Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

August 9, 2024 updated by: Galderma R&D

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

The main purpose of the study was to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.

Study Overview

Status

Completed

Conditions

Moderate-to-Severe Atopic Dermatitis

Intervention / Treatment

Detailed Description

This was a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent subjects of age 12 years and above with moderate-to-severe AD. Eligible subjects had a documented history of inadequate response to topical AD medication(s). Approximately 750 subjects were randomized in 2:1 to receive either nemolizumab or placebo, stratified by baseline disease severity (Investigator's Global Assessment (IGA) = 3, moderate; IGA = 4, severe) and peak pruritus numeric rating scale (PP NRS) severity (PP NRS >= 7; PP NRS < 7). A minimum of 250 subjects were randomized in each PP NRS strata. All nemolizumab-treated subjects who were clinical responders at Week 16 (i.e., the end of initial treatment [Initial Treatment Period]/beginning of Maintenance Period) were re-randomized (1:1:1) to different treatment regimens (nemolizumab injections Q4W or every 8 weeks (Q8W) [with placebo injections at Weeks 20, 28, 36, and 44 to maintain the blind] or placebo Q4W). A clinical responder was defined as a subject at Week 16 with an IGA of 0 (clear) or 1 (almost clear) or a >= 75% improvement in EASI from baseline (EASI-75). All placebo-treated subjects who responded to placebo during the Initial Treatment Period continued to receive placebo Q4W in the Maintenance Period.

Study Type

Interventional

Enrollment (Actual)

