ClinicalTrials.gg
Not yet recruitingNCT06833307Updated Feb 18, 2025

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

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

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
6 Years to 18 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Children and Adolescents Aged 6 to 18 With Moderate-to-Severe Plaque Psoriasis
03

In context

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd. is the lead sponsor of 102 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. between 6 and 18years 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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    SHR-1314

    Drug: SHR-1314

Interventions

  • SHR-1314: dose 1 SHR-1314:dose 2 SHR-1314:dose 3

06

What researchers measure

Primary outcomes

  1. Safety assessment including adverse events at Week 16

    Time frame: Week 16

  2. PK parameters: Cmax at Week 12

    Time frame: Week 12

Secondary outcomes

  1. Percentage of subjects who achieve at least 75% improvement in PASI score (PASI 75) at Week 12

    Time frame: Week 12

  2. sPGA of 0 or 1 response at Week 12

    Time frame: Week 12

  3. Percentage of subjects who achieve at least 90% improvement in PASI score (PASI 90)at Week 12

    Time frame: Week 12

07

Study locations

2 sites
  • Capital Medical University Affiliated Children's Hospital
    Beijing, Beijing Municipality 100045, China
    • Zigang Xu · Principal investigator
  • Shanghai Huashan Hospital
    Shanghai, Shanghai Municipality 200040, China
    • Jinhua Xu · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2025; primary completion for Jul 2026, 17 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2025
First posted
Feb 18, 2025
StartEst.
Feb 2025
Primary completionEst.
Jul 2026
CompletionEst.
Aug 2026
Last update
Feb 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06833307
Responsible party
Sponsor
First posted
Feb 18, 2025
Start date
Feb 2025 (estimated)
Primary completion
Jul 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Feb 18, 2025

Study contacts

xiaoyan bai
Contact
xiaoyan.bai@hengrui.com
+0518-81220121

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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