Purpose

Safety and efficacy of nemolizumab in subjects with moderate-to-severe atopic dermatitis

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Male or female subjects aged ≥ 12 years at the screening visit Note: Enrollment of subjects aged 12 to 17 years will begin after an IDMC has assessed interim safety data from the phase 2 study (Protocol 116912) and provided recommendations to the sponsor, who will then determine the eligibility of this age group for enrollment in the study. 2. Chronic AD that has been documented for at least 2 years 3. EASI score ≥ 16 4. IGA score ≥ 3 5. AD involvement ≥ 10% of BSA 6. Documented recent history of inadequate response to topical medications (TCS with or without TCI). 7. Female subjects of childbearing potential must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Exclusion Criteria

  1. Body weight < 30 kg. 2. Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study 3. Cutaneous infection within 1 week or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week 4. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) 5. Any clinically significant issue, based investigator judgement

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Treatment

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo
Placebo
  • Drug: Placebo
    Placebo
Experimental
Nemolizumab
Nemolizumab Active
  • Drug: Nemolizumab
    Nemolizumab
    Other names:
    • CD14152

Recruiting Locations

Galderma Investigational Site
Little Rock, Arkansas 72205

Galderma Investigational Site
Beverly Hills, California 90212
Contact:
310-273-6558

Galderma Investigational Site
Fountain Valley, California 92708
Contact:
714-531-2966

Galderma Investigational Site
Lomita, California 90717
Contact:
310-373-8120

Galderma Investigational Site
Los Angeles, California 90025
Contact:
310-966-9022

Galderma Investigational Site
San Diego, California 92108
Contact:
619-521-2830

Galderma Investigational Site
San Francisco, California 94115
Contact:
415-353-9684

Galderma Investigational Site
Santa Monica, California 90404
Contact:
310-828-8887

Galderma Investigational Site
Cape Coral, Florida 33991
Contact:
239-800-3028

Galderma Investigational Site
Hialeah, Florida 33012
Contact:
305-821-6112

Galderma Investigational Site
Hialeah, Florida 33016

Galderma Investigational Site
Jacksonville, Florida 32256
Contact:
904-619-8157

Galderma Investigational Site
Miami Lakes, Florida 33014
Contact:
305-424-7420

Galderma Investigational Site
Miami Lakes, Florida 33016
Contact:
786-483-7856

New Investigational Site
Miami, Florida 33125

Galderma Investigational Site
Miami, Florida 33126
Contact:
3054000814

Galderma Investigational Site
Miami, Florida 33145
Contact:
786-391-1137

Galderma Investigational Site
Miami, Florida 33174
Contact:
786-536-9009

Galderma Investigational Site
Miami, Florida 33176
Contact:
786-636-6695

Galderma Investigational Site
Pembroke Pines, Florida 33028
Contact:
954-435-5100

Galderma Investigational Site
Macon, Georgia 31217
Contact:
478-742-2180

Galderma Invesitigational Site
Newnan, Georgia 30263
Contact:
770-252-6900

Galderma Investigational Site
Nampa, Idaho 83687
Contact:
208-906-1600

Galderma Investigational Site
Skokie, Illinois 60076
Contact:
630-920-1900

Galderma Investigational Site
Skokie, Illinois 60077

Galderma Investigational Site
Indianapolis, Indiana 46250
Contact:
317-516-5030

Galderma Investigational Site
Louisville, Kentucky 40241
Contact:
502-585-9059

Galderma Investigational Site
Bay City, Michigan 48706
Contact:
989-895-9100

Galderma Investigational Site
Troy, Michigan 48084
Contact:
248-244-8448

Galderma Investigational Site
Ypsilanti, Michigan 48197
Contact:
734-528-0477

Galderma Investigational Site
Saint Joseph, Missouri 64506
Contact:
816-364-1515

Galderma Investigational Site
Missoula, Montana 59808
Contact:
406-549-1124

Galderma Investigational Site
Omaha, Nebraska 68144
Contact:
402-932-0353

Galderma Investigational Site
Henderson, Nevada 89052

Galderma Investigational Site
Lebanon, New Hampshire 003766
Contact:
603-650-3104

Galderma Investigational Site
Albuquerque, New Mexico 87106
Contact:
505-855-5505

Galderma Investigational Site
Brooklyn, New York 11203
Contact:
718-270-1229

Galderma Investigational Site
New York, New York 10023
Contact:
212-523-3812

Galderma Investigational Site
New York, New York 10075
Contact:
212-772-7242

Galderma Investigational Site
Durham, North Carolina 27710
Contact:
919-684-1830

Galderma Investigational Site
Wilmington, North Carolina 28405-3176
Contact:
910-833-1954

Galderma Investigational Site
Wilmington, North Carolina 28405
Contact:
910-256-4350

Galderma Investigational Site
Bexley, Ohio 43209
Contact:
614-725-5010

Galderma Investigational Site
Dublin, Ohio 43016
Contact:
614-336-7880

Galderma Investigaitonal Site
Norman, Oklahoma 73071
Contact:
405-329-0474

Galderma Investigational Site
Philadelphia, Pennsylvania 19103
Contact:
215-563-7330

Galderma Investigational Site
Plymouth Meeting, Pennsylvania 19103

Galderma Investigational Site
Plymouth Meeting, Pennsylvania 19462

Galderma Investigational Site
Charleston, South Carolina 29425
Contact:
843-792-9784

Galderma Investigational Site
Rapid City, South Dakota 57702
Contact:
605-348-4141

Galderma Investigational Site
Arlington, Texas 76011
Contact:
817-795-7546

Galderma Investigational Site
Austin, Texas 78723
Contact:
512-628-1920

Galderma Investigational Site
Dallas, Texas 75230
Contact:
972-661-2729

Galderma Investigational Site
Dripping Springs, Texas 78620
Contact:
512-714-3795

Galderma Investigational Site
Frisco, Texas 75034
Contact:
972-704-2400

Galderma Investigational Site
Houston, Texas 77056
Contact:
713-985-0210

Galderma Investigational Site
Houston, Texas 77401
Contact:
713-669-9222

Galderma Investigational Site
Burke, Virginia 22015
Contact:
703-426-0800

Galderma Investigational Site #3
Fairfax, Virginia 22031
Contact:
703-641-9666

More Details

NCT ID
NCT03985943
Status
Recruiting
Sponsor
Galderma R&D

Study Contact

Galderma Research & Development
817-961-5000
clinical.studies@galderma.com

Detailed Description

Assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe AD

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.