941

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Darlinghurst, New South Wales, Australia, 2010
    - Galderma Investigational Site 5441
  - Kogarah, New South Wales, Australia, 2217
    - Galderma Investigational Site 5759
  - Westmead, New South Wales, Australia, 2145
    - Galderma Investigational Site 6152
- Queensland
  - Benowa, Queensland, Australia, 4217
    - Galderma Investigational Site 5638
  - Brisbane, Queensland, Australia, 4102
    - Galderma Investigational Site 6161
- South Australia
  - Woodville, South Australia, Australia, 5011
    - Galderma Investigational Site 6159
- Victoria
  - Carlton, Victoria, Australia, 3053
    - Galderma Investigational Site 6131
  - East Melbourne, Victoria, Australia, 3002
    - Galderma Investigational Site 5366
  - Parkville, Victoria, Australia, 3050
    - Galderma Investigational Site 5458
- Western Australia
  - Fremantle, Western Australia, Australia, 6160
    - Galderma Investigational Site 5453
  - Victoria Park, Western Australia, Australia, 6100
    - Galderma Investigational Site 6153
Austria
- - Vienna, Austria, 1220
    - Galderma Investigational Site 6158
- Styria
  - Graz, Styria, Austria, 8036
    - Galderma Investigational Sites 6157
- Wien
  - Vienna, Wien, Austria, 1090
    - Galderma Investigational Site 6194
Canada
- - Niagara Falls, Canada, L2H 1H5
    - Galderma Investigational Site 8780
  - Ottawa, Canada, K1G 6C6
    - Galderma Investigational Site 8610
  - Saint John, Canada, A1C2H5
    - Galderma Investigational Site 8000
  - Waterloo, Canada, N2J 1C4
    - Galderma Investigational Site 8731
- Alberta
  - Calgary, Alberta, Canada, T2G 1B1
    - Galderma Investigational Site 8085
  - Calgary, Alberta, Canada, T2J 7E1
    - Galderma Investigational Site 8903
  - Calgary, Alberta, Canada, T3E 0B2
    - Galderma Investigational Site 8215
  - Edmonton, Alberta, Canada, T6G 1C3
    - Galderma Investigational Site 8824
  - Edmonton, Alberta, Canada, T6G 1C9
    - Galderma Investigational Site 8722
  - Edmonton, Alberta, Canada, T5J 3S9
    - Galderma Investigational Site 8088
- British Columbia
  - Surrey, British Columbia, Canada, V3V 0C6
    - Galderma Investigational Site 8161
- Ontario
  - Barrie, Ontario, Canada, L4M 7G1
    - Galderma Investigational Site 8586
  - Guelph, Ontario, Canada, N1L 0B7
    - Galderma Investigational Site 8904
  - Ottawa, Ontario, Canada, K1H7X3
    - Galderma Investigational Site 8901
  - Toronto, Ontario, Canada, M3H 5Y8
    - Galderma Investigational Site 8336
  - Toronto, Ontario, Canada, M4W 2N4
    - Galderma Investigational Site 8899
Czechia
- - Brno, Czechia, 656 91
    - Galderma Investigational Site 6055
  - Náchod, Czechia, 547 01
    - Galderma Investigational Site 5225
  - Olomouc, Czechia, 779 00
    - Galderma Investigational Site 6030
  - Prague, Czechia, 100 00
    - Galderma Investigational Site 6024
  - Prague, Czechia, 120 00
    - Galderma Investigational Site 6240
  - Praha, Czechia, 110 00
    - Galderma Investigational Site 6054
  - Praha, Czechia, 150 06
    - Galderma Investigational Site 6025
  - Praha, Czechia, 11000
    - Galderma Investigational Site 6021
Germany
- - Bad Bentheim, Germany, 48455
    - Galderma Investigational Site 6022
  - Berlin, Germany, 13055
    - Galderma Investigational Site 6110
  - Bielefeld, Germany, 33647
    - Galderma Investigational Site 6061
  - Buxtehude, Germany, 21614
    - Galderma Investigational Site 6066
  - Darmstadt, Germany, 64283
    - Galderma Investigational Site 5368
  - Dülmen, Germany, 48249
    - Galderma Investigational Site 6028
  - Münster, Germany, 48149
    - Galderma Investigational Site 6039
  - Osnabrück, Germany, 49074
    - Galderma Investigational Site 5918
  - Stuttgart, Germany, 70499
    - Galderma Investigational Site 6109
- Hesse
  - Langenau, Hesse, Germany, 89129
    - Galderma Investigational Site 6146
- NRW
  - Berlin, NRW, Germany, 12203
    - Galderma Investigational Site 6172
- Niedersachesen
  - Tuebingen, Niedersachesen, Germany, 72076
    - Galderma Investigational Site 6214
- Schleswig-Holst
  - Kiel, Schleswig-Holst, Germany, 24105
    - Galderma Investigational Site 5437
Korea, Republic of
- - Bucheon, Korea, Republic of, 14584
    - Galderma Investigational Site 6095
  - Busan, Korea, Republic of, 49241
    - Galderma Investigational Site 6100
  - Gyeonggi-do, Korea, Republic of, 15355
    - Galderma Investigational Site 6098
  - Gyeonggi-do, Korea, Republic of, 18450
    - Galderma Investigational Site 6154
  - Incheon, Korea, Republic of, 21431
    - Galderma Investigational Site 6138
  - Incheon, Korea, Republic of, 21565
    - Galderma Investigational Site 6120
  - Incheon, Korea, Republic of, 22332
    - Galderma Investigational Site 6093
