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Dermatitis, AtopicPhase 2NCT04365387

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

A Phase 2 study testing Nemolizumab in people with Dermatitis, Atopic, run by Galderma R&D at 64 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 12 to 54 years
Conditions the study is for
Dermatitis, Atopic
What is being tested?
Nemolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
242 participants
Where
64 sitesUnited States
Study dates
5 Mar 2020to 7 Jul 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 54 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

64 sites in 1 country.

64 sites in 1 country

United States64 sites

  • Galderma Investigational Site (Site#8831)

    Anaheim, California, 92801

  • Galderma Investigational Site (Site#8846)

    Austin, Texas, 78742

  • Galderma Investigational Site (Site#8855)

    Beaumont, Texas, 77702

  • Galderma Investigational Site (SIte#8870)

    Boca Raton, Florida, 33433

  • Galderma Investigational Site (Site#8876)

    Bridgeton, Missouri, 63044

  • Galderma Investigational Site (Site#8854)

    Canoga Park, California, 91303

  • Galderma Investigational Site (Site#8578)

    Cerritos, California, 90703

  • Galderma Investigational Site (Site#8777)

    Charleston, South Carolina, 29407

  • Galderma Investigational Site (Site#8786)

    Clearwater, Florida, 33765

  • Galderma Investigational Site (Site#8033)

    Clinton Township, Michigan, 48038-1137

  • Galderma Investigational Site (Site#8245)

    Dallas, Texas, 75231

  • Galderma Investigational Site (Site#8792)

    Doral, Florida, 33122

  • Galderma Investigational Site (Site#8129)

    Fort Gratiot, Michigan, 48059

  • Galderma Investigational Site (Site#8447)

    Fort Smith, Arkansas, 72916

  • Galderma Investigational Site (Site#8791)

    Fresno, California, 93720

  • Galderma Investigational Site (Site#8200)

    Goodlettsville, Tennessee, 37072

  • Galderma Investigational Site (Site#8391)

    Hialeah, Florida, 33013

  • Galderma Investigational Site (Site#8868)

    Houston, Texas, 77004

  • Galderma Investigational Site (Site#8845)

    Huntington Beach, California, 92647

  • Galderma Investigational Site (Site#8142)

    Indianapolis, Indiana, 46250

  • Galderma Investigational Site (Site#8833)

    Inglewood, California, 90301

  • Galderma Investigational Site 2 (Site#8833)

    Inglewood, California, 90301

  • Galderma Investigational Site (Site#8836)

    Jacksonville, Florida, 32256

  • Galderma Investigational Site (Site#8817)

    Katy, Texas, 77494

  • Galderma Investigational Site (Site#8828)

    Kew Gardens, New York, 11415

  • Galderma Investigational Site (Site#8847)

    Las Vegas, Nevada, 89118

  • Galderma Investigational Site (Site#8848)

    Las Vegas, Nevada, 89144

  • Galderma Investigational Site 2 (Site#8864)

    Las Vegas, Nevada, 89144

  • Galderma Investigational Site (Site#8858)

    Long Beach, California, 90806

  • Galderma Investigational Site (Site#8130)

    Los Angeles, California, 90045

  • Galderma Investigational Site (Site#8813)

    Los Angeles, California, 90057

  • Galderma Investigational Site (Site#8850)

    Margate, Florida, 33063

  • Galderma Investigational Site (Site#8841)

    Medford, Oregon, 97504

  • Galderma Investigational Site (Site#8812)

    Metairie, Louisiana, 70005

  • Galderma Investigational Site (Site#8851)

    Miami, Florida, 33135

  • Galderma Investigational Site (Site#9921)

    Miami Lakes, Florida, 33014

  • Galderma Investigational Site (Site#8739)

    Normal, Illinois, 61761

  • Galderma Investigational Site (Site#8840)

    Ocoee, Florida, 34761

  • Galderma Investigational Site (Site#8857)

    Oklahoma City, Oklahoma, 73118

  • Galderma Investigational Site (Site#8844)

    Orem, Utah, 84058

  • Galderma Investigational Site (Site#8788)

    Orlando, Florida, 32801

  • Galderma Investigational Site (Site#8213)

    Ormond Beach, Florida, 32174

  • Galderma Investigational Site (Site#8856)

    Ormond Beach, Florida, 32174

  • Galderma Investigational Site (Site#8856)

    Ormond Beach, Florida, 33174

  • Galderma Investigational Site (Site#8532)

    Overland Park, Kansas, 66215

  • Galderma Investigational Site (Site#8428)

    Philadelphia, Pennsylvania, 19104

  • Galderma Investigational Site (Site#9922)

    Phoenix, Arizona, 85018

  • Galderma Investigational Site (Site#8787)

    Plano, Texas, 75093

  • Galderma Investigational Site (Site#8837)

    Pomona, California, 91767

  • Galderma Investigational Site (Site#8420)

    Portsmouth, New Hampshire, 03801

  • Galderma Investigational Site (Site#9919)

    Raleigh, North Carolina, 27617

  • Galderma Investigational Site (Site#9924)

    Raritan, New Jersey, 08869

  • Galderma Investigational Site (Site#8329)

    San Antonio, Texas, 78229-3409

  • Galderma Investigational Site (Site#8873)

    Scottsdale, Arizona, 85260

  • Galderma Investigational Site (Site#8795)

    Shelby, North Carolina, 28150

  • Galderma Investigational Site (Site#9935)

    Springville, Utah, 84663

  • Galderma Investigational Site (Site#8843)

    Sweetwater, Florida, 33172

  • Galderma Investigational Site (Site#8764)

    Tampa, Florida, 33613

  • Galderma Investigational Site 2 (Site#8816)

    Tampa, Florida, 33613

  • Galderma Investigational Site (Site#8839)

    Tampa, Florida, 33615

  • Galderma Investigational Site (Site#8793)

    Towson, Maryland, 21204

  • Galderma Investigational Site (Site#8849)

    Troy, Michigan, 48084

  • Galderma Investigational Site (Site#8003)

    Webster, Texas, 77598

  • Galderma Investigational Site (Site#8353)

    Yardley, Pennsylvania, 19067

Other trials in United States

About this study

Official title: 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).

Read the 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).

Being tested
Nemolizumab, Placebo
Keywords
Eczema, AD, Vaccine, Nemolizumab, Pruritis, Itchy
Medical subject headings
Dermatitis, Atopic, Eczema, Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NemolizumabDrug

    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.

  • PlaceboDrug

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

Study groups in NCT04365387
Study groupRoleWhat they receive
NemolizumabExperimentalParticipants 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.
Receives: Drug: Nemolizumab
PlaceboPlacebo comparatorParticipants received a placebo via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At Week 16 (4 weeks post-vaccination)

Secondary outcomes (5)

  1. 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.

    Measured: At Week 16 (4 weeks post-vaccination)

  2. 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.

    Measured: At Week 16

  3. 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.

    Measured: At Week 16

  4. 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.

    Measured: At Week 16

  5. 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.

    Measured: At Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2020
  2. Study start5 Mar 2020
  3. Primary completion7 Jul 2023
  4. Study completion7 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04365387
Sponsor's protocol ID
RD.06.SPR.118380
Status last verified
May 2025
First submitted
24 Apr 2020
Last updated
1 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nemolizumab in people with Dermatitis, Atopic, run by Galderma R&D at 64 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04365387.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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