A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis

NCT ID: NCT05003531

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-23

Study Completion Date

2023-01-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the efficacy and safety of IBI112 administered in different dose regimens for the treatment of patients with plaque psoriasis

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IBI112 dose 1

Participants will receive IBI112 dose 1 subcutaneous injection(SC)

Group Type EXPERIMENTAL

IBI112 dose 1

Intervention Type DRUG

Participants will receive placebo or dose 1 IBI112 SC

IBI112 dose 4

Participants will receive IBI112 dose 4 subcutaneous injection(SC)

Group Type EXPERIMENTAL

IBI112 dose 4

Intervention Type DRUG

Participants will receive placebo or dose 4 IBI112 SC

IBI112 dose 2

Participants will receive IBI112 dose 2 subcutaneous injection(SC)

Group Type EXPERIMENTAL

IBI112 dose 2

Intervention Type DRUG

Participants will receive placebo or dose 2 IBI112 SC

IBI112 dose 3

Participants will receive IBI112 dose 3 subcutaneous injection(SC)

Group Type EXPERIMENTAL

IBI112 dose 3

Intervention Type DRUG

Participants will receive placebo or dose 3 IBI112 SC

Placebo

Participants will receive placebo subcutaneous injection(SC)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Participants will receive placebo SC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IBI112 dose 2

Participants will receive placebo or dose 2 IBI112 SC

Intervention Type DRUG

IBI112 dose 4

Participants will receive placebo or dose 4 IBI112 SC

Intervention Type DRUG

IBI112 dose 1

Participants will receive placebo or dose 1 IBI112 SC

Intervention Type DRUG

IBI112 dose 3

Participants will receive placebo or dose 3 IBI112 SC

Intervention Type DRUG

placebo

Participants will receive placebo SC

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* 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-12, IL-17, or IL-23within 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

PeKing University People's Hostpital

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CIBI112A201

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.