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NCT04365387 Clinical Trial

A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04365387
Other study ID # RD.06.SPR.118380
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 5, 2020
Est. completion date July 7, 2023

Study information
Verified date August 2023
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility
Status Completed
Enrollment 225
Est. completion date July 7, 2023
Est. primary completion date July 7, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years to 54 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Galderma Investigational Site (Site#8831) Anaheim California
United States Galderma Investigational Site (Site#8846) Austin Texas
United States Galderma Investigational Site (Site#8855) Beaumont Texas
United States Galderma Investigational Site (SIte#8870) Boca Raton Florida
United States Galderma Investigational Site (Site#8876) Bridgeton Missouri
United States Galderma Investigational Site (Site#8854) Canoga Park California
United States Galderma Investigational Site (Site#8578) Cerritos California
United States Galderma Investigational Site (Site#8777) Charleston South Carolina
United States Galderma Investigational Site (Site#8786) Clearwater Florida
United States Galderma Investigational Site (Site#8033) Clinton Township Michigan
United States Galderma Investigational Site (Site#8245) Dallas Texas
United States Galderma Investigational Site (Site#8792) Doral Florida
United States Galderma Investigational Site (Site#8129) Fort Gratiot Michigan
United States Galderma Investigational Site (Site#8447) Fort Smith Arkansas
United States Galderma Investigational Site (Site#8791) Fresno California
United States Galderma Investigational Site (Site#8200) Goodlettsville Tennessee
United States Galderma Investigational Site (Site#8391) Hialeah Florida
United States Galderma Investigational Site (Site#8868) Houston Texas
United States Galderma Investigational Site (Site#8845) Huntington Beach California
United States Galderma Investigational Site (Site#8142) Indianapolis Indiana
United States Galderma Investigational Site (Site#8833) Inglewood California
United States Galderma Investigational Site 2 (Site#8833) Inglewood California
United States Galderma Investigational Site (Site#8836) Jacksonville Florida
United States Galderma Investigational Site (Site#8817) Katy Texas
United States Galderma Investigational Site (Site#8828) Kew Gardens New York
United States Galderma Investigational Site (Site#8847) Las Vegas Nevada
United States Galderma Investigational Site (Site#8848) Las Vegas Nevada
United States Galderma Investigational Site 2 (Site#8864) Las Vegas Nevada
United States Galderma Investigational Site (Site#8858) Long Beach California
United States Galderma Investigational Site (Site#8130) Los Angeles California
United States Galderma Investigational Site (Site#8813) Los Angeles California
United States Galderma Investigational Site (Site#8850) Margate Florida
United States Galderma Investigational Site (Site#8841) Medford Oregon
United States Galderma Investigational Site (Site#8812) Metairie Louisiana
United States Galderma Investigational Site (Site#8851) Miami Florida
United States Galderma Investigational Site (Site#9921) Miami Lakes Florida
United States Galderma Investigational Site (Site#8739) Normal Illinois
United States Galderma Investigational Site (Site#8840) Ocoee Florida
United States Galderma Investigational Site (Site#8857) Oklahoma City Oklahoma
United States Galderma Investigational Site (Site#8844) Orem Utah
United States Galderma Investigational Site (Site#8788) Orlando Florida
United States Galderma Investigational Site (Site#8856) Ormond Beach Florida
United States Galderma Investigational Site (Site#8856) Ormond Beach Florida
United States Galderma Investigational Site (Site#8532) Overland Park Kansas
United States Galderma Investigational Site (Site#9922) Phoenix Arizona
United States Galderma Investigational Site (Site#8787) Plano Texas
United States Galderma Investigational Site (Site#8837) Pomona California
United States Galderma Investigational Site (Site#8420) Portsmouth New Hampshire
United States Galderma Investigational Site (Site#9919) Raleigh North Carolina
United States Galderma Investigational Site (Site#9924) Raritan New Jersey
United States Galderma Investigational Site (Site#8329) San Antonio Texas
United States Galderma Investigational Site (Site#8873) Scottsdale Arizona
United States Galderma Investigational Site (Site#8795) Shelby North Carolina
United States Galderma Investigational Site (Site#9935) Springville Utah
United States Galderma Investigational Site (Site#8843) Sweetwater Florida
United States Galderma Investigational Site (Site#8764) Tampa Florida
United States Galderma Investigational Site (Site#8839) Tampa Florida
United States Galderma Investigational Site 2 (Site#8816) Tampa Florida
United States Galderma Investigational Site (Site#8793) Towson Maryland
United States Galderma Investigational Site (Site#8849) Troy Michigan
United States Galderma Investigational Site (Site#8003) Webster Texas
United States Galderma Investigational Site (Site#8353) Yardley Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with a Positive Serum Immunoglobulin G (IgG) Response to Tetanus Toxoid at 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. Week 16 (4 weeks post-vaccination)
Secondary Percentage of Participants with a Positive Serum IgG Response to Tetanus Toxoid at 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. Week 16 (4 weeks post-vaccination)
Secondary Percentage of Participants with Serum Aanti-tetanus IgG Concentrations of >= 0.1 IU/mL at Week 16 Percentage of participants with serum anti-tetanus IgG concentrations of >= 0.1 IU/mL at Week 16 will be reported. Week 16
Secondary Percentage of Participants with Serum Aanti-tetanus IgG Concentrations of >= 1.0 IU/mL at Week 16 Percentage of participants with serum anti-tetanus IgG concentrations of >= 1.0 IU/mL at Week 16 will be reported. Week 16
Secondary Percentage of Participants with a Positive Serum Bactericidal Antibody (SBA) Response to Meningococcal Serogroup C Polysaccharide at 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. Week 16
Secondary Percentage of Participants with a Positive SBA Response to Meningococcal Serogroup C Polysaccharide at 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. Week 16
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