A Phase 3 interventional study of SHR-1314 in Children and Adolescents Aged 6 to 18 With Moderate-to-Severe Plaque Psoriasis, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. Not yet recruiting at 2 sites in China. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-18.
Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 3, Interventional, and Treatment
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
Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 102 studies on the registry; 71 are open to participants now.
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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:
Drug: SHR-1314
SHR-1314: dose 1 SHR-1314:dose 2 SHR-1314:dose 3
Safety assessment including adverse events at Week 16
Time frame: Week 16
PK parameters: Cmax at Week 12
Time frame: Week 12
Percentage of subjects who achieve at least 75% improvement in PASI score (PASI 75) at Week 12
Time frame: Week 12
sPGA of 0 or 1 response at Week 12
Time frame: Week 12
Percentage of subjects who achieve at least 90% improvement in PASI score (PASI 90)at Week 12
Time frame: Week 12
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Feb 2025; primary completion for Jul 2026, 17 months later.
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This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vunakizumab
Suzhou Suncadia Biopharmaceuticals Co., Ltd. →