Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
Purpose
Safety and efficacy of nemolizumab in subjects with moderate-to-severe atopic dermatitis
Condition
- Moderate-to-Severe Atopic Dermatitis
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Arm | Description | Assigned Intervention |
---|---|---|
Placebo Comparator Placebo |
Placebo |
|
Experimental Nemolizumab |
Nemolizumab Active |
|
Recruiting Locations
Galderma Investigational Site
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Galderma Investigational Site
Beverly Hills, California 90212
Beverly Hills, California 90212
Contact:
310-273-6558
310-273-6558
Galderma Investigational Site
Fountain Valley, California 92708
Fountain Valley, California 92708
Contact:
714-531-2966
714-531-2966
Galderma Investigational Site
Lomita, California 90717
Lomita, California 90717
Contact:
310-373-8120
310-373-8120
Galderma Investigational Site
Los Angeles, California 90025
Los Angeles, California 90025
Contact:
310-966-9022
310-966-9022
Galderma Investigational Site
San Diego, California 92108
San Diego, California 92108
Contact:
619-521-2830
619-521-2830
Galderma Investigational Site
San Francisco, California 94115
San Francisco, California 94115
Contact:
415-353-9684
415-353-9684
Galderma Investigational Site
Santa Monica, California 90404
Santa Monica, California 90404
Contact:
310-828-8887
310-828-8887
Galderma Investigational Site
Cape Coral, Florida 33991
Cape Coral, Florida 33991
Contact:
239-800-3028
239-800-3028
Galderma Investigational Site
Hialeah, Florida 33012
Hialeah, Florida 33012
Contact:
305-821-6112
305-821-6112
Galderma Investigational Site
Hialeah, Florida 33016
Hialeah, Florida 33016
Galderma Investigational Site
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Contact:
904-619-8157
904-619-8157
Galderma Investigational Site
Miami Lakes, Florida 33014
Miami Lakes, Florida 33014
Contact:
305-424-7420
305-424-7420
Galderma Investigational Site
Miami Lakes, Florida 33016
Miami Lakes, Florida 33016
Contact:
786-483-7856
786-483-7856
New Investigational Site
Miami, Florida 33125
Miami, Florida 33125
Galderma Investigational Site
Miami, Florida 33126
Miami, Florida 33126
Contact:
3054000814
3054000814
Galderma Investigational Site
Miami, Florida 33145
Miami, Florida 33145
Contact:
786-391-1137
786-391-1137
Galderma Investigational Site
Miami, Florida 33174
Miami, Florida 33174
Contact:
786-536-9009
786-536-9009
Galderma Investigational Site
Miami, Florida 33176
Miami, Florida 33176
Contact:
786-636-6695
786-636-6695
Galderma Investigational Site
Pembroke Pines, Florida 33028
Pembroke Pines, Florida 33028
Contact:
954-435-5100
954-435-5100
Galderma Investigational Site
Macon, Georgia 31217
Macon, Georgia 31217
Contact:
478-742-2180
478-742-2180
Galderma Invesitigational Site
Newnan, Georgia 30263
Newnan, Georgia 30263
Contact:
770-252-6900
770-252-6900
Galderma Investigational Site
Nampa, Idaho 83687
Nampa, Idaho 83687
Contact:
208-906-1600
208-906-1600
Galderma Investigational Site
Skokie, Illinois 60076
Skokie, Illinois 60076
Contact:
630-920-1900
630-920-1900
Galderma Investigational Site
Skokie, Illinois 60077
Skokie, Illinois 60077
Galderma Investigational Site
Indianapolis, Indiana 46250
Indianapolis, Indiana 46250
Contact:
317-516-5030
317-516-5030
Galderma Investigational Site
Louisville, Kentucky 40241
Louisville, Kentucky 40241
Contact:
502-585-9059
502-585-9059
Galderma Investigational Site
Bay City, Michigan 48706
Bay City, Michigan 48706
Contact:
989-895-9100
989-895-9100
Galderma Investigational Site
Troy, Michigan 48084
Troy, Michigan 48084
Contact:
248-244-8448
