A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab
- Registration Number
- NCT04365387
- Lead Sponsor
- Galderma R&D
- 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).
- Detailed Description
This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent subjects (≥ 12 to 54 years) with moderate-to-severe AD. Eligible subjects must have a documented history of inadequate response to topical AD medication(s). Approximately 200 subjects will be randomized 1:1 to receive either 30 mg nemolizumab (with a 60 mg loading dose) or placebo, stratified by baseline disease severity (IGA = 3, moderate; IGA = 4, severe). The study consists 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive a placebo via 2 SC injections at baseline. Placebo will then be administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12. Nemolizumab Nemolizumab Participants will receive a loading dose of nemolizumab (60 milligram \[mg\]) via 2 subcutaneous (SC) injections at baseline. Nemolizumab (30 mg) will then be administered via a single subcutaneous injection every 4 weeks (Q4W) at Weeks 4, 8, and 12.
- Primary Outcome Measures
Name Time Method Percentage of Participants with a Positive Serum Immunoglobulin G (IgG) Response to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination) 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) will be reported.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Serum Aanti-tetanus IgG Concentrations of >= 0.1 IU/mL at Week 16 Week 16 Percentage of participants with serum anti-tetanus IgG concentrations of \>= 0.1 IU/mL at Week 16 will be reported.
Percentage of Participants with Serum Aanti-tetanus IgG Concentrations of >= 1.0 IU/mL at Week 16 Week 16 Percentage of participants with serum anti-tetanus IgG concentrations of \>= 1.0 IU/mL at Week 16 will be reported.
Percentage of Participants with a Positive Serum IgG Response to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination) 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 (\>=) 2-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) will be reported.
Percentage of Participants with a Positive Serum Bactericidal Antibody (SBA) Response to Meningococcal Serogroup C Polysaccharide at Week 16 Week 16 Percentage of participants with a positive SBA response to meningococcal serogroup C polysaccharide, defined as \>= 4-fold increase in serum bactericidal assay (SBA) reciprocal titer from baseline, at Week 16 (4 weeks postvaccination) will be reported.
Percentage of Participants with a Positive SBA Response to Meningococcal Serogroup C Polysaccharide at Week 16 Week 16 Percentage of participants with a positive SBA response to meningococcal serogroup C polysaccharide, defined as SBA reciprocal titer \>= 8, at Week 16 will be reported.
Trial Locations
- Locations (61)
Galderma Investigational Site (Site#8813)
🇺🇸Los Angeles, California, United States
Galderma Investigational Site (Site#8786)
🇺🇸Clearwater, Florida, United States
Galderma Investigational Site (Site#8792)
🇺🇸Doral, Florida, United States
Galderma Investigational Site (Site#8200)
🇺🇸Goodlettsville, Tennessee, United States
Galderma Investigational Site (Site#8391)
🇺🇸Hialeah, Florida, United States
Galderma Investigational Site (Site#8868)
🇺🇸Houston, Texas, United States
Galderma Investigational Site (Site#8447)
🇺🇸Fort Smith, Arkansas, United States
Galderma Investigational Site (Site#8739)
🇺🇸Normal, Illinois, United States
Galderma Investigational Site (Site#8795)
🇺🇸Shelby, North Carolina, United States
Galderma Investigational Site (Site#8003)
🇺🇸Webster, Texas, United States
Galderma Investigational Site (Site#9922)
🇺🇸Phoenix, Arizona, United States
Galderma Investigational Site (Site#8851)
🇺🇸Miami, Florida, United States
Galderma Investigational Site (Site#8847)
