PsoriasisNCT04459780
Characterization and Functionality of Calcium Channels Cav1.4 of Th17 Lymphocytes in Human With Psoriasis
A study testing Skin biopsies and Blood sample in people with Psoriasis, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Psoriasis
- What is being tested?
- Skin biopsies and Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2016to 13 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- Being tested
- Skin biopsies, Blood sample
- Keywords
- Th17, Cav1.4, Lymphocyte, Channel
- Medical subject headings
- Psoriasis, Cone-Rod Dystrophy, X-Linked, 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsiesBiological
3 biopsies on lesion skin (and one more for the first fifteen subjects in group 1)
Blood sampleBiological
One blood sample for the group 1 only.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : 20 subjects with plaque psoriasis | Experimental | Intervention: skin biopsies and blood sample Receives: Biological: Skin biopsies; Biological: Blood sample |
| Group 2 : 10 subjects with atopic dermatitis | Experimental | Intervention: skin biopsies Receives: Biological: Skin biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of Cav1.4 calcium channels in Th17 lymphocytes
Immunohistochemistry (IHC) and in situ hybridation (HIS)
Measured: Baseline
Secondary outcomes (3)
Role of Cav1.4 channels on the activation of Th17 lymphocytes
Fonctional study : intracellular marquing and qPCR (with TLDA technology (TaqMan Low Density Arrrays)) and ELISA method
Measured: Baseline
Transcriptomic signature relating to the signaling channel Cav1.4
qPCR with TLDA technology (TaqMan Low Density Arrrays)
Measured: Baseline
Epigenetic signature, in particular changes in overall methylation and specific promoter methylation
Pyrosequencing
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start25 Oct 2016
- Primary completion13 Nov 2017
- Study completion13 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Paul CARL, Pr., Principal investigator, Service de Dermatologie - Hôpital Larrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459780
- Sponsor's protocol ID
- CaPSO17
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Functionality of Calcium Channels Cav1.4 of Th17 Lymphocytes in Human With Psoriasis
- ClinicalTrials.gov ID
- NCT04459780
- Acronym / sponsor ID
- CaPSO17
- Conditions
- Psoriasis
- Keywords
- Th17, Cav1.4, Lymphocyte, Channel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 25 Oct 2016 (actual)
- Primary completion
- 13 Nov 2017 (actual)
- Study completion
- 13 Nov 2017 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1 : 20 subjects with plaque psoriasis | Experimental | Biological: Skin biopsies, Biological: Blood sampleIntervention: skin biopsies and blood sample |
| Group 2 : 10 subjects with atopic dermatitis | Experimental | Biological: Skin biopsiesIntervention: skin biopsies |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Skin biopsies3 biopsies on lesion skin (and one more for the first fifteen subjects in group 1) | Biological | Group 1 : 20 subjects with plaque psoriasis, Group 2 : 10 subjects with atopic dermatitis |
| Blood sampleOne blood sample for the group 1 only. | Biological | Group 1 : 20 subjects with plaque psoriasis |
Primary outcome
Expression of Cav1.4 calcium channels in Th17 lymphocytes
Time frame: Baseline
Immunohistochemistry (IHC) and in situ hybridation (HIS)
3 secondary outcomes
Role of Cav1.4 channels on the activation of Th17 lymphocytes
Time frame: Baseline
Transcriptomic signature relating to the signaling channel Cav1.4
Time frame: Baseline
Epigenetic signature, in particular changes in overall methylation and specific promoter methylation
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- 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.
Paul CARL, Pr. principal investigator
Service de Dermatologie - Hôpital Larrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsies and Blood sample in people with Psoriasis, run by Pierre Fabre Dermo Cosmetique 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 7 inclusion and 0 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 14 Jul 2020. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Expression of Cav1.4 calcium channels in Th17 lymphocytes (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2020.