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Trial record 1 of 1 for:    Galderma | atopic dermatitis | Ormond Beach
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A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab

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ClinicalTrials.gov Identifier: NCT04365387
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Tracking Information
First Submitted Date  ICMJE April 24, 2020
First Posted Date  ICMJE April 28, 2020
Last Update Posted Date May 14, 2020
Actual Study Start Date  ICMJE March 5, 2020
Estimated Primary Completion Date July 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
Percentage of Participants with a Positive Serum Immunoglobulin G (IgG) Response to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination) [ Time Frame: Week 16 (4 weeks post-vaccination) ]
Percentage of participants with a positive serum IgG response to tetanus toxoid, defined as greater than or equal to (>=) 4-fold increase in anti-tetanus IgG concentrations from baseline in participants with pre-vaccination anti-tetanus IgG concentrations >= 0.1 international unit per milliliter (IU/mL); or >= 0.2 IU/mL anti-tetanus IgG concentrations in participants with pre-vaccination antitetanus IgG concentrations less than (<) 0.1 IU/mL, at Week 16 (4 weeks post-vaccination) will be reported.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
  • Percentage of Participants with a Positive Serum IgG Response to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination) [ Time Frame: Week 16 (4 weeks post-vaccination) ]
    Percentage of participants with a positive serum IgG response to tetanus toxoid, defined as greater than or equal to (>=) 2-fold increase in anti-tetanus IgG concentrations from baseline in participants with pre-vaccination anti-tetanus IgG concentrations >= 0.1 international unit per milliliter (IU/mL); or >= 0.2 IU/mL anti-tetanus IgG concentrations in participants with pre-vaccination antitetanus IgG concentrations less than (<) 0.1 IU/mL, at Week 16 (4 weeks post-vaccination) will be reported.
  • Percentage of Participants with Serum Aanti-tetanus IgG Concentrations of >= 0.1 IU/mL at Week 16 [ Time Frame: Week 16 ]
    Percentage of participants with serum anti-tetanus IgG concentrations of >= 0.1 IU/mL at Week 16 will be reported.
  • Percentage of Participants with Serum Aanti-tetanus IgG Concentrations of >= 1.0 IU/mL at Week 16 [ Time Frame: Week 16 ]
    Percentage of participants with serum anti-tetanus IgG concentrations of >= 1.0 IU/mL at Week 16 will be reported.
  • Percentage of Participants with a Positive Serum Bactericidal Antibody (SBA) Response to Meningococcal Serogroup C Polysaccharide at Week 16 [ Time Frame: Week 16 ]
    Percentage of participants with a positive SBA response to meningococcal serogroup C polysaccharide, defined as >= 4-fold increase in serum bactericidal assay (SBA) reciprocal titer from baseline, at Week 16 (4 weeks postvaccination) will be reported.
  • Percentage of Participants with a Positive SBA Response to Meningococcal Serogroup C Polysaccharide at Week 16 [ Time Frame: Week 16 ]
    Percentage of participants with a positive SBA response to meningococcal serogroup C polysaccharide, defined as SBA reciprocal titer >= 8, at Week 16 will be reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
  • Percentage of Participants with a Positive Serum IgG Response to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination) [ Time Frame: Week 16 (4 weeks post-vaccination) ]
    Percentage of participants with a positive serum IgG response to tetanus toxoid, defined as greater than or equal to (>=) 2-fold increase in anti-tetanus IgG concentrations from baseline in participants with pre-vaccination anti-tetanus IgG concentrations >= 0.1 international unit per milliliter (IU/mL); or >= 0.2 IU/mL anti-tetanus IgG concentrations in participants with pre-vaccination antitetanus IgG concentrations less than (<) 0.1 IU/mL, at Week 16 (4 weeks post-vaccination) will be reported.
  • Percentage of Participants with Serum Aanti-tetanus IgG Concentrations of >= 0.1 IU/mL at Week 16 [ Time Frame: Week 16 ]
    Percentage of participants with serum anti-tetanus IgG concentrations of >= 0.1 IU/mL at Week 16 will be reported.
  • Percentage of Participants with Serum Aanti-tetanus IgG Concentrations of >= 1.0 IU/mL at Week 16 [ Time Frame: Week 16 ]
    Percentage of participants with serum anti-tetanus IgG concentrations of >= 1.0 IU/mL at Week 16 will be reported.
  • Percentage of Participants with a Positive Serum Bactericidal Antibody (SBA) Response to Meningococcal Serogroup C Polysaccharide at Week 16 [ Time Frame: Week 16 ]
    Percentage of participants with a positive SBA response to meningococcal serogroup C polysaccharide, defined as >= 4-fold increase in serum bactericidal assay (SBA) reciprocal titer from baseline, at Week 16 (4 weeks postvaccination) will be reported.
  • Percentage of Participants with a Positive SBA Response to Meningococcal Serogroup C Polysaccharide at Week 16 [ Time Frame: Week 16 ]
    Percentage of participants with a positive SBA response to meningococcal serogroup C polysaccharide, defined as SBA reciprocal titer >= 8, at Week 16 will be reported.
  • Percentage of Participants with an Investigator Global Assessment (IGA) Success Through Week 16 [ Time Frame: Up to Week 16 ]
    Percentage of participants with an IGA success (defined as an IGA of 0 [clear] or 1 [almost clear] and a >= 2-point reduction from baseline) at each visit through Week 16 will be reported.
  • Percentage of Participants Achieving a 75 Percent (%) Response from Baseline in Eczema Area and Severity Index (EASI) Through Week 16 [ Time Frame: Up to Week 16 ]
    Percentage of participants achieving a 75% response from baseline in EASI at each visit through Week 16 will be reported. The EASI is used to assess the severity and the extent of AD signs with composite score ranging from 0 to 72. The degree of severity of each sign (E=erythema, I=induration/papulation, Ex=excoriation, L=lichenification) in each of the 4 body regions is evaluated based on a scale ranging from 0 to 3 (0: none; 1: mild; 2: moderate; 3: severe).
