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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Nemolizumab | Experimental | Nemolizumab Active |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| Nemolizumab |
| 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 | 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 | 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 | 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. |
| 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 | 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Subjects with chronic, stable use of prophylactic treatment for recurrent herpes viral infection can be included in this clinical study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site 8880 | North Little Rock | Arkansas | 72117 | United States | ||
| Galderma Investigational Site 8578 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40360966 | Derived | Silverberg JI, Filipenko D, Dias Barbosa C, Rodriguez D, Chambenoit O, Jack K, Piketty C, Subramanian R, Puelles J. Patients' Experiences of Atopic Dermatitis and Nemolizumab Treatment: An In-Trial Interview Study Embedded in a Phase 3 Clinical Trial (ARCADIA). Patient. 2025 Sep;18(5):511-521. doi: 10.1007/s40271-025-00741-x. Epub 2025 May 13. | |
| 40116983 |
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A total of 941 randomized 2:1 to receive either nemolizumab or placebo.At Week 16, 272 nemolizumab-treated participants were clinical responders (defined as IGA of 0[clear] or 1[almost clear]or Eczema Area and Severity Index [EASI]-75) re-randomized to receive nemolizumab Q4W,nemolizumab Q8W,or placebo during Maintenance Period.100 participants received placebo in Initial Treatment, responded to placebo at Week 16,re-assigned to placebo and continued to receive placebo Q4W in Maintenance Period.
The study was conducted at 177 active sites in Australia, Austria, Canada, Czech Republic, Germany, Great Britain, Korea, Latvia, Lithuania, Netherlands, New Zealand, Poland, Spain and the United States from 27 June 2019 to 11 August 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Participants received placebo via 2 subcutaneous (SC) injections at Day 1, thereafter, every 4 weeks (Q4W) at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period. |
| FG001 | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Treatment(Day 1-Week 16 Predose) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2021 | Jun 18, 2024 |
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Treatment
| Drug |
Nemolizumab |
|
|
| Week 16 |
| Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at 16: Severe Pruritus Population | 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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Cerritos |
| California |
| 90703 |
| United States |
| Galderma Investigational Site 8636 | Fountain Valley | California | 92708 | United States |
| Galderma Investigational Site 8888 | Fullerton | California | 92835 | United States |
| Galderma Investigational Site 8686 | Lomita | California | 90717 | United States |
| Galderma Investigational Site 8674 | Los Angeles | California | 90025 | United States |
| Galderma Investigational Site 8125 | San Francisco | California | 94115 | United States |
| Galderma Investigational Site 8895 | Santa Ana | California | 92703 | United States |
| Galderma Investigational Site 8608 | Santa Monica | California | 90404 | United States |
| Galderma Investigational Site 8897 | Brandon | Florida | 33511 | United States |
| Galderma Investigational Site 8805 | Cape Coral | Florida | 33991 | United States |
| Galderma Investigational Site 8902 | Doral | Florida | 33122 | United States |
| Galderma Investigational Site 8804 | Hialeah | Florida | 33016 | United States |
| Galderma Investigational Site 8711 | Jacksonville | Florida | 32256 | United States |
| Galderma Investigational Site 8710 | Miami | Florida | 33126 | United States |
| Galderma Investigational Site 8801 | Miami | Florida | 33145 | United States |
| Galderma Investigational Site 8737 | Miami | Florida | 33174 | United States |
| Galderma Investigational Site 8708 | Miami | Florida | 33176 | United States |
| Galderma Investigational Site 8806 | Miami Lakes | Florida | 33014 | United States |
| Galderma Investigational Site 8800 | Miami Lakes | Florida | 33016 | United States |
| Galderma Investigational Site 8734 | Pembroke Pines | Florida | 33028 | United States |
| Galderma Investigational Site 8744 | Macon | Georgia | 31217 | United States |
| Galderma Investigational Site 8728 | Newnan | Georgia | 30263 | United States |
