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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult participants with moderate-to-severe atopic dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo qw | Experimental | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection every week (qw) from Week 1 to Week 15. |
|
| Dupilumab 300 mg qw | Experimental | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15. |
|
| Dupilumab 300 mg q2w | Experimental | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 15. |
|
| Dupilumab 200 mg q2w | Experimental | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15. |
|
| Dupilumab 300 mg q4w | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16 | IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a static 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders. |
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The inclusion criteria included, but were not limited to, the following:
The exclusion criteria included, but were not limited to, the following:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26454361 | Result | Thaci D, Simpson EL, Beck LA, Bieber T, Blauvelt A, Papp K, Soong W, Worm M, Szepietowski JC, Sofen H, Kawashima M, Wu R, Weinstein SP, Graham NM, Pirozzi G, Teper A, Sutherland ER, Mastey V, Stahl N, Yancopoulos GD, Ardeleanu M. Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2016 Jan 2;387(10013):40-52. doi: 10.1016/S0140-6736(15)00388-8. Epub 2015 Oct 8. | |
| 26777100 |
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Randomization was stratified by disease severity (moderate Investigator's global assessment [IGA] = 3 versus severe IGA = 4 atopic dermatitis) and region (Japan versus rest of world). Assignment to arms was done centrally in 1:1:1:1:1:1 ratio for Dupilumab (300 mg qw; 300 mg q2w; 200 mg q2w; 300 mg q4w and 100 mg q4w) and Placebo.
The study was conducted at 95 study sites in 7 countries. A total of 452 participants were screened between 15 May 2013 and 10 January 2014. 380 participants were randomized and 379 were treated. 72 participants were screen failures mainly due to exclusion criteria met and inclusion criteria not met.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dupilumab 300 mg qw | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection every week (qw) from Week 1 to Week 15. |
| FG001 | Dupilumab 300 mg q2w |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab every 4 weeks (q4w) and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15.
|
| Dupilumab 100 mg q4w | Experimental | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15. |
|
| Placebo | Drug |
|
| Week 16 |
| Percentage of Participants Who Achieved IGA Score Reduction of ≥2 at Week 16 | IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic success is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders. | Week 16 |
| Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16 | Pruritus NRS is an assessment tool that is used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). | Baseline to Week 16 |
| Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16 | Pruritus NRS is an assessment tool that is used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). | Baseline to Week 16 |
| Absolute Change in EASI Score From Baseline to Week 16 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | Baseline to Week 16 |
| Percent Change in SCORing Atopic Dermatitis (SCORAD) Scores From Baseline to Week 16 | SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). | Baseline to Week 16 |
| Absolute Change in SCORAD Scores From Baseline to Week 16 | SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). | Baseline to Week 16 |
| Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score (EASI-50, EASI-75 and EASI-90 Respectively) at Week 16 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50, EASI-75 and EASI-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in EASI score respectively from baseline to Week 16. | Week 16 |
| Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16 | SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). SCORAD-50, SCORAD-75 and SCORAD-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in SCORAD score respectively from baseline to Week 16. | Week 16 |
| Percent Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 16 | POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]). | Baseline to Week 16 |
| Absolute Change in POEM Scores From Baseline to Week 16 | POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]). | Baseline to Week 16 |
| Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16 | Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0=none, 1=mild, 2=moderate and 3=severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease). | Baseline to Week 16 |
