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Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03389893
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : June 12, 2019
Sponsor:
Collaborators:
Regeneron Pharmaceuticals
Sanofi
Atopic Dermatitis Research Network
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE December 27, 2017
First Posted Date  ICMJE January 4, 2018
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE July 11, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2017)
Comparison by Treatment Assignment in Staphylococcus Aureus Abundance on Lesional Skin [ Time Frame: Day 28 (Post treatment initiation) ]
As measured by microbial DNA (femA qPCR).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03389893 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2018)
  • Comparison by Treatment Assignment in Staphylococcus Aureus Abundance on Non-Lesional Skin [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    As measured by microbial DNA (femA qPCR).
  • Comparison by Treatment Assignment in Basal Transepidermal Water Loss (TEWL) of Non-Lesional and Lesional Skin [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    TEWL skin barrier assessment is a noninvasive in vivo measurement of water loss across the stratum corneum that is used to characterize skin water barrier function. Basal TEWL =baseline measure (prior to tape stripping).
  • Comparison by Treatment Assignment in Transepidermal Water Loss (TEWL) Area Under the Curve on Non-Lesional Skin [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    TEWL skin barrier assessment will be assessed per protocol: prior to tape stripping and repeated after 5, 10, and 15 tape strips.
  • Comparison by Treatment Assignment of the Change in Transepidermal Water Loss (TEWL) Per Every 5 Tape Strips on Non-Lesional Skin [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    The skin tape strip collection is comprised of 1 set of 15 strips from non-lesional skin and is collected as part of the TEWL skin barrier assessment. Change in TEWL will be analyzed measuring the slope of change per every 5 tape strips.
  • Mean Percent Change from Baseline by Treatment Assignment in Eczema Area and Severity Index (EASI) [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    The EASI is a standardized investigator-assessed instrument that measures the severity of clinical signs in atopic dermatitis (AD).
  • Mean Percent Change from Baseline by Treatment Assignment in the Investigator Global Assessment (IGA) [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    The IGA is a standardized investigator-assessed instrument that measures the severity of clinical signs in atopic dermatitis (AD).
  • Mean Percent Change from Baseline by Treatment Assignment in the SCORing Atopic Dermatitis (SCORAD) [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    The SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology;186 (1): 23-31. 1993.
  • Mean Percent Change from Baseline by Treatment Assignment in Pruritus Numerical Rating Scale (Pruritus NRS) [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants will be asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary will be used to assess itch. Mean change from Baseline to Week 16 in average of daily itch/pruritus based on the NRS will assessed, using mean and standard deviation (SD). Baseline is defined as the assessment prior to the first treatment initiation dose.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2017)
  • Comparison by Treatment Assignment in Staphylococcus Aureus Abundance on Non-Lesional Skin [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    As measured by microbial DNA (femA qPCR).
  • Comparison by Treatment Assignment in Basal Transepidermal Water Loss (TEWL) of Non-Lesional and Lesional Skin [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    TEWL skin barrier assessment is a noninvasive in vivo measurement of water loss across the stratum corneum that is used to characterize skin water barrier function. Basal TEWL =baseline measure (prior to tape stripping).
  • Comparison by Treatment Assignment in Transepidermal Water Loss (TEWL) Area Under the Curve on Non-Lesional Skin [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    TEWL skin barrier assessment will be assessed per protocol: prior to tape stripping and repeated after 5, 10, and 15 tape strips.
  • Comparison by Treatment Assignment of the Change in Transepidermal Water Loss (TEWL) Per Every 5 Tape Strips on Non-Lesional Skin [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    The skin tape strip collection is comprised of 1 set of 15 strips from non-lesional skin and is collected as part of the TEWL skin barrier assessment. Change in TEWL will be analyzed measuring the slope of change per every 5 tape strips.
  • Mean Percent Change from Baseline by Treatment Assignment in Eczema Area and Severity Index (EASI) [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    The EASI is a standardized investigator-assessed instrument that measures the severity of clinical signs in atopic dermatitis (AD).