| Galderma Investigational Site 8887 | Union City | Georgia | 30291 | United States |
| Galderma Investigational Site 8890 | Blackfoot | Idaho | 83221 | United States |
| Galderma Investigational Site 8819 | Nampa | Idaho | 83687 | United States |
| Galderma Investigational Site 8571 | Skokie | Illinois | 60076 | United States |
| Galderma Investigational Site 8712 | Skokie | Illinois | 60077 | United States |
| Galderma Investigational Site 8142 | Indianapolis | Indiana | 46250 | United States |
| Galderma Investigational Site 8771 | Louisville | Kentucky | 40241 | United States |
| Galderma Investigational Site 8882 | Bangor | Maine | 04401 | United States |
| Galderma Investigational Site 8743 | Ann Arbor | Michigan | 48109 | United States |
| Galderma Investigational Site 8512 | Bay City | Michigan | 48706 | United States |
| Galderma Investigational Site 8155 | Troy | Michigan | 48084 | United States |
| Galderma Investigational Site 8748 | Ypsilanti | Michigan | 48197 | United States |
| Galderma Investigational Site 8521 | Saint Joseph | Missouri | 64506 | United States |
| Galderma Investigational Site 8718 | Missoula | Montana | 59808 | United States |
| Galderma Investigational Site 8810 | Omaha | Nebraska | 68144 | United States |
| Galderma Investigational Site 8740 | Henderson | Nevada | 89052 | United States |
| Galderma Investigational Site 8242 | Brooklyn | New York | 11203 | United States |
| Galderma Investigational Site 8620 | New York | New York | 10023 | United States |
| Galderma Investigational Site 8279 | New York | New York | 10075 | United States |
| Galderma Investigational Site 8648 | Wilmington | North Carolina | 28405 | United States |
| Galderma Investigational Site 8702 | Bexley | Ohio | 43209 | United States |
| Galderma Investigational Site 8595 | Dublin | Ohio | 43016 | United States |
| Galderma Investigational Site 8206 | Norman | Oklahoma | 73071 | United States |
| Galderma Investigational Site 8857 | Oklahoma City | Oklahoma | 73118 | United States |
| Galderma Investigational Site 8255 | Philadelphia | Pennsylvania | 19103 | United States |
| Galderma Investigational Site 8802 | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Galderma Investigational Site 8736 | Charleston | South Carolina | 29425 | United States |
| Galderma Investigational Site 8818 | Rapid City | South Dakota | 57702 | United States |
| Galderma Investigational Site 8133 | Arlington | Texas | 76011 | United States |
| Galderma Investigational Site 8238 | Dallas | Texas | 75230 | United States |
| Galderma Investigational Site 8827 | Dripping Springs | Texas | 78620 | United States |
| Galderma Investigational Site 8664 | Frisco | Texas | 75034 | United States |
| Galderma Investigational Site 8042 | Houston | Texas | 77056 | United States |
| Galderma Investigational Site 8862 | Fairfax | Virginia | 22031 | United States |
| Galderma Investigational Site 5441 | Darlinghurst | New South Wales | 2010 | Australia |
| Galderma Investigational Site 5759 | Kogarah | New South Wales | 2217 | Australia |
| Galderma Investigational Site 6152 | Westmead | New South Wales | 2145 | Australia |
| Galderma Investigational Site 5638 | Benowa | Queensland | 4217 | Australia |
| Galderma Investigational Site 6161 | Brisbane | Queensland | 4102 | Australia |
| Galderma Investigational Site 6159 | Woodville | South Australia | 5011 | Australia |
| Galderma Investigational Site 6131 | Carlton | Victoria | 3053 | Australia |
| Galderma Investigational Site 5366 | East Melbourne | Victoria | 3002 | Australia |
| Galderma Investigational Site 5458 | Parkville | Victoria | 3050 | Australia |
| Galderma Investigational Site 5453 | Fremantle | Western Australia | 6160 | Australia |
| Galderma Investigational Site 6153 | Victoria Park | Western Australia | 6100 | Australia |
| Galderma Investigational Site 6194 | Vienna | State of Vienna | 1090 | Austria |
| Galderma Investigational Sites 6157 | Graz | Styria | 8036 | Austria |
| Galderma Investigational Site 6158 | Vienna | 1220 | Austria |
| Galderma Investigational Site 8085 | Calgary | Alberta | T2G 1B1 | Canada |
| Galderma Investigational Site 8903 | Calgary | Alberta | T2J 7E1 | Canada |
| Galderma Investigational Site 8215 | Calgary | Alberta | T3E 0B2 | Canada |
| Galderma Investigational Site 8088 | Edmonton | Alberta | T5J 3S9 | Canada |
| Galderma Investigational Site 8824 | Edmonton | Alberta | T6G 1C3 | Canada |
| Galderma Investigational Site 8722 | Edmonton | Alberta | T6G 1C9 | Canada |
| Galderma Investigational Site 8161 | Surrey | British Columbia | V3V 0C6 | Canada |
