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

Sponsor
Galderma R&D (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03985943
Collaborator
(none)
750
Enrollment
202
Locations
2
Arms
37.8
Anticipated Duration (Months)
3.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of the study is 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is 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 must have a documented history of inadequate response to topical AD medication(s). Approximately 750 subjects will be 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
750 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Treatment
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date :
Jun 30, 2019
Anticipated Primary Completion Date :
Aug 25, 2022
Anticipated Study Completion Date :
Aug 25, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placebo

Drug: Placebo
Placebo
Experimental: Nemolizumab

Nemolizumab Active

Drug: Nemolizumab
Nemolizumab
Other Names:
  • CD14152

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of subjects with an IGA success (IGA of 0 or 1) and a ≥ 2-point reduction [Baseline to Week 16]

      IGA success rate defined as the proportion of subjects who achieve an IGA score of 1 (Almost Clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 16.

    2. Proportion of subjects with EASI-75 [Baseline to Week 16]

    Secondary Outcome Measures

    1. Proportion of subjects with an improvement of PP NRS ≥ 4 [Week 16]

    2. Proportion of subjects with PP NRS < 2 [Week 16]

    3. Proportion of subjects with an improvement of sleep disturbance NRS (SD NRS) ≥ 4 [Week 16]

    4. Proportion of subjects with an improvement of PP NRS ≥ 4 [Week 4]

    5. Proportion of subjects with PP NRS < 2 [Week 4]

    6. Proportion of subjects with an improvement of PP NRS ≥ 4 [Week 2]

    7. Proportion of subjects with an improvement of PP NRS ≥ 4 [Week 1]

    8. Proportion of subjects with EASI-75 and improvement of PP NRS ≥ 4 [Week 16]

    9. Proportion of subjects with IGA success and improvement of PP NRS ≥ 4 [Week 16]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Male or female subjects aged ≥ 12 years at the screening visit Note: Enrollment of subjects aged 12 to 17 years has been opened after the IDMC has assessed interim safety data from the phase 2 study (Protocol 116912) and provided recommendations to the sponsor, who then determined the eligibility of this age group for enrollment in the study

    • Chronic AD that has been documented for at least 2 years

    • EASI score ≥ 16

    • IGA score ≥ 3

    • AD involvement ≥ 10% of BSA

    • PPNRS score of at least 4.0 at the screening and baseline visit

    • Documented recent history of inadequate response to topical medications (TCS with or without 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 kg

    • Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study

    • 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 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, eg, monoclonal antibody) or to any of the study drug excipients