🇺🇸Las Vegas, Nevada, United States
Galderma Investigational Site (Site#8329)
🇺🇸San Antonio, Texas, United States
Galderma Investigational Site (Site#8848)
🇺🇸Las Vegas, Nevada, United States
Galderma Investigational Site (Site#8764)
🇺🇸Tampa, Florida, United States
Galderma Investigational Site 2 (Site#8816)
🇺🇸Tampa, Florida, United States
Galderma Investigational Site (Site#8839)
🇺🇸Tampa, Florida, United States
Galderma Investigational Site (Site#8857)
🇺🇸Oklahoma City, Oklahoma, United States
Galderma Investigational Site (Site#8873)
🇺🇸Scottsdale, Arizona, United States
Galderma Investigational Site (Site#8831)
🇺🇸Anaheim, California, United States
Galderma Investigational Site (Site#8854)
🇺🇸Canoga Park, California, United States
Galderma Investigational Site (Site#8578)
🇺🇸Cerritos, California, United States
Galderma Investigational Site (Site#8791)
🇺🇸Fresno, California, United States
Galderma Investigational Site (Site#8845)
🇺🇸Huntington Beach, California, United States
Galderma Investigational Site 2 (Site#8833)
🇺🇸Inglewood, California, United States
Galderma Investigational Site (Site#8833)
🇺🇸Inglewood, California, United States
Galderma Investigational Site (Site#8858)
🇺🇸Long Beach, California, United States
Galderma Investigational Site (Site#8130)
🇺🇸Los Angeles, California, United States
Galderma Investigational Site (SIte#8870)
🇺🇸Boca Raton, Florida, United States
Galderma Investigational Site (Site#8837)
🇺🇸Pomona, California, United States
Galderma Investigational Site (Site#8850)
🇺🇸Margate, Florida, United States
Galderma Investigational Site (Site#8836)
🇺🇸Jacksonville, Florida, United States
Galderma Investigational Site (Site#9921)
🇺🇸Miami Lakes, Florida, United States
Galderma Investigational Site (Site#8840)
🇺🇸Ocoee, Florida, United States
Galderma Investigational Site (Site#8856)
🇺🇸Ormond Beach, Florida, United States
Galderma Investigational Site (Site#8843)
🇺🇸Sweetwater, Florida, United States
Galderma Investigational Site (Site#8142)
🇺🇸Indianapolis, Indiana, United States
Galderma Investigational Site (Site#8532)
🇺🇸Overland Park, Kansas, United States
Galderma Investigational Site (Site#8812)
🇺🇸Metairie, Louisiana, United States
Galderma Investigational Site (Site#8793)
🇺🇸Towson, Maryland, United States
Galderma Investigational Site (Site#8033)
🇺🇸Clinton Township, Michigan, United States
Galderma Investigational Site (Site#8129)
🇺🇸Fort Gratiot, Michigan, United States
Galderma Investigational Site (Site#8849)
🇺🇸Troy, Michigan, United States
Galderma Investigational Site (Site#8876)
🇺🇸Bridgeton, Missouri, United States
Galderma Investigational Site (Site#9924)
🇺🇸Raritan, New Jersey, United States
Galderma Investigational Site 2 (Site#8864)
🇺🇸Las Vegas, Nevada, United States
Galderma Investigational Site (Site#8420)
🇺🇸Portsmouth, New Hampshire, United States
Galderma Investigational Site (Site#8828)
🇺🇸Kew Gardens, New York, United States
Galderma Investigational Site (Site#8841)
🇺🇸Medford, Oregon, United States
Galderma Investigational Site (Site#8353)
🇺🇸Yardley, Pennsylvania, United States
Galderma Investigational Site (Site#9919)
🇺🇸Raleigh, North Carolina, United States
Galderma Investigational Site (Site#8855)
🇺🇸Beaumont, Texas, United States
Galderma Investigational Site (Site#8245)
🇺🇸Dallas, Texas, United States
Galderma Investigational Site (Site#8817)
🇺🇸Katy, Texas, United States
Galderma Investigational Site (Site#8787)
🇺🇸Plano, Texas, United States
Galderma Investigational Site (Site#8844)
🇺🇸Orem, Utah, United States
Galderma Investigational Site (Site#9935)
🇺🇸Springville, Utah, United States
Galderma Investigational Site (Site#8788)
🇺🇸Orlando, Florida, United States
Galderma Investigational Site (Site#8777)
🇺🇸Charleston, South Carolina, United States
Galderma Investigational Site (Site#8846)
🇺🇸Austin, Texas, United States