Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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 and Over|
Inclusion Criteria:1. Men or women at least 18 years of age at time of screening. 2. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization. 3. Moderate to severe psoriasis as defined at Baseline/ randomization by: PASI score of 12 or greater, and sPGA score of 3 or greater (based on a static scale of 0
- - 5), and Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater.
Exclusion Criteria:1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline/randomization. 2. Drug-induced psoriasis. 3. Had a clinically significant flare of psoriasis during the 12 weeks prior to baseline (Week 0). 4. Presence of other skin conditions (e.g. skin infections, seborrheic dermatitis) that in the judgement of the Investigator could interfere with assessment of psoriasis. 5. History of inflammatory bowel disease or have other ongoing active autoimmune diseases. 6. At screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 7. History of congestive heart failure (New York Heart Association [NYHA] functional classification ≥III), cerebro-cardiovascular events, or serious bleeding events at screening and / or randomization that in the judgement of the Investigator prevents the subject from participating in the study. 8. Active systemic infections (other than common cold) during the 4 weeks before randomization (e.g., hepatitis), or serious infections requiring hospitalization and/or intravenous injection of antibiotic treatment within eight weeks prior torandomization. 9. History of depression and/or suicidal ideation or any suicidal behavior based on an assessment with the Columbina Suicide Severity Rating Scale (C-SSRS) at screening and baseline (Posner K et al, 2011), The subjects will be exluded if any answer to question is "yes" in the questionnaire orare clinically judged by the investigator to be at risk for suicide. 10. All subjects will be tested for tuberculosis status using IGRA and X-ray test. 11. Have evidence of positive test for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies. 12. Have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Jiangsu HengRui Medicine Co., Ltd.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Moderate-to-Severe Plaque Psoriasis|
Experimental: Treatment group A
Placebo Comparator: Treatment group B
Drug: - SHR-1314
Drug: - Placebo