| Changes in GISS Cumulative Score From Baseline to Week 16 | Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none,1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease). | Baseline to Week 16 |
| Mobile |
| Alabama |
| United States |
| Tucson | Arizona | United States |
| Bakersfield | California | United States |
| San Diego | California | United States |
| Santa Monica | California | United States |
| Jacksonville | Florida | United States |
| Ormond Beach | Florida | United States |
| Skokie | Illinois | United States |
| New Orleans | Louisiana | United States |
| Andover | Massachusetts | United States |
| Boston | Massachusetts | United States |
| Troy | Michigan | United States |
| St Louis | Missouri | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Winston-Salem | North Carolina | United States |
| Portland | Oregon | United States |
| Pittsburgh | Pennsylvania | United States |
| Johnston | Rhode Island | United States |
| Greer | South Carolina | United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Seattle | Washington | United States |
| Vancouver (2 Locations) | British Columbia | Canada |
| Winnipeg | Manitoba | Canada |
| Barrie | Ontario | Canada |
| Hamilton | Ontario | Canada |
| Markham | Ontario | Canada |
| Oakville | Ontario | Canada |
| Peterborough | Ontario | Canada |
| Richmond Hill | Ontario | Canada |
| Waterloo | Ontario | Canada |
| Windsor | Ontario | Canada |
| Saint-Hyacinthe | Quebec | Canada |
| Québec | Canada |
| Kutná Hora | Czechia |
| Náchod | Czechia |
| Prague | Czechia |
| Svitavy | Czechia |
| Ústí nad Labem | Czechia |
| Augsburg | Germany |
| Baden | Germany |
| Berlin | Germany |
| Bonn | Germany |
| Dresden | Germany |
| Dülmen | Germany |
| Frankfurt am Main | Germany |
| Frankfurt/Main, Hessen | Germany |
| Gera | Germany |
| Hamburg | Germany |
| Heidelberg | Germany |
| Kiel | Germany |
| Mahlow | Germany |
| Munich | Germany |
| Münster | Germany |
| Osnabrück | Germany |
| Tübingen | Germany |
| Borsod-Abauj-Zemplen | Hungary |
| Budapest | Hungary |
| Kaposvár | Hungary |
| Szeged | Hungary |
| Szolnok | Hungary |
| Tolna | Hungary |
| Fukuoka | Japan |
| Hokkaido | Japan |
| Saitama | Japan |
| Tokyo, Bunkyo-ku | Japan |
| Tokyo, Chiyoda-ku | Japan |
| Tokyo, Nakano-ku | Japan |
| Tokyo, Nerima-ku | Japan |
| Tokyo, Shibuya-ku | Japan |
| Tokyo, Shinagawa-ku | Japan |
| Tokyo, Shinjuku-ku (2 Locations) | Japan |
| Tokyo, Suginami-ku (2 Locations) | Japan |
| Yokohama | Japan |
| Gdansk (2 Locations) | Poland |
| Katowice | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Poznan | Poland |
| Warsaw (2 Locations) | Poland |
| Wroclaw | Poland |
| Result |
| Simpson EL, Bieber T, Eckert L, Wu R, Ardeleanu M, Graham NM, Pirozzi G, Mastey V. Patient burden of moderate to severe atopic dermatitis (AD): Insights from a phase 2b clinical trial of dupilumab in adults. J Am Acad Dermatol. 2016 Mar;74(3):491-8. doi: 10.1016/j.jaad.2015.10.043. Epub 2016 Jan 14. |
| 27268421 | Result | Simpson EL, Gadkari A, Worm M, Soong W, Blauvelt A, Eckert L, Wu R, Ardeleanu M, Graham NMH, Pirozzi G, Sutherland ER, Mastey V. Dupilumab therapy provides clinically meaningful improvement in patient-reported outcomes (PROs): A phase IIb, randomized, placebo-controlled, clinical trial in adult patients with moderate to severe atopic dermatitis (AD). J Am Acad Dermatol. 2016 Sep;75(3):506-515. doi: 10.1016/j.jaad.2016.04.054. Epub 2016 Jun 4. |
| 36723913 | Derived | Paller AS, Silverberg JI, Cork MJ, Guttman-Yassky E, Lockshin B, Irvine AD, Kim MB, Kabashima K, Chen Z, Lu Y, Bansal A, Rossi AB, Shabbir A. Efficacy and Safety of Dupilumab in Patients With Erythrodermic Atopic Dermatitis: A Post Hoc Analysis of 6 Randomized Clinical Trials. JAMA Dermatol. 2023 Mar 1;159(3):255-266. doi: 10.1001/jamadermatol.2022.6192. |
| 35986664 | Derived | Kamal MA, Davis JD, Kovalenko P, Srinivasan K, Simpson EL, Nakahara T, Sugaya M, Igarashi A, Ardeleanu M, Xu C, Arima K. Pharmacokinetics, pharmacodynamics, and exposure-efficacy of dupilumab in adults with atopic dermatitis. Clin Transl Sci. 2022 Oct;15(10):2342-2354. doi: 10.1111/cts.13363. Epub 2022 Aug 20. |
| 33165005 | Derived | Silverberg JI, Simpson EL, Guttman-Yassky E, Cork MJ, de Bruin-Weller M, Yosipovitch G, Eckert L, Chen Z, Ardeleanu M, Shumel B, Hultsch T, Rossi AB, Hamilton JD, Orengo JM, Ruddy M, Graham NMH, Pirozzi G, Gadkari A. Dupilumab Significantly Modulates Pain and Discomfort in Patients With Atopic Dermatitis: A Post Hoc Analysis of 5 Randomized Clinical Trials. Dermatitis. 2021 Oct 1;32(1S):S81-S91. doi: 10.1097/DER.0000000000000698. |
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab every 2 weeks (q2w) from Week 1 to Week 15.
