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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

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).

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: Nemolizumab Drug: Placebo Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 5, 2020
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : January 27, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Tetanus

Arm Intervention/treatment
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.
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.

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.
Drug: Placebo
Placebo will be administered by 2 SC injections at baseline and a single dose at Weeks 4, 8, and 12.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 54 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04365387


Contacts
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Contact: Galderma Research & Development 817-961-5000 clinical.studies@galderma.com

Locations
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Sponsors and Collaborators
Galderma R&D
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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT04365387    
Other Study ID Numbers: RD.06.SPR.118380
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Galderma R&D:
Eczema
AD
Vaccine
Nemolizumab
Pruritis
Itchy
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases