- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01872546
Skin Transcriptional Profiles In Psoriatic Patients Under Adalimumab Biotherapy (CYTOPSO)
May 28, 2026 updated by: Poitiers University Hospital
Characterization of Skin Th17 Transcriptional Profiles in Psoriatic Patients Under Adalimumab Biotherapy
The expertise in the characterization of transcriptomics profile in lesional psoriatic skin and on the availability of innovative therapy for these patients.The investigators propose to follow the modification of the skin transcriptomics profile in psoriatic patients during successful Adalimumab biotherapy.
Skin transcriptomics profiles of normal skin, psoriatic non lesional skin, and psoriatic lesional skin before and after biotherapy will be compared.
The investigators will focus on the modification of the cytokine "signature" in these skin lesions and of some markers of keratinocyte inflammation.
The modification of the transcriptomics profile induced by the biotherapy will be correlated to the clinical response Psoriasis Area and Severity Index.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Poitiers, France, 86021
- CHU Poitiers
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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
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults with chronic plaque psoriasis involving at least 10% of body surface area with no previous biotherapy.
- Adalimumab prescribed in usual practice
Exclusion Criteria:
- Patients presenting a contraindication to the use of Adalimumab: hypersensibility in Adalimumab or in one of the excipients.
- Patients presenting an evolutionary tuberculosis or the other severe infections such as sepsis and opportunist infections.
- Patients with one cardiac insufficiencies moderated in severe.
- Patients under anakinra or abatacept.
- Patients with a current participation in another study of clinical research.
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Adalimumab
Adalimumab was administered subcutaneously at a dose of 80 mg at Week 0 and 40 mg every other week starting from Week 1 to Week 16.
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Adalimumab was administered subcutaneously at a dose of 80 mg at Week 0 and 40 mg every other week starting from Week 1 to Week 16.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Area and Severity Index (PASI)
Time Frame: 4 weeks
|
Number of patients with a reduction in PASI score at 4 weeks
|
4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dermatology Life Quality Index (DLQI) Scores
Time Frame: 4 weeks
|
Number of patients with a reduction in DLGI score at 4 weeks
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Croquette M, Faugeroux A, Fonlupt C, Godet J, Frouin E, Garcia M, Bernard FX, Cordier-Dirikoc S, Pedretti N, Larid G, Favot L, Roblot P, Boutin D, Hainaut-Wierzbicka E, Heymann D, Lecron JC, Morel F, Jegou JF. IL-34 Exerts Anti-Inflammatory Activities on Keratinocytes and Is Downregulated in Psoriatic-Inflamed Skin. J Invest Dermatol. 2023 Dec;143(12):2521-2524.e5. doi: 10.1016/j.jid.2023.05.023. Epub 2023 Jun 12. No abstract available.
- Buffiere-Morgado A, Couderc E, Delwail A, Favot L, Jegou JF, Solau E, Guillet G, Lecron JC, Morel F. Characterization of skin Th17 transcriptional profiles in psoriatic patients under adalimumab biotherapy. Eur J Dermatol. 2017 Dec 1;27(6):579-589. doi: 10.1684/ejd.2017.3127.
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 (Actual)
January 1, 2013
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
March 27, 2013
First Submitted That Met QC Criteria
June 5, 2013
First Posted (Estimated)
June 7, 2013
Study Record Updates
Last Update Posted (Actual)
June 24, 2026
Last Update Submitted That Met QC Criteria
May 28, 2026
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CYTOPSO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.