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Trial record 1 of 1 for:    Dupilumab, 1314
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Study of Dupilumab and Immune Responses in Adults With Atopic Dermatitis (AD)

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ClinicalTrials.gov Identifier: NCT02210780
Recruitment Status : Completed
First Posted : August 7, 2014
Results First Posted : May 7, 2020
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 5, 2014
First Posted Date  ICMJE August 7, 2014
Results First Submitted Date  ICMJE March 20, 2020
Results First Posted Date  ICMJE May 7, 2020
Last Update Posted Date May 7, 2020
Actual Study Start Date  ICMJE August 5, 2014
Actual Primary Completion Date September 15, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2020)
Percentage of Participants With a Positive Response (≥4-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16 [ Time Frame: Week 16 ]
A positive response was defined as a ≥ 4-fold increase from pre-vaccination at baseline in anti-tetanus immunoglobulin G (IgG) titer for participants with a pre-vaccination tetanus antibody titers ≥ 0.1 IU/ml or a titer of ≥ 0.2 IU/ml for participants with pre-vaccination titers of <0.1 IU/ml. There was no planned statistical hypothesis testing regarding the difference in immune response between the 2 treatment groups for this study, therefore no formal statistical hypothesis between groups was performed.
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2014)
Proportion of participants with a positive response to administered vaccine [ Time Frame: At week 16 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2020)
  • Percentage of Participants With a Positive Response (≥2-Fold Increase) to Tetanus Toxoid (the Adacel [Tdap] Vaccine) at Week 16 [ Time Frame: Week 16 ]
    Participants with positive response defined as a ≥2-fold increase from pre-vaccination baseline in anti-tetanus IgG titer for participants with pre-vaccination tetanus antibody titers ≥0.1 IU/ml or a titer of ≥0.2 IU/ml for participants with pre-vaccination titers of <0.1 IU/ml.
  • Percentage of Participants With a Positive Response (SBA Antibody Titer of ≥8 for Serogroup C) to Menomune Vaccine at Week 16 [ Time Frame: Week 16 ]
    A positive response to the Menomune vaccine was a serum bactericidal antibody (SBA) titer of ≥8 for serogroup C.
  • Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 16 [ Time Frame: Week 16 ]
    IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were counted as non-responders.
  • Percentage of Participants Achieving an Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16 [ Time Frame: Week 16 ]
    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.
  • Percentage of Participants Achieving an Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16 [ Time Frame: Week 16 ]
    The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.
  • Change From Baseline in Peak Weekly Averaged Pruritis Numerical Rating Scale (NRS) Scores at Week 16 [ Time Frame: Baseline to Week 16 ]
    Pruritus NRS was an assessment tool that was used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Weekly average obtained in the 7-day period prior to the baseline visit. Values after first rescue medication use were set to missing and missing values were imputed by Last observation carried forward (LOCF).
  • Change From Baseline in Body Surface Area (BSA) Affected by AD at Week 16 [ Time Frame: Baseline to Week 16 ]
    BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined. Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
  • Change From Baseline in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations and Lichenification) at Week 16 [ Time Frame: Baseline to Week 16 ]
    Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease). Values after first rescue treatment were set to missing. Analysis was completed using MMRM model which includes treatment, randomization strata, visit, baseline value, treatment-by-visit interaction, and baseline-by-visit interaction as covariates. These results are observed results without imputation.
  • Changes From Baseline in GISS Cumulative Score to Week 16 [ Time Frame: Baseline to Week 16 ]
    Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
  • Change in Patient Oriented Eczema Measure (POEM) Score From Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
    The POEM was a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2014)
  • Proportion of patients with a positive response at week 16 [ Time Frame: At week 16 ]
    Proportion of patients with a positive response at study week 16
  • Menomune response [ Time Frame: At week 16 ]
    Menomune response: an Serum Bactericidal Antibody (SBA) titer
  • Proportion of patients who achieve IGA (0-1) [ Time Frame: At week 16 ]
    Proportion of patients who achieve Investigator's Global Assessment ([IGA] (0-1) at week 16
  • Proportion of patients achieving at least 50% reduction in EASI scores [ Time Frame: At week 16 ]
    Proportion of patients achieving at least 50% reduction in Eczema Area and Severity Index (EASI) scores at week 16
  • Proportion of patients achieving at least 75% reduction in EASI scores [ Time Frame: At week 16 ]
