Clinical trial NCT04365387: A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess Immunization Responses in Adult and Adolescent Subjects With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Keywords: Eczema
AD
Vaccine
Nemolizumab
Pruritis
Itchy
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2020-04-28
Enrollment: 242
Sex: ALL
Minimum age (years): 12
Maximum age (years): 54
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: At Week 16 (4 weeks post-vaccination)
Secondary outcomes:
measure: 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)
timeFrame: At Week 16 (4 weeks post-vaccination)
measure: Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 0.1 IU/mL at Week 16
timeFrame: At Week 16
measure: Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 1.0 IU/mL at Week 16
timeFrame: At Week 16
measure: Percentage of Participants With a Positive Serum Bactericidal Antibody (SBA) Response to Meningococcal Serogroup C (MenC) Polysaccharide at Week 16
timeFrame: At Week 16
measure: Percentage of Participants With a Positive SBA Response (Defined as SBA Reciprocal Titer ≥8) to MenC Polysaccharide at Week 16
timeFrame: At Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Galderma Investigational Site (Site#9922)
state: Arizona
city: Scottsdale
country: United States
facility: Galderma Investigational Site (Site#8873)
state: Arizona
city: Fort Smith
country: United States
facility: Galderma Investigational Site (Site#8447)
state: Arkansas
city: Anaheim
country: United States
facility: Galderma Investigational Site (Site#8831)
state: California
city: Canoga Park
country: United States
facility: Galderma Investigational Site (Site#8854)
state: California
city: Cerritos
country: United States
facility: Galderma Investigational Site (Site#8578)
state: California
city: Fresno
country: United States
facility: Galderma Investigational Site (Site#8791)
state: California
city: Huntington Beach
country: United States
facility: Galderma Investigational Site (Site#8845)
state: California
city: Inglewood
country: United States
facility: Galderma Investigational Site (Site#8833)
state: California
city: Inglewood
country: United States
facility: Galderma Investigational Site 2 (Site#8833)
state: California
city: Long Beach
country: United States
facility: Galderma Investigational Site (Site#8858)
state: California
city: Los Angeles
country: United States
facility: Galderma Investigational Site (Site#8130)
state: California
city: Los Angeles
country: United States
facility: Galderma Investigational Site (Site#8813)
state: California
city: Pomona
country: United States
facility: Galderma Investigational Site (Site#8837)
state: California
city: Boca Raton
country: United States
facility: Galderma Investigational Site (SIte#8870)
state: Florida
city: Clearwater
country: United States
facility: Galderma Investigational Site (Site#8786)
state: Florida
city: Doral
country: United States
facility: Galderma Investigational Site (Site#8792)
state: Florida
city: Hialeah
country: United States
facility: Galderma Investigational Site (Site#8391)
state: Florida
city: Jacksonville
country: United States
facility: Galderma Investigational Site (Site#8836)
state: Florida
city: Margate
country: United States
facility: Galderma Investigational Site (Site#8850)
state: Florida
city: Miami Lakes
country: United States
facility: Galderma Investigational Site (Site#9921)
state: Florida
city: Miami
country: United States
facility: Galderma Investigational Site (Site#8851)
state: Florida
city: Ocoee
country: United States
facility: Galderma Investigational Site (Site#8840)
state: Florida
city: Orlando
country: United States
facility: Galderma Investigational Site (Site#8788)
state: Florida
city: Ormond Beach
country: United States
facility: Galderma Investigational Site (Site#8213)
state: Florida
city: Ormond Beach
country: United States
facility: Galderma Investigational Site (Site#8856)
state: Florida
city: Ormond Beach
country: United States
facility: Galderma Investigational Site (Site#8856)
state: Florida
city: Sweetwater
country: United States
facility: Galderma Investigational Site (Site#8843)
state: Florida
city: Tampa
country: United States
facility: Galderma Investigational Site (Site#8764)
state: Florida
city: Tampa
country: United States
facility: Galderma Investigational Site 2 (Site#8816)
state: Florida
city: Tampa
country: United States
facility: Galderma Investigational Site (Site#8839)
state: Florida
city: Normal
country: United States
facility: Galderma Investigational Site (Site#8739)
state: Illinois
city: Indianapolis
country: United States
facility: Galderma Investigational Site (Site#8142)
state: Indiana
city: Overland Park
country: United States
facility: Galderma Investigational Site (Site#8532)
state: Kansas
city: Metairie
country: United States
facility: Galderma Investigational Site (Site#8812)
state: Louisiana
city: Towson
country: United States
facility: Galderma Investigational Site (Site#8793)
state: Maryland
city: Clinton Township
country: United States
facility: Galderma Investigational Site (Site#8033)
state: Michigan
city: Fort Gratiot
country: United States
facility: Galderma Investigational Site (Site#8129)
state: Michigan
city: Troy
country: United States
facility: Galderma Investigational Site (Site#8849)
state: Michigan
city: Bridgeton
country: United States
facility: Galderma Investigational Site (Site#8876)
state: Missouri
city: Las Vegas
country: United States
facility: Galderma Investigational Site (Site#8847)
state: Nevada
city: Las Vegas
country: United States
facility: Galderma Investigational Site (Site#8848)
state: Nevada
city: Las Vegas
country: United States
facility: Galderma Investigational Site 2 (Site#8864)
state: Nevada
city: Portsmouth
country: United States
facility: Galderma Investigational Site (Site#8420)
state: New Hampshire
city: Raritan
country: United States
facility: Galderma Investigational Site (Site#9924)
state: New Jersey
city: Kew Gardens
country: United States
facility: Galderma Investigational Site (Site#8828)
state: New York
city: Raleigh
country: United States
facility: Galderma Investigational Site (Site#9919)
state: North Carolina
city: Shelby
country: United States
facility: Galderma Investigational Site (Site#8795)
state: North Carolina
city: Oklahoma City
country: United States
facility: Galderma Investigational Site (Site#8857)
state: Oklahoma
city: Medford
country: United States
facility: Galderma Investigational Site (Site#8841)
state: Oregon
city: Philadelphia
country: United States
facility: Galderma Investigational Site (Site#8428)
state: Pennsylvania
city: Yardley
country: United States
facility: Galderma Investigational Site (Site#8353)
state: Pennsylvania
city: Charleston
country: United States
facility: Galderma Investigational Site (Site#8777)
state: South Carolina
city: Goodlettsville
country: United States
facility: Galderma Investigational Site (Site#8200)
state: Tennessee
city: Austin
country: United States
facility: Galderma Investigational Site (Site#8846)
state: Texas
city: Beaumont
country: United States
facility: Galderma Investigational Site (Site#8855)
state: Texas
city: Dallas
country: United States
facility: Galderma Investigational Site (Site#8245)
state: Texas
city: Houston
country: United States
facility: Galderma Investigational Site (Site#8868)
state: Texas
city: Katy
country: United States
facility: Galderma Investigational Site (Site#8817)
state: Texas
city: Plano
country: United States
facility: Galderma Investigational Site (Site#8787)
state: Texas
city: San Antonio
country: United States
facility: Galderma Investigational Site (Site#8329)
state: Texas
city: Webster
country: United States
facility: Galderma Investigational Site (Site#8003)
state: Texas
city: Orem
country: United States
facility: Galderma Investigational Site (Site#8844)
state: Utah
city: Springville
country: United States
facility: Galderma Investigational Site (Site#9935)
state: Utah
Study officials:
References: