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

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: Nemolizumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nemolizumab<br>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. | Drug: Nemolizumab<br>* Nemolizumab will be administered by 2 SC injections as 60-mg loading dose at baseline and a single 30-mg dose at Weeks 4, 8, and 12.<br>|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* Placebo will be administered by 2 SC injections at baseline and a single dose at Weeks 4, 8, and 12.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with a Positive Serum Immunoglobulin G (IgG) Response 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) will be reported. | Week 16 (4 weeks post-vaccination) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with a Positive Serum IgG Response 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 (>=) 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. | Week 16 (4 weeks post-vaccination) | 
| Percentage of Participants with Serum Aanti-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 will be reported. | Week 16 | 
| Percentage of Participants with Serum Aanti-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 will be reported. | Week 16 | 
| Percentage of Participants with a Positive Serum Bactericidal Antibody (SBA) Response to Meningococcal Serogroup C Polysaccharide at 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. | Week 16 | 
| Percentage of Participants with a Positive SBA Response to Meningococcal Serogroup C Polysaccharide at 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. | Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eczema, AD, Vaccine, Nemolizumab, Pruritis, Itchy