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, 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

Study Overview

• Status: Not yet recruiting
• Conditions: Children and Adolescents Aged 6 to 18 With Moderate-to-Severe Plaque Psoriasis
• Intervention / Treatment: Drug: SHR-1314

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: xiaoyan bai; Phone Number: +0518-81220121; Email: xiaoyan.bai@hengrui.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100045
      • Capital Medical University Affiliated Children's Hospital
      • Principal Investigator: Zigang Xu
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Shanghai Huashan Hospital
      • Principal Investigator: Jinhua Xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1314	Drug: SHR-1314; SHR-1314: dose 1 SHR-1314:dose 2 SHR-1314:dose 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety assessment including adverse events at Week 16	Week 16
PK parameters: Cmax at Week 12	Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
sPGA of 0 or 1 response at Week 12	Week 12
Percentage of subjects who achieve at least 75% improvement in PASI score (PASI 75) at Week 12	Week 12
Percentage of subjects who achieve at least 90% improvement in PASI score (PASI 90)at Week 12	Week 12

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: SHR-1314-307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No