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

A Randomized, Double-Blind, Placebo-Controlled Study to Assess Immunization Responses in Adult and Adolescent Subjects With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab

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).

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: Nemolizumab; Drug: Placebo

Detailed Description

This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent participants (≥ 12 to 54 years) with moderate-to-severe AD. Eligible participants must have a documented history of inadequate response to topical AD medication(s). Approximately 200 participants were randomized 1:1 to receive either 30 mg nemolizumab (with a 60 mg loading dose) or placebo, stratified by baseline disease severity Investigator Global Assessment (IGA) (IGA = 3, moderate; IGA = 4, severe). The study consisted 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: Interventional
• Enrollment (Actual): 242
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Galderma Investigational Site (Site#9922)
    • Scottsdale, Arizona, United States, 85260
      • Galderma Investigational Site (Site#8873)
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Galderma Investigational Site (Site#8447)
  • California
    • Anaheim, California, United States, 92801
      • Galderma Investigational Site (Site#8831)
    • Canoga Park, California, United States, 91303
      • Galderma Investigational Site (Site#8854)
    • Cerritos, California, United States, 90703
      • Galderma Investigational Site (Site#8578)
    • Fresno, California, United States, 93720
      • Galderma Investigational Site (Site#8791)
    • Huntington Beach, California, United States, 92647
      • Galderma Investigational Site (Site#8845)
    • Inglewood, California, United States, 90301
      • Galderma Investigational Site (Site#8833)
    • Inglewood, California, United States, 90301
      • Galderma Investigational Site 2 (Site#8833)
    • Long Beach, California, United States, 90806
      • Galderma Investigational Site (Site#8858)
    • Los Angeles, California, United States, 90045
      • Galderma Investigational Site (Site#8130)
    • Los Angeles, California, United States, 90057
      • Galderma Investigational Site (Site#8813)
    • Pomona, California, United States, 91767
      • Galderma Investigational Site (Site#8837)
  • Florida
    • Boca Raton, Florida, United States, 33433
      • Galderma Investigational Site (SIte#8870)
    • Clearwater, Florida, United States, 33765
      • Galderma Investigational Site (Site#8786)
    • Doral, Florida, United States, 33122
      • Galderma Investigational Site (Site#8792)
    • Hialeah, Florida, United States, 33013
      • Galderma Investigational Site (Site#8391)
    • Jacksonville, Florida, United States, 32256
      • Galderma Investigational Site (Site#8836)
    • Margate, Florida, United States, 33063
      • Galderma Investigational Site (Site#8850)
    • Miami, Florida, United States, 33135
      • Galderma Investigational Site (Site#8851)
    • Miami Lakes, Florida, United States, 33014
      • Galderma Investigational Site (Site#9921)
    • Ocoee, Florida, United States, 34761
      • Galderma Investigational Site (Site#8840)
    • Orlando, Florida, United States, 32801
      • Galderma Investigational Site (Site#8788)
    • Ormond Beach, Florida, United States, 32174
      • Galderma Investigational Site (Site#8856)
    • Ormond Beach, Florida, United States, 33174
      • Galderma Investigational Site (Site#8856)
    • Ormond Beach, Florida, United States, 32174
      • Galderma Investigational Site (Site#8213)
    • Sweetwater, Florida, United States, 33172
      • Galderma Investigational Site (Site#8843)
    • Tampa, Florida, United States, 33613
      • Galderma Investigational Site (Site#8764)
    • Tampa, Florida, United States, 33613
      • Galderma Investigational Site 2 (Site#8816)
    • Tampa, Florida, United States, 33615
      • Galderma Investigational Site (Site#8839)
  • Illinois
    • Normal, Illinois, United States, 61761
      • Galderma Investigational Site (Site#8739)
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Galderma Investigational Site (Site#8142)
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Galderma Investigational Site (Site#8532)
  • Louisiana
    • Metairie, Louisiana, United States, 70005
      • Galderma Investigational Site (Site#8812)
  • Maryland
    • Towson, Maryland, United States, 21204
      • Galderma Investigational Site (Site#8793)
  • Michigan
    • Clinton Township, Michigan, United States, 48038-1137
      • Galderma Investigational Site (Site#8033)
    • Fort Gratiot, Michigan, United States, 48059
      • Galderma Investigational Site (Site#8129)
    • Troy, Michigan, United States, 48084
      • Galderma Investigational Site (Site#8849)
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • Galderma Investigational Site (Site#8876)
  • Nevada
    • Las Vegas, Nevada, United States, 89118
      • Galderma Investigational Site (Site#8847)
    • Las Vegas, Nevada, United States, 89144
      • Galderma Investigational Site (Site#8848)
    • Las Vegas, Nevada, United States, 89144
      • Galderma Investigational Site 2 (Site#8864)
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Galderma Investigational Site (Site#8420)
  • New Jersey