    • Any clinically significant issue, based on investigator judgement

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Galderma Investigational Site 8750 Little Rock Arkansas United States 72205
    2 Galderma Investigational Site 8880 North Little Rock Arkansas United States 72117
    3 Galderma Investigational Site 8456 Beverly Hills California United States 90212
    4 Galderma Investigational Site 8578 Cerritos California United States 90703
    5 Galderma Investigational Site 8636 Fountain Valley California United States 92708
    6 Galderma Investigational Site 8888 Fullerton California United States 92835
    7 Galderma Investigational Site 8686 Lomita California United States 90717
    8 Galderma Investigational Site 8674 Los Angeles California United States 90025
    9 Galderma Investigational Site 8891 North Hollywood California United States 91606
    10 Galderma Investigational Site 8671 San Diego California United States 92108
    11 Galderma Investigational Site 8125 San Francisco California United States 94115
    12 Galderma Investigational Site 8895 Santa Ana California United States 92703
    13 Galderma Investigational Site 8608 Santa Monica California United States 90404
    14 Galderma Investigational Site 8111 Washington District of Columbia United States 20037
    15 Galderma Investigational Site 8897 Brandon Florida United States 33511
    16 Galderma Investigational Site 8805 Cape Coral Florida United States 33991
    17 Galderma Investigational Site 8902 Doral Florida United States 33122
    18 Galderma Investigational Site 8804 Hialeah Florida United States 33016
    19 Galderma Investigational Site 8711 Jacksonville Florida United States 32256
    20 Galderma Investigational Site 8806 Miami Lakes Florida United States 33014
    21 Galderma Investigational Site 8800 Miami Lakes Florida United States 33016
    22 Galderma Investigational Site 8710 Miami Florida United States 33126
    23 Galderma Investigational Site 8801 Miami Florida United States 33145
    24 Galderma Investigational Site 8737 Miami Florida United States 33174
    25 Galderma Investigational Site 8708 Miami Florida United States 33176
    26 Galderma Investigational Site 8734 Pembroke Pines Florida United States 33028
    27 Galderma Investigational Site 8889 Tampa Florida United States 33511
    28 Galderma Investigational Site 8744 Macon Georgia United States 31217
    29 Galderma Investigational Site 8728 Newnan Georgia United States 30263
    30 Galderma Investigational Site 8887 Union City Georgia United States 30291
    31 Galderma Investigational Site 8890 Blackfoot Idaho United States 83221
    32 Galderma Investigational Site 8819 Nampa Idaho United States 83687
    33 Galderma Investigational Site 8571 Skokie Illinois United States 60076
    34 Galderma Investigational Site 8712 Skokie Illinois United States 60077
    35 Galderma Investigational Site 8142 Indianapolis Indiana United States 46250
    36 Galderma Investigational Site 8771 Louisville Kentucky United States 40241
    37 Galderma Investigational Site 8882 Bangor Maine United States 04401
    38 Galderma Investigational Site 8743 Ann Arbor Michigan United States 48109
    39 Galderma Investigational Site 8512 Bay City Michigan United States 48706
    40 Galderma Investigational Site 8155 Troy Michigan United States 48084
    41 Galderma Investigational Site 8748 Ypsilanti Michigan United States 48197
    42 Galderma Investigational Site 8521 Saint Joseph Missouri United States 64506
    43 Galderma Investigational Site 8718 Missoula Montana United States 59808
    44 Galderma Investigational Site 8810 Omaha Nebraska United States 68144
    45 Galderma Investigational Site 8740 Henderson Nevada United States 89052
    46 Galderma Investigational Site 8109 Lebanon New Hampshire United States 003766
    47 Galderma Investigational Site 8826 Albuquerque New Mexico United States 87106
    48 Galderma Investigational Site 8242 Brooklyn New York United States 11203
    49 Galderma Investigational Site 8620 New York New York United States 10023
    50 Galderma Investigational Site 8279 New York New York United States 10075
    51 Galderma Investigational Site 8772 Durham North Carolina United States 27710
    52 Galderma Investigational Site 8726 Wilmington North Carolina United States 28405-3176
    53 Galderma Investigational Site 8648 Wilmington North Carolina United States 28405
    54 Galderma Investigational Site 8702 Bexley Ohio United States 43209
    55 Galderma Investigational Site 8595 Dublin Ohio United States 43016
    56 Galderma Investigational Site 8206 Norman Oklahoma United States 73071
    57 Galderma Investigational Site 8857 Oklahoma City Oklahoma United States 73118
    58 Galderma Investigational Site 8255 Philadelphia Pennsylvania United States 19103
    59 Galderma Investigational Site 8802 Plymouth Meeting Pennsylvania United States 19462
    60 Galderma Investigational Site 8736 Charleston South Carolina United States 29425
    61 Galderma Investigational Site 8818 Rapid City South Dakota United States 57702
    62 Galderma Investigational Site 8133 Arlington Texas United States 76011