| Galderma Investigational Site 8586 | Barrie | Ontario | L4M 7G1 | Canada |
| Galderma Investigational Site 8904 | Guelph | Ontario | N1L 0B7 | Canada |
| Galderma Investigational Site 8901 | Ottawa | Ontario | K1H7X3 | Canada |
| Galderma Investigational Site 8336 | Toronto | Ontario | M3H 5Y8 | Canada |
| Galderma Investigational Site 8899 | Toronto | Ontario | M4W 2N4 | Canada |
| Galderma Investigational Site 8780 | Niagara Falls | L2H 1H5 | Canada |
| Galderma Investigational Site 8610 | Ottawa | K1G 6C6 | Canada |
| Galderma Investigational Site 8000 | Saint John | A1C2H5 | Canada |
| Galderma Investigational Site 8731 | Waterloo | N2J 1C4 | Canada |
| Galderma Investigational Site 6055 | Brno | 656 91 | Czechia |
| Galderma Investigational Site 5225 | Náchod | 547 01 | Czechia |
| Galderma Investigational Site 6030 | Olomouc | 779 00 | Czechia |
| Galderma Investigational Site 6024 | Prague | 100 00 | Czechia |
| Galderma Investigational Site 6054 | Prague | 110 00 | Czechia |
| Galderma Investigational Site 6021 | Prague | 11000 | Czechia |
| Galderma Investigational Site 6240 | Prague | 120 00 | Czechia |
| Galderma Investigational Site 6025 | Prague | 150 06 | Czechia |
| Galderma Investigational Site 6146 | Langenau | Hesse | 89129 | Germany |
| Galderma Investigational Site 6214 | Tübingen | Niedersachesen | 72076 | Germany |
| Galderma Investigational Site 6172 | Berlin | North Rhine-Westphalia | 12203 | Germany |
| Galderma Investigational Site 5437 | Kiel | Schleswig-Holst | 24105 | Germany |
| Galderma Investigational Site 6022 | Bad Bentheim | 48455 | Germany |
| Galderma Investigational Site 6110 | Berlin | 13055 | Germany |
| Galderma Investigational Site 6061 | Bielefeld | 33647 | Germany |
| Galderma Investigational Site 6066 | Buxtehude | 21614 | Germany |
| Galderma Investigational Site 5368 | Darmstadt | 64283 | Germany |
| Galderma Investigational Site 6028 | Dülmen | 48249 | Germany |
| Galderma Investigational Site 6039 | Münster | 48149 | Germany |
| Galderma Investigational Site 5918 | Osnabrück | 49074 | Germany |
| Galderma Investigational Site 6109 | Stuttgart | 70499 | Germany |
| Galderma Investigational Site 6113 | Liepāja | LV-3401 | Latvia |
| Galderma Investigational Site 6134 | Riga | LV-1006 | Latvia |
| Galderma Investigational Site 6059 | Riga | LV-1009 | Latvia |
| Galderma Investigational Site 6060 | Talsi | LV-3201 | Latvia |
| Galderma Investigational Site 6111 | Kaunas | LT-50161 | Lithuania |
| Galderma Investigational Site 6072 | Klaipėda | LT-92288 | Lithuania |
| Galderma Investigational Site 6112 | Vilnius | LT-08411 | Lithuania |
| Galderma Investigational Site 6212 | Groningen | 9713 | Netherlands |
| Galderma Investigational Site 6108 | Rotterdam | 3015 GD | Netherlands |
| Galderma Investigational Site 6027 | Utrecht | 3584 CX | Netherlands |
| Galderma Investigational Site 6119 | Hamilton | 3204 | New Zealand |
| Galderma Investigational Site 6118 | Wellington | 6021 | New Zealand |
| Galderma Investigational Site 6255 | Częstochowa | 42-202 | Poland |
| Galderma Investigational Site 6075 | Gdansk | 80-214 | Poland |
| Galderma Investigational Site 6243 | Gdansk | 80-382 | Poland |
| Galderma Investigational Site 5138 | Gdansk | 80-462 | Poland |
| Galderma Investigational Site 6244 | Gdynia | 81-537 | Poland |
| Galderma Investigational Site 6087 | Katowice | 40-040 | Poland |
| Galderma Investigational Site 6245 | Lodz | 90-127 | Poland |
| Galderma Investigational Site 5570 | Lodz | 90-265 | Poland |
| Galderma Investigational Site 6231 | Lodz | 94-050 | Poland |
| Galderma Investigational Site 6071 | Lublin | 20-081 | Poland |
| Galderma Investigational Site 6237 | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Galderma Investigational Site 6127 | Poznan | 60-702 | Poland |
| Galderma Investigational Site 6223 | Szczecin | 70-332 | Poland |
| Galderma Investigational Site 6065 | Warsaw | 01-192 | Poland |
| Galderma Investigational Site 6122 | Warsaw | 02-507 | Poland |
| Galderma Investigational Site 6242 | Warsaw | 02-793 | Poland |
| Galderma Investigational Site 6064 | Warsaw | 02-953 | Poland |
| Galderma Investigational Site 6222 | Warsaw | 02-962 | Poland |
| Galderma Investigational Site 6047 | Wroclaw | 50-381 | Poland |
| Galderma Investigational Site 5005 | Wroclaw | 53-658 | Poland |
| Galderma Investigational Site 6095 | Bucheon-si | 14584 | South Korea |
| Galderma Investigational Site 6100 | Busan | 49241 | South Korea |
| Galderma Investigational Site 6098 | Gyeonggi-do | 15355 | South Korea |
| Galderma Investigational Site 6154 | Gyeonggi-do | 18450 | South Korea |
