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 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
- 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 Nemolizumab 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. Placebo 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.
- Primary Outcome Measures
Name Time Method 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) 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.
- Secondary Outcome Measures
Name Time Method 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 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.
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 \>= 0.1 IU/mL at Week 16 were reported. The detection and characterization of antibodies to tetanus toxoid was performed using a validated immunoassay.
Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 1.0 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 were reported. The detection and characterization of antibodies to tetanus toxoid was performed using a validated immunoassay.
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 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.
Percentage of Participants With a Positive SBA Response (Defined as SBA Reciprocal Titer ≥8) to MenC Polysaccharide at Week 16 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.
Trial Locations
- Locations (63)
Galderma Investigational Site (Site#8213)
🇺🇸Ormond Beach, Florida, United States
Galderma Investigational Site (Site#8428)
🇺🇸Philadelphia, Pennsylvania, United States
Galderma Investigational Site (Site#9922)
🇺🇸Phoenix, Arizona, United States
Galderma Investigational Site (Site#8873)
🇺🇸Scottsdale, Arizona, United States
Galderma Investigational Site (Site#8447)
🇺🇸Fort Smith, Arkansas, 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
Scroll for more (53 remaining)Galderma Investigational Site (Site#8213)🇺🇸Ormond Beach, Florida, United States