Chronic Plaque PsoriasisPhase 2CYTOPSONCT01872546
Skin Transcriptional Profiles In Psoriatic Patients Under Adalimumab Biotherapy
A Phase 2 study testing Adalimumab Every Week in people with Chronic Plaque Psoriasis, run by Poitiers University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- Adalimumab Every Week
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Sep 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with chronic plaque psoriasis involving at least 10% of body surface area with no previous biotherapy.
- Adalimumab prescribed in usual practice
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- Adalimumab Every Week
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab Every WeekDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Experimental | 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. Receives: Drug: Adalimumab Every Week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area and Severity Index (PASI)
Number of patients with a reduction in PASI score at 4 weeks
Measured: 4 weeks
Secondary outcomes (1)
Dermatology Life Quality Index (DLQI) Scores
Number of patients with a reduction in DLGI score at 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872546
- Sponsor's protocol ID
- CYTOPSO
- Acronym
- CYTOPSO
- Status last verified
- Oct 2016
- First submitted
- 27 Mar 2013
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37315881Buffiere-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.
PubMed 29171393
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Skin Th17 Transcriptional Profiles in Psoriatic Patients Under Adalimumab Biotherapy
- ClinicalTrials.gov ID
- NCT01872546
- Acronym / sponsor ID
- CYTOPSO / CYTOPSO
- Conditions
- Chronic Plaque Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Posted 24 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Experimental | Drug: Adalimumab Every WeekAdalimumab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with chronic plaque psoriasis involving at least 10% of body surface area with no previous biotherapy.
- Adalimumab prescribed in usual practice
Key exclusion criteria (5 listed)
- 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.
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 Every WeekAdalimumab 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. | Drug | Adalimumab |
Primary outcome
Area and Severity Index (PASI)
Time frame: 4 weeks
Number of patients with a reduction in PASI score at 4 weeks
1 secondary outcome
Dermatology Life Quality Index (DLQI) Scores
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37315881Croquette 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.
- Results publication: PubMed 29171393Buffiere-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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adalimumab Every Week in people with Chronic Plaque Psoriasis, run by Poitiers University Hospital at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 24 Jun 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area and Severity Index (PASI) (time frame: 4 weeks). 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 NCT01872546, which also lists 2 linked publications.
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 24 Jun 2026.