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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 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 administered via subcutaneous injection |
|
| Nemolizumab | Experimental | Nemolizumab administered via subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo |
| |
| Nemolizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Investigator's Global Assessment (IGA) Success at Week 16: 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 Investigator's Global Assessment (IGA) Success at Week 16: 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. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. 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 |
| 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 8749 | Birmingham | Alabama | 35244 | United States | ||
| Galderma Investigational Site 8893 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40116983 | Derived | 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 |
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A total of 787 randomized 2:1 to receive either nemolizumab or placebo.At Week 16, 235 nemolizumab treated participants were clinical responders(IGA of 0[clear] or 1[almost clear]or Eczema Area and Severity Index [EASI]-75) re-randomized to receive nemolizumab Q4,nemolizumab Q8W,or placebo during Maintenance Period.85 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 136 active sites in Belgium, Bulgaria, Estonia, France, Georgia, Germany, Hungary, Italy, Poland, Singapore, and the United States from 27 June 2019 to 26 September 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Initial Treatment Period (Baseline - Week 16 Predose): Nemolizumab 30 mg | Participants received nemolizumab 30 milligrams (mg) via 2 subcutaneous (SC) injections at Day 1, thereafter, Q4W at Weeks 4, 8, and 12 by a single SC injection during Initial Treatment Period. |
| FG001 | Initial Treatment Period (Baseline - Week 16 Predose): Placebo |
| 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 |
|
|
| Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 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. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. 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 |
| 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 |
| Birmingham |
| Alabama |
| 35244 |
| United States |
| Galderma Investigational Site 8866 | Guntersville | Alabama | 35976 | United States |
| Galderma Investigational Site 8808 | Scottsdale | Arizona | 85255 | United States |
| Galderma Investigational Site 8906 | Bell Gardens | California | 90201 | United States |
| Galderma Investigational Site 8905 | Canoga Park | California | 91304 | United States |
| Galderma Investigational Site 8577 | Encinitas | California | 92024 | United States |
| Galderma Investigational Site 8673 | Garden Grove | California | 92840 | United States |
| Galderma Investigational Site 8683 | Los Angeles | California | 90033 | United States |
| Galderma Investigational Site 8907 | Newport Beach | California | 92660 | United States |
| Galderma Investigational Site 8799 | Ontario | California | 91762 | United States |
| Galderma Investigational Site 8745 | Pasadena | California | 91105 | United States |
| Galderma Investigational Site 8658 | San Diego | California | 92123 | United States |
| Galderma Investigational Site 8536 | Santa Ana | California | 92705 | United States |
| Galderma Investigational Site 8820 | Westminster | California | 92683 | United States |
| Galderma Investigational Site 8637 | Farmington | Connecticut | 06030 | United States |
| Galderma Investigational Site 8875 | Delray Beach | Florida | 33484 | United States |
| Galderma Investigational Site 8391 | Hialeah | Florida | 33013 | United States |
| Galderma Investigational Site 8727 | Hialeah | Florida | 33016 | United States |
| Galderma Investigational Site 8523 | Largo | Florida | 33770 | United States |
| Galderma Investigational Site 8719 | Miami | Florida | 33125 | United States |
| Galderma Investigational Site 8656 | Miami | Florida | 33137 | United States |
| Galderma Investigational Site 8704 | Miami | Florida | 33155 | United States |
| Galderma Investigational Site 8706 | Miami | Florida | 33175 | United States |
| Galderma Investigational Site 8203 | Tampa | Florida | 33607 | United States |
| Galderma Investigational Site 8839 | Tampa | Florida | 33615 | United States |
| Galderma Investigational Site 8729 | Rolling Meadows | Illinois | 60008 | United States |
| Galderma Investigational Site 8724 | New Albany | Indiana | 47150 | United States |
| Galderma Investigational Site 8554 | Detroit | Michigan | 48202 | United States |
| Galderma Investigational Site 8825 | Las Vegas | Nevada | 89106 | United States |
| Galderma Investigational Site 8506 | Hackensack | New Jersey | 07601 | United States |
| Galderma Investigational Site 8741 | Buffalo | New York | 14221 | United States |
| Galderma Investigational Site 8723 | Cortland | New York | 13045 | United States |
| Galderma Investigational Site 8733 | New York | New York | 10022 | United States |
