Severe Plaque Psoriasis in Chinese ChildrenPhase 4NCT07529925
A Clinical Trail of Adalimumab in Treating Chinese Children With Severe Plaque Psoriasis
A Phase 4 study testing Adalimumab Solution for Injection in people with Severe Plaque Psoriasis in Chinese Children, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Severe Plaque Psoriasis in Chinese Children
- What is being tested?
- Adalimumab Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2026to May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)"
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Adalimumab Solution for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab Solution for InjectionDrug
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 group | Role | What they receive |
|---|---|---|
| Adalimumab Solution for Injection 20mg/40mg | Experimental | 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. Receives: Drug: Adalimumab Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 16
Secondary outcomes (6)
Psoriasis Area and Severity Index 75 at weeks 8, 32, and 52
Proportion of subjects achieving PASI 75 at weeks 8, 32, and 52
Measured: Week 8, Week 32, Week 52
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
Measured: Week 8, Week 16, Week 32, Week 52
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
Measured: Week 8, Week 16, Week 32, Week 52
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
Measured: Week 8, Week 16, Week 32, Week 52
Children's Dermatology Life Quality Index (CDLQI) score
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.
Measured: Week 8, Week 16, Week 32, Week 52
Incidence of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious ADRs
Incidence of adverse events (AE), serious adverse events (SAE), adverse drug reactions (ADR), and serious ADRs
Measured: Up to 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Plaque Psoriasis in Chinese ChildrenStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529925
- Sponsor's protocol ID
- ADM-IV-03
- Status last verified
- Jan 2026
- First submitted
- 8 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study on the Efficacy and Safety of Adalimumab in Treating Chinese Children With Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07529925
- Acronym / sponsor ID
- ADM-IV-03
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab Solution for Injection 20mg/40mg | Experimental | Drug: Adalimumab Solution for InjectionFor 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. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)"
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adalimumab Solution for InjectionAdalimumab 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. | Drug | Adalimumab Solution for Injection 20mg/40mg |
Primary outcome
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).
6 secondary outcomes
Psoriasis Area and Severity Index 75 at weeks 8, 32, and 52
Time frame: Week 8, Week 32, Week 52
Psoriasis Area and Severity Index 90
Time frame: Week 8, Week 16, Week 32, Week 52
Psoriasis Area and Severity Index 100
Time frame: 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
Children's Dermatology Life Quality Index (CDLQI) score
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab Solution for Injection in people with Severe Plaque Psoriasis in Chinese Children, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Yang, Doctor (13922207231, yangbin101@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index 75 at week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.