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

NCT ID: NCT04365387

Last Updated: 2025-06-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-05

Study Completion Date

2023-07-07

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Nemolizumab

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Galderma Investigational Site (Site#9922)

Phoenix, Arizona, United States

Site Status

Galderma Investigational Site (Site#8873)

Scottsdale, Arizona, United States

Site Status

Galderma Investigational Site (Site#8447)

Fort Smith, Arkansas, United States

Site Status

Galderma Investigational Site (Site#8831)

Anaheim, California, United States

Site Status

Galderma Investigational Site (Site#8854)

Canoga Park, California, United States

Site Status

Galderma Investigational Site (Site#8578)

Cerritos, California, United States

Site Status

Galderma Investigational Site (Site#8791)

Fresno, California, United States

Site Status

Galderma Investigational Site (Site#8845)

Huntington Beach, California, United States

Site Status

Galderma Investigational Site (Site#8833)

Inglewood, California, United States

Site Status

Galderma Investigational Site 2 (Site#8833)

Inglewood, California, United States

Site Status

Galderma Investigational Site (Site#8858)

Long Beach, California, United States

Site Status

Galderma Investigational Site (Site#8130)

Los Angeles, California, United States

Site Status

Galderma Investigational Site (Site#8813)

Los Angeles, California, United States

Site Status

Galderma Investigational Site (Site#8837)

Pomona, California, United States

Site Status

Galderma Investigational Site (SIte#8870)

Boca Raton, Florida, United States

Site Status

Galderma Investigational Site (Site#8786)

Clearwater, Florida, United States

Site Status

Galderma Investigational Site (Site#8792)

Doral, Florida, United States

Site Status

Galderma Investigational Site (Site#8391)

Hialeah, Florida, United States

Site Status

Galderma Investigational Site (Site#8836)

Jacksonville, Florida, United States

Site Status

Galderma Investigational Site (Site#8850)

Margate, Florida, United States

Site Status

Galderma Investigational Site (Site#8851)

Miami, Florida, United States

Site Status

Galderma Investigational Site (Site#9921)

Miami Lakes, Florida, United States

Site Status

Galderma Investigational Site (Site#8840)

Ocoee, Florida, United States

Site Status

Galderma Investigational Site (Site#8788)

Orlando, Florida, United States

Site Status

Galderma Investigational Site (Site#8213)

Ormond Beach, Florida, United States

Site Status

Galderma Investigational Site (Site#8856)

Ormond Beach, Florida, United States

Site Status

Galderma Investigational Site (Site#8856)

Ormond Beach, Florida, United States

Site Status

Galderma Investigational Site (Site#8843)

Sweetwater, Florida, United States

Site Status

Galderma Investigational Site (Site#8764)

Tampa, Florida, United States

Site Status

Galderma Investigational Site 2 (Site#8816)

Tampa, Florida, United States

Site Status

Galderma Investigational Site (Site#8839)

Tampa, Florida, United States

Site Status

Galderma Investigational Site (Site#8739)

Normal, Illinois, United States

Site Status

Galderma Investigational Site (Site#8142)

Indianapolis, Indiana, United States

Site Status

Galderma Investigational Site (Site#8532)

Overland Park, Kansas, United States

Site Status

Galderma Investigational Site (Site#8812)

Metairie, Louisiana, United States

Site Status

Galderma Investigational Site (Site#8793)

Towson, Maryland, United States

Site Status

Galderma Investigational Site (Site#8033)

Clinton Township, Michigan, United States

Site Status

Galderma Investigational Site (Site#8129)

Fort Gratiot, Michigan, United States

Site Status

Galderma Investigational Site (Site#8849)

Troy, Michigan, United States

Site Status

Galderma Investigational Site (Site#8876)

Bridgeton, Missouri, United States

Site Status

Galderma Investigational Site (Site#8847)

Las Vegas, Nevada, United States

Site Status

Galderma Investigational Site (Site#8848)

Las Vegas, Nevada, United States

Site Status

Galderma Investigational Site 2 (Site#8864)

Las Vegas, Nevada, United States

Site Status

Galderma Investigational Site (Site#8420)

Portsmouth, New Hampshire, United States

Site Status

Galderma Investigational Site (Site#9924)

Raritan, New Jersey, United States

Site Status

Galderma Investigational Site (Site#8828)

Kew Gardens, New York, United States

Site Status

Galderma Investigational Site (Site#9919)

Raleigh, North Carolina, United States

Site Status

Galderma Investigational Site (Site#8795)

Shelby, North Carolina, United States

Site Status

Galderma Investigational Site (Site#8857)

Oklahoma City, Oklahoma, United States

Site Status

Galderma Investigational Site (Site#8841)

Medford, Oregon, United States

Site Status

Galderma Investigational Site (Site#8428)

Philadelphia, Pennsylvania, United States

Site Status

Galderma Investigational Site (Site#8353)

Yardley, Pennsylvania, United States

Site Status

Galderma Investigational Site (Site#8777)

Charleston, South Carolina, United States

Site Status

Galderma Investigational Site (Site#8200)

Goodlettsville, Tennessee, United States

Site Status

Galderma Investigational Site (Site#8846)

Austin, Texas, United States

Site Status

Galderma Investigational Site (Site#8855)

Beaumont, Texas, United States

Site Status

Galderma Investigational Site (Site#8245)

Dallas, Texas, United States

Site Status

Galderma Investigational Site (Site#8868)

Houston, Texas, United States

Site Status

Galderma Investigational Site (Site#8817)

Katy, Texas, United States

Site Status

Galderma Investigational Site (Site#8787)

Plano, Texas, United States

Site Status

Galderma Investigational Site (Site#8329)

San Antonio, Texas, United States

Site Status

Galderma Investigational Site (Site#8003)

Webster, Texas, United States

Site Status

Galderma Investigational Site (Site#8844)

Orem, Utah, United States

Site Status

Galderma Investigational Site (Site#9935)

Springville, Utah, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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RD.06.SPR.118380

Identifier Type: -

Identifier Source: org_study_id

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