  - Seoul, Korea, Republic of, 02841
    - Galderma Investigational Site 6105
  - Seoul, Korea, Republic of, 03080
    - Galderma Investigational Site 5659
  - Seoul, Korea, Republic of, 03722
    - Galderma Investigational Site 6116
  - Seoul, Korea, Republic of, 04763
    - Galderma Investigational Site 6129
  - Seoul, Korea, Republic of, 05030
    - Galderma Investigational Site 6103
  - Seoul, Korea, Republic of, 06591
    - Galderma Investigational Site 6056
  - Seoul, Korea, Republic of, 06973
    - Galderma Investigational Site 6094
  - Seoul, Korea, Republic of, 07441
    - Galderma Investigational Site 6099
Latvia
- - Liepāja, Latvia, LV-3401
    - Galderma Investigational Site 6113
  - Riga, Latvia, LV-1006
    - Galderma Investigational Site 6134
  - Riga, Latvia, LV-1009
    - Galderma Investigational Site 6059
  - Talsi, Latvia, LV-3201
    - Galderma Investigational Site 6060
Lithuania
- - Kaunas, Lithuania, LT-50161
    - Galderma Investigational Site 6111
  - Klaipėda, Lithuania, LT-92288
    - Galderma Investigational Site 6072
  - Vilnius, Lithuania, LT-08411
    - Galderma Investigational Site 6112
Netherlands
- - Groningen, Netherlands, 9713
    - Galderma Investigational Site 6212
  - Rotterdam, Netherlands, 3015 GD
    - Galderma Investigational Site 6108
  - Utrecht, Netherlands, 3584 CX
    - Galderma Investigational Site 6027
New Zealand
- - Hamilton, New Zealand, 3204
    - Galderma Investigational Site 6119
  - Wellington, New Zealand, 6021
    - Galderma Investigational Site 6118
Poland
- - Czestochowa, Poland, 42-202
    - Galderma Investigational Site 6255
  - Gdańsk, Poland, 80-214
    - Galderma Investigational Site 6075
  - Gdańsk, Poland, 80-382
    - Galderma Investigational Site 6243
  - Gdańsk, Poland, 80-462
    - Galderma Investigational Site 5138
  - Gdynia, Poland, 81-537
    - Galderma Investigational Site 6244
  - Katowice, Poland, 40-040
    - Galderma Investigational Site 6087
  - Lublin, Poland, 20-081
    - Galderma Investigational Site 6071
  - Ostrowiec Świętokrzyski, Poland, 27-400
    - Galderma Investigational Site 6237
  - Poznań, Poland, 60-702
    - Galderma Investigational Site 6127
  - Szczecin, Poland, 70-332
    - Galderma Investigational Site 6223
  - Warszawa, Poland, 01-192
    - Galderma Investigational Site 6065
  - Warszawa, Poland, 02-507
    - Galderma Investigational Site 6122
  - Warszawa, Poland, 02-793
    - Galderma Investigational Site 6242
  - Warszawa, Poland, 02-953
    - Galderma Investigational Site 6064
  - Warszawa, Poland, 02-962
    - Galderma Investigational Site 6222
  - Wrocław, Poland, 50-381
    - Galderma Investigational Site 6047
  - Wrocław, Poland, 53-658
    - Galderma Investigational Site 5005
  - Łódź, Poland, 90-127
    - Galderma Investigational Site 6245
  - Łódź, Poland, 90-265
    - Galderma Investigational Site 5570
  - Łódź, Poland, 94-050
    - Galderma Investigational Site 6231
Spain
- - Alicante, Spain, 03010
    - Galderma Investigational Site 6057
  - Barcelona, Spain, 08036
    - Galderma Investigational Site 6037
  - Barcelona, Spain, 08916
    - Galderma Investigational Site 6035
  - Barcelona, Spain, 8907
    - Galderma Investigational Site 5580
  - Las Palmas De Gran Canaria, Spain, 35010
    - Galderma Investigational Site 6106
  - Madrid, Spain, 28006
    - Galderma Investigational Site 6058
  - Madrid, Spain, 28034
    - Galderma Investigational Site 5842
  - Madrid, Spain, 28046
    - Galderma Investigational Site 6190
  - Madrid, Spain, 28223
    - Galderma Investigational Site 6036
  - Madrid, Spain, 28922
    - Galderma Investigational Site 5551
  - Pamplona, Spain, 31008
    - Galderma Investigational Site 6191
United Kingdom
- - Barnsley, United Kingdom, S75 3DL
    - Galderma Investigational Site 6202
  - Blackpool, United Kingdom, FY2 0JH
    - Galderma Investigational Site 6207
  - Cannock, United Kingdom, WS11 0BN
    - Galderma Investigational Site 6203
  - Glasgow, United Kingdom, G3 8SJ
    - Galderma Investigational Site 6104
  - Liverpool, United Kingdom, L34 1BH
    - Galderma Investigational Site 6204
  - London, United Kingdom, SE1 9RT
    - Galderma Investigational Site 6121
  - Manchester, United Kingdom, M13 9NQ
    - Galderma Investigational Site 6205
  - Stockton-on-Tees, United Kingdom, TS17 6EW
    - Galderma Investigational Site 6206
United States
- Arkansas
  - North Little Rock, Arkansas, United States, 72117
    - Galderma Investigational Site 8880
- California
  - Cerritos, California, United States, 90703
    - Galderma Investigational Site 8578
  - Fountain Valley, California, United States, 92708
    - Galderma Investigational Site 8636
  - Fullerton, California, United States, 92835
    - Galderma Investigational Site 8888