  • Mean Percent Change from Baseline by Treatment Assignment in the Investigator Global Assessment (IGA) [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    The IGA is a standardized investigator-assessed instrument that measures the severity of clinical signs in atopic dermatitis (AD).
  • Mean Percent Change from Baseline by Treatment Assignment in the SCORing Atopic Dermatitis (SCORAD) [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    The SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology;186 (1): 23-31. 1993.
  • Mean Percent Change from Baseline by Treatment Assignment in Pruritus Numerical Rating Scale (Pruritus NRS) [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    The pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period.
Current Other Pre-specified Outcome Measures
 (submitted: December 27, 2017)
  • EXPLORATORY: Composition of Bacterial Taxa [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    16S rRNA microbiome data (e.g., bacterial sequence reads) will be employed to identify changes in community composition and diversity at lesional and non-lesional skin sites prior to and throughout dupilumab or placebo treatment.
  • EXPLORATORY: Abundance of bacterial taxa in lesional and non-lesional skin [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    The aim is to assess the effect of dupilumab on the skin transcriptome in lesional and non-lesional skin. Inclusion in this exploratory aim is restricted to non-University of Rochester Medical Center study participants only.
  • EXPLORATORY: Gene expression in the skin transcriptome in non-lesional skin [ Time Frame: Day 0 (Prior to treatment) and 7 ]
    The aim is to assess the effect of dupilumab on gene expression in the skin transcriptome of non-lesional skin.
  • EXPLORATORY: Gene expression in the skin transcriptome in lesional skin [ Time Frame: Day 0 (Prior to treatment), 7, and 21 ]
    The aim is to assess the effect of dupilumab on the gene expression in the skin transcriptome of lesional skin.
  • EXPLORATORY: Lipid profiles of Non-Lesional and Lesional Skin [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    The aim is to assess the effect of dupilumab on lipids, which play a role in the skin barrier, will be extracted from the skin tape strips and measured using mass spectrometry methodology. Skin tape strip method allows characterization of components of the epidermis, dermis, and immune cells present in the skin.
  • EXPLORATORY: Expression of S. Aureus Superantigens and Toxins on Lesional and Non-Lesional Skin [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    The aim is to assess the effect of dupilumab on the expression of the bacterium Staphylococcus aureus (S. aureus) superantigens and toxins on lesional and non-lesional skin.
  • EXPLORATORY: Confocal Imaging of Tight Junctions and Relationship to LCs in the Epidermis from Non-Lesional Skin [ Time Frame: Days 0 (Prior to treatment), 7 and 21 ]
    The aim is to assess the effect of dupilumab on non-lesional skin barrier structure and Langerhans cells (LC) by confocal imaging. Inclusion in this exploratory aim is limited to University of Rochester Medical Center study participants.
  • EXPLORATORY: Percent of Coagulase-Negative Staphylococci [CoNS] Isolates that Kill S. Aureus on Lesional and Non-Lesional Skin [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    The aim is to assess the effect of dupilumab on the function of the skin microbiome (e.g., the ability of Coagulase-negative staphylococci isolates [CoNS] to kill S. aureus) in lesional and non-lesional skin.
  • EXPLORATORY: Peripheral Blood Mononuclear Cells (PBMCs) Immunoprofiling [ Time Frame: Days 0 (Prior to treatment), 14 and 28 ]
    The aim is to assess the effect of dupilumab on PBMC immunoprofiles.Flow cytometry analysis will be performed on PBMCs, using phenotyping panels to identify resting leukocyte populations, as well as T cell responses to antigens and myeloid responses to Toll-like receptor (TLR) ligands.
  • EXPLORATORY: Levels of serum biomarkers (e.g. Th2 biomarkers) [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    The aim is to assess the effect of dupilumab on serum biomarkers (e.g. T helper type 2 [Th2] biomarkers).
  • EXPLORATORY: Levels of Serum Anti-Drug Antibodies (ADA) [ Time Frame: Day 0 (Prior to treatment), 16 weeks ]
    The presence of anti-drug antibodies will be assessed and compared between intervention groups.
  • EXPLORATORY: The presence of single nucleotide polymorphisms (SNPs) [ Time Frame: Day 0 (Prior to treatment) ]
    Towards discovery and replication of susceptibility loci in atopic dermatitis pathogenesis.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis
Official Title  ICMJE Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis, Dupilumab Study
Brief Summary The purpose of this study is to understand the effect that T helper 2 (Th2) blockade has on well-described pathophysiological features of Atopic Dermatitis (AD), for example: barrier, epidermal activation, dysbiosis and epidermal lipids.
Detailed Description

