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NCT04365387

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

Completed Phase 2 Results posted Last updated 5 June 2025
What this trial tests

Phase 2 trial testing Nemolizumab in Dermatitis, Atopic in 242 participants. Completed in 7 July 2023.

Timeline
5 March 2020
Primary endpoint
7 July 2023
7 July 2023

Quick facts

Lead sponsorGalderma R&D
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment242
Start date5 March 2020
Primary completion7 July 2023
Estimated completion7 July 2023
Sites64 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Galderma R&D — full company profile →

Who can join

Adults 12 to 54, any sex, with Dermatitis, Atopic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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) Primary · 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.

GroupValue95% CI
Nemolizumab67.5
Placebo65.4
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) Secondary · 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.

GroupValue95% CI
Nemolizumab78.8
Placebo83.3
Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 0.1 IU/mL at Week 16 Secondary · 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.

GroupValue95% CI
Nemolizumab100
Placebo100
Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 1.0 IU/mL at Week 16 Secondary · 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.

GroupValue95% CI
Nemolizumab97.5
Placebo96.2
Percentage of Participants With a Positive Serum Bactericidal Antibody (SBA) Response to Meningococcal Serogroup C (MenC) Polysaccharide at Week 16 Secondary · 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.

GroupValue95% CI
Nemolizumab77.0
Placebo63.6
Percentage of Participants With a Positive SBA Response (Defined as SBA Reciprocal Titer ≥8) to MenC Polysaccharide at Week 16 Secondary · 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.

GroupValue95% CI
Nemolizumab83.3
Placebo81.9

Adverse events — posted to ClinicalTrials.gov

Time frame: From Day 1 up to end of study (Week 24). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nemolizumab
Serious: 0/119 (0%)
Deaths: 0/119
Placebo
Serious: 1/115 (1%)
Deaths: 0/115

Serious adverse events (1 terms)

ReactionSystemNemolizumabPlacebo
AsthmaRespiratory, thoracic and mediastinal disorders
Other adverse events (78 terms — click to expand)

ReactionSystemNemolizumabPlacebo
Dermatitis atopicSkin and subcutaneous tissue disorders
HeadacheNervous system disorders
COVID-19Infections and infestations
AsthmaRespiratory, thoracic and mediastinal disorders
HyperlipidaemiaMetabolism and nutrition disorders
ProteinuriaRenal and urinary disorders
Alanine aminotransferase increasedInvestigations
Gamma-glutamyltransferase increasedInvestigations
ArthralgiaMusculoskeletal and connective tissue disorders
DiarrhoeaGastrointestinal disorders
UrticariaSkin and subcutaneous tissue disorders
Dermatitis contactSkin and subcutaneous tissue disorders
Drug eruptionSkin and subcutaneous tissue disorders
ErythemaSkin and subcutaneous tissue disorders
Photosensitivity reactionSkin and subcutaneous tissue disorders
Rash papularSkin and subcutaneous tissue disorders
Skin ulcerSkin and subcutaneous tissue disorders
Superficial inflammatory dermatosisSkin and subcutaneous tissue disorders
NasopharyngitisInfections and infestations
Acute sinusitisInfections and infestations
COVID-19 pneumoniaInfections and infestations
CellulitisInfections and infestations
InfectionInfections and infestations
PharyngitisInfections and infestations
Root canal infectionInfections and infestations
Subcutaneous abscessInfections and infestations
TonsillitisInfections and infestations
Tooth abscessInfections and infestations
Upper respiratory tract infectionInfections and infestations
Urinary tract infectionInfections and infestations
Viral upper respiratory tract infectionInfections and infestations
Blood creatine phosphokinase increasedInvestigations
Blood lactate dehydrogenase increasedInvestigations
Blood alkaline phosphatase increasedInvestigations
Blood bilirubin increasedInvestigations
Blood triglycerides increasedInvestigations
Blood uric acid increasedInvestigations
Electrocardiogram T wave amplitude decreasedInvestigations
Lymphocyte count increasedInvestigations
Neutrophil count decreasedInvestigations

Most-reported serious reactions: Asthma.

Data from ClinicalTrials.gov NCT04365387 adverse events section.

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Biologics for Treatment of Atopic Dermatitis: Current Status and Future Prospect.
    Ratchataswan T, Banzon TM, Thyssen JP, Weidinger S, et al · · 2021 · cited 102× · PMID 33685604 · DOI 10.1016/j.jaip.2020.11.034
  2. Th2 Modulation of Transient Receptor Potential Channels: An Unmet Therapeutic Intervention for Atopic Dermatitis.
    Meng J, Li Y, Fischer MJM, Steinhoff M, et al · · 2021 · cited 86× · PMID 34276687 · DOI 10.3389/fimmu.2021.696784
  3. Current Insights into Immunology and Novel Therapeutics of Atopic Dermatitis.
    Kader HA, Azeem M, Jwayed SA, Al-Shehhi A, et al · · 2021 · cited 61× · PMID 34200009 · DOI 10.3390/cells10061392
  4. Blockage of the IL-31 Pathway as a Potential Target Therapy for Atopic Dermatitis.
    Orfali RL, Aoki V. · · 2023 · cited 29× · PMID 36839897 · DOI 10.3390/pharmaceutics15020577
  5. A Systematic Review of Atopic Dermatitis: The Intriguing Journey Starting from Physiopathology to Treatment, from Laboratory Bench to Bedside.
    Radi G, Campanti A, Diotallevi F, Martina E, et al · · 2022 · cited 17× · PMID 36359220 · DOI 10.3390/biomedicines10112700
  6. Biologics and oral small-molecule inhibitors for treatment of pediatric atopic dermatitis: Opportunities and challenges.
    Zhao A, Pan C, Li M. · · 2023 · cited 6× · PMID 37736359 · DOI 10.1002/ped4.12400

Verify or expand the search:

Other trials of Nemolizumab

Trials testing the same drug.

Other recruiting trials for Dermatitis, Atopic

Currently open trials in the same condition.

Other Galderma R&D trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing