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Atopic Dermatitis (AD)Phase 4NCT03389893

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

A Phase 4 study testing Dupilumab in people with Atopic Dermatitis (AD), run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atopic Dermatitis (AD)
What is being tested?
Dupilumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
9 sitesUnited States
Study dates
25 Jul 2018to 9 Sep 2020
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • 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,
Show all 40Show fewer
  • 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)

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • National Jewish Health

    Denver, Colorado, 80206

  • Duke University

    Durham, North Carolina, 27710

  • University of Florida

    Gainesville, Florida, 32611

  • University of California San Diego

    La Jolla, California, 92093

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis, Dupilumab Study

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.

Read the 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.

Being tested
Dupilumab, Placebo
Keywords
randomized double-masked (blind) placebo-controlled trial, T helper 2 (Th2) effect, cutaneous microbial community, skin barrier
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    Also called Dupixent®, IL4Ra mAb

    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.)

  • PlaceboDrug

    Also called Dupilumab 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.

Study groups in NCT03389893
Study groupRoleWhat they receive
Dupilumab w/OLEExperimentalParticipants 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.
Receives: Drug: Dupilumab; Drug: Placebo
Placebo Comparator w/OLEPlacebo comparatorParticipants 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.
Receives: Drug: Dupilumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Staphylococcus Aureus Abundance on Lesional Skin, Dupilumab+Open Label Extension and Follow-Up Versus Placebo+Open Label Extension and Follow-Up

    Staphylococcus aureus (S. aureus) abundance was measured by microbial DNA (femA qPCR) on lesional skin at Day 28, measurement is expressed in relative Colony Forming Units (rCFU)/cm^2).

    The abundance of S. aureus is summarized as the geometric mean ratio (and corresponding 95% confidence interval) between the dupilumab and placebo arms. The geometric mean ratio is reported from an ANCOVA model with fixed effects for clinical site, disease severity at Day 0 (as measured by EASI >21.1 [severe] or ≤21.1 [non-severe]) and S. aureus abundance at Day 0.

    Measured: Day 28 (Post treatment initiation)

Secondary outcomes (9)

  1. Staphylococcus Aureus Abundance on Lesional Skin, Dupilumab+Open Label Extension and Follow-Up Versus Placebo+Open Label Extension and Follow-Up

    Staphylococcus aureus (S. aureus) abundance was measured by microbial DNA (femA qPCR) on lesional skin at Days 0, 3, 7, 14, 21, 42, 77 and 112.

    The abundance of S. aureus is summarized as the geometric mean ratio (GMR) and corresponding 95% confidence interval between the dupilumab and placebo arms. The GMR is reported from a linear mixed model for repeated measures with fixed effects for S. aureus abundance on lesional skin at Day 0, treatment arm, clinical site, disease severity at Day 0 as measured by EASI ≥ 21.1 or < 21.1, time point of measurement (as a categorical variable), and an interaction term between treatment arm and pre-specified time point(s).

    A linear mixed model similar to the model specified above was fit for every time point measured. The model was used to estimate the GMR between treatment arms at Days 77 and 112 and the ratio within treatment arm between Day 77 and Day 42 and between Day 112 and Day 42.

    Measured: Day 0 (Prior to treatment), 3, 7, 14, 21, 42, 77 and 112

  2. Staphylococcus Aureus Abundance on Non-lesional Skin, Dupilumab+Open Label Extension and Follow-Up Versus Placebo+Open Label Extension and Follow-Up

    Staphylococcus aureus (S. aureus) abundance was measured by microbial DNA (femA qPCR) on non-lesional skin at Days 0, 3, 7, 14, 21, 28, 42, 77 and 112.

    The abundance of S. aureus is summarized as the geometric mean ratio (GMR) and corresponding 95% confidence interval between the dupilumab and placebo arms. The GMR is reported from a linear mixed model for repeated measures with fixed effects for S. aureus abundance on non-lesional skin at Day 0, treatment arm, clinical site, disease severity at Day 0 as measured by EASI ≥ 21.1 or < 21.1, time point of measurement (as a categorical variable), and an interaction term between treatment arm and pre-specified time point(s).

    A linear mixed model similar to the model specified above was fit for every time point measured. The model estimated the GMR between treatment arms at Days 77 and 112 and the ratio within treatment arm between Day 77 and Day 42 and between Day 112 and Day 42.