| Galderma Investigational Site 6138 | Incheon | 21431 | South Korea |
| Galderma Investigational Site 6120 | Incheon | 21565 | South Korea |
| Galderma Investigational Site 6093 | Incheon | 22332 | South Korea |
| Galderma Investigational Site 6105 | Seoul | 02841 | South Korea |
| Galderma Investigational Site 5659 | Seoul | 03080 | South Korea |
| Galderma Investigational Site 6116 | Seoul | 03722 | South Korea |
| Galderma Investigational Site 6129 | Seoul | 04763 | South Korea |
| Galderma Investigational Site 6103 | Seoul | 05030 | South Korea |
| Galderma Investigational Site 6056 | Seoul | 06591 | South Korea |
| Galderma Investigational Site 6094 | Seoul | 06973 | South Korea |
| Galderma Investigational Site 6099 | Seoul | 07441 | South Korea |
| Galderma Investigational Site 6057 | Alicante | 03010 | Spain |
| Galderma Investigational Site 6037 | Barcelona | 08036 | Spain |
| Galderma Investigational Site 6035 | Barcelona | 08916 | Spain |
| Galderma Investigational Site 5580 | Barcelona | 8907 | Spain |
| Galderma Investigational Site 6106 | Las Palmas de Gran Canaria | 35010 | Spain |
| Galderma Investigational Site 6058 | Madrid | 28006 | Spain |
| Galderma Investigational Site 5842 | Madrid | 28034 | Spain |
| Galderma Investigational Site 6190 | Madrid | 28046 | Spain |
| Galderma Investigational Site 6036 | Madrid | 28223 | Spain |
| Galderma Investigational Site 5551 | Madrid | 28922 | Spain |
| Galderma Investigational Site 6191 | Pamplona | 31008 | Spain |
| Galderma Investigational Site 6202 | Barnsley | S75 3DL | United Kingdom |
| Galderma Investigational Site 6207 | Blackpool | FY2 0JH | United Kingdom |
| Galderma Investigational Site 6203 | Cannock | WS11 0BN | United Kingdom |
| Galderma Investigational Site 6104 | Glasgow | G3 8SJ | United Kingdom |
| Galderma Investigational Site 6204 | Liverpool | L34 1BH | United Kingdom |
| Galderma Investigational Site 6121 | London | SE1 9RT | United Kingdom |
| Galderma Investigational Site 6205 | Manchester | M13 9NQ | United Kingdom |
| Galderma Investigational Site 6206 | Stockton-on-Tees | TS17 6EW | United Kingdom |
| Silverberg JI, Rodriguez DN, Dias-Barbosa C, Filipenko D, Ulianov L, Piketty C, Puelles J. Psychometric Validation of the Subject Sleep Diary in Patients with Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2025 Apr;15(4):963-995. doi: 10.1007/s13555-025-01385-3. Epub 2025 Mar 21. |
| 39067461 | Derived | Silverberg JI, Wollenberg A, Reich A, Thaci D, Legat FJ, Papp KA, Stein Gold L, Bouaziz JD, Pink AE, Carrascosa JM, Rewerska B, Szepietowski JC, Krasowska D, Havlickova B, Kalowska M, Magnolo N, Pauser S, Nami N, Sauder MB, Jain V, Padlewska K, Cheong SY, Fleuranceau Morel P, Ulianov L, Piketty C; ARCADIA 1 and ARCADIA 2 Study Investigators. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials. Lancet. 2024 Aug 3;404(10451):445-460. doi: 10.1016/S0140-6736(24)01203-0. Epub 2024 Jul 24. |
| 39008191 | Derived | Dias-Barbosa C, Silverberg JI, Stander S, Rodriguez D, Fofana F, Filipenko D, Ulianov L, Piketty C, Puelles J. Capturing patient-reported sleep disturbance in atopic dermatitis clinical trials. J Patient Rep Outcomes. 2024 Jul 15;8(1):73. doi: 10.1186/s41687-024-00751-7. |
Participants received nemolizumab 30 milligrams (mg) via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period. |
| FG002 | Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4W | Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a greater than and equal to (>=) 75 percent (%) improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period. |
| FG003 | Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q8W | Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a >=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, every 8 weeks (Q8W) at Weeks 20, 28, 36, and 44 by a single SC injection during Maintenance Period. |
| FG004 | Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Placebo Q4W | Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a >=75% improvement in EASI from Baseline) at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period. |
| FG005 | Maintenance Period (Week 16-Week 48): Placebo Q4W Re-assigned to Placebo Q4W | Participants who received placebo, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a >=75% improvement in EASI from Baseline) at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period. |
| Safety Population | Safety population (SP) consisted of all participants who received at least 1 dose of study drug. |
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| COMPLETED |
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| NOT COMPLETED |
