Plaque PsoriasisNCT05803187
Clinical Study of Stage IV Psoriasis in Children With Geleli
An observational study of Plaque Psoriasis, run by Bio-Thera Solutions at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Plaque Psoriasis
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2023to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A total of 80 children and adolescents with severe plaque psoriasis were enrolled in this study. Selected recipient Candidates must meet all inclusion criteria and not meet any exclusion criteria. Before performing any specific evaluation or Prior to the procedure, all subjects and/or guardians must sign written informed consent.
Who may be able to join
- ) 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.
Who cannot join
- A history of severe allergies or allergic reactions to monoclonal antibodies
- Active infectious diseases ( including tuberculosis, hepatitis B, AIDS, syphilis, etc. )
- Conform to any of the following criteria associated with latent or active TB infection :
- A history of active TB ≤3 years prior to screening (but if > 3 years, and a history of complete treatment Piece record, can also be grouped) During the screening period, there were signs or symptoms indicating active TB during medical history and / or physical examination ; recent close contact with people with active tuberculosis ( TB ) ; At the time of screening the interferon gamma release test tested positive if the subject's first interferon If the gamma release test results are inconclusive, the subject is excluded from the study;For subjects who have completed appropriate standard treatment for latent TB prior to screening and have no additional risk factors, radiographic findings or support for specific signs of latent or active TB,Possible for positive or inconclusive results. Exceptions will be made. The investigator will need to consult with a qualified infectomist to determine the risk of TB (including extra-pulmonary) and Discuss and decide with the sponsor;
- Two pairs of hepatitis B surface antigen ( HBsAg ) were positive in screening. Or HBsAg negative, HBcAb positive and HBV-DNA positive.
- There are serious, progressive or uncontrollable kidney, liver, blood, gastrointestinal, lung, heart blood. Tube, nerve or brain disease symptoms.
Show all 14Show fewer
- Patients received anti-tumor necrosis factor ( TNF ) or other biological agents with potential therapeutic effects on psoriasis within the previous 12 weeks.
- Patients received intravenous anti-infective therapy within 30 days or oral anti-infective therapy within 14 days.
- Local glucocorticoids, vitamin D derivatives, retinoic acid, calcineurin inhibitors ( TCI ) and other topical preparations with pharmacologically active ingredients were received within 7 days.
- Local or UVB phototherapy within 7 days or psoralen or psoralen combined with ultraviolet A ( UVA ) phototherapy within 14 days.
- Systemic treatment with non-biological agents for psoriasis including methotrexate, retinoic acids, cyclosporine, apulmiast, azathioprine, hydroxyurea, leflunomide, mexicophenol ester, sulfadiazine, calcineurase inhibitors, 6⁃ thiguanine for 14 days prior to baseline
- Those who received any live vaccine within 3 months prior to receiving the first dose of the study drug, or during the study period.
- Patients with erythrodermic psoriasis, pustular psoriasis, drug-induced or aggravated psoriasis, and newly minted guttate psoriasis
- Patients who were judged unsuitable for inclusion by other investigators
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: A Prospective, Observaional Multi-Center Phase IV Study to Evaluate the Efficacy and Safety of QLETLI (Adalimumab Biosimilar) in Pediatric and Juvenile Subjects With Severe Plaque Psoriasis (PISCES Trials)
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.
- Conditions
- Plaque Psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis lesion area and severity index (PASI)
Proportion of patients with a 75% decrease in PASI score at week 16 compared to baseline
Measured: Week 16 after administration
Physician Global Assessment (PGA)
Proportion of patients with a PGA score of 0 ( clearance ) or 1 ( very mild ) at week 16
Measured: Week 16 after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start5 Apr 2023
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Gu, Senior, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803187
- Sponsor's protocol ID
- BAT-1406-008-CR
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang Y, Pan T, Shi X, Zhang G, Cheng F, Geng S, Gu H, Li S, Diao Q, Wang X, Lu Y, Ji C, Li Y, Shi Y, Gu J, Chen L. Efficacy and Safety of the First Adalimumab Biosimilar in Chinese Children with Severe Plaque Psoriasis: The PISCES Study, a Multicenter Prospective Study. Dermatol Ther (Heidelb). 2026 Sep 6. doi: 10.1007/s13555-026-01897-6. Online ahead of print.
PubMed 42701929
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observaional Multi-Center Phase IV Study to Evaluate the Efficacy and Safety of QLETLI (Adalimumab Biosimilar) in Pediatric and Juvenile Subjects With Severe Plaque Psoriasis (PISCES Trials)
- ClinicalTrials.gov ID
- NCT05803187
- Acronym / sponsor ID
- BAT-1406-008-CR
- Conditions
- Plaque Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 7 Apr 2023 (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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A total of 80 children and adolescents with severe plaque psoriasis were enrolled in this study. Selected recipient Candidates must meet all inclusion criteria and not meet any exclusion criteria. Before performing any specific evaluation or Prior to the procedure, all subjects and/or guardians must sign written informed consent.
Key inclusion criteria (6 listed)
- ) 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
Key exclusion criteria (14 listed)
- A history of severe allergies or allergic reactions to monoclonal antibodies
- Active infectious diseases ( including tuberculosis, hepatitis B, AIDS, syphilis, etc. )
- Conform to any of the following criteria associated with latent or active TB infection :
- A history of active TB ≤3 years prior to screening (but if > 3 years, and a history of complete treatment Piece record, can also be grouped) During the screening period, there were signs or symptoms indicating active TB during medical history and / or physical examination ; recent close contact with people with active tuberculosis ( TB ) ; At the time of screening the interferon gamma release test tested positive if the subject's first interferon If the gamma release test results are inconclusive, the subject is excluded from the study;For subjects who have completed appropriate standard treatment for latent TB prior to screening and have no additional risk factors, radiographic findings or support for specific signs of latent or active TB,Possible for positive or inconclusive results. Exceptions will be made. The investigator will need to consult with a qualified infectomist to determine the risk of TB (including extra-pulmonary) and Discuss and decide with the sponsor;
- Two pairs of hepatitis B surface antigen ( HBsAg ) were positive in screening. Or HBsAg negative, HBcAb positive and HBV-DNA positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psoriasis lesion area and severity index (PASI)
Time frame: Week 16 after administration
Proportion of patients with a 75% decrease in PASI score at week 16 compared to baseline
Physician Global Assessment (PGA)
Time frame: Week 16 after administration
Proportion of patients with a PGA score of 0 ( clearance ) or 1 ( very mild ) at week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Derived from this study: PubMed 42701929Huang Y, Pan T, Shi X, Zhang G, Cheng F, Geng S, Gu H, Li S, Diao Q, Wang X, Lu Y, Ji C, Li Y, Shi Y, Gu J, Chen L. Efficacy and Safety of the First Adalimumab Biosimilar in Chinese Children with Severe Plaque Psoriasis: The PISCES Study, a Multicenter Prospective Study. Dermatol Ther (Heidelb). 2026 Sep 6. doi: 10.1007/s13555-026-01897-6. Online ahead of print.
Related trials for Plaque Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
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. This study is not recruiting at the moment.
Jun Gu, Senior principal investigator
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plaque Psoriasis, run by Bio-Thera Solutions at 1 site in China.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis lesion area and severity index (PASI) (time frame: Week 16 after administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05803187, which also lists 1 linked publication.
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 13 Mar 2026.