Clinical trial NCT04459780: Characterization and Functionality of Calcium Channels Cav1.4 of Th17 Lymphocytes in Human With Psoriasis
Official title: Characterization and Functionality of Calcium Channels Cav1.4 of Th17 Lymphocytes in Human With Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: Th17
Cav1.4
Lymphocyte
Channel
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
Collaborators: name: Centre National de la Recherche Scientifique, France
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2020-07-07
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, open-label, comparative, parallel group and intra-individual patho-physiological study :

* Group 1 : 20 subjects with plaque psoriasis
* Group 2 : 10 subject with atopic dermatitis
Primary purpose: BASIC_SCIENCE

Brief summary: It's clearly known that lymphocyte activation in particular Th17 response, plays a major role in the development of plaque psoriasis. New therapies targeting this pathway are showing great clinical efficacy in patients with moderate to severe plaque psoriasis.

Pioneering observations have shown that the expression of Cav1.4 channels in Th17 lymphocytes and they're functional role is supported by the inhibition of IL-17 production by a pharmacological inhibitor of Cav1 channels that is effective in a mouse model of Psoriasis.

This data strongly suggest that the Cav1.4 channel, via its involvement in the signalling responsible for the production of Th17 cytokines represents an interesting therapeutic target in Psoriasis.

The aim of the study is to explore biological functions related to the activation of the Cav1.4 pathway in Psoriasis.

Detailed description: * Evaluate the expression of Cav1.4 calcium channels by Th17 lymphocytes from plaque psoriasis.
* To assess:

  * The role of Cav1.4 channels on the activation of Th17 lymphocytes
  * The transcriptomic signature relating to the signalling channel Cav1.4
  * The epigenetic signature, in particular changes in overall methylation and specific promoter methylation

Eligibility criteria: Inclusion Criteria:

* Group 1 : Subject with plaque psoriasis (diagnosis confirmed by dermatologist) with a plaque IGA score ≥ 3
* Group 2 : Subject with atopic dermatitis according to the UK Working party criteria with an IGA plaque score ≥3

Exlusion Criteria:

* Group 1 : Other chronic inflammatory dermatosis than plaque psoriasis at the sites to be sampled
* Group 2 : Other chronic inflammatory dermatosis than Atopic Dermatitis at the sites to be sampled
* For both groups: Ongoing treatment with calcium channel blockers
* For both groups: Any current topical treatment on the biopsied or systemic plaque for psoriasis or AD (including phototherapy)

Primary outcomes:
measure: Expression of Cav1.4 calcium channels in Th17 lymphocytes
timeFrame: Baseline
Secondary outcomes:
measure: Role of Cav1.4 channels on the activation of Th17 lymphocytes
timeFrame: Baseline
measure: Transcriptomic signature relating to the signaling channel Cav1.4
timeFrame: Baseline
measure: Epigenetic signature, in particular changes in overall methylation and specific promoter methylation
timeFrame: Baseline
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Service de Dermatologie - Hôpital Larrey
Study officials:
affiliation: Service de Dermatologie - Hôpital Larrey
name: Paul CARL, Pr.
role: PRINCIPAL_INVESTIGATOR
References: