A Clinical Trail of Adalimumab in Treating Chinese Children With Severe Plaque Psoriasis

A Multicenter, Open-label Study on the Efficacy and Safety of Adalimumab in Treating Chinese Children With Severe Plaque Psoriasis

This study is a real-world clinical study of adalimumab. The project plans to enrol 30 participants and aims to evaluate the efficacy and safety of adalimumab in Chinese children with plaque psoriasis, with the primary endpoint being the proportion of participants achieving PASI 75 (PASI score reduction ≥75% from baseline) at week 16.

Study Overview

• Status: Not yet recruiting
• Conditions: Severe Plaque Psoriasis in Chinese Children
• Intervention / Treatment: Drug: Adalimumab Solution for Injection

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Bin Yang, Doctor; Phone Number: 13922207231; Email: yangbin101@hotmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Subjects and their guardians must sign an informed consent form. The research protocol/informed consent form for data collection and data verification should comply with local laws and regulations.
• Age 4 years ≤ age ≤ 17 years, regardless of gender;
• Subjects weigh ≥ 15kg;
• Subjects who respond poorly to local treatment and/or phototherapy or are unsuitable for such treatments;
• Diagnosed with severe plaque psoriasis in children according to the "Chinese Expert Consensus on the Diagnosis and Treatment of Pediatric Psoriasis (2021)"

Exclusion Criteria:

• Based on the prescribing information of Adalimumab Solution for Injection and the judgment of the treating physician, the subject is not eligible for treatment with Adalimumab Solution for Injection;
• Subjects who received psoralen combined with long-wave ultraviolet (UVA) therapy within 14 days prior to the screening period, or topical medium-wave ultraviolet (UVB) therapy within 7 days prior to the screening period;
• Subjects who received non-biological systemic treatments for paediatric psoriasis within 14 days prior to the screening period;
• Subjects who are currently using or have used other biological Disease-Modifying Antirheumatic Drug treatments within 12 weeks prior to the screening period;
• Subjects with significantly active psoriasis within 12 weeks prior to enrolment;
• Subjects who have received any live vaccine within 3 months prior to the first dose of Adalimumab Solution for Injection, or who plan to receive live vaccines during the study;
• Subjects currently participating in other clinical studies;
• Subjects deemed unsuitable for participation in this trial by the investigator.

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: Adalimumab Solution for Injection 20mg/40mg; For a body weight of 15 kg~30 kg, the initial dose is 20 mg, with 20mg administered every 2 weeks starting 1 week after the first dose. For a body weight ≥30 kg, the initial dose is 40 mg, with 40mg administered every 2 weeks starting 1 week after the first dose.

Drug: Adalimumab Solution for Injection; Adalimumab is a fully human anti-tumour necrosis factor-alpha monoclonal antibody that inhibits the downstream inflammatory cascade by blocking Tumor Necrosis Factor-α (TNF-α), a core inflammatory factor in psoriasis. In March 2020, adalimumab was approved in China for the treatment of severe plaque psoriasis in children and adolescents aged four years and older who have not responded well to topical therapies and phototherapy or are unsuitable for such treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area and Severity Index 75 at week 16	The proportion of subjects achieving PASI 75 at week 16 (PASI score decreased by ≥75% from baseline).	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psoriasis Area and Severity Index 75 at weeks 8, 32, and 52	Proportion of subjects achieving PASI 75 at weeks 8, 32, and 52	Week 8, Week 32, Week 52
Psoriasis Area and Severity Index 90	Proportion of subjects achieving PASI 90 (PASI score decreased by ≥90% from baseline) at weeks 8, 16, 32, and 52	Week 8, Week 16, Week 32, Week 52
Psoriasis Area and Severity Index 100	Proportion of subjects achieving PASI 100 (100% reduction in PASI score from baseline) at Weeks 8, 16, 32 and 52	Week 8, Week 16, Week 32, Week 52
Achieve a Physician's Global Assessment (PGA) score of clear (0) or very mild (1)	Proportion of subjects who achieved a PGA score of clear (0) or almost clear (1) at weeks 8, 16, 32, and 52	Week 8, Week 16, Week 32, Week 52
Children's Dermatology Life Quality Index (CDLQI) score	The changes from baseline in the Children's Dermatology Life Quality Index (CDLQI) score at Weeks 8, 16, 32 and 52 were used to assess efficacy.	Week 8, Week 16, Week 32, Week 52
Incidence of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious ADRs	Incidence of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious ADRs	Up to 54 weeks

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: ADM-IV-03

Drug and device information, study documents

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