Health TrialsbyHealthPanel

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

ConditionSevere Plaque Psoriasis in Chinese Children
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age4-17
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Adalimumab Solution for Injection 20mg/40mgExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
Week 16

Secondary outcomes

1

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

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

Time frame
Week 8, Week 32, Week 52
2

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

Time frame
Week 8, Week 16, Week 32, Week 52
3

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

Time frame
Week 8, Week 16, Week 32, Week 52
4

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: