A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Galderma R&D
Study ID
NCT04204616
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Prurigo Nodularis

Eligibility Criteria

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

Interventions

  • Nemolizumab — DRUG
    Nemolizumab 30 mg will be administered as subcutaneous (SC) injection.

Study Details

The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN).

Key Dates

Start date
Jan 11, 2021
Status verified
Nov 2025
Primary completion
Oct 26, 2026
Completion
Oct 26, 2026

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nemolizumab
    Participants weighing less than (\<) 90kilogram (kg) will receive 30 milligram (mg) nemolizumab every 4 weeks (Q4W) and participants weighing greater than or equal to (\>=) 90 kg will receive 60 mg nemolizumab (two 30-mg injections) Q4W.

Primary Outcome Measure

Incidence of Adverse Events (AEs) by Severity [ Time Frame: Up to 192 weeks ]

Locations (57)

FacilityCityStateZIPSite coordinators
Galderma Investigational SiteBirminghamAlabama35233-
Galderma Investigational SiteBirminghamAlabama35244-
Galderma Investigational SiteFountain ValleyCalifornia92708-
Galderma Investigational SiteLos AngelesCalifornia90045-
Galderma Investigational SiteSan DiegoCalifornia92123-
Galderma Investigational SiteSan DiegoCalifornia92130-
Galderma Investigational SiteSanta MonicaCalifornia94404-
Galderma Investigational SiteWashington D.C.District of Columbia20037-
Galderma Investigational SiteAventuraFlorida33180-
Galderma Investigational SiteDelray BeachFlorida33484-
Galderma Investigational SiteHollywoodFlorida33021-
Galderma Investigational SiteLargoFlorida33770-
Galderma Investigational SiteMiamiFlorida33125-
Galderma Investigational SiteMiamiFlorida33136-
Galderma Investigational SiteNorth Miami BeachFlorida33162-
Galderma Investigational SiteOrmond BeachFlorida32174-
Galderma Investigational SitePembroke PinesFlorida33028-
Galderma Investigational SiteTampaFlorida33607-
Galderma Investigational Galderma Investigational SiteColumbusGeorgia31904-
Galderma Investigational SiteMaconGeorgia31217-
Galderma Investigational SiteNewnanGeorgia30263-
Galderma Investigational Galderma Investigational SiteChicagoIllinois60613-
Galderma Investigational SiteChicagoIllinois60602-
Galderma I Galderma Investigational SiteLake BluffIllinois60044-
Galderma Investigational SiteIndianapolisIndiana46250-
Galderma Investigational SiteTopekaKansas66614-
Galderma Investigational SiteLouisvilleKentucky40241-
Galderma Investigational SiteBaltimoreMaryland21231-
Galderma Investigational SiteBostonMassachusetts02111-
Galderma Investigational SiteAnn ArborMichigan48109-
Galderma Investigational SiteSaint JosephMichigan49085-
Galderma Investigational SiteSaint JosephMissouri64506-
Galderma Investigational SiteSt LouisMissouri63110-
Galderma Investigational SiteHendersonNevada89052-
Galderma Investigational Galderma Investigational SiteNew YorkNew York10065-
Galderma Investigational SiteNew YorkNew York10021-
Galderma Investigational SiteHigh PointNorth Carolina27262-
Galderma Investigational SiteRaleighNorth Carolina27617-
Galderma Investigational SiteWinston-SalemNorth Carolina27104-
Galderma Investigational SiteCincinnatiOhio45627-
Galderma Investigational SiteClevelandOhio44106-
Galderma Investigational SiteDublinOhio43016-
Galderma Investigational SitePhiladelphiaPennsylvania19103-
Galderma Investigational SiteAndersonSouth Carolina29621-
Galderma Investigational SiteKnoxvilleTennessee37909-
Galderma Investigational SiteMurfreesboroTennessee37130-
Galderma Investigational Galderma Investigational SiteAustinTexas78738-
Galderma Investigational SiteDallasTexas75230-
Galderma Investigational SiteDripping SpringsTexas78620-
Galderma Investigational SiteHoustonTexas77401-
Galderma Investigational SitePflugervilleTexas78660-
Galderma Investigational SiteWebsterTexas77004-
Galderma Investigational SiteSalt Lake CityUtah84117-
Galderma Investigational Galderma Investigational SiteSpringvilleUtah84663-
Galderma Investigational SiteFairfaxVirginia22031-
Galderma Investigational SiteLynchburgVirginia24501-
Galderma Investigational SiteMorgantownWest Virginia26505-

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By research site
Galderma Investigational Site· Birmingham, ALGalderma Investigational Site· Fountain Valley, CAGalderma Investigational Site· Los Angeles, CAGalderma Investigational Site· San Diego, CAGalderma Investigational Site· Santa Monica, CAGalderma Investigational Site· Washington D.C., DC

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