    Measured: Day 0 (Prior to treatment), 3, 7, 14, 21, 28, 42, 77 and 112

  3. Transepidermal Water Loss (TEWL) of Non-lesional and Lesional Skin, Dupilumab+Open Label Extension and Follow-Up Versus Placebo+Open Label Extension and Follow-Up

    TEWL assessment is a noninvasive in vivo measurement of water loss across the stratum corneum that is used to characterize skin barrier function. Basal TEWL =baseline measure (prior to tape stripping). An increase in TEWL values shows damage to the skin barrier function.

    Basal TEWL was measured on non-lesional and lesional skin. Basal TEWL is summarized as the mean difference between the dupilumab and placebo arms. The mean difference is reported from two linear mixed models for repeated measures (lesional and non-lesional) with fixed effects for treatment arm, basal TEWL at Day 0, clinical site, and disease severity at Day 0 as measured by EASI ≥ 21.1 or < 21.1 at Days 3, 7, 14, 21, 28, and 42. Two linear mixed models similar to the models specified above were fit for every time point measured. The model was used to estimate the mean difference between treatment arms at Days 77 and 112 and the ratio within treatment arm between Day 77 and Day 42 and between Day 112 and Day 42.

    Measured: Day 0 (Prior to treatment), 3, 7, 14, 21, 28, 42, 77 and 112

  4. Transepidermal Water Loss (TEWL) Area Under the Curve (AUC) on Non-Lesional Skin, Dupilumab+Open Label Extension and Follow-Up Versus Placebo+Open Label Extension and Follow-Up

    TEWL skin barrier assessment was assessed prior to tape stripping and repeated after 5, 10, and 15 tape strips. TEWL AUC was calculated using the trapezoidal rule and represents skin barrier integrity. An increase in TEWL values shows damage to the skin barrier function.

    TEWL AUC was measured on non-lesional skin at Days 0, 7, 14, 21, 28, 42, 77 and 112. The mean difference (between Groups) is reported from a linear mixed model for repeated measures with a random effect for participant and fixed effects for treatment arm, TEWL AUC at Day 0, clinical site, and disease severity at Day 0 as measured by EASI ≥ 21.1 or < 21.1 at Days 7, 14, 21, 28, and 42.

    A linear mixed model similar to the model specified above was fit for every time point measured. The model was used to estimate the mean difference between treatment arms at Days 77 and 112 and the mean difference within treatment arm between Day 77 and Day 42 and between Day 112 and Day 42.

    Measured: Day 0 (Prior to treatment), 7, 14, 21, 28, 42, 77 and 112

  5. Transepidermal Water Loss (TEWL) Slope on Non-Lesional Skin, Dupilumab+Open Label Extension and Follow-Up Versus Placebo+Open Label Extension and Follow-Up

    The skin tape strip collection was comprised of 1 set of 15 strips from non-lesional skin and was collected as part of the TEWL skin barrier assessment.

    The TEWL values measured at every 5 tape strips were used to model the TEWL slope. TEWL slope assesses skin barrier integrity. An increase in TEWL values shows damage to the skin barrier function.

    TEWL slope is summarized as the mean difference (and corresponding 95% confidence interval) between the dupilumab and placebo arms. The mean difference in slope for each Day is reported from a linear mixed model for repeated measures with a fixed effects for basal TEWL prior to tape stripping, treatment arm, clinical site, disease severity at Day 0 as measured by EASI ≥ 21.1 or < 21.1, tape strip number, and an interaction term between treatment arm and tape strip number.

    Measured: Day 0 (Prior to treatment), 7, 14, 21, 28, 42, 77 and 112

  6. Eczema Area and Severity Index (EASI) Score Within Each Treatment Group, Dupilumab+Open Label Extension and Follow-Up Versus Placebo+Open Label Extension and Follow-Up

    EASI is a composite score (range: 0-72) measuring physical signs of atopic dermatitis, including area of involvement and severity. Severity components include: erythema, papulation, excoriation and lichenification [0=absent, 1=mild, 2=moderate, 3=severe] for each body region (head/neck, trunk, arms, legs). Area of involvement (%) is assessed for each body region. Area and severity of each body region is weighted based on size of region, and region scores are added for the total score. Scores ≤7 are considered mild, >7 and ≤21 are considered moderate, and >21 are considered severe.

