NCT05645627

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of IBI112 in the treatment of participants with moderate to severe plaque-type psoriasis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 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

December 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 10, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

December 1, 2022

Last Update Submit

October 28, 2024

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

  • Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 16

    PASI 90 is defined as at least a 90% reduction in PASI relative to baseline

    Week 16

  • Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 16

    sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe

    Week 16

Secondary Outcomes (10)

  • Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16

    Week 16

  • Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 16

    Week 16

  • Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 16

    Week 16

  • Change from Baseline in Dermatology life quality index(DLQI) at week 16

    Week 16

  • Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 52

    Week 52

  • +5 more secondary outcomes

Study Arms (3)

Group 1

PLACEBO COMPARATOR

Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 48

Drug: placebo /IBI112

Group 2

EXPERIMENTAL

Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 2 IBI112 through week 48

Drug: IBI112

Group 3

EXPERIMENTAL

Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 3 IBI112 through week 48

Drug: IBI112

Interventions

IBI112DRUG

IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48

Group 2
placebo /IBI112DRUG

placebo by subcutaneous injection cross over IBI112 by subcutaneous injection at week 16 through week 48

Group 1

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
  • Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)

You may not qualify if:

  • History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
  • Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
  • Has received any therapeutic agent directly targeted to IL-17within 6 months of the first administration of study agent
  • Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent
  • Has received any conventional therapeutic agent within 1 months of the first administration of study agent
  • Has received any topic therapeutic agent within 2 weeks of the first administration of study agent

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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 9, 2022

Study Start

February 10, 2023

Primary Completion

August 9, 2023

Study Completion

August 1, 2024

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations

CN(1)