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

May 28, 2026 updated by: Galderma R&D

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
242

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 7, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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