This is a multi-center, randomized, double-masked, placebo-controlled trial investigating the effect of 6 weeks of dupilumab treatment on quantitative and qualitative measures of cutaneous microbial community structure, skin barrier biology, and circulating T cell profiles, in adults with chronic moderate-to-severe atopic dermatitis (AD).

After obtaining informed consent, eligible participants will return to clinic for their Treatment Initiation Visit (Day 0) and will be randomized 2:1 active to placebo. Participants will receive three doses of dupilumab or placebo based on their randomization assignment. The first dose (600 mg loading dose of dupilumab or placebo) will be administered on Day 0 and the second and third doses (300 mg dupilumab or placebo) on Day 14 and Day 28, respectively.

Participants will return to clinic on Days 3, 7, and 21 during the double-masked portion of the study. Participants will begin the open-label extension (OLE) at Day 42 and will receive dupilumab (600 mg loading dose [two 300 mg injections] for those initially randomized to the placebo group and a 300 mg dose plus placebo injection for those initially randomized to the dupilumab group). Participants will return to clinic on Days 77 and 112 during the OLE portion of the study. During all visits (Day 0-Day 112), Adverse Events (AEs), concomitant medications, and medical history will be assessed and physical exams including assessment of AD severity will be performed. Blood, urine, skin swabs, skin tape strips, and skin biopsies, as applicable, will be collected, and barrier assessments will be performed per the Schedule of Events, per protocol. Samples will be collected prior to dupilumab or placebo administration on Days 0, 14, 28, and 42. After Day 112, a follow-up call (Day 182) will be made to assess for pregnancy, current medications, and adverse events (AEs).

If concerns arise between regularly scheduled visits, participants will be instructed to contact study personnel and may be asked to return to the study site for an "Unscheduled Visit." Participants may be asked to return for Unscheduled Visits, as needed for the duration of the study, to provide additional blood, skin swabs, skin tape strips, or skin biopsies,as applicable, for further mechanistic and functional studies, if biosamples are lost or destroyed, or if insufficient yields were obtained at a previous study visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis (AD)
Intervention  ICMJE
  • Drug: Dupilumab
    Dupilumab, an interleukin (IL)-4 receptor alpha (IL-4Rα) antagonist, is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. (FDA approved on March 28, 2017.)
    Other Names:
    • Dupixent®
    • IL4Ra mAb
  • Drug: Placebo
    Placebo will contain the identical formulation as the dupilumab formulation without the active mAb and will be given by exactly the same route and schedule through Day 28.
    Other Name: Dupilumab placebo
Study Arms  ICMJE
  • Experimental: Dupilumab w/OLE

    Participants will receive a loading dose of dupilumab (two 300 mg subcutaneous (subcut) injections (total of 600 mgs)) on Day 0, followed by 300 mg dose of dupilumab by subcut injection every 2 weeks (Days 14 and 28).

    Open Label Extension (OLE): Participants will begin a 10 week OLE on Day 42, beginning with a loading dose of two subcut administered injections (one 300 mg dose of dupilumab and one dose of placebo, in order to protect prior masking/blind).Participants will then maintain a regimen of 300 mg of dupilumab by subcut injection every two weeks through Day 98.

    The subcut injections will be administered in the abdomen (except for the 2 inches (5 cm) around the navel-not allowed), thighs, or upper arms. Injection sites will be rotated with each dose.

    Interventions:
    • Drug: Dupilumab
    • Drug: Placebo
  • Placebo Comparator: Placebo Comparator w/OLE

    Participants will receive a loading dose of placebo (two placebo subcutaneous (subcut) injections) on Day 0 followed by one dose of placebo by subcut injections every 2 weeks (Days 14 and 28).

