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

April 8, 2026 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Multicenter, Open-label Study on the Efficacy and Safety 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Adalimumab Solution for Injection
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Week 8, Week 32, Week 52
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
Week 8, Week 16, Week 32, Week 52
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
Week 8, Week 16, Week 32, Week 52
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
Week 8, Week 16, Week 32, Week 52
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.
Week 8, Week 16, Week 32, Week 52
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
Up to 54 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADM-IV-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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