248-244-8448
Galderma Investigational Site
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Contact:
734-528-0477
734-528-0477
Galderma Investigational Site
Saint Joseph, Missouri 64506
Saint Joseph, Missouri 64506
Contact:
816-364-1515
816-364-1515
Galderma Investigational Site
Missoula, Montana 59808
Missoula, Montana 59808
Contact:
406-549-1124
406-549-1124
Galderma Investigational Site
Omaha, Nebraska 68144
Omaha, Nebraska 68144
Contact:
402-932-0353
402-932-0353
Galderma Investigational Site
Henderson, Nevada 89052
Henderson, Nevada 89052
Galderma Investigational Site
Lebanon, New Hampshire 003766
Lebanon, New Hampshire 003766
Contact:
603-650-3104
603-650-3104
Galderma Investigational Site
Albuquerque, New Mexico 87106
Albuquerque, New Mexico 87106
Contact:
505-855-5505
505-855-5505
Galderma Investigational Site
Brooklyn, New York 11203
Brooklyn, New York 11203
Contact:
718-270-1229
718-270-1229
Galderma Investigational Site
New York, New York 10023
New York, New York 10023
Contact:
212-523-3812
212-523-3812
Galderma Investigational Site
New York, New York 10075
New York, New York 10075
Contact:
212-772-7242
212-772-7242
Galderma Investigational Site
Durham, North Carolina 27710
Durham, North Carolina 27710
Contact:
919-684-1830
919-684-1830
Galderma Investigational Site
Wilmington, North Carolina 28405-3176
Wilmington, North Carolina 28405-3176
Contact:
910-833-1954
910-833-1954
Galderma Investigational Site
Wilmington, North Carolina 28405
Wilmington, North Carolina 28405
Contact:
910-256-4350
910-256-4350
Galderma Investigational Site
Bexley, Ohio 43209
Bexley, Ohio 43209
Contact:
614-725-5010
614-725-5010
Galderma Investigational Site
Dublin, Ohio 43016
Dublin, Ohio 43016
Contact:
614-336-7880
614-336-7880
Galderma Investigaitonal Site
Norman, Oklahoma 73071
Norman, Oklahoma 73071
Contact:
405-329-0474
405-329-0474
Galderma Investigational Site
Philadelphia, Pennsylvania 19103
Philadelphia, Pennsylvania 19103
Contact:
215-563-7330
215-563-7330
Galderma Investigational Site
Plymouth Meeting, Pennsylvania 19103
Plymouth Meeting, Pennsylvania 19103
Galderma Investigational Site
Plymouth Meeting, Pennsylvania 19462
Plymouth Meeting, Pennsylvania 19462
Galderma Investigational Site
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Contact:
843-792-9784
843-792-9784
Galderma Investigational Site
Rapid City, South Dakota 57702
Rapid City, South Dakota 57702
Contact:
605-348-4141
605-348-4141
Galderma Investigational Site
Arlington, Texas 76011
Arlington, Texas 76011
Contact:
817-795-7546
817-795-7546
Galderma Investigational Site
Austin, Texas 78723
Austin, Texas 78723
Contact:
512-628-1920
512-628-1920
Galderma Investigational Site
Dallas, Texas 75230
Dallas, Texas 75230
Contact:
972-661-2729
972-661-2729
Galderma Investigational Site
Dripping Springs, Texas 78620
Dripping Springs, Texas 78620
Contact:
512-714-3795
512-714-3795
Galderma Investigational Site
Frisco, Texas 75034
Frisco, Texas 75034
Contact:
972-704-2400
972-704-2400
Galderma Investigational Site
Houston, Texas 77056
Houston, Texas 77056
Contact:
713-985-0210
713-985-0210
Galderma Investigational Site
Houston, Texas 77401
Houston, Texas 77401
Contact:
713-669-9222
713-669-9222
Galderma Investigational Site
Burke, Virginia 22015
Burke, Virginia 22015
Contact:
703-426-0800
703-426-0800
Galderma Investigational Site #3
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Contact:
703-641-9666
703-641-9666
More Details
- NCT ID
- NCT03985943
- Status
- Recruiting
- Sponsor
- Galderma R&D
Detailed Description
Assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe AD