Dupilumab Impact on Skin Resident Memory T Cells

Last updated: March 20, 2020
Sponsor: Association pour la Recherche Clinique et Immunologique
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergy

Scalp Disorders

Hives (Urticaria)

Treatment

N/A

Clinical Study ID

NCT03983460
18082A0002
  • Ages > 18
  • All Genders

Study Summary

The main objective of the study consists in characterizing the immune cells that are present/persist in the skin and the blood of atopic dermatitis (AD) patients treated with Dupilumab, as well as with potent/very potent topical corticosteroids (TCS: betamethasone valerate cream 0.1% or clobetasol propionate cream 0.05%). A specific attention will be paid on the presence/persistence of skin Trm and ILCs.

The study population will consist of 20 adult patients suffering from moderate to severe Atopic Dermatitis and eligible for Dupilumab treatment. (Patients should have inadequate response, intolerance or contraindication to systemic anti-inflammatory treatments).

This is an exploratory, prospective, single-site, randomized, open labeled study. There is a treatment period of 168 days (24 weeks) and a post-treatment follow-up period of maximum 102 days.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject over 18 years of age

  • Subject able to read, understand and give documented informed consent

  • Subject willing and able to comply with the protocol requirements for the duration ofthe study

  • Subject with health insurance coverage according to local regulations

  • For woman with childbearing potential :

  • Use of a highly effective method of birth control from at least 1 month prior tostudy enrollment until the last visit

  • Negative urine pregnancy test at inclusion visit A highly effective method ofbirth controlled is defined as one which results in a low failure rate (i.e. lessthan 1% per year) when used consistently and correctly, such as implants,combined oral contraceptives, intrauterine device, double barrier methods (e.g.condom with spermicide), sexual abstinence or vasectomized partner. Woman with nochildbearing potential is defined as: woman with amenorrhea for at least 12months (without an alternative medical cause); woman who had undergone apermanent sterilization method (eg bilateral tubal occlusion which includes tuballigation procedures, hysterectomy, bilateral salpingectomy, bilateraloophorectomy); or otherwise be incapable of pregnancy.

  • Subject diagnosed with moderate-to-severe AD, defined as SCORAD≥20 and/or EASI≥7 (Eichenfield et al., 2014)

  • Subject with AD involvement of 10% (or more) Body Surface Area (BSA) according tocomponent A of SCORAD

  • Subject with I, II, III or IV skin phototype (according to Fitzpatrick scale)

  • Subject accepting skin prick-tests and skin biopsies

  • Subject having a least one non lesional area on the body (off head and neck, feet andhands)

  • Subject eligible for systemic treatment

  • Failure, intolerance or contraindication to available systemic treatments (i.e.cyclosporine/methotrexate)

Exclusion

Exclusion Criteria:

  • Pregnancy or breast-feeding women, or planning to become pregnant or breastfeed duringthe study

  • Women unwilling to use adequate birth control, if of reproductive potential andsexually active.

  • Subject currently experiencing or having a history of other concomitant skinconditions that would interfere with evaluation of AD

  • History of allergic reaction to local anesthetic product

  • History of wound healing disorders (e.g. hypertrophic scars, keloids)

  • Subject with known active infection to HBV, HCV or HIV

  • Subject with known helminth infection

  • Subject with known blood dyscrasia

  • Subject having an allergen immunotherapy within 3 months before study

  • Subject treated by antihistamine 5 days before study. Please note, antihistamineadministered to treat allergic rhino conjunctivitis is allowed after V1.

  • Subject treated with an investigational drug within 8 weeks or within 5 half-life (ifknown), whichever is longer, before the baseline visit

  • Subject treated with cyclosporine, methotrexate oral corticosteroids, azathioprine,mycophenolate mofetil, and/or any other systemic immunosuppressor/immunomodulatorwithin 4 weeks before the study

  • Subject treated by a biologic therapy within 5 half-life before the study

  • Subject treated with ultraviolet therapy within 4 weeks before study

  • Subject treated with a live (attenuated) vaccine within 12 weeks before baseline visit

  • Subject having a planned surgery during the study

  • Subject presenting clinically significant medical disease that is uncontrolled despitetreatment that is likely, in the opinion of the investigator, to impact patient'sability to participate in the study or to impact the study efficacy or safetyassessments

  • Subject with any additional condition that, in the opinion of the investigator, mayinterfere with the assessment or put the subject at risk

  • Linguistic or mentally incapacity to sign the consent form

  • Subject protect by the law (adult under guardianship, or hospitalized in a public orprivate institution for a reason other than study, or incarcerated)

  • Subject in an exclusion period from a previous study or who is participating inanother clinical trial

Study Design

Total Participants: 20
Study Start date:
March 09, 2020
Estimated Completion Date:
September 30, 2021

Connect with a study center

  • Service d'Allergologie et Immunologie Clinique - Hôpital Lyon Sud

    Pierre-Bénite, 69495
    France

    Active - Recruiting

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