    63 Galderma Investigational Site 8298 Austin Texas United States 78723
    64 Galderma Investigational Site 8238 Dallas Texas United States 75230
    65 Galderma Investigational Site 8827 Dripping Springs Texas United States 78620
    66 Galderma Investigational Site 8664 Frisco Texas United States 75034
    67 Galderma Investigational Site 8042 Houston Texas United States 77056
    68 Galderma Investigational Site 8670 Houston Texas United States 77401
    69 Galderma Investigational Site 8738 Burke Virginia United States 22015
    70 Galderma Investigational Site 8862 Fairfax Virginia United States 22031
    71 Galderma Investigational Site 5441 Darlinghurst New South Wales Australia 2010
    72 Galderma Investigational Site 5759 Kogarah New South Wales Australia 2217
    73 Galderma Investigational Site 6152 Westmead New South Wales Australia 2145
    74 Galderma Investigational Site 5638 Benowa Queensland Australia 4217
    75 Galderma Investigational Site 6161 Brisbane Queensland Australia 4102
    76 Galderma Investigational Site 6159 Woodville South Australia Australia 5011
    77 Galderma Investigational Site 6131 Carlton Victoria Australia 3053
    78 Galderma Investigational Site 5366 East Melbourne Victoria Australia 3002
    79 Galderma Investigational Site 5458 Parkville Victoria Australia 3050
    80 Galderma Investigational Site 6160 Parkville Victoria Australia 3052
    81 Galderma Investigational Site 5453 Fremantle Western Australia Australia 6160
    82 Galderma Investigational Site 6153 Victoria Park Western Australia Australia 6100
    83 Galderma Investigational Sites 6157 Graz Styria Austria 8036
    84 Galderma Investigational Site 6194 Vienna Wien Austria 1090
    85 Galderma Investigational Site 6156 Linz Austria 4020
    86 Galderma Investigational Site 6158 Vienna Austria 1220
    87 Galderma Investigational Site 8085 Calgary Alberta Canada T2G 1B1
    88 Galderma Investigational Site 8903 Calgary Alberta Canada T2J 7E1
    89 Galderma Investigational Site 8215 Calgary Alberta Canada T3E 0B2
    90 Galderma Investigational Site 8088 Edmonton Alberta Canada T5J 3S9
    91 Galderma Investigational Site 8824 Edmonton Alberta Canada T6G 1C3
    92 Galderma Investigational Site 8722 Edmonton Alberta Canada T6G 1C9
    93 Galderma Investigational Site 8161 Surrey British Columbia Canada V3V 0C6
    94 Galderma Investigational Site 8586 Barrie Ontario Canada L4M 7G1
    95 Galderma Investigational Site 8904 Guelph Ontario Canada N1L 0B7
    96 Galderma Investigational Site 8901 Ottawa Ontario Canada K1H7X3
    97 Galderma Investigational Site 8336 Toronto Ontario Canada M3H 5Y8
    98 Galderma Investigational Site 8899 Toronto Ontario Canada M4W 2N4
    99 Galderma Investigational Site 8780 Niagara Falls Canada L2H 1H5
    100 Galderma Investigational Site 8610 Ottawa Canada K1G 6C6
    101 Galderma Investigational Site 8000 Saint John Canada A1C2H5
    102 Galderma Investigational Site 8731 Waterloo Canada N2J 1C4
    103 Galderma Investigational Site 6055 Brno Czechia 656 91
    104 Galderma Investigational Site 5225 Náchod Czechia 547 01
    105 Galderma Investigational Site 6030 Olomouc Czechia 779 00
    106 Galderma Investigational Site 6024 Prague Czechia 100 00
    107 Galderma Investigational Site 6240 Prague Czechia 120 00
    108 Galderma Investigational Site 6054 Praha Czechia 110 00
    109 Galderma Investigational Site 6021 Praha Czechia 11000
    110 Galderma Investigational Site 6025 Praha Czechia 150 06
    111 Galderma Investigational Site 6146 Langenau Hesse Germany 89129
    112 Galderma Investigational Site 6214 Tuebingen Niedersachesen Germany 72076
    113 Galderma Investigational Site 6172 Berlin NRW Germany 12203
    114 Galderma Investigational Site 5437 Kiel Schleswig-Holst Germany 24105
    115 Galderma Investigational Site 6022 Bad Bentheim Germany 48455
    116 Galderma Investigational Site 6110 Berlin Germany 13055
    117 Galderma Investigational Site 6061 Bielefeld Germany 33647
    118 Galderma Investigational Site 6066 Buxtehude Germany 21614
    119 Galderma Investigational Site 5368 Darmstadt Germany 64283
    120 Galderma Investigational Site 6028 Dülmen Germany 48249
    121 Galderma Investigational Site 6033 Lubeck Germany 23538
    122 Galderma Investigational Site 6039 Münster Germany 48149
    123 Galderma Investigational Site 5918 Osnabrück Germany 49074
    124 Galderma Investigational Site 6109 Stuttgart Germany 70499
    125 Galderma Investigational Site 6095 Bucheon Korea, Republic of 14584
    126 Galderma Investigational Site 6100 Busan Korea, Republic of 49241
    127 Galderma Investigational Site 6098 Gyeonggi-do Korea, Republic of 15355
    128 Galderma Investigational Site 6154 Gyeonggi-do Korea, Republic of 18450
    129 Galderma Investigational Site 6138 Incheon Korea, Republic of 21431
    130 Galderma Investigational Site 6120 Incheon Korea, Republic of 21565
    131 Galderma Investigational Site 6093 Incheon Korea, Republic of 22332
    132 Galderma Investigational Site 6105 Seoul Korea, Republic of 02841
    133 Galderma Investigational Site 5659 Seoul Korea, Republic of 03080
    134 Galderma Investigational Site 6166 Seoul Korea, Republic of 03722
