Not yet recruiting NCT06833307
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-1314.
- Who it may be relevant to
- Registry conditions: Children and Adolescents Aged 6 to 18 With Moderate-to-Severe Plaque Psoriasis. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- Drug SHR-1314
SHR-1314: dose 1 SHR-1314:dose 2 SHR-1314:dose 3
Primary outcome measures
- Safety assessment including adverse events at Week 16 [Time frame: Week 16]
- PK parameters: Cmax at Week 12 [Time frame: Week 12]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Capital Medical University Affiliated Children's Hospital — Beijing
- Shanghai Huashan Hospital — Shanghai
Identifiers
NCT: NCT06833307 · SHR-1314-307