    The mean EASI score in each treatment arm is reported from a linear mixed model for repeated measures with fixed effects for EASI at Day 0, treatment arm, clinical site, time point of measurement, and an interaction term between treatment arm and pre-specified time point(s), Additionally, a similar model was fit using all time points.

    Measured: Day 0 (Prior to treatment), 3, 7, 14, 21, 28, 42, 77 and 112

  7. Investigator Global Assessment (IGA) Score Within Each Treatment Group, Dupilumab+Open Label Extension and Follow-Up Versus Placebo+Open Label Extension and Follow-Up

    Investigator Global Assessment (IGA) score is a subjective scale measuring disease severity. Based on a 5-point scale from 0 (completely clear) to 4 (severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.

    The mean IGA score in each treatment arm is reported from a linear mixed model for repeated measures with fixed effects for IGA at Day 0, treatment arm, clinical site, disease severity at Day 0 as measured by EASI ≥ 21.1 or < 21.1, time point of measurement, and an interaction term between treatment arm and pre-specified time point(s). Additionally, a similar model was fit using all time points.

    Measured: Day 0 (Prior to treatment), 3, 7, 14, 21, 28, 42, 77 and 112

  8. SCORing Atopic Dermatitis (SCORAD) Score Within Each Treatment Group, Dupilumab+Open Label Extension and Follow-Up Versus Placebo+Open Label Extension and Follow-Up

    SCORAD is a composite index comprising a) the amount/extent of body surface area affected, b) subjective symptom visual analog assessments of itch and sleep loss [itch: 0 (no itch) to 10 (worst itch imaginable) / sleep loss: 0 (no sleep loss) to 10 (worst imaginable sleep loss)], and c) 6 disease intensity assessments [dryness, erythema, edema/papulation, excoriation, lichenification and oozing/crusting, each graded from 0-3: 0 (none), 1 (mild), 2 (moderate) and 3 (severe). The score ranges from 0 (no AD present) to 103 (severe).

    The mean SCORAD score in each treatment arm is reported from a linear mixed model for repeated measures with fixed effects for SCORAD at Day 0, treatment arm, clinical site, disease severity at Day 0 as measured by EASI ≥ 21.1 or < 21.1, time point of measurement, and an interaction term between treatment arm and pre-specified time point(s). Additionally, a similar model was fit using all time points.

    Measured: Day 0 (Prior to treatment), 3, 7, 14, 21, 28, 42, 77 and 112

  9. Pruritus Numerical Rating Scale (Pruritus NRS) Score Within Each Treatment Group, Dupilumab+Open Label Extension and Follow-Up Versus Placebo+Open Label Extension and Follow-Up

    Pruritus NRS scale is an assessment tool that is used to report the average intensity of a participant's pruritus (itch) during a 24-hour recall period. Participants were asked to report the average itch experienced during the past 24 hours on a scale of 0 - 10 [0= no itch; 10= worst imaginable itch]).

    The mean Pruritus NRS score in each treatment arm is reported from a linear mixed model for repeated measures with fixed effects for Pruritus NRS at Day 0, treatment arm, clinical site, disease severity at Day 0 as measured by EASI ≥ 21.1 or < 21.1, time point of measurement, and an interaction term between treatment arm and pre-specified time point(s). Additionally, a similar model was fit using all time points.

    Measured: Day 0 (Prior to treatment), 3, 7, 14, 21, 28, 42, 77 and 112

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2018
  2. Study start25 Jul 2018
  3. Primary completion3 Apr 2020
  4. Study completion9 Sep 2020

Why it stopped: Due to inability to meet accrual goals within the funding period.

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03389893
Sponsor's protocol ID
DAIT ADRN-09
Other IDs
U19AI117673, NIAID DAIT CRMS ID#: 38439
Status last verified
Sep 2021
First submitted
27 Dec 2017
Last updated
4 Oct 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dupilumab in people with Atopic Dermatitis (AD), run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.

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 16 inclusion and 40 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: stopped early, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Staphylococcus Aureus Abundance on Lesional Skin, Dupilumab+Open Label Extension and Follow-Up Versus Placebo+Open Label Extension and Follow-Up (time frame: Day 28 (Post treatment initiation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03389893.

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 4 Oct 2021.

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