  - Lomita, California, United States, 90717
    - Galderma Investigational Site 8686
  - Los Angeles, California, United States, 90025
    - Galderma Investigational Site 8674
  - San Francisco, California, United States, 94115
    - Galderma Investigational Site 8125
  - Santa Ana, California, United States, 92703
    - Galderma Investigational Site 8895
  - Santa Monica, California, United States, 90404
    - Galderma Investigational Site 8608
- Florida
  - Brandon, Florida, United States, 33511
    - Galderma Investigational Site 8897
  - Cape Coral, Florida, United States, 33991
    - Galderma Investigational Site 8805
  - Doral, Florida, United States, 33122
    - Galderma Investigational Site 8902
  - Hialeah, Florida, United States, 33016
    - Galderma Investigational Site 8804
  - Jacksonville, Florida, United States, 32256
    - Galderma Investigational Site 8711
  - Miami, Florida, United States, 33145
    - Galderma Investigational Site 8801
  - Miami, Florida, United States, 33174
    - Galderma Investigational Site 8737
  - Miami, Florida, United States, 33176
    - Galderma Investigational Site 8708
  - Miami, Florida, United States, 33126
    - Galderma Investigational Site 8710
  - Miami Lakes, Florida, United States, 33014
    - Galderma Investigational Site 8806
  - Miami Lakes, Florida, United States, 33016
    - Galderma Investigational Site 8800
  - Pembroke Pines, Florida, United States, 33028
    - Galderma Investigational Site 8734
- Georgia
  - Macon, Georgia, United States, 31217
    - Galderma Investigational Site 8744
  - Newnan, Georgia, United States, 30263
    - Galderma Investigational Site 8728
  - Union City, Georgia, United States, 30291
    - Galderma Investigational Site 8887
- Idaho
  - Blackfoot, Idaho, United States, 83221
    - Galderma Investigational Site 8890
  - Nampa, Idaho, United States, 83687
    - Galderma Investigational Site 8819
- Illinois
  - Skokie, Illinois, United States, 60077
    - Galderma Investigational Site 8712
  - Skokie, Illinois, United States, 60076
    - Galderma Investigational Site 8571
- Indiana
  - Indianapolis, Indiana, United States, 46250
    - Galderma Investigational Site 8142
- Kentucky
  - Louisville, Kentucky, United States, 40241
    - Galderma Investigational Site 8771
- Maine
  - Bangor, Maine, United States, 04401
    - Galderma Investigational Site 8882
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Galderma Investigational Site 8743
  - Bay City, Michigan, United States, 48706
    - Galderma Investigational Site 8512
  - Troy, Michigan, United States, 48084
    - Galderma Investigational Site 8155
  - Ypsilanti, Michigan, United States, 48197
    - Galderma Investigational Site 8748
- Missouri
  - Saint Joseph, Missouri, United States, 64506
    - Galderma Investigational Site 8521
- Montana
  - Missoula, Montana, United States, 59808
    - Galderma Investigational Site 8718
- Nebraska
  - Omaha, Nebraska, United States, 68144
    - Galderma Investigational Site 8810
- Nevada
  - Henderson, Nevada, United States, 89052
    - Galderma Investigational Site 8740
- New York
  - Brooklyn, New York, United States, 11203
    - Galderma Investigational Site 8242
  - New York, New York, United States, 10023
    - Galderma Investigational Site 8620
  - New York, New York, United States, 10075
    - Galderma Investigational Site 8279
- North Carolina
  - Wilmington, North Carolina, United States, 28405
    - Galderma Investigational Site 8648
- Ohio
  - Bexley, Ohio, United States, 43209
    - Galderma Investigational Site 8702
  - Dublin, Ohio, United States, 43016
    - Galderma Investigational Site 8595
- Oklahoma
  - Norman, Oklahoma, United States, 73071
    - Galderma Investigational Site 8206
  - Oklahoma City, Oklahoma, United States, 73118
    - Galderma Investigational Site 8857
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19103
    - Galderma Investigational Site 8255
  - Plymouth Meeting, Pennsylvania, United States, 19462
    - Galderma Investigational Site 8802
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Galderma Investigational Site 8736
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Galderma Investigational Site 8818
- Texas
  - Arlington, Texas, United States, 76011
    - Galderma Investigational Site 8133
  - Dallas, Texas, United States, 75230
    - Galderma Investigational Site 8238
  - Dripping Springs, Texas, United States, 78620
    - Galderma Investigational Site 8827
  - Frisco, Texas, United States, 75034
    - Galderma Investigational Site 8664
  - Houston, Texas, United States, 77056
    - Galderma Investigational Site 8042
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Galderma Investigational Site 8862

