Tests SHR-1314 injections in children with moderate to severe plaque psoriasis
Tests SHR-1314 injections in children aged 6 to under 18 with plaque psoriasis.
Plain-language title generated from the registry record
Registry title: The Efficacy and Safety of SHR-1314 in the Treatment of Pediatric Patients of Age 6 to <18 Years With Moderate to Severe Plaque Psoriasis
Key facts
- Where
- Beijing and Shanghai, ChinaSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 18 years old?
Source: NCT06833307, who can take part
Where in China
- Capital Medical University Affiliated Children's HospitalBeijing, ChinaNo longer taking part
- Shanghai Huashan HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Trial code
- NCT06833307
- Record updated
- 18 February 2025
- Original description
The purpose of this study is to assess efficacy, safety of subcutaneous SHR-1314 in pediatric patients of age 6 to <18 years with moderate-to-Severe plaque psoriasisRead full original descriptionShow less
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Efficacy and Safety of SHR-1314 in the Treatment of Pediatric Patients of Age 6 to <18 Years With Moderate to Severe Plaque Psoriasis
The purpose of this study is to assess efficacy, safety of subcutaneous SHR-1314 in pediatric patients of age 6 to <18 years with moderate-to-Severe plaque psoriasis
Inclusion: between 6 and 18years 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.
Exclusion: Drug-induced psoriasis; Had a clinically significant flare of psoriasis during the 12 weeks prior to baseline (Week 0); 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; 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; 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; Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline/randomization.