| FG002 | Dupilumab 200 mg q2w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15. |
| FG003 | Dupilumab 300 mg q4w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab every 4 weeks (q4w) and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| FG004 | Dupilumab 100 mg q4w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| FG005 | Placebo | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline population included safety analysis set (SAF) that included all randomized participants who received any investigational product and analyzed as treated. One participant randomized into Dupilumab 200 mg q2w arm was not treated and hence, excluded from the baseline population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dupilumab 300 mg qw | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15. |
| BG001 | Dupilumab 300 mg q2w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15. |
| BG002 | Dupilumab 200 mg q2w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15. |
| BG003 | Dupilumab 300 mg q4w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| BG004 | Dupilumab 100 mg q4w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| BG005 | Placebo | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. |
| BG006 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 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 | Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | Full analysis set (FAS) that included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed = participants with EASI score assessment at specified time-point. Efficacy data was set to missing after use of rescue medication. Missing values imputed by last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Deviation | Percent change | Baseline to Week 16 |
|
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| Secondary | Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16 | IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a static 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders. | Analysis was performed on FAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved IGA Score Reduction of ≥2 at Week 16 | IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic success is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders. | Analysis was performed on FAS. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 16 |
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| Secondary | Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16 | Pruritus NRS is an assessment tool that is used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). | Analysis was performed on FAS. Here, number of participants analyzed = participants with pruritus NRS assessment at specified time-point. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF. | Posted | Mean | Standard Deviation | Percent change | Baseline to Week 16 |
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| Secondary | Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16 | Pruritus NRS is an assessment tool that is used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). | Analysis was performed on FAS. Here, number of participants analyzed =participants with pruritus NRS assessment at specified time-points. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in EASI Score From Baseline to Week 16 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | Analysis was performed on FAS. Here, number of participants analyzed = participants with EASI score assessment at specified time-points. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline to Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in SCORing Atopic Dermatitis (SCORAD) Scores From Baseline to Week 16 | SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). | Analysis was performed on FAS. Here, number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline to Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in SCORAD Scores From Baseline to Week 16 | SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). | Analysis was performed on FAS. Here, number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score (EASI-50, EASI-75 and EASI-90 Respectively) at Week 16 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50, EASI-75 and EASI-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in EASI score respectively from baseline to Week 16. | Analysis was performed on FAS. Participants with a missing EASI score at Week 16 were treated as non-responders. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16 | SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). SCORAD-50, SCORAD-75 and SCORAD-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in SCORAD score respectively from baseline to Week 16. | Analysis was performed on FAS. Participants with a missing SCORAD score at Week 16 were treated as non-responders. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 16 | POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]). | Analysis was performed on FAS. Here, number of participants analyzed = participants with POEM score assessment at specified time-points. Missing values imputed by LOCF. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline to Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in POEM Scores From Baseline to Week 16 | POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]). | Analysis was performed on FAS. Here, number of participants analyzed = participants with POEM score assessment at specified time-points. Missing values imputed by LOCF. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 16 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16 | Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0=none, 1=mild, 2=moderate and 3=severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease). | Analysis was performed on FAS. Here, number of participants analyzed = participants with GISS score assessment at specified time-points. Missing values imputed by LOCF. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 16 |
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| Secondary | Changes in GISS Cumulative Score From Baseline to Week 16 | Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none,1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease). | Analysis was performed on FAS. Here, number of participants analyzed = participants with GISS score assessment at specified time-points. Missing values imputed by LOCF. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline to Week 16 |
|
Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Baseline to Week 32) regardless of seriousness or relationship to investigational product
TEAEs that developed during the treatment and follow-up period (time period from the administration of first dose of study drug to the EOS visit [Week 32]).
