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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05003531
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Innovent Biologics (Suzhou) Co. Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis
Arms & Interventions

Arms

Experimental: IBI112 dose 1

Participants will receive IBI112 dose 1 subcutaneous injection(SC)

Experimental: IBI112 dose 4

Participants will receive IBI112 dose 4 subcutaneous injection(SC)

Experimental: IBI112 dose 2

Participants will receive IBI112 dose 2 subcutaneous injection(SC)

Experimental: IBI112 dose 3

Participants will receive IBI112 dose 3 subcutaneous injection(SC)

Placebo Comparator: Placebo

Participants will receive placebo subcutaneous injection(SC)

Interventions

Drug: - IBI112 dose 2

Participants will receive placebo or dose 2 IBI112 SC

Drug: - IBI112 dose 4

Participants will receive placebo or dose 4 IBI112 SC

Drug: - IBI112 dose 1

Participants will receive placebo or dose 1 IBI112 SC

Drug: - IBI112 dose 3

Participants will receive placebo or dose 3 IBI112 SC

Drug: - placebo

Participants will receive placebo SC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

PeKing University People's Hostpital, Beijing, Beijing, China

Status

Recruiting

Address

PeKing University People's Hostpital

Beijing, Beijing, 100044

Site Contact

Jianzhong Zhang

rmzjz@126.com

+86 010 88326666

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