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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT07529925
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Severe Plaque Psoriasis in Chinese Children

Eligibility Criteria

Sex
ALL
Age
4 Years - 17 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Jan 2026
Primary completion
Apr 30, 2028
Completion
May 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Psoriasis Area and Severity Index 75 at week 16 [ Time Frame: Week 16 ]

Central Contacts