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 | Dupilumab 300 mg qw | Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection qw from Week 1 to Week 15. | 1 | 63 | 35 | 63 | ||
| EG001 | Dupilumab 300 mg q2w | Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 300 mg injection of Dupilumab q2w from Week 1 to Week 15. | 2 | 64 | 34 | 64 | ||
| EG002 | Dupilumab 200 mg q2w | Participants who received 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15. | 1 | 61 | 34 | 61 | ||
| EG003 | Dupilumab 300 mg q4w | Participants who received 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15. | 3 | 65 | 39 | 65 | ||
| EG004 | Dupilumab 100 mg q4w | Participants who received 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw when Dupilumab not administered from Week 1 to Week 15. | 5 | 65 | 38 | 65 | ||
| EG005 | Placebo | Participants who received 2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection every week (qw) from Week 1 to Week 15. | 4 | 61 | 38 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | meddra (16.0) | Systematic Assessment |
| |
| Hip dysplasia | Congenital, familial and genetic disorders | meddra (16.0) | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | meddra (16.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | meddra (16.0) | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | meddra (16.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | meddra (16.0) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | meddra (16.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | meddra (16.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | meddra (16.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | meddra (16.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | meddra (16.0) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | meddra (16.0) | Systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | meddra (16.0) | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | meddra (16.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | meddra (16.0) | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | meddra (16.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | meddra (16.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra (16.0) | Systematic Assessment |
| |
| Fatigue | General disorders | meddra (16.0) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | meddra (16.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | meddra (16.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | meddra (16.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | meddra (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | meddra (16.0) | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | meddra (16.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | meddra (16.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | meddra (16.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra (16.0) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | meddra (16.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | meddra (16.0) | Systematic Assessment |
|
Not less than 45 days prior to submission for publication or presentation, the Institution shall, or cause the Principal Investigator to, provide the Sponsor with a copy of the Manuscript. The Institution shall consider in good faith any comments from the Sponsor regarding the content, and shall delete Confidential Information upon written request of the Sponsor. At the Sponsor's request, the Institution shall delay publication for an additional 60 days to allow patent applications to be filed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals, Inc | clinicaltrials@regeneron.com |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| 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 |
|---|---|
| C582203 | dupilumab |
Not provided
Not provided
Not provided
| Male |
|
| Superiority or Other |
| Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). | ANCOVA | <0.0001 | Threshold for significance at 0.05 level. | LS mean difference | -50.1 | Standard Error of the Mean | 6.67 | 2-Sided | 95 | -63.3 | -37.0 | Dupilumab 300 mg q2w vs Placebo | Superiority or Other |
| Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). | ANCOVA | <0.0001 | Threshold for significance at 0.05 level. | LS mean difference | -47.4 | Standard Error of the Mean | 6.76 | 2-Sided | 95 | -60.6 | -34.1 | Dupilumab 200 mg q2w vs Placebo | Superiority or Other |
| Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). | ANCOVA | <0.0001 | Threshold for significance at 0.05 level. | LS mean difference | -45.4 | Standard Error of the Mean | 6.66 | 2-Sided | 95 | -58.5 | -32.3 | Dupilumab 300 mg q4w vs Placebo | Superiority or Other |
| Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). | ANCOVA | <0.0001 | Threshold for significance at 0.05 level. | LS mean difference | -26.8 | Standard Error of the Mean | 6.65 | 2-Sided | 95 | -39.8 | -13.7 | Dupilumab 100 mg q4w vs Placebo | Superiority or Other |
| OG003 | Dupilumab 300 mg q4w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG004 | Dupilumab 100 mg q4w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG005 | Placebo | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. |
|
|
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
| OG003 | Dupilumab 300 mg q4w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG004 | Dupilumab 100 mg q4w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG005 | Placebo | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. |
|
|
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15. |
| OG003 | Dupilumab 300 mg q4w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG004 | Dupilumab 100 mg q4w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG005 | Placebo | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. |
|
|
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15. |
| OG003 | Dupilumab 300 mg q4w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG004 | Dupilumab 100 mg q4w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG005 | Placebo | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. |
|
|
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15.
| OG003 | Dupilumab 300 mg q4w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG004 | Dupilumab 100 mg q4w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG005 | Placebo | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. |
|
|
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15. |
| OG003 | Dupilumab 300 mg q4w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG004 | Dupilumab 100 mg q4w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG005 | Placebo | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. |
|
|
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15. |
| OG003 | Dupilumab 300 mg q4w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG004 | Dupilumab 100 mg q4w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG005 | Placebo | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. |
|
|
| Dupilumab 200 mg q2w |
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15. |
| OG003 | Dupilumab 300 mg q4w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG004 | Dupilumab 100 mg q4w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG005 | Placebo | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. |
|
|
| OG002 | Dupilumab 200 mg q2w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15. |
| OG003 | Dupilumab 300 mg q4w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG004 | Dupilumab 100 mg q4w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG005 | Placebo | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. |
|
|
| OG003 | Dupilumab 300 mg q4w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG004 | Dupilumab 100 mg q4w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG005 | Placebo | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. |
|
|
| OG003 | Dupilumab 300 mg q4w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG004 | Dupilumab 100 mg q4w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG005 | Placebo | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. |
|
|
Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single injection of Placebo (for Dupilumab) alternating with single 200 mg injection of Dupilumab q2w from Week 1 to Week 15. |
| OG003 | Dupilumab 300 mg q4w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG004 | Dupilumab 100 mg q4w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG005 | Placebo | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. |
|
|
| OG003 | Dupilumab 300 mg q4w | Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a single 300 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG004 | Dupilumab 100 mg q4w | Two subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1, followed by a single 100 mg injection of Dupilumab q4w and Placebo (for Dupilumab) qw (when Dupilumab not administered) from Week 1 to Week 15. |
| OG005 | Placebo | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15. |
|
|
|
|
|
|