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Skin Transcriptional Profiles In Psoriatic Patients Under Adalimumab Biotherapy

Characterization of Skin Th17 Transcriptional Profiles in Psoriatic Patients Under Adalimumab Biotherapy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01872546
Acronym
CYTOPSO
Enrollment
18
Registered
2013-06-07
Start date
2013-01-01
Completion date
2013-09-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Plaque Psoriasis

Brief 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. 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.

Interventions

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.

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Area and Severity Index (PASI)4 weeksNumber of patients with a reduction in PASI score at 4 weeks

Secondary

MeasureTime frameDescription
Dermatology Life Quality Index (DLQI) Scores4 weeksNumber of patients with a reduction in DLGI score at 4 weeks

Countries

France

Baseline characteristics

Characteristic
Age, Customized
Mean age
51.67 Years
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
15 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 15
other
Total, other adverse events
0 / 15
serious
Total, serious adverse events
0 / 15

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026