CompletedNot Applicable

Clinical Study of Stage IV Psoriasis in Children With Geleli

China80 participantsStarted 2023-04-05

Plain-language summary

This study is a multicenter, prospective, observational phase IV clinical study. A total of 80 children and adolescents with severe plaque psoriasis were included in the study. The study is expected to last for 24 weeks (169 days). This study will evaluate the efficacy and safety of Valerie ® (Adalimumab Injection) in Chinese children over 4 years old and adolescents with severe plaque psoriasis.

Who can participate

Age range

4 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. ) Patients and / or patient guardians voluntarily participated in the study and signed informed consent
. )Age ≥ 4 years and \< 18 years, male or female
. ) The weight of patients should be 15 kg or more
. ) Patients diagnosed with plaque psoriasis for at least 6 months ; at the same time, the researchers clarified the diagnosis of psoriasis
. ) Patients with poor efficacy or unsuitable for local treatment and / or phototherapy
. ) For patients with severe plaque psoriasis, the definition should meet one of the following conditions : Psoriasis static clinician overall assessment PGA score ≥ 4 points The body surface area of psoriatic lesions was BSA \> 10 %. Psoriasis area and severity index PASI \> 12 Children 's skin disease quality of life index ( CDLQI ) score \> 10 points.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Psoriasis lesion area and severity index (PASI)

Timeframe: Week 16 after administration

Physician Global Assessment (PGA)

Timeframe: Week 16 after administration

Trial details

NCT IDNCT05803187

SponsorBio-Thera Solutions

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-03-30

View on ClinicalTrials.gov More Plaque Psoriasis trials

Plain-language summary

Who can participate

Age range

4 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. ) Patients and / or patient guardians voluntarily participated in the study and signed informed consent
. )Age ≥ 4 years and \< 18 years, male or female
. ) The weight of patients should be 15 kg or more
. ) Patients diagnosed with plaque psoriasis for at least 6 months ; at the same time, the researchers clarified the diagnosis of psoriasis
. ) Patients with poor efficacy or unsuitable for local treatment and / or phototherapy
. ) For patients with severe plaque psoriasis, the definition should meet one of the following conditions : Psoriasis static clinician overall assessment PGA score ≥ 4 points The body surface area of psoriatic lesions was BSA \> 10 %. Psoriasis area and severity index PASI \> 12 Children 's skin disease quality of life index ( CDLQI ) score \> 10 points.

Clinical Study of Stage IV Psoriasis in Children With Geleli

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Clinical Study of Stage IV Psoriasis in Children With Geleli

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria