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

NCT07529925 | Not Yet Recruiting Phase 4

• 1 other identifier: ADM-IV-03
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Severe Plaque Psoriasis in Chinese Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Psoriasis Area and Severity Index 75 at weeks 8, 32, and 52

  Week 8, Week 32, Week 52

• Psoriasis Area and Severity Index 90

  Week 8, Week 16, Week 32, Week 52

• Psoriasis Area and Severity Index 100

  Week 8, Week 16, Week 32, Week 52

• Achieve a Physician's Global Assessment (PGA) score of clear (0) or very mild (1)

  Week 8, Week 16, Week 32, Week 52

• Children's Dermatology Life Quality Index (CDLQI) score

  Week 8, Week 16, Week 32, Week 52

Study Arms (1)

Adalimumab Solution for Injection 20mg/40mg

EXPERIMENTAL

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

Interventions

Adalimumab Solution for Injection DRUG

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.

Adalimumab Solution for Injection 20mg/40mg

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)"

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Bin Yang, Doctor

CONTACT

13922207231; yangbin101@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-01