IBI112 through week 44

Primary Outcome Measures

Name	Time	Method
Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response	Week 56

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Skin Disease Hospital; 🇨🇳 Shanghai, Shanghai, China