Clinical trial NCT03100344: Dose-ranging Study of Nemolizumab in Atopic Dermatitis
Official title: Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Dose-ranging Study to Assess the Efficacy and Safety of Nemolizumab in Moderate-to-severe Atopic Dermatitis Subjects With Severe Pruritus Receiving Topical Corticosteroids (TCS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments.

Detailed description: The aim of the study is to assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving topical corticosteroids, who were not adequately controlled with topical treatments.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects ≥ 18 years (or legal age when higher)
* Chronic AD, that has been present for at least 2 years before the visit
* Eczema Area and Severity Index (EASI) score ≥12
* Investigator Global Assessment (IGA) score ≥ 3
* AD involvement ≥ 10% of Body Surface Area (BSA)
* Severe pruritus on at least 3 of the last 7 days before the visit
* Documented recent history (within 6 months before the visit) of inadequate response to topical medications
* Female subjects must fulfill one of the criteria below:

  * Female subjects of non-childbearing potential
  * Female subjects of childbearing potential who agree to a true abstinence or to use an effective or highly effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration

Exclusion Criteria:

* Body weight \< 45 kg
* subjects with a medical history of asthma requiring hospitalization in the last 12 months before screening visit and/or whose asthma has not been well-controlled during the last 3 months before the screening visit and/or Peak Expiratory Flow (PEF) \<80% of the predicted value
* Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period
* Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit or during the run-in period
* History of intolerance to low or mid potency TCS or for whom TCS is not advisable

Primary outcomes:
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24
timeFrame: From Baseline to Week 24
Secondary outcomes:
measure: Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24
timeFrame: Week 24
measure: Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24
timeFrame: From Week 1 to Week 24
measure: Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
timeFrame: Baseline, Week 24
measure: Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
timeFrame: Baseline, Week 24
measure: Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
timeFrame: Baseline, Week 24
measure: Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
timeFrame: Baseline, Week 24
measure: Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24
timeFrame: From Week 1 to Week 24
measure: Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
timeFrame: From Week 1 to Week 24
measure: Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
timeFrame: From Week 1 to Week 24
measure: Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
timeFrame: From Week 1 to Week 24
measure: Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24
timeFrame: Week 1 to Week 24
measure: Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24
timeFrame: From Baseline to Week 24
measure: Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
timeFrame: At baseline and Week 24
measure: Number of Participants With Adverse Events
timeFrame: From screening to Follow-up visit (Week 32)/Early termination visit
measure: Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
timeFrame: Baseline to Week 24
measure: Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
timeFrame: Baseline to Week 24
measure: Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Galderma Investigational site
state: Alabama
city: Fort Smith
country: United States
facility: Galderma Investigational site
state: Arkansas
city: Beverly Hills
country: United States
facility: Galderma Investigational site
state: California
city: Fountain Valley
country: United States
facility: Galderma Investigational site
state: California
city: Fremont
country: United States
facility: Galderma Investigational site
state: California
city: Rolling Hills Estates
country: United States
facility: Galderma Investigational site
state: California
city: Santa Ana
country: United States
facility: Galderma Investigational site
state: California
city: Santa Monica
country: United States
facility: Galderma Investigational site
state: California
city: Miami
country: United States
facility: Galderma Investigational site
state: Florida
city: Tampa
country: United States
facility: Galderma Investigational site
state: Florida
city: Tampa
country: United States
facility: Galderma Investigational Site
state: Florida
city: Columbus
country: United States
facility: Galderma Investigational site
state: Georgia
city: Sandy Springs
country: United States
facility: Galderma Investigational site
state: Georgia
city: Darien
country: United States
facility: Galderma Investigational Site
state: Illinois
city: Overland Park
country: United States
facility: Galderma Investigational Site
state: Kansas
city: New Orleans
country: United States
facility: Galderma Investigational site
state: Louisiana
city: Farmington Hills
country: United States
facility: Galderma Investigational Site
state: Michigan
city: Forest Hills
country: United States
facility: Galderma Investigational site
state: New York
city: New York
country: United States
facility: Galderma Investigational site
state: New York
city: New York
country: United States
facility: Galderma Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Galderma Investigational site
state: North Carolina
city: Johnston
country: United States
facility: Galderma Investigational Site
state: Rhode Island
city: Dallas
country: United States
facility: Galderma Investigational site
state: Texas
city: San Antonio
country: United States
facility: Galderma Investigational site
state: Texas
city: Waco
country: United States
facility: Galderma Investigational Site
state: Texas
city: Richmond
country: United States
facility: Galderma Investigational site
state: Virginia
city: Benowa
country: Australia
facility: Galderma Investigational Site
city: Kogarah
country: Australia
facility: Galderma Investigational Site
city: Melbourne
country: Australia
facility: Galderma Investigational Site
city: Phillip
country: Australia
facility: Galderma Investigational Site
city: Calgary
country: Canada
facility: Galderma Investigational Site
city: Markham
country: Canada
facility: Galderma Investigational Site
city: Oakville
country: Canada
facility: Galderma Investigational Site
city: Ottawa
country: Canada
facility: Galderma Investigational Site
city: Ottawa
country: Canada
facility: Galderma Investigational Site
city: Peterborough
country: Canada
facility: Galderma Investigational Site
city: Richmond Hill
country: Canada
facility: Galderma Investigational Site
city: Sainte-Foy
country: Canada
facility: Galderma Investigational Site
city: Waterloo
country: Canada
facility: Galderma Investigational Site
city: Bordeaux
country: France
facility: Galderma Investigational Site
city: Lille
country: France
facility: Galderma Investigational Site
city: Marseille
country: France
facility: Galderma Investigational Site
city: Nice
country: France
facility: Galderma Investigational Site
city: Paris
country: France
facility: Galderma Investigational Site
city: Toulouse
country: France
facility: Galderma Investigational Site
city: Berlin
country: Germany
facility: Galderma Investigational Site
city: Berlin
country: Germany
facility: Galderma Investigational Site
city: Darmstadt
country: Germany
facility: Galderma Investigational Site
city: Erlangen
country: Germany
facility: Galderma Investigational Site
city: Frankfurt
country: Germany
facility: Galderma Investigational Site
city: Hamburg
country: Germany
facility: Galderma Investigational Site
city: Hannöver
country: Germany
facility: Galderma Investigational Site
city: Heidelberg
country: Germany
facility: Galderma Investigational Site
city: Langenau
country: Germany
facility: Galderma Investigational Site
city: Mainz
country: Germany
facility: Galderma Investigational Site
city: München
country: Germany
facility: Galderma Investigational Site
city: Osnabrück
country: Germany
facility: Galderma Investigational Site
city: Stuttgart
country: Germany
facility: Galderma Investigational Site
city: Katowice
country: Poland
facility: Galderma Investigational Site
city: Katowice
country: Poland
facility: Galderma Investigational Site
city: Kraków
country: Poland
facility: Galderma Investigational Site
city: Lublin
country: Poland
facility: Galderma Investigational Site
city: Warsaw
country: Poland
facility: Galderma Investigational Site
city: Warsaw
country: Poland
facility: Galderma Investigational Site
city: Warsaw
country: Poland
facility: Galderma Investigational Site
city: Wrocław
country: Poland
facility: Galderma Investigational Site
city: Łódź
country: Poland
facility: Galderma Investigational Site
Study officials:
References:
citation: Silverberg JI, Pinter A, Pulka G, Poulin Y, Bouaziz JD, Wollenberg A, Murrell DF, Alexis A, Lindsey L, Ahmad F, Piketty C, Clucas A. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020 Jan;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013. Epub 2019 Aug 23.