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

Primary Purpose

Dermatitis, Atopic

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nemolizumab
Placebo
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Eczema, AD, Vaccine, Nemolizumab, Pruritis, Itchy

Eligibility Criteria

12 Years - 54 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Galderma Investigational Site (Site#9922)
  • Galderma Investigational Site (Site#8873)
  • Galderma Investigational Site (Site#8447)
  • Galderma Investigational Site (Site#8831)
  • Galderma Investigational Site (Site#8854)
  • Galderma Investigational Site (Site#8578)
  • Galderma Investigational Site (Site#8791)
  • Galderma Investigational Site (Site#8845)
  • Galderma Investigational Site (Site#8833)
  • Galderma Investigational Site 2 (Site#8833)
  • Galderma Investigational Site (Site#8858)
  • Galderma Investigational Site (Site#8130)
  • Galderma Investigational Site (Site#8813)
  • Galderma Investigational Site (Site#8837)
  • Galderma Investigational Site (SIte#8870)
  • Galderma Investigational Site (Site#8786)
  • Galderma Investigational Site (Site#8792)
  • Galderma Investigational Site (Site#8391)
  • Galderma Investigational Site (Site#8836)
  • Galderma Investigational Site (Site#8850)
  • Galderma Investigational Site (Site#9921)
  • Galderma Investigational Site (Site#8851)
  • Galderma Investigational Site (Site#8840)
  • Galderma Investigational Site (Site#8788)
  • Galderma Investigational Site (Site#8856)
  • Galderma Investigational Site (Site#8856)
  • Galderma Investigational Site (Site#8843)
  • Galderma Investigational Site (Site#8764)
  • Galderma Investigational Site 2 (Site#8816)
  • Galderma Investigational Site (Site#8839)
  • Galderma Investigational Site (Site#8739)
  • Galderma Investigational Site (Site#8142)
  • Galderma Investigational Site (Site#8532)
  • Galderma Investigational Site (Site#8812)
  • Galderma Investigational Site (Site#8793)
  • Galderma Investigational Site (Site#8033)
  • Galderma Investigational Site (Site#8129)
  • Galderma Investigational Site (Site#8849)
  • Galderma Investigational Site (Site#8876)
  • Galderma Investigational Site (Site#8847)
  • Galderma Investigational Site (Site#8848)
  • Galderma Investigational Site 2 (Site#8864)
  • Galderma Investigational Site (Site#8420)
  • Galderma Investigational Site (Site#9924)
  • Galderma Investigational Site (Site#8828)
  • Galderma Investigational Site (Site#9919)
  • Galderma Investigational Site (Site#8795)
  • Galderma Investigational Site (Site#8857)
  • Galderma Investigational Site (Site#8841)
  • Galderma Investigational Site (Site#8353)
  • Galderma Investigational Site (Site#8777)
  • Galderma Investigational Site (Site#8200)
  • Galderma Investigational Site (Site#8846)
  • Galderma Investigational Site (Site#8855)
  • Galderma Investigational Site (Site#8245)
  • Galderma Investigational Site (Site#8868)
  • Galderma Investigational Site (Site#8817)
  • Galderma Investigational Site (Site#8787)
  • Galderma Investigational Site (Site#8329)
  • Galderma Investigational Site (Site#8003)
  • Galderma Investigational Site (Site#8844)
  • Galderma Investigational Site (Site#9935)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nemolizumab

