ImmunoclassificationNCT05503875
Immunoclassification of Psoriasis: a Strategy for Precision Medicine
A study testing adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors, methotrexate in people with Immunoclassification and Psoriasis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Through the combination of clinical manifestations and omics, the investigators aim to explore the skin cell atlas in different stages of psoriasis lesions, establish a clinical classification standard for psoriasis, and guide the precise treatment of psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunoclassification, Psoriasis
- What is being tested?
- adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors, methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2027
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1.18 to 75 years of age 2.Moderate to severe chronic psoriasis, BSA≥3% 3.Duration of psoriasis≥6 months 4.Patients must be candidate for systemic therapy 5.Informed consent must be obtained 6.For female, ß-hCG test is negative and contraception is accepted
Who cannot join
- Having severe infections, including hepatitis, HIV and tuberculosis
- Having significant allergies to biological agents
- Having a history of malignancy
- Refusal of contraception
- Having serious or unstable/uncontrolled illnesses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
XiaoYong Man, 13600516219, manxy@zju.edu.cn
About this study
Through the combination of clinical manifestations and omics, the investigators aim to explore the skin cell atlas in different stages of psoriasis lesions, establish a clinical classification standard for psoriasis, and guide the precise treatment of psoriasis.
Read the detailed description
Psoriasis is a heterogeneous condition that can affect skin and other structures. Over the past decade, considerable advances have been made both in our understanding of the pathogenesis of psoriasis and in the revolutionized immunotherapy of its diverse manifestations. Psoriasis heterogeneity and its cutaneous microenvironment is the leading cause of resistance in patients.
Novel approaches, including single-cell RNA sequencing technology and CyTOF, are proposed as methodological solutions. By their combination with immunotherapy, we can specifically evaluate the mechanism of psoriasis in the face of immunotherapy agents at the single-cell resolution by detecting the transcriptional activity of cytokines, immune checkpoints, screening neoantigens with high transcription levels, identifying rare cells, and assisting the dissection of the critical immune-metabolic pathways in this complex disease. We aim to improve short-term and long-term precision treatment strategies for patients with psoriasis.
- Conditions
- Immunoclassification, Psoriasis
- Being tested
- adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors, methotrexate
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors, methotrexateBiological
Psoriasis patients will be treated with adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors or methotrexate.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Patients will be treated with adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors or methotrexate. Receives: Biological: adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors, methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the number of immune cells (dendritic cells, macrophages) in the lesional skin, non-lesional skin of psoriasis patients and healthy skin.
The intensity of specific cell subsets will be assessed by flow cytometry in psoriasis patients and healthy controls.
Measured: 16 months
Molecular analysis of psoriasis lesional skin by single-cell RNA sequencing.
To analyze the intensity of cytokines or chemokines, such as IL-17, IL-23, TNF in the dermis and epidermis of psoriasis patients
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Jan 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunoclassificationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503875
- Sponsor's protocol ID
- 2022-0205
- Status last verified
- Jan 2024
- First submitted
- 11 Jul 2022
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoclassification of Psoriasis: a Strategy for Precision Medicine
- ClinicalTrials.gov ID
- NCT05503875
- Acronym / sponsor ID
- 2022-0205
- Conditions
- Immunoclassification, Psoriasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Aug 2022 (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.
Through the combination of clinical manifestations and omics, the investigators aim to explore the skin cell atlas in different stages of psoriasis lesions, establish a clinical classification standard for psoriasis, and guide the precise treatment of psoriasis.
Detailed description
Psoriasis is a heterogeneous condition that can affect skin and other structures. Over the past decade, considerable advances have been made both in our understanding of the pathogenesis of psoriasis and in the revolutionized immunotherapy of its diverse manifestations. Psoriasis heterogeneity and its cutaneous microenvironment is the leading cause of resistance in patients.
Novel approaches, including single-cell RNA sequencing technology and CyTOF, are proposed as methodological solutions. By their combination with immunotherapy, we can specifically evaluate the mechanism of psoriasis in the face of immunotherapy agents at the single-cell resolution by detecting the transcriptional activity of cytokines, immune checkpoints, screening neoantigens with high transcription levels, identifying rare cells, and assisting the dissection of the critical immune-metabolic pathways in this complex disease. We aim to improve short-term and long-term precision treatment strategies for patients with psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Biological: adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors, methotrexatePatients will be treated with adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors or methotrexate. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.18 to 75 years of age 2.Moderate to severe chronic psoriasis, BSA≥3% 3.Duration of psoriasis≥6 months 4.Patients must be candidate for systemic therapy 5.Informed consent must be obtained 6.For female, ß-hCG test is negative and contraception is accepted
Key exclusion criteria (5 listed)
- Having severe infections, including hepatitis, HIV and tuberculosis
- Having significant allergies to biological agents
- Having a history of malignancy
- Refusal of contraception
- Having serious or unstable/uncontrolled illnesses
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, secukinumab, ixekizumab, guselkumab, Jak inhibitors, methotrexatePsoriasis patients will be treated with adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors or methotrexate. | Biological | treatment |
Primary outcome
Differences in the number of immune cells (dendritic cells, macrophages) in the lesional skin, non-lesional skin of psoriasis patients and healthy skin.
Time frame: 16 months
The intensity of specific cell subsets will be assessed by flow cytometry in psoriasis patients and healthy controls.
Molecular analysis of psoriasis lesional skin by single-cell RNA sequencing.
Time frame: 16 months
To analyze the intensity of cytokines or chemokines, such as IL-17, IL-23, TNF in the dermis and epidermis of psoriasis patients
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 12 Jan 2024.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors, methotrexate in people with Immunoclassification and Psoriasis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Jan 2024. 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?
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 Xiao-yong Man (13600516219, manxy@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the number of immune cells (dendritic cells, macrophages) in the lesional skin, non-lesional skin of psoriasis patients and healthy skin. (time frame: 16 months). 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?
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 12 Jan 2024.