  • Percentage of Participants with an Improvement of Peak Pruritus Numeric Rating Scale (NRS) >= 4 from Baseline at Each Visit Through Week 16 [ Time Frame: Up to Week 16 ]
    Percentage of participants with an improvement of peak pruritus NRS >= 4 from baseline at each visit through Week 16 will be reported. The peak pruritus NRS is a scale to be used by the participants to report the maximum intensity of their pruritus (itch) on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
  • Change from Baseline in EASI Through Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in EASI at each visit through Week 16 will be reported.
  • Change from Baseline in Peak Pruritus NRS Score Through Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in peak pruritus NRS score through Week 16 will be reported.
  • Percentage of Participants with an Improvement of Average Pruritus (AP) NRS >= 4 from Baseline through Week 16 [ Time Frame: Up to Week 16 ]
    Percentage of participants with an improvement of AP NRS >= 4 from baseline through Week 16 will be reported. The average pruritus NRS is a scale to be used by the participants to report the average intensity of their pruritus (itch) on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
  • Change from Baseline in AP NRS Score Through Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in AP NRS score through Week 16 will be reported.
  • Percentage of Participants with an improvement of sleep disturbance NRS >= 4 from baseline through Week 16 [ Time Frame: Up to Week 16 ]
    Percentage of participants with an improvement of sleep disturbance NRS >= 4 from baseline through Week 16 will be reported.
  • Change from Baseline in Sleep Disturbance NRS Score Through Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in sleep disturbance NRS score through Week 16 will be reported.
  • Change from Baseline in Percent Body Surface Area (BSA) Affected at Each Visit Through Week 16 [ Time Frame: Baseline and Week 16 ]
    Change from baseline in percent BSA affected at each visit through Week 16 will be reported.
  • Percentage of Participants with Adverse Events (AEs) by Severity [ Time Frame: Up to 28 weeks ]
    An assessment of severity grade of an AE will be made follows: mild, moderate, and severe.
  • Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 28 weeks ]
    An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
  • Percentage of Participants with Treatment-emergent AEs (TEAEs) and Adverse Events of Special Interest (AESI) [ Time Frame: From the first dose date of study treatment through 12 weeks ]
    Percentage of participants with TEAEs and AESI will be reported. TEAEs are AEs which will occur through 12 weeks from first dose that were absent before treatment or that worsened relative to pre-treatment state.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab
Brief Summary The purpose of this study is to assess the effect of nemolizumab (CD14152) on humoral immune responses to tetanus and meningococcal vaccination in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD).
Detailed Description This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent subjects (≥ 12 to 54 years) with moderate-to-severe AD. Eligible subjects must have a documented history of inadequate response to topical AD medication(s). Approximately 200 subjects will be randomized 1:1 to receive either 30 mg nemolizumab (with a 60 mg loading dose) or placebo, stratified by baseline disease severity (IGA = 3, moderate; IGA = 4, severe). The study consists of a 2- to 4-week screening period, a 16-week treatment period, and an 8-week follow-up period (12 weeks after the last study drug injection).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dermatitis, Atopic
Intervention  ICMJE
  • Drug: Nemolizumab
    Nemolizumab will be administered by 2 SC injections as 60-mg loading dose at baseline and a single 30-mg dose at Weeks 4, 8, and 12.
  • Drug: Placebo
    Placebo will be administered by 2 SC injections at baseline and a single dose at Weeks 4, 8, and 12.
Study Arms  ICMJE
  • Experimental: Nemolizumab
    Participants will receive a loading dose of nemolizumab (60 milligram [mg]) via 2 subcutaneous (SC) injections at baseline. Nemolizumab (30 mg) will then be administered via a single subcutaneous injection every 4 weeks (Q4W) at Weeks 4, 8, and 12.
    Intervention: Drug: Nemolizumab
  • Placebo Comparator: Placebo
    Participants will receive a placebo via 2 SC injections at baseline. Placebo will then be administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12.
    Intervention: 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: April 24, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 27, 2022
Estimated Primary Completion Date July 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic AD for at least 2 years
  • EASI score >= 16
  • IGA score >= 3
  • AD involvement >= 10% of BSA
  • Peak (maximum) pruritus NRS score of at least 4.0

Exclusion Criteria:

  • Body weight < 30 kilogram (kg)
  • History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) or to any of the study drug excipients
  • History of severe allergic reaction to either vaccine or to vaccine components including alum, thimerosal, phenol
  • Participants for whom administration of the meningococcal vaccine provided in this study is contraindicated or medically inadvisable
  • Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this study is contraindicated or medically inadvisable
  • Receipt of any vaccine (except inactivated influenza vaccine) within 12 weeks prior to screening, any meningococcal vaccine within 1 year prior to screening, or any tetanus-, diphtheria-, or pertussis-containing vaccine within 5 years prior to screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 54 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Galderma Research & Development 817-961-5000 clinical.studies@galderma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04365387
Other Study ID Numbers  ICMJE RD.06.SPR.118380
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma R&D
Study Sponsor  ICMJE Galderma R&D
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Galderma R&D
Verification Date February 2020

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