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

Key Inclusion Criteria:

Male or female subjects aged greater than and equal to (>=) 12 years at the screening visit.
Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for at least 2 years before the screening visit.
Eczema Area and Severity Index (EASI) score >=16 at the screening and baseline visits.
Investigator Global Assessment (IGA) score >= 3 (scale of 0 to 4) at the screening and baseline visits.
AD involvement >= 10 percent (%) of body surface area (BSA) at screening and baseline visits.
Peak Pruritus Numerical Rating Scale (PPNRS) score of at least 4.0 at the screening and baseline visit.
Documented recent history of inadequate response to topical medications (topical corticosteroids [TCS] with or without Topical calcineurin inhibitors [TCI]).
Female subjects of childbearing potential (that is, fertile, following menarche and until becoming postmenopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Key Exclusion Criteria:

Body weight (<) 30 kilograms (kg).
Exacerbation of asthma requiring hospitalization in the preceding 12 months. Uncontrolled asthma in the preceding 3 months.
Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit.
Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.

Note: Subjects with chronic, stable use of prophylactic treatment for recurrent herpes viral infection can be included in this clinical study.

History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, example, monoclonal antibody) or to any of the study drug excipients.
Any clinically significant issue, based on investigator judgement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Placebo
Experimental: Nemolizumab Nemolizumab Active	Drug: Nemolizumab Nemolizumab Other Names: CD14152

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): Intent-To-Treat (ITT) Population Time Frame: Week 16	IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of atopic dermatitis (AD) and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data at Week 16 were considered non-responders.	Week 16
Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a >= 2-point Reduction): Severe Pruritus Population Time Frame: Week 16	IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of AD and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders.	Week 16
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population Time Frame: Week 16	EASI-75 was defined as >=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD(erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head & neck, upper limbs, trunk & lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data at Week 16 were considered non-responders. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD.	Week 16
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at 16: Severe Pruritus Population Time Frame: Week 16	EASI-75 was defined as >=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification)scored separately for each of 4 body regions (head & neck, upper limbs, trunk & lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data at Week 16 were considered non-responders. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population Time Frame: Week 16	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure.	Week 16
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population Time Frame: Week 16	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure.	Week 16
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population Time Frame: Week 16	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 16
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population Time Frame: Week 16	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 16
Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population Time Frame: Week 16	The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 16
Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population Time Frame: Week 16	The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following question in their local language: how would you rate your sleep last night? On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 16
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population Time Frame: Week 4	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 4
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: Severe Pruritus Population Time Frame: Week 4	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 4
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population Time Frame: Week 4	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 4
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population Time Frame: Week 4	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 4
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population Time Frame: Week 2	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 2
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population Time Frame: Week 2	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 2
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population Time Frame: Week 1	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 1
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: Severe Pruritus Population Time Frame: Week 1	The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.	Week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2019

Primary Completion (Actual)

December 29, 2021

Study Completion (Actual)

August 11, 2022

Study Registration Dates

First Submitted

June 11, 2019

First Submitted That Met QC Criteria

June 11, 2019

First Posted (Actual)

June 14, 2019

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

RD.06.SPR.118161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Moderate-to-Severe Atopic Dermatitis

Clinical Trials on Placebo

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