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| Maintenance Period (Week 16-Week 48) |
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The ITT population consisted of all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period. |
| BG001 | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Participants received nemolizumab 30 mg via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 16 |
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| Primary | Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a >= 2-point Reduction): Severe Pruritus Population | 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. | Severe pruritus population consisted of all randomized participants with a baseline PP NRS >=7. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 16 |
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| Primary | Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population | 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. | The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 16 |
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| Primary | Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at 16: Severe Pruritus Population | 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. | Severe pruritus population consisted of all randomized participants with a baseline PP NRS >=7. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population | 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. | The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population | 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. | Severe pruritus population consisted of all randomized participants with a baseline PP NRS >=7. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population | 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. | The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population | 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. | Severe pruritus population consisted of all randomized participants with a baseline PP NRS >=7. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population | 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. | The ITT population consisted of all randomized participants. | Posted | Number | percentage of subjects | Week 16 |
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| Secondary | Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population | 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. | Severe pruritus population consisted of all randomized participants with a baseline PP NRS >=7. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population | 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. | The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 4 |
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| Secondary | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: Severe Pruritus Population | 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. | Severe pruritus population consisted of all randomized participants with a baseline PP NRS >=7. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 4 |
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| Secondary | Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population | 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. | The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 4 |
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| Secondary | Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population | 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. | Severe pruritus population consisted of all randomized participants with a baseline PP NRS >=7. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 4 |
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| Secondary | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population | 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. | The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 2 |
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| Secondary | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population | 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. | Severe pruritus population consisted of all randomized participants with a baseline PP NRS >=7. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 2 |
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| Secondary | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population | 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. | The ITT population consisted of all randomized participants. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 1 |
