Characterization and Functionality of Calcium Channels Cav1.4 of Th17 Lymphocytes in Human With Psoriasis

NCT ID: NCT04459780

Last Updated: 2020-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-25
• Study Completion Date: 2017-11-13

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

Conditions

Psoriasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group 1 : 20 subjects with plaque psoriasis

Intervention: skin biopsies and blood sample

Group Type: EXPERIMENTAL

Skin biopsies

Intervention Type: BIOLOGICAL

3 biopsies on lesion skin (and one more for the first fifteen subjects in group 1)

Blood sample

Intervention Type: BIOLOGICAL

One blood sample for the group 1 only.

Group 2 : 10 subjects with atopic dermatitis

Intervention: skin biopsies

Group Type: EXPERIMENTAL

Skin biopsies

Intervention Type: BIOLOGICAL

3 biopsies on lesion skin (and one more for the first fifteen subjects in group 1)

Interventions

Skin biopsies

3 biopsies on lesion skin (and one more for the first fifteen subjects in group 1)

Intervention Type: BIOLOGICAL

Blood sample

One blood sample for the group 1 only.

Intervention Type: BIOLOGICAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Pierre Fabre Dermo Cosmetique

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul CARL, Pr.

Role: PRINCIPAL_INVESTIGATOR

Service de Dermatologie - Hôpital Larrey

Locations

Service de Dermatologie - Hôpital Larrey

Toulouse, , France

Countries

France

Other Identifiers

CaPSO17

Identifier Type: -

Identifier Source: org_study_id