NCT04459780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2017

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

July 1, 2020

Last Update Submit

July 10, 2020

Conditions

Psoriasis

Keywords

Th17Cav1.4LymphocyteChannel

Outcome Measures

Primary Outcomes (1)

  • Expression of Cav1.4 calcium channels in Th17 lymphocytes

    Immunohistochemistry (IHC) and in situ hybridation (HIS)

    Baseline

Secondary Outcomes (3)

  • Role of Cav1.4 channels on the activation of Th17 lymphocytes

    Baseline

  • Transcriptomic signature relating to the signaling channel Cav1.4

    Baseline

  • Epigenetic signature, in particular changes in overall methylation and specific promoter methylation

    Baseline

Study Arms (2)

Group 1 : 20 subjects with plaque psoriasis

EXPERIMENTAL

Intervention: skin biopsies and blood sample

Biological: Skin biopsiesBiological: Blood sample

Group 2 : 10 subjects with atopic dermatitis

EXPERIMENTAL

Intervention: skin biopsies

Biological: Skin biopsies

Interventions

Skin biopsiesBIOLOGICAL

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

Group 1 : 20 subjects with plaque psoriasisGroup 2 : 10 subjects with atopic dermatitis
Blood sampleBIOLOGICAL

One blood sample for the group 1 only.

Group 1 : 20 subjects with plaque psoriasis

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Dermatologie - Hôpital Larrey

Toulouse, 31400, France

Location

MeSH Terms

Conditions

PsoriasisCone-Rod Dystrophy, X-Linked, 3

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Paul CARL, Pr.

    Service de Dermatologie - Hôpital Larrey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 7, 2020

Study Start

October 25, 2016

Primary Completion

November 13, 2017

Study Completion

November 13, 2017

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)