Efficacy 、Safety and PK of SHR-1314 in Patients With Moderate-to-Severe Plaque Psoriasis
- Registration Number
- NCT04839016
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in Patients with Moderate-to-Severe Plaque Psoriasis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 660
-
Men or women at least 18 years of age at time of screening.
-
Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
-
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.
-
Subject has moderate to severe chronic plaque-type psoriasis that is inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy.
-
Body Mass Index (BMI) is 18 kg/m2 or above at screening
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline/randomization.
- Drug-induced psoriasis.
- Had a clinically significant flare of psoriasis during the 12 weeks prior to baseline (Week 0).
- Presence of other skin conditions (e.g. skin infections, seborrheic dermatitis) that in the judgement of the Investigator could interfere with assessment of psoriasis.
- History of inflammatory bowel disease or have other ongoing active autoimmune diseases.
- 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.
- 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.
- 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.
- 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.
- All subjects will be tested for tuberculosis status using IGRA and X-ray test.
- Have evidence of positive test for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group B Placebo - Treatment group A SHR-1314 -
- Primary Outcome Measures
Name Time Method Percentage of subjects who achieve at least 90% improvement in PASI score (PASI 90) at Week 12 Week 12 sPGA of 0 or 1 response at Week 12 Week 12
- Secondary Outcome Measures
Name Time Method Percentage of subjects who achieve at least 75% improvement in PASI score (PASI 75) at Week 12； Week 12； sPGA of 0 response at Week 12 Week 12 Percentage of subjects who achieve at least 100% improvement in PASI score (PASI 100) at Week 12 Week 12