    Proportion of patients achieving at least 75% reduction in EASI scores at week 16
  • Change from baseline in maximum itch intensity (NRS) [ Time Frame: At week 16 ]
    The change from baseline in maximum itch intensity [(numerical rating scale (NRS)] at week 16
  • Change from baseline in BSA [ Time Frame: At week 16 ]
    The change from baseline in body surface area (BSA) at week 16
  • Change from baseline in the erythema of GISS [ Time Frame: At week 16 ]
    The change from baseline in the erythema of Global Individual Signs Score (GISS) at week 16
  • Change from baseline in the infiltration of GISS [ Time Frame: At week 16 ]
    The change from baseline in the infiltration of GISS at week 16
  • Change from baseline in the infiltration/ papulation of GISS [ Time Frame: At week 16 ]
    The change from baseline in the infiltration/ papulation of GISS at week 16
  • Change from baseline in the excoriations of GISS [ Time Frame: At week 16 ]
    The change from baseline in the excoriations of GISS at week 16
  • Change from baseline in the lichenification of GISS [ Time Frame: At week 16 ]
    The change from baseline in the lichenification of GISS at week 16
  • Change from baseline to week 16 in POEM [ Time Frame: baseline to week 16 ]
    Change from baseline to week 16 in Patient Oriented Eczema Measure (POEM)
  • TEAEs [ Time Frame: baseline through week 20 ]
    Incidence of serious treatment-emergent adverse events (TEAEs) through week 20
  • Study drug discontinuation due to a TEAE [ Time Frame: baseline through week 20 ]
    Incidence of study drug discontinuation due to a TEAE through week 20
  • Incidence of skin-infections [ Time Frame: baseline through week 20 ]
    Incidence of skin-infections through week 20
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Dupilumab and Immune Responses in Adults With Atopic Dermatitis (AD)
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Study Investigating Vaccine Responses in Adults With Moderate to Severe Atopic Dermatitis Treated With Dupilumab
Brief Summary This was a 32-week, randomized, double-blind, placebo-controlled, parallel-group study assessing immunization responses to vaccination in adults with moderate to severe atopic dermatitis who are treated with subcutaneous dupilumab.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: Dupilumab
    Administered via subcutaneous injection.
    Other Names:
    • REGN668
    • SAR231893
    • Dupixent
  • Drug: Placebo
    An inactive substance containing no medicine administered via subcutaneous injection.
Study Arms  ICMJE
  • Experimental: Placebo qw
    Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
    Intervention: Drug: Placebo
  • Experimental: Dupilumab 300 mg qw
    Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15.
    Intervention: Drug: Dupilumab
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2015)
194
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2014)
200
Actual Study Completion Date  ICMJE September 15, 2015
Actual Primary Completion Date September 15, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Male or female adults ages 18 to 64 years with Chronic AD (according to the American Academy of Dermatology Consensus Criteria, [Eichenfeld 2004])that has been present for at least 3 years before the screening visit
  2. Participants with documented recent history (within 6 months before the screening visit) of inadequate response to a sufficient course of outpatient treatment with topical AD medication(s), or for whom topical AD therapies are otherwise inadvisable (e.g., because of side effects or safety risks).
  3. Eczema Area and Severity Index (EASI) score ≥16 at the screening visit and the baseline visit
  4. Investigator's Global Assessment (IGA) score ≥3 (on the 0-4 IGA scale) at the screening and baseline visits
  5. ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits

Key Exclusion Criteria:

  1. Prior treatment with dupilumab (REGN668/ SAR231893)
  2. Patients needing >10 mg of daily prednisone (including equivalent doses of other steroids) or high dose systemic corticosteroids (≥2 mg/kg) for 14 days or longer during the 16 week treatment period of the study
  3. History of Guillain-Barre syndrome
  4. History of severe allergic reaction to either vaccine or to vaccine components including alum, thimerosal, phenol
  5. Patients with a severe reaction to natural rubber latex products (some packaging components of the vaccines contain rubber latex and may cause a reaction in susceptible individuals)
  6. Treatment with biologics within 4 months of baseline visit
  7. Chronic or acute infection requiring treatment with antibiotics, antivirals, antiparasitics, antifungals within 4 weeks before screening visit or superficial skin infections within 1 week of screening visit

The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02210780
Other Study ID Numbers  ICMJE R668-AD-1314
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Regeneron Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Regeneron Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date April 2020

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