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

NCT ID: NCT05645627

Last Updated: 2024-10-29

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-10

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

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

Group Type PLACEBO_COMPARATOR

placebo /IBI112

Intervention Type DRUG

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

Group 2

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

Group Type EXPERIMENTAL

IBI112

Intervention Type DRUG

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

Group 3

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

Group Type EXPERIMENTAL

IBI112

Intervention Type DRUG

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

Interventions

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IBI112

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

Intervention Type DRUG

placebo /IBI112

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

Intervention Type DRUG

IBI112

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

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Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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CIBI112A301

Identifier Type: -

Identifier Source: org_study_id

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