    Open Label Extension (OLE): Participants will begin a 10 week OLE on Day 42, beginning with a loading dose of dupilumab (two 300 mg subcut injections (total of 600 mgs)-protection of prior masking/blind maintained). Participants will then maintain a regimen of 300 mg of dupilumab by subcut injection every two weeks through Day 98.

    The subcut injections will be administered in the abdomen (except for the 2 inches (5 cm) around the navel-not allowed), thighs, or upper arms. Injection sites will be rotated with each dose.

    Interventions:
    • Drug: Dupilumab
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 27, 2017)
99
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be able to understand and provide informed consent
  • Chronic AD, (according to the Atopic Dermatitis Research Network [ADRN] Standard Diagnostic Criteria), that has been present for at least 3 years before the Screening Visit
  • EASI score ≥12 at the Screening Visit and ≥16 at the Treatment Initiation Visit
  • Investigator Global Assessment (IGA) score ≥3 (on the 0-4 IGA scale) at the Screening and Treatment Initiation Visits
  • ≥10% body surface area of AD involvement at the Screening and Treatment Initiation Visits
  • Must have active lesions (minimum of 3 of at least 4x4 cm^2 each on the upper or lower extremities, excluding the palms of the hands and soles of the feet) at the Screening and Treatment Initiation Visits
  • Documented recent history (within 6 months before the Screening Visit) of inadequate response to outpatient treatment with topical corticosteroids of medium to high potency (± topical calcineurin inhibitors as appropriate), or for whom topical treatments are otherwise inadvisable
  • Must agree to apply a stable dose of a topical emollient (moisturizer) at least twice daily for at least 7 days before the Treatment Initiation Visit, and must confirm application at the Treatment Initiation Visit
  • Individuals with asthma must adhere to asthma controller medication(s) for the duration of the study including the open-label and follow-up portions
  • Females of childbearing potential must have a negative pregnancy test at the Screening and Treatment Initiation Visits
  • Females with reproductive potential* and sexually active must agree to use FDA approved methods of birth control for the duration of the study, including during the open-label and follow-up portions of the study:

    --FDA approved methods of birth control include hormonal contraceptives, intrauterine device, double barrier contraception (i.e., condom plus diaphragm), or male partner with documented vasectomy.

    ---*Menopause is defined as at least 12 consecutive months without menses; if in question, a follicle stimulating hormone of ≥25 U/mL must be documented. Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented, as applicable; if documented, women with these conditions are not required to use additional contraception.

  • Males who are sexually active must agree to use an acceptable method of birth control (e.g. barrier methods with vaginal spermicide, surgical sterilization or surgically sterilized partner), or have a female partner practicing an approved birth control method for females as described in Inclusion Criterion above.
  • Willing and able to comply with all clinic visits and study-related procedures
  • Able to understand and complete study-related questionnaires

Exclusion Criteria:

  • Inability or unwillingness of an individual to give written informed consent or comply with study protocol
  • Known systemic hypersensitivity to any of the excipients of the dupilumab or placebo study products
  • Known or suspected immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution, or otherwise recurrent immune-compromised status, as judged by the investigator
  • Known history of human immunodeficiency virus (HIV) infection
  • Ocular disorder that, in the opinion of the investigator, could adversely affect the individual's risk for study participation. Examples include, but are not limited to, individuals with a history of or active case of:

