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

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06049810
• Collaborator: (none)
• Enrollment: 550
• Arms: 6
• Anticipated Duration (Months): 26

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: IBI112; Drug: IBI112/placebo; Drug: IBI112/placebo; Drug: IBI112; Drug: IBI112; Drug: IBI112	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 550 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Participant, Care Provider, Investigator
• Primary Purpose: 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.
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Jun 3, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 3 Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44	Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44
Experimental: Group 4 Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44	Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44
Experimental: Group 6 Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44	Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44
Placebo Comparator: Group 5 Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & placebo through week 44	Drug: IBI112/placebo; Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & placebo through week 44
Experimental: Group 1 Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44	Drug: IBI112; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44 by subcutaneous injection
Placebo Comparator: Group 2 Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44	Drug: IBI112/placebo; Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44 by subcutaneous injection

Outcome Measures

Primary Outcome Measures

1. Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response [Week 56]

Secondary Outcome Measures

1. Percentage of participants with a PASI75 Response [Week 56]

2. Percentage of participants with a PASI100 Response [Week 56]

3. Percentage of participants with a static Investigator's Global Assessment (sIGA) score of 0 or 1 [Week 56]

4. Percentage of participants with Dermatology Life Quality Index (DLQI) Score [Week 56]

5. Percentage of participants with a sIGA score of 0 [Week 56]

6. Cumulative Maintenance Rate of PASI 90 Response Through Week 56 to Evaluate Loss of a PASI 90 Response [Week 56]

7. Changes of PASI Scores participants who relapse and retreatment [Week 56]

8. Changes of sIGA score in participants who relapse and retreatment [Week 56]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
• ClinicalTrials.gov Identifier: NCT06049810
• Other Study ID Numbers: CIBI112A302CN
• First Posted: Sep 22, 2023
• Last Update Posted: Sep 22, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of Sep 22, 2023