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NCT Number: NCT07529925

A Clinical Trail 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.

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Key information

Conditions

Severe Plaque Psoriasis in Chinese Children

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Psoriasis Area and Severity Index 75 at week 16

    Time frame: Week 16

    The proportion of subjects achieving PASI 75 at week 16 (PASI score decreased by ≥75% from baseline).

Secondary outcomes

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

    Time frame: Week 8, Week 32, Week 52

    Proportion of subjects achieving PASI 75 at weeks 8, 32, and 52

  2. Psoriasis Area and Severity Index 90

    Time frame: Week 8, Week 16, Week 32, Week 52

    Proportion of subjects achieving PASI 90 (PASI score decreased by ≥90% from baseline) at weeks 8, 16, 32, and 52

  3. Psoriasis Area and Severity Index 100

    Time frame: Week 8, Week 16, Week 32, Week 52

    Proportion of subjects achieving PASI 100 (100% reduction in PASI score from baseline) at Weeks 8, 16, 32 and 52

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

    Time frame: Week 8, Week 16, Week 32, Week 52

    Proportion of subjects who achieved a PGA score of clear (0) or almost clear (1) at weeks 8, 16, 32, and 52

  5. Children's Dermatology Life Quality Index (CDLQI) score

    Time frame: Week 8, Week 16, Week 32, Week 52

    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.

  6. Incidence of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious ADRs

    Time frame: Up to 54 weeks

    Incidence of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious ADRs

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Yang, Doctor

CONTACT

[email protected]

13922207231

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.