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

Innovent Biologics

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: IBI112/placebo; Drug: IBI112

Study type: Interventional

Funder types: Industry

Identifiers

NCT06049810

CIBI112A302CN

Details and patient eligibility

About

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

Enrollment: 566 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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566 participants in 6 patient groups, including a placebo group

Group 3

Experimental group

Description:

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

Treatment:

Drug: IBI112

Drug: IBI112

Drug: IBI112

Drug: IBI112

Group 4

Experimental group

Description:

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

Treatment:

Drug: IBI112

Drug: IBI112

Drug: IBI112

Drug: IBI112

Group 6

Experimental group

Description:

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

Treatment:

Drug: IBI112

Drug: IBI112

Drug: IBI112

Drug: IBI112

Group 5

Placebo Comparator group

Description:

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

Treatment:

Drug: IBI112/placebo

Drug: IBI112/placebo

Group 1

Experimental group

Description:

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

Treatment:

Drug: IBI112

Drug: IBI112

Drug: IBI112

Drug: IBI112

Group 2

Placebo Comparator group

Description:

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

Treatment:

Drug: IBI112/placebo

Drug: IBI112/placebo