IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment

Study Purpose

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

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:

1. Have a diagnosis of plaque-type psoriasis for at least 6 months; 2. 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; 3. Must be a candidate for either systemic therapy or phototherapy for psoriasis.

Exclusion Criteria:

1. 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. 2. Participants who have ever received IBI112 or IL-23 inhibitor. 3. 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. 4. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the participant. 5. Is pregnant, nursing, or planning a pregnancy (both men and women) within 6 months following the last administration of the study drug

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.

NCT06049810
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 3
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: Group 3

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

Experimental: Group 4

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

Experimental: Group 6

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

Placebo Comparator: Group 5

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

Experimental: Group 1

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

Placebo Comparator: Group 2

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

Interventions

Drug: - IBI112

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

Drug: - IBI112/placebo

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

Drug: - IBI112/placebo

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

Drug: - IBI112

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

Drug: - IBI112

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

Drug: - IBI112

Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44 by subcutaneous injection

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

Shanghai Skin Disease Hospital, Shanghai, Shanghai, China

Status

Recruiting

Address

Shanghai Skin Disease Hospital

Shanghai, Shanghai, 200443

Site Contact

Yuling Shi

shiyuling1973@126.com

021-36803156

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