    • herpes keratitis,
    • Sjogren's Syndrome,
    • keratoconjunctivitis sicca or Dry Eye Syndrome that requires daily use of supplemental lubrication, or
    • ocular condition(s) requiring the regular use of ocular corticosteroids or cyclosporine.
  • Parasitic infection, except for vaginal trichomoniasis, within 12 months of the Treatment Initiation Visit, or high risk for contracting parasitic infections (e.g., living in or traveling to endemic areas)
  • Presence of skin comorbidities that may interfere with study assessments
  • History of malignancy within 5 years before the Treatment Initiation Visit except completely treated in situ carcinoma of the cervix, and completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin or melanoma in situ
  • History of non-malignant lymphoproliferative disorders
  • History of alcohol or drug abuse within 2 years before the Screening Visit
  • Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the individual's participation in the study. Examples include, but are not limited to, individuals with short life expectancy, uncontrolled diabetes (HbA1c ≥9%), cardiovascular conditions (e.g., stage III or IV cardiac failure according to the New York Heart Association classification), severe renal conditions (e.g., individuals on dialysis), hepato-biliary conditions (e.g., Child-Pugh class B or C), neurological conditions (e.g., demyelinating diseases), active major autoimmune diseases (e.g., lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), other severe endocrinological, gastrointestinal, metabolic, pulmonary, or lymphatic diseases.
  • Any other medical or psychological condition including relevant laboratory abnormalities at screening that, in the opinion of the investigator, suggests a new and/or insufficiently understood disease, may present an unreasonable risk to the study participant as a result of his/her participation in this clinical trial, may make individual's participation unreliable, or may interfere with study assessments. This includes hypersensitivity to local anesthetics (e.g., lidocaine or Novocain), bleeding disorders, treatment with anticoagulants or other conditions that make the biopsy procedure inadvisable.
  • Planned major surgical procedure during the screening period or study treatment (i.e. Screening through Day 112)
  • Member of the investigational team or his/her immediate family
  • Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed during the study including the open-label and follow up portions of the study
  • Individuals unwilling to use adequate birth control, if of reproductive potential and sexually active. Adequate birth control is defined as agreement to consistently practice an approved method of contraception for the duration of the study, including the open-label and follow up portions of the study.
  • History of keloid formation
  • History of serious life-threatening reaction to latex, tape, or adhesives
  • Prior treatment with dupilumab
  • Individuals with asthma who have required use of a systemic corticosteroid within 3 months prior to the Treatment Initiation Visit or who require a dose greater than 880 mcg/day of fluticasone propionate or equivalent inhaled corticosteroid to maintain asthma control
  • Treatment with biologics as follows:

    • Any cell-depleting agents, including but not limited to rituximab, within 6 months before the Treatment Initiation Visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer
    • Infliximab, adalimumab, golimumab, certolizumab pegol, abatacept, etanercept, anakinra within 16 weeks before the Treatment Initiation Visit for any indication, or
    • Other biologics within 5 half-lives (if known) or 16 weeks before the Treatment Initiation Visit, whichever is longer
  • Treatment with a live (attenuated) vaccine within 12 weeks before the Treatment Initiation Visit or planning to receive a live vaccine during the study (through Day 182)
  • Use of an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the Treatment Initiation Visit
  • Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before the Treatment Initiation Visit, or superficial skin infections within 1 week before the Treatment Initiation Visit
  • The following treatments within 4 weeks before the Treatment Initiation Visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the screening period and study treatment (i.e., Screening through Day 112):

    • Systemic corticosteroids
    • Immunosuppressive/immunomodulating drugs (e.g., cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, or methotrexate)
  • Use of phototherapy (such as narrow band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + UVA [PUVA]) or a tanning booth/parlor within 4 weeks of the Treatment Initiation Visit
  • Treatment with bleach bath within 3 weeks before the Treatment Initiation Visit
  • Use of a chlorinated hot tub within 3 weeks before the Treatment Initiation Visit
  • Treatment with topical corticosteroids, phosphodiesterase inhibitors (crisaborole), or calcineurin inhibitors (tacrolimus or pimecrolimus) within 1 week before the Treatment Initiation Visit
  • Initiation of treatment of AD with prescription moisturizers or moisturizers containing ceramide, hyaluronic acid, urea, or filaggrin during the screening period (participants may continue using stable doses of such moisturizers if initiated before the Screening Visit)
  • Planned or anticipated use of any prohibited medications or procedures during the screening period and study treatment (i.e., Screening through Day 112)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03389893
Other Study ID Numbers  ICMJE DAIT ADRN-09
U19AI117673 ( U.S. NIH Grant/Contract )
UM2AI117870 ( U.S. NIH Grant/Contract )
NIAID DAIT CRMS ID#: 38439 ( Other Identifier: DAIT NIAID )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE
  • Regeneron Pharmaceuticals
  • Sanofi
  • Atopic Dermatitis Research Network
Investigators  ICMJE
Study Chair: Lisa A. Beck, MD University of Rochester
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP