Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases (ImmuneSkinBank)

Identification Des Marqueurs Biologiques cutanés et Sanguins prédictifs de réponse Aux Traitements systémiques au Cours Des Maladies cutanées Inflammatoires Chroniques

Chronic inflammatory skin diseases constitute a heterogeneous group of pathologies. They affect the skin but also other organs (joints, lungs, muscles, etc.). Their prognosis and response to treatments is extremely variable. The discovery of prognosis factors will help to precisely guide the treatment regimen and its intensification based on individual markers. The identification of new therapeutic targets is essential to develop new innovative treatments for inflammatory skin diseases.

The main objective is to identify new cellular or molecular prognostic factors associated with treatment response at 1 year in inflammatory skin diseases.

The secondary objectives are a better understanding of the pathophysiology of chronic inflammatory skin diseases, the identification of new cellular, molecular and microbiological prognostic factors associated with the clinical state after 10 years of evolution and the identification of prognostic markers of drug toxicity.

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriasis; Atopic Dermatitis; Dermatomyositis; Hidradenitis Suppurativa; Lichen Planus; Cutaneous Lupus; Cutaneaous Scleroderma; Neutrophilic Dermatosis; Cutaneous Granulomatosis; Active Leprosy
• Intervention / Treatment: Other: Sampling; Other: Sampling

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Jérôme Lambert, MD PhD; Phone Number: +33 142499742; Email: jerome.lambert@u-paris.fr
• Study Contact Backup: Name: Charles Cassius, MD; Phone Number: +33 630944832; Email: charles.cassius@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients affected by inflammatory skin disease and controls

Description

Inclusion Criteria:

Patients:

• Age>18 years
• Informed consent signed by the patient
• Diagnosis of moderate to severe chronic inflammatory skin disease (IGA score 3 or 4) including: atopic dermatitis, psoriasis, hidradenitis suppurativa, lichen planus, cutaneous lupus, dermatomyositis, cutaneous scleroderma (=morphea), neutrophilic dermatosis, cutaneous granulomatosis
• Or diagnosis of active leprosy (tuberculoid, lepromatous, reversion type 1, reversion type 2, hypersensitivity type 3), excluding pure neurological leprosy. Classification into 5 stages according to the Ridley and Jopling classification [1], Reversion reaction (type 1 reaction) and leprous erythema nodosum (type 2 reaction).

Healthy controls :

• Age>18 years
• Plastic surgery patients who have had any type of surgery resulting in healthy skin remnants
• Informed consent signed by the patient
• Absence of known cutaneous or systemic inflammatory disease.

Exclusion Criteria:

• Under guardianship or curatorship
• Pregnant or breastfeeding woman
• Lack of affiliation with a social security system
• Systemic treatment in progress or received less than 3 months ago.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Affected by inflammatory skin disease	Other: Sampling; Collection of an additional volume of blood Superficial skin biopsy Skin swab; Other: Sampling; Collection of an additional volume of blood Preservation of post-operative skin remnants Skin swab
Controls; Plastic surgery patients who have had any type of surgery resulting in healthy skin remnants	Other: Sampling; Collection of an additional volume of blood Superficial skin biopsy Skin swab; Other: Sampling; Collection of an additional volume of blood Preservation of post-operative skin remnants Skin swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic response	It is defined as complete or partial remission on the Investigator/Physician Global Assessment (IGA/PGA) scale.	At 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression of markers of blood and skin immunological signaling pathways	Mainly Th1, Th2, Th9, Th17, Th22 and Treg	At inclusion
Expression of markers of blood and skin immunological signaling pathways	Mainly Th1, Th2, Th9, Th17, Th22 and Treg	At 4 months
Expression of markers of blood and skin immunological signaling pathways	Mainly Th1, Th2, Th9, Th17, Th22 and Treg	At 1 year
Expression of markers of blood T cell populations and skin transcriptomics		At inclusion
Expression of markers of blood T cell populations and skin transcriptomics		At 4 months
Expression of markers of blood T cell populations and skin transcriptomics		At 1 year
Therapeutic response	Based on markers of blood T cell populations and skin transcriptomics	At inclusion
Therapeutic response	Based on markers of blood T cell populations and skin transcriptomics	At 4 months
Therapeutic response	Based on markers of blood T cell populations and skin transcriptomics	At 1 year
Therapeutic response	Based on markers of blood T cell populations and skin transcriptomics	At 2 years
Therapeutic response	Based on markers of blood T cell populations and skin transcriptomics	At 3 years
Therapeutic response	Based on markers of blood T cell populations and skin transcriptomics	At 4 years
Therapeutic response	Based on markers of blood T cell populations and skin transcriptomics	At 5 years
Therapeutic response	Based on markers of blood T cell populations and skin transcriptomics	At 6 years
Therapeutic response	Based on markers of blood T cell populations and skin transcriptomics	At 7 years
Therapeutic response	Based on markers of blood T cell populations and skin transcriptomics	At 8 years
Therapeutic response	Based on markers of blood T cell populations and skin transcriptomics	At 9 years
Therapeutic response	Based on markers of blood T cell populations and skin transcriptomics	At 10 years
Microbiota markers	Identification of cluster specific to the pathology, identification of an over-representation of one or more microbiological species. For patients and controls	At inclusion
Microbiota markers	Identification of cluster specific to the pathology, identification of an over-representation of one or more microbiological species. For patients only	At 1 year
Proportion of patients suffering from adverse effects of systemic treatments	According to the CTCAE classification and MedDRA	At inclusion
Proportion of patients suffering from adverse effects of systemic treatments	According to the CTCAE classification and MedDRA	At 4 months
Proportion of patients suffering from adverse effects of systemic treatments	According to the CTCAE classification and MedDRA	At 1 year
Proportion of patients suffering from adverse effects of systemic treatments	According to the CTCAE classification and MedDRA	At 2 years
Proportion of patients suffering from adverse effects of systemic treatments	According to the CTCAE classification and MedDRA	At 3 years
Proportion of patients suffering from adverse effects of systemic treatments	According to the CTCAE classification and MedDRA	At 4 years
Proportion of patients suffering from adverse effects of systemic treatments	According to the CTCAE classification and MedDRA	At 5 years
Proportion of patients suffering from adverse effects of systemic treatments	According to the CTCAE classification and MedDRA	At 6 years
Proportion of patients suffering from adverse effects of systemic treatments	According to the CTCAE classification and MedDRA	At 7 years
Proportion of patients suffering from adverse effects of systemic treatments	According to the CTCAE classification and MedDRA	At 8 years
Proportion of patients suffering from adverse effects of systemic treatments	According to the CTCAE classification and MedDRA	At 9 years
Proportion of patients suffering from adverse effects of systemic treatments	According to the CTCAE classification and MedDRA	At 10 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2035
• Study Completion (Estimated): October 1, 2044

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Sweat Gland Diseases; Infections; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neuromuscular Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Skin Diseases, Infectious; Skin Diseases, Papulosquamous; Suppuration; Skin Diseases, Bacterial; Mycobacterium Infections; Polymyositis; Myositis; Mycobacterium Infections, Nontuberculous; Lichenoid Eruptions; Psoriasis; Dermatitis; Skin Diseases; Dermatomyositis; Hidradenitis Suppurativa; Hidradenitis; Lichen Planus; Leprosy
• Other Study ID Numbers: APHP240183

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No