Dose-ranging Study of Nemolizumab in Atopic Dermatitis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Galderma R&D
Study ID
NCT03100344
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nemolizumab — DRUG
    Injection every 4 weeks during 24 weeks (last injection at week 20)
  • Placebo — DRUG
    Injection every 4 weeks during 24 weeks (last injection at week 20)

Study Details

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.

Key Dates

Start date
Jun 14, 2017
Status verified
Oct 2019
Primary completion
Jul 19, 2018
Completion
Sep 21, 2018

Study Design

Enrollment
226 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Nemolizumab (low dose)
  • Experimental: Group 2
    Nemolizumab (medium dose)
  • Experimental: Group 3
    Nemolizumab (high dose)
  • Placebo Comparator: Group 4
    Nemolizumab placebo

Primary Outcome Measure

Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24 [ Time Frame: From Baseline to Week 24 ]

Locations (26)

FacilityCityStateZIPSite coordinators
Galderma Investigational siteBirminghamAlabama35209-
Galderma Investigational siteFort SmithArkansas72916-
Galderma Investigational siteBeverly HillsCalifornia90212-
Galderma Investigational siteFountain ValleyCalifornia92708-
Galderma Investigational siteFremontCalifornia94538-
Galderma Investigational siteRolling Hills EstatesCalifornia90274-
Galderma Investigational siteSanta AnaCalifornia92701-
Galderma Investigational siteSanta MonicaCalifornia90404-
Galderma Investigational siteMiamiFlorida33135-
Galderma Investigational siteTampaFlorida33607-
Galderma Investigational SiteTampaFlorida33624-
Galderma Investigational siteColumbusGeorgia31904-
Galderma Investigational siteSandy SpringsGeorgia30328-
Galderma Investigational SiteDarienIllinois60561-
Galderma Investigational SiteOverland ParkKansas66215-
Galderma Investigational siteNew OrleansLouisiana70115-
Galderma Investigational SiteFarmington HillsMichigan78334-
Galderma Investigational siteForest HillsNew York11375-
Galderma Investigational siteNew YorkNew York10025-
Galderma Investigational SiteNew YorkNew York10075-
Galderma Investigational siteChapel HillNorth Carolina27516-
Galderma Investigational SiteJohnstonRhode Island02919-
Galderma Investigational siteDallasTexas75230-
Galderma Investigational siteSan AntonioTexas78218-
Galderma Investigational SiteWacoTexas76710-
Galderma Investigational siteRichmondVirginia23220-

Find similar trials in Birmingham, AL

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Galderma Investigational site· Birmingham, ALGalderma Investigational site· Fort Smith, ARGalderma Investigational site· Beverly Hills, CAGalderma Investigational site· Fountain Valley, CAGalderma Investigational site· Fremont, CAGalderma Investigational site· Rolling Hills Estates, CA

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