| Galderma Investigational Site 8823 | Greensboro | North Carolina | 27408 | United States |
| Galderma Investigational Site 8030 | Raleigh | North Carolina | 27612 | United States |
| Galderma Investigational Site 8747 | Cincinnati | Ohio | 45219 | United States |
| Galderma Investigational Site 8212 | Portland | Oregon | 97210 | United States |
| Galderma Investigational Site 8721 | Pittsburgh | Pennsylvania | 15213 | United States |
| Galderma Investigational Site 8713 | North Charleston | South Carolina | 29420 | United States |
| Galderma Investigational Site 8705 | Chattanooga | Tennessee | 37421 | United States |
| Galderma Investigational Site 8807 | Houston | Texas | 77029 | United States |
| Galderma Investigational Site 8618 | Waco | Texas | 76710 | United States |
| Galderma Investigational Site 8003 | Webster | Texas | 77598 | United States |
| Galderma Investigational Site 8672 | Salt Lake City | Utah | 84117 | United States |
| Galderma Investigational Site 8896 | Richmond | Virginia | 23219 | United States |
| Galderma Investigational Site 8434 | Seattle | Washington | 98105 | United States |
| Galderma Investigational Site 5448 | Brussels | 1200 | Belgium |
| Galderma Investigational Site 6164 | Ghent | 9000 | Belgium |
| Galderma Investigational Site 6038 | Leuven | 3000 | Belgium |
| Galderma Investigational Site 6162 | Liège | 4000 | Belgium |
| Galderma Investigational Site 6029 | Pleven | 5800 | Bulgaria |
| Galderma Investigational Site 6051 | Sofia | 1407 | Bulgaria |
| Galderma Investigational Site 6078 | Sofia | 1408 | Bulgaria |
| Galderma Investigational Site 6102 | Sofia | 1431 | Bulgaria |
| Galderma Investigational Site 6165 | Sofia | 1431 | Bulgaria |
| Galderma Investigational Site 6216 | Sofia | 1528 | Bulgaria |
| Galderma Investigational Site 6046 | Sofia | 1606 | Bulgaria |
| Galderma Investigational Site 6080 | Sofia | 1606 | Bulgaria |
| Galderma Investigational Site 6079 | Sofia | 1618 | Bulgaria |
| Galderma Investigational Site 6250 | Sofia | 1784 | Bulgaria |
| Galderma Investigational Site 6251 | Stara Zagora | 6000 | Bulgaria |
| Galderma Investigational Site 6068 | Tallinn | 10134 | Estonia |
| Galderma Investigational Site 6069 | Tallinn | 10138 | Estonia |
| Galderma Investigational Site 6067 | Tartu | 50417 | Estonia |
| Galderma Investigational Site 6198 | Le Mans | 72037 | France |
| Galderma Investigational Site 5031 | Lille | 59037 | France |
| Galderma Investigational Site 6170 | Martigues | 13500 | France |
| Galderma Investigational Site 6167 | Nantes | 44093 | France |
| Galderma Investigational Site 5140 | Nice | 6200 | France |
| Galderma Investigational Site 6133 | Paris | 75015 | France |
| Galderma Investigational Site 6166 | Paris | 75475 | France |
| Galderma Investigational Site 5407 | Pierre-Bénite | 69495 | France |
| Galderma Investigational Site 6135 | Quimper | 29 107 | France |
| Galderma Investigational Site 6197 | Toulon | 83800 | France |
| Galderma Investigational Site 6169 | Toulouse | 31000 | France |
| Galderma Investigational Site 6168 | Valence | 26000 | France |
| Galderma Investigational Site 6238 | Tbilisi | 0159 | Georgia |
| Galderma Investigational Site 6227 | Tbilisi | 0186 | Georgia |
| Galderma Investigational Site 6230 | Tbilisi | 0186 | Georgia |
| Galderma Investigation Site 6228 | Tbilisi | 159 | Georgia |
| Galderma Investigational Site 6224 | Tbilisi | 159 | Georgia |
| Galderma Investigational Site 6235 | Tbilisi | 159 | Georgia |
| Galderma Investigational Site 6234 | Tbilisi | 186 | Georgia |
| Galderma Investigational Site 6236 | Zugdidi | 2100 | Georgia |
| Galderma Investigational Site 5482 | Aachen | 52074 | Germany |
| Galderma Investigational Site 5566 | Augsburg | 86179 | Germany |
| Galderma Investigational Site 6082 | Bonn | 53127 | Germany |
| Galderma Investigational Site 6132 | Dresden | 01097 | Germany |
| Galderma Investigational Site 6031 | Düsseldorf | 40225 | Germany |
| Galderma Investigational Site 6083 | Frankfurt | 60437 | Germany |
| Galderma Investigational Site 5442 | Gera | 7548 | Germany |
| Galderma Investigational Site 6081 | Goettigen | 37075 | Germany |
| Galderma Investigational Site 6062 | Halle | 6120 | Germany |
| Galderma Investigational Site 6041 | Hamburg | 20251 | Germany |
| Galderma Investigational Site 6150 | Hamburg | 20537 | Germany |
| Galderma Investigational Site 6040 | Hamburg | 22391 | Germany |
| Galderma Investigational Site 5469 | Heidelberg | 69120 | Germany |
| Galderma Investigational Site 6086 | Kiel | 24148 | Germany |
| Galderma Investigational Site 6084 | Mainz | 55131 | Germany |
| Galderma Investigational Site 5382 | Munich | 80337 | Germany |
| Galderma Investigational Site 6147 | Budapest | 1036 | Hungary |
| Galderma Investigational Site 5513 | Budapest | 1085 | Hungary |
| Galderma Investigational Site 5567 | Debrecen | 4025 | Hungary |
| Galderma Investigational Site 6026 | Debrecen | 4032 | Hungary |
| Galderma Investigational Site 6254 | Gyula | 5700 | Hungary |
| Galderma Investigational Site 6053 | Veszprém | 8200 | Hungary |
| Galderma Investigational Site 6145 | Bologna | 40138 | Italy |