    • Raritan, New Jersey, United States, 08869
      • Galderma Investigational Site (Site#9924)
  • New York
    • Kew Gardens, New York, United States, 11415
      • Galderma Investigational Site (Site#8828)
  • North Carolina
    • Raleigh, North Carolina, United States, 27617
      • Galderma Investigational Site (Site#9919)
    • Shelby, North Carolina, United States, 28150
      • Galderma Investigational Site (Site#8795)
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Galderma Investigational Site (Site#8857)
  • Oregon
    • Medford, Oregon, United States, 97504
      • Galderma Investigational Site (Site#8841)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Galderma Investigational Site (Site#8428)
    • Yardley, Pennsylvania, United States, 19067
      • Galderma Investigational Site (Site#8353)
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Galderma Investigational Site (Site#8777)
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Galderma Investigational Site (Site#8200)
  • Texas
    • Austin, Texas, United States, 78742
      • Galderma Investigational Site (Site#8846)
    • Beaumont, Texas, United States, 77702
      • Galderma Investigational Site (Site#8855)
    • Dallas, Texas, United States, 75231
      • Galderma Investigational Site (Site#8245)
    • Houston, Texas, United States, 77004
      • Galderma Investigational Site (Site#8868)
    • Katy, Texas, United States, 77494
      • Galderma Investigational Site (Site#8817)
    • Plano, Texas, United States, 75093
      • Galderma Investigational Site (Site#8787)
    • San Antonio, Texas, United States, 78229-3409
      • Galderma Investigational Site (Site#8329)
    • Webster, Texas, United States, 77598
      • Galderma Investigational Site (Site#8003)
  • Utah
    • Orem, Utah, United States, 84058
      • Galderma Investigational Site (Site#8844)
    • Springville, Utah, United States, 84663
      • Galderma Investigational Site (Site#9935)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 54 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nemolizumab; Participants received a loading dose of nemolizumab (60 milligram [mg]) via 2 subcutaneous (SC) injections at baseline. Nemolizumab (30 mg) was administered via a single subcutaneous injection every 4 weeks (Q4W) at Weeks 4, 8, and 12.	Drug: Nemolizumab; Nemolizumab was 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 received a placebo via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12.	Drug: Placebo; Placebo was administered by 2 SC injections at baseline and a single dose at Weeks 4, 8, and 12.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Positive Serum Immunoglobulin G (IgG) Response (>= 4-Fold Increase or >= 0.2 IU/mL in Anti-Tetanus IgG Concentrations) 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) were reported.	At Week 16 (4 weeks post-vaccination)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Positive Serum IgG Response (>=2-Fold Increase or >= 0.2 IU/mL in Anti-tetanus IgG Concentrations) to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination)	Percentage of participants with a positive serum IgG response to tetanus toxoid, defined as >= 2-fold increase in anti-tetanus IgG concentrations from baseline in participants with pre-vaccination anti-tetanus IgG concentrations >= 0.1 IU/mL; or >= 0.2 IU/mL anti-tetanus IgG concentrations in participants with pre-vaccination Anti tetanus IgG concentrations < 0.1 IU/mL, at Week 16 (4 weeks post-vaccination) were reported.	At Week 16 (4 weeks post-vaccination)
Percentage of Participants With Serum Anti-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 were reported. The detection and characterization of antibodies to tetanus toxoid was performed using a validated immunoassay.	At Week 16
Percentage of Participants With Serum Anti-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 were reported. The detection and characterization of antibodies to tetanus toxoid was performed using a validated immunoassay.	At Week 16
Percentage of Participants With a Positive Serum Bactericidal Antibody (SBA) Response to Meningococcal Serogroup C (MenC) Polysaccharide at Week 16	Percentage of participants with a positive SBA response to meningococcal serogroup C polysaccharide, defined as >= 4-fold increase in SBA reciprocal titer from baseline (using non-imputed values), at Week 16 (4 weeks postvaccination) were reported.	At Week 16
Percentage of Participants With a Positive SBA Response (Defined as SBA Reciprocal Titer ≥8) to MenC Polysaccharide at Week 16	Percentage of participants with a positive SBA response to MenC polysaccharide, defined as SBA reciprocal titer >= 8, at Week 16 were reported. Immune response to meningococcal vaccination was determined by measuring functional antibody responses using an SBA assay.	At Week 16

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2020
• Primary Completion (Actual): July 7, 2023
• Study Completion (Actual): July 7, 2023

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Vaccine; AD; Eczema; Nemolizumab; Pruritis; Itchy
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Skin Manifestations; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Dermatitis, Atopic; Eczema; Pruritus; nemolizumab
• Other Study ID Numbers: RD.06.SPR.118380

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No