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

NCT04365387 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: RD.06.SPR.118380
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 64

Brief 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).

Conditions

Dermatitis, Atopic

Keywords

Eczema; AD; Vaccine; Nemolizumab; Pruritis; Itchy

Outcome Measures

Primary Outcomes (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.

  At Week 16 (4 weeks post-vaccination)

Secondary Outcomes (5)

• 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)

  At Week 16 (4 weeks post-vaccination)

• Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 0.1 IU/mL at Week 16

  At Week 16

• Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 1.0 IU/mL at Week 16

  At Week 16

• Percentage of Participants With a Positive Serum Bactericidal Antibody (SBA) Response to Meningococcal Serogroup C (MenC) Polysaccharide at Week 16

  At Week 16

• Percentage of Participants With a Positive SBA Response (Defined as SBA Reciprocal Titer ≥8) to MenC Polysaccharide at Week 16

  At Week 16

Study Arms (2)

Nemolizumab

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Nemolizumab 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.

Nemolizumab

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 12 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (64)

Galderma Investigational Site (Site#9922)

Phoenix, Arizona, 85018, United States

Location

Galderma Investigational Site (Site#8873)

Scottsdale, Arizona, 85260, United States

Location

Galderma Investigational Site (Site#8447)

Fort Smith, Arkansas, 72916, United States

Location

Galderma Investigational Site (Site#8831)

Anaheim, California, 92801, United States

Location

Galderma Investigational Site (Site#8854)

Canoga Park, California, 91303, United States

Location

Galderma Investigational Site (Site#8578)

Cerritos, California, 90703, United States

Location

Galderma Investigational Site (Site#8791)

Fresno, California, 93720, United States

Location

Galderma Investigational Site (Site#8845)

Huntington Beach, California, 92647, United States

Location

Galderma Investigational Site (Site#8833)

Inglewood, California, 90301, United States

Location

Galderma Investigational Site 2 (Site#8833)

Inglewood, California, 90301, United States

Location

Galderma Investigational Site (Site#8858)

Long Beach, California, 90806, United States

Location

Galderma Investigational Site (Site#8130)

Los Angeles, California, 90045, United States

Location

Galderma Investigational Site (Site#8813)

Los Angeles, California, 90057, United States

Location

Galderma Investigational Site (Site#8837)

Pomona, California, 91767, United States

Location

Galderma Investigational Site (SIte#8870)

Boca Raton, Florida, 33433, United States

Location

Galderma Investigational Site (Site#8786)

Clearwater, Florida, 33765, United States

Location

Galderma Investigational Site (Site#8792)

Doral, Florida, 33122, United States

Location

Galderma Investigational Site (Site#8391)

Hialeah, Florida, 33013, United States

Location

Galderma Investigational Site (Site#8836)

Jacksonville, Florida, 32256, United States

Location

Galderma Investigational Site (Site#8850)

Margate, Florida, 33063, United States

Location

Galderma Investigational Site (Site#8851)

Miami, Florida, 33135, United States

Location

Galderma Investigational Site (Site#9921)

Miami Lakes, Florida, 33014, United States

Location

Galderma Investigational Site (Site#8840)

Ocoee, Florida, 34761, United States

Location

Galderma Investigational Site (Site#8788)

Orlando, Florida, 32801, United States

Location

Galderma Investigational Site (Site#8213)

Ormond Beach, Florida, 32174, United States

Location

Galderma Investigational Site (Site#8856)

Ormond Beach, Florida, 32174, United States

Location

Galderma Investigational Site (Site#8856)

Ormond Beach, Florida, 33174, United States

Location

Galderma Investigational Site (Site#8843)

Sweetwater, Florida, 33172, United States

Location

Galderma Investigational Site (Site#8764)

Tampa, Florida, 33613, United States

Location

Galderma Investigational Site 2 (Site#8816)

Tampa, Florida, 33613, United States

Location

Galderma Investigational Site (Site#8839)

Tampa, Florida, 33615, United States

Location

Galderma Investigational Site (Site#8739)

Normal, Illinois, 61761, United States

Location

Galderma Investigational Site (Site#8142)

Indianapolis, Indiana, 46250, United States

Location

Galderma Investigational Site (Site#8532)

Overland Park, Kansas, 66215, United States

Location

Galderma Investigational Site (Site#8812)

Metairie, Louisiana, 70005, United States

Location

Galderma Investigational Site (Site#8793)

Towson, Maryland, 21204, United States

Location

Galderma Investigational Site (Site#8033)

Clinton Township, Michigan, 48038-1137, United States

Location

Galderma Investigational Site (Site#8129)

Fort Gratiot, Michigan, 48059, United States

Location

Galderma Investigational Site (Site#8849)

Troy, Michigan, 48084, United States

Location

Galderma Investigational Site (Site#8876)

Bridgeton, Missouri, 63044, United States

Location

Galderma Investigational Site (Site#8847)

Las Vegas, Nevada, 89118, United States

Location

Galderma Investigational Site (Site#8848)

Las Vegas, Nevada, 89144, United States

Location

Galderma Investigational Site 2 (Site#8864)

Las Vegas, Nevada, 89144, United States

Location

Galderma Investigational Site (Site#8420)

Portsmouth, New Hampshire, 03801, United States

Location

Galderma Investigational Site (Site#9924)

Raritan, New Jersey, 08869, United States

Location

Galderma Investigational Site (Site#8828)

Kew Gardens, New York, 11415, United States

Location

Galderma Investigational Site (Site#9919)

Raleigh, North Carolina, 27617, United States

Location

Galderma Investigational Site (Site#8795)

Shelby, North Carolina, 28150, United States

Location

Galderma Investigational Site (Site#8857)

Oklahoma City, Oklahoma, 73118, United States

Location

Galderma Investigational Site (Site#8841)

Medford, Oregon, 97504, United States

Location

Galderma Investigational Site (Site#8428)

Philadelphia, Pennsylvania, 19104, United States

Location

Galderma Investigational Site (Site#8353)

Yardley, Pennsylvania, 19067, United States

Location

Galderma Investigational Site (Site#8777)

Charleston, South Carolina, 29407, United States

Location

Galderma Investigational Site (Site#8200)

Goodlettsville, Tennessee, 37072, United States

Location

Galderma Investigational Site (Site#8846)

Austin, Texas, 78742, United States

Location

Galderma Investigational Site (Site#8855)

Beaumont, Texas, 77702, United States

Location

Galderma Investigational Site (Site#8245)

Dallas, Texas, 75231, United States

Location

Galderma Investigational Site (Site#8868)

Houston, Texas, 77004, United States

Location

Galderma Investigational Site (Site#8817)

Katy, Texas, 77494, United States

Location

Galderma Investigational Site (Site#8787)

Plano, Texas, 75093, United States

Location

Galderma Investigational Site (Site#8329)

San Antonio, Texas, 78229-3409, United States

Location

Galderma Investigational Site (Site#8003)

Webster, Texas, 77598, United States

Location

Galderma Investigational Site (Site#8844)

Orem, Utah, 84058, United States

Location

Galderma Investigational Site (Site#9935)

Springville, Utah, 84663, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Pruritus

Interventions

nemolizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sponsor
• Organization: Galderma Research & Development, LLC

aestheticclinicaltrials@galderma.com

817 961 5000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: March 5, 2020
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: June 5, 2025
• Results First Posted: June 5, 2025

Record last verified: 2025-05

Locations

US (64)