NCT06049810

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
566

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

October 10, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2025

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

September 13, 2023

Last Update Submit

August 13, 2025

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

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

    Week 56

Secondary Outcomes (8)

  • Percentage of participants with a PASI75 Response

    Week 56

  • Percentage of participants with a PASI100 Response

    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

  • Percentage of participants with a sIGA score of 0

    Week 56

  • +3 more secondary outcomes

Study Arms (6)

Group 3

EXPERIMENTAL

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

Drug: IBI112

Group 4

EXPERIMENTAL

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

Drug: IBI112

Group 6

EXPERIMENTAL

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

Drug: IBI112

Group 5

PLACEBO COMPARATOR

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

Drug: IBI112/placebo

Group 1

EXPERIMENTAL

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

Drug: IBI112

Group 2

PLACEBO COMPARATOR

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

Drug: IBI112/placebo

Interventions

IBI112DRUG

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

Group 3
IBI112/placeboDRUG

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

Group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, 200443, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Participant, Care Provider, Investigator
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 22, 2023

Study Start

October 10, 2023

Primary Completion

April 29, 2025

Study Completion

July 28, 2025

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)