| Galderma Investigational Site 6141 | Chieti | 66013 | Italy |
| Galderma Investigational Site 6045 | L’Aquila | 67100 | Italy |
| Galderma Investigational Site 6151 | Parma | 43124 | Italy |
| Galderma Investigational Site 6180 | Pavia | 27100 | Italy |
| Galderma Investigational Site 6143 | Pisa | 56126 | Italy |
| Galderma Investigational Site 6044 | Roma | 00133 | Italy |
| Galderma Investigational Site 6049 | Roma | 00168 | Italy |
| Galderma Investigational Site 6177 | Rome | 00 144 | Italy |
| Galderma Investigational Site 6155 | Rozzano | 20089 | Italy |
| Galderma Investigational Site 6175 | Vicenza | 36100 | Italy |
| Galderma Investigational Site 5773 | Bialystok | 15-453 | Poland |
| Galderma Investigational Site 6097 | Chorzów | 41-500 | Poland |
| Galderma Investigational Site 5021 | Katowice | 40-611 | Poland |
| Galderma Investigational Site 5362 | Krakow | 30-033 | Poland |
| Galderma Investigational Site 6052 | Krakow | 31-559 | Poland |
| Galderma Investigational Site 5363 | Lodz | 90-436 | Poland |
| Galderma Investigational Site 5367 | Lublin | 20-080 | Poland |
| Galderma Investigational Site 5377 | Nowa Sól | 67-100 | Poland |
| Galderma Investigational Site 6063 | Olsztyn | 10-229 | Poland |
| Galderma Investigational Site 6085 | Poznan | 60-529 | Poland |
| Galderma Investigational Site 5495 | Rzeszów | 35-055 | Poland |
| Galderma Investigational Site 6130 | Szczecin | 71-434 | Poland |
| Galderma Investigational Site 6048 | Tarnów | 33-100 | Poland |
| Galderma Investigational Site 6126 | Warsaw | 01-142 | Poland |
| Galderma Investigational Site 5707 | Warsaw | 01-817 | Poland |
| Galderma Investigational Site 6185 | Wroclaw | 50-566 | Poland |
| Galderma Investigational Site 6096 | Wroclaw | 51-318 | Poland |
| Galderma Investigational Site 6124 | Singapore | 119228 | Singapore |
| Galderma Investigational Site 6077 | Singapore | 169608 | Singapore |
| Galderma Investigational Site 5499 | Singapore | 308205 | Singapore |
| 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 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. |
| 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 >=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. |
| 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 16, 24, 32, and 40 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. |
| Treated |
|
| Safety Population | The safety population comprised all participants who received at least 1 dose of study drug. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Period (Week 16-Week 48) |
|
|
The ITT population consisted of all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 Investigator's Global Assessment (IGA) Success at Week 16: 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 Investigator's Global Assessment (IGA) Success at Week 16: 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. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. 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. | 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 Week 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. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD. 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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| 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. Data was planned to be collected and analyzed for Initial Treatment Period. | Posted | Number | percentage of participants | Week 16 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 safety population 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): 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. | 0 | 519 | 13 | 519 | 71 | 519 |
| EG001 | 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 | 263 | 3 | 263 | 40 | 263 |
| 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 | 79 | 6 | 79 | 17 | 79 |
| 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 | 77 | 0 | 77 | 11 | 77 |
| 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 | 77 | 2 | 77 | 26 | 77 |
| 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 | 84 | 1 | 84 | 16 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Congenital cyst | Congenital, familial and genetic disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Eosinophilic colitis | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Infected cyst | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Ophthalmic herpes zoster | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Superinfection bacterial | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Psychogenic tremor | Psychiatric disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
|
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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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Physician Decision |
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| Other |
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| Re-randomized/Re-assigned but not Treated |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| 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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