Severe Plaque Psoriasis in Chinese Children
Conditions
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.
Interventions
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.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index 75 at week 16 | Week 16 | The proportion of subjects achieving PASI 75 at week 16 (PASI score decreased by ≥75% from baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index 75 at weeks 8, 32, and 52 | Week 8, Week 32, Week 52 | Proportion of subjects achieving PASI 75 at weeks 8, 32, and 52 |
| Psoriasis Area and Severity Index 90 | 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 |
| Psoriasis Area and Severity Index 100 | 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 |
| Achieve a Physician's Global Assessment (PGA) score of clear (0) or very mild (1) | 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 |
| Children's Dermatology Life Quality Index (CDLQI) score | 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. |
| Incidence of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious ADRs | Up to 54 weeks | Incidence of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious ADRs |
Contacts
CONTACTBin Yang, Doctor
Outcome results
None listed