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
April 24, 2020
Last Updated
August 21, 2023
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT04365387
Brief Title
A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
July 7, 2023 (Actual)
Study Completion Date
October 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Eczema, AD, Vaccine, Nemolizumab, Pruritis, Itchy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
245 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nemolizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Nemolizumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered by 2 SC injections at baseline and a single dose at Weeks 4, 8, and 12.
Primary Outcome Measure Information:
Title
Percentage of Participants with a Positive Serum Immunoglobulin G (IgG) Response to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination)
Description
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.
Time Frame
Week 16 (4 weeks post-vaccination)
Secondary Outcome Measure Information:
Title
Percentage of Participants with a Positive Serum IgG Response to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination)
Description
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.
Time Frame
Week 16 (4 weeks post-vaccination)
Title
Percentage of Participants with Serum Aanti-tetanus IgG Concentrations of >= 0.1 IU/mL at Week 16
Description
Percentage of participants with serum anti-tetanus IgG concentrations of >= 0.1 IU/mL at Week 16 will be reported.
Time Frame
Week 16
Title
Percentage of Participants with Serum Aanti-tetanus IgG Concentrations of >= 1.0 IU/mL at Week 16
Description
Percentage of participants with serum anti-tetanus IgG concentrations of >= 1.0 IU/mL at Week 16 will be reported.
Time Frame
Week 16
Title
Percentage of Participants with a Positive Serum Bactericidal Antibody (SBA) Response to Meningococcal Serogroup C Polysaccharide at Week 16
Description
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.
Time Frame
Week 16
Title
Percentage of Participants with a Positive SBA Response to Meningococcal Serogroup C Polysaccharide at Week 16
Description
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.
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Galderma Investigational Site (Site#9922)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Galderma Investigational Site (Site#8873)
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Galderma Investigational Site (Site#8447)
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Facility Name
Galderma Investigational Site (Site#8831)
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Galderma Investigational Site (Site#8854)
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Galderma Investigational Site (Site#8578)
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Galderma Investigational Site (Site#8791)
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Galderma Investigational Site (Site#8845)
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Galderma Investigational Site (Site#8833)
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Galderma Investigational Site 2 (Site#8833)
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Galderma Investigational Site (Site#8858)
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Galderma Investigational Site (Site#8130)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Galderma Investigational Site (Site#8813)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Galderma Investigational Site (Site#8837)
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Galderma Investigational Site (SIte#8870)
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33433
Country
United States
Facility Name
Galderma Investigational Site (Site#8786)
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Galderma Investigational Site (Site#8792)
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Galderma Investigational Site (Site#8391)
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Galderma Investigational Site (Site#8836)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Galderma Investigational Site (Site#8850)
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Facility Name
Galderma Investigational Site (Site#9921)
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Galderma Investigational Site (Site#8851)
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Galderma Investigational Site (Site#8840)
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Galderma Investigational Site (Site#8788)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Galderma Investigational Site (Site#8856)
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Galderma Investigational Site (Site#8856)
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Galderma Investigational Site (Site#8843)
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Galderma Investigational Site (Site#8764)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Galderma Investigational Site 2 (Site#8816)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Galderma Investigational Site (Site#8839)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Galderma Investigational Site (Site#8739)
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Galderma Investigational Site (Site#8142)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Galderma Investigational Site (Site#8532)
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Galderma Investigational Site (Site#8812)
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70005
Country
United States
Facility Name
Galderma Investigational Site (Site#8793)
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Galderma Investigational Site (Site#8033)
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038-1137
Country
United States
Facility Name
Galderma Investigational Site (Site#8129)
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Galderma Investigational Site (Site#8849)
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Galderma Investigational Site (Site#8876)
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Galderma Investigational Site (Site#8847)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89118
Country
United States
Facility Name
Galderma Investigational Site (Site#8848)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Galderma Investigational Site 2 (Site#8864)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Galderma Investigational Site (Site#8420)
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Galderma Investigational Site (Site#9924)
City
Raritan
State/Province
New Jersey
ZIP/Postal Code
08869
Country
United States
Facility Name
Galderma Investigational Site (Site#8828)
City
Kew Gardens
State/Province
New York
ZIP/Postal Code
11415
Country
United States
Facility Name
Galderma Investigational Site (Site#9919)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617
Country
United States
Facility Name
Galderma Investigational Site (Site#8795)
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Galderma Investigational Site (Site#8857)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Galderma Investigational Site (Site#8841)
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Galderma Investigational Site (Site#8353)
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Galderma Investigational Site (Site#8777)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Galderma Investigational Site (Site#8200)
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Galderma Investigational Site (Site#8846)
City
Austin
State/Province
Texas
ZIP/Postal Code
78742
Country
United States
Facility Name
Galderma Investigational Site (Site#8855)
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Galderma Investigational Site (Site#8245)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Galderma Investigational Site (Site#8868)
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Galderma Investigational Site (Site#8817)
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Galderma Investigational Site (Site#8787)
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Galderma Investigational Site (Site#8329)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3409
Country
United States
Facility Name
Galderma Investigational Site (Site#8003)
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Galderma Investigational Site (Site#8844)
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Galderma Investigational Site (Site#9935)
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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