A Phase 2 Study of Jaktinib in Participants With Moderate to Severe Psoriasis

Study Purpose

This is study designed to investigate the efficacy and safety of Jaktinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.

Recruitment Criteria

Accepts Healthy Volunteers

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

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.

Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 18~65 years old (including lower limit), no gender limit; - You must have active chronic plaque psoriasis for at least 6 months prior to entry into the study; - You must have active plaque psoriasis covering at least 10% body surface area; You must have Psoriasis Area and Severity Index (PASI) score of at least 12;You must have Static Physician's Global Assessment (sPGA) score of at least 3; - The patient can communicate well with the investigator and follow the research and follow-up procedures; - Understand and voluntarily sign the informed consent form.

Exclusion Criteria:

- You must not have prior treatment with an oral Janus kinase (JAK) inhibitor; - You must not have received a phototherapy within 4 weeks prior to entry into the study; - You must not have a history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV); - You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse

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.


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.

Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Principal Investigator

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

Xinghua Gao, PhD
Principal Investigator Affiliation First Hospital of China Medical University
Agency Class

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

Overall Status Recruiting
Countries China

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

Moderate-to-Severe Plaque Psoriasis
Arms & Interventions


Experimental: Jaktinib 50mg Bid

Jaktinib 50mg Bid+ Placebo 50mg Bid+ Placebo 75mg Bid

Experimental: Jaktinib 75mg Bid

Jaktinib 75mg Bid+ Placebo 50mg*2 Bid

Experimental: Jaktinib 100mg Bid

Jaktinib 50mg*2 Bid+ Placebo 75mg Bid

Placebo Comparator: Placebo

Placebo 50mg*2 Bid+ Placebo 75mg Bid


Drug: - Jaktinib

Administered orally

Drug: - Placebo

Administered orally

Contact a Trial Team

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International Sites

Shenyang, Liaoning, China




The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110000

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