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| Secondary | Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: Severe Pruritus Population | 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. | Severe pruritus population consisted of all randomized participants with a baseline PP NRS >=7. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 1 |
|
Initial Treatment Period: From baseline to Week 16 pre-dose; Maintenance Period: From end of Initial Treatment Period (i.e., Week 16) to Week 48
The SP comprised all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Initial Treatment Period (Baseline - Week 16 Predose): Placebo | Participants received placebo via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period. | 0 | 321 | 4 | 321 | 67 | 321 |
| EG001 | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Participants received nemolizumab 30 milligrams (mg) via 2 SC injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period. | 0 | 616 | 6 | 616 | 144 | 616 |
| EG002 | Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q4W | Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a >=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period. | 0 | 91 | 4 | 91 | 27 | 91 |
| EG003 | Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Q8W | Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a >=75% improvement in EASI from Baseline) at Week 16 received nemolizumab 30 mg, every 8 weeks (Q8W) at Weeks 16, 24, 32, and 40 by a single SC injection during Maintenance Period. | 0 | 90 | 3 | 90 | 28 | 90 |
| EG004 | Maintenance Period (Week 16-Week 48): Nemolizumab 30 mg Q4W to Placebo Q4W | Participants who received nemolizumab, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a >=75% improvement in EASI from Baseline) at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period. | 0 | 91 | 2 | 91 | 33 | 91 |
| EG005 | Maintenance Period (Week 16-Week 48): Placebo Q4W Re-assigned to Placebo Q4W | Participants who received placebo, Q4W during Initial Treatment Period and were clinical responders (defined as participants with an IGA of 0 (clear) or 1 (almost clear) or a >=75% improvement in EASI from Baseline) at Week 16 received placebo, Q4W at Weeks 16, 20, 24, 28, 32, 36, 40, and 44 by a single SC injection during Maintenance Period. | 0 | 100 | 1 | 100 | 35 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | MedDRA(25.0) | Non-systematic Assessment |
| |
| Salivary gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(25.0) | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(25.0) | Non-systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA(25.0) | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA(25.0) | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA(25.0) | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA(25.0) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA(25.0) | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA(25.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA(25.0) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA(25.0) | Non-systematic Assessment |
| |
| Splenic injury | Injury, poisoning and procedural complications | MedDRA(25.0) | Non-systematic Assessment |
| |
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA(25.0) | Non-systematic Assessment |
| |
| Periarthiritis | Musculoskeletal and connective tissue disorders | MedDRA(25.0) | Non-systematic Assessment |
| |
| Plasmablastic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA(25.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA(25.0) | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA(25.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA(25.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA(25.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA(25.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA(25.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA(25.0) | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA(25.0) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 10, 2022 | Jun 18, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000612881 | nemolizumab |
Not provided
Not provided
Not provided
| Adverse Event |
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| Subjects request |
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| Lost to Follow-up |
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| Protocol Deviation |
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| Physician/PI Decision |
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| Other |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Participants |
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