    135 Galderma Investigational Site 6129 Seoul Korea, Republic of 04763
    136 Galderma Investigational Site 6103 Seoul Korea, Republic of 05030
    137 Galderma Investigational Site 6056 Seoul Korea, Republic of 06591
    138 Galderma Investigational Site 6094 Seoul Korea, Republic of 06973
    139 Galderma Investigational Site 6099 Seoul Korea, Republic of 07441
    140 Galderma Investigational Site 6113 Liepāja Latvia LV-3401
    141 Galderma Investigational Site 6134 Riga Latvia LV-1006
    142 Galderma Investigational Site 6059 Riga Latvia LV-1009
    143 Galderma Investigational Site 6060 Talsi Latvia LV-3201
    144 Galderma Investigational Site 6111 Kaunas Lithuania LT-50161
    145 Galderma Investigational Site 6072 Klaipėda Lithuania LT-92288
    146 Galderma Investigational Site 6073 Vilnius Lithuania LT-07195
    147 Galderma Investigational Site 6112 Vilnius Lithuania LT-08411
    148 Galderma Investigational Site 6212 Groningen Netherlands 9713
    149 Galderma Investigational Site 6108 Rotterdam Netherlands 3015 GD
    150 Galderma Investigational Site 6027 Utrecht Netherlands 3584 CX
    151 Galderma Investigational Site 6119 Hamilton New Zealand 3204
    152 Galderma Investigational Site 6118 Wellington New Zealand 6021
    153 Galderma Investigational Site 6255 Czestochowa Poland 42-202
    154 Galderma Investigational Site 6075 Gdańsk Poland 80-214
    155 Galderma Investigational Site 6243 Gdańsk Poland 80-382
    156 Galderma Investigational Site 5138 Gdańsk Poland 80-462
    157 Galderma Investigational Site 6244 Gdynia Poland 81-537
    158 Galderma Investigational Site 6087 Katowice Poland 40-040
    159 Galderma Investigational Site 6071 Lublin Poland 20-081
    160 Galderma Investigational Site 6237 Ostrowiec Świętokrzyski Poland 27-400
    161 Galderma Investigational Site 6127 Poznań Poland 60-702
    162 Galderma Investigational Site 6088 Rzeszów Poland 35-055
    163 Galderma Investigational Site 6223 Szczecin Poland 70-332
    164 Galderma Investigational Site 6065 Warszawa Poland 01-192
    165 Galderma Investigational Site 6122 Warszawa Poland 02-507
    166 Galderma Investigational Site 6242 Warszawa Poland 02-793
    167 Galderma Investigational Site 6064 Warszawa Poland 02-953
    168 Galderma Investigational Site 6222 Warszawa Poland 02-962
    169 Galderma Investigational Site 6047 Wrocław Poland 50-381
    170 Galderma Investigational Site 5005 Wrocław Poland 53-658
    171 Galderma Investigational Site 6245 Łódź Poland 90-127
    172 Galderma Investigational Site 5570 Łódź Poland 90-265
    173 Galderma Investigational Site 6231 Łódź Poland 94-050
    174 Galderma Investigational Site 6057 Alicante Spain 03010
    175 Galderma Investigational Site 6037 Barcelona Spain 08036
    176 Galderma Investigational Site 5550 Barcelona Spain 08041
    177 Galderma Investigational Site 6035 Barcelona Spain 08916
    178 Galderma Investigational Site 5580 Barcelona Spain 8907
    179 Galderma Investigational Site 6106 Las Palmas De Gran Canaria Spain 35010
    180 Galderma Investigational Site 6058 Madrid Spain 28006
    181 Galderma Investigational Site 5842 Madrid Spain 28034
    182 Galderma Investigational Site 6190 Madrid Spain 28046
    183 Galderma Investigational Site 6036 Madrid Spain 28223
    184 Galderma Investigational Site 5551 Madrid Spain 28922
    185 Galderma Investigational Site 6186 Majadahonda Spain 28222
    186 Galderma Investigational Site 6193 Málaga Spain 29010
    187 Galderma Investigational Site 6191 Pamplona Spain 31008
    188 Galderma Investigational Site 5970 Valencia Spain 46026
    189 Galderma Investigational Site 6202 Barnsley United Kingdom S75 3DL
    190 Galderma Investigational Site 6207 Blackpool United Kingdom FY2 0JH
    191 Galderma Investigational Site 6203 Cannock United Kingdom WS11 0BN
    192 Galderma Investigational Site 6246 Cardiff United Kingdom CF15 9SS
    193 Galderma Investigational Site 6248 Chorley United Kingdom PR7 7NA
    194 Galderma Investigational Site 6090 Dudley United Kingdom DY1 2HQ
    195 Galderma Investigational Site Dudley United Kingdom DY1 2HQ
    196 Galderma Investigational Site 6249 Edgbaston United Kingdom B15 2SQ
    197 Galderma Investigational Site 6104 Glasgow United Kingdom G3 8SJ
    198 Galderma Investigational Site 6204 Liverpool United Kingdom L34 1BH
    199 Galderma Investigational Site 6121 London United Kingdom SE1 9RT
    200 Galderma Investigational Site 6205 Manchester United Kingdom M13 9NQ
    201 Galderma Investigational Site 6208 Newcastle United Kingdom NE1 4LP
    202 Galderma Investigational Site 6206 Stockton-on-Tees United Kingdom TS17 6EW

    Sponsors and Collaborators

    • Galderma R&D

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Galderma R&D
    ClinicalTrials.gov Identifier:
    NCT03985943
    Other Study ID Numbers:
    • RD.06.SPR.118161
    First Posted:
    Jun 14, 2019
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Galderma R&D
    CD14152
    Nemolizumab
    Atopic Dermatitis
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Eczema

    Study Results

    No Results Posted as of Aug 25, 2022