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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection once weekly (qw) from Week 1 to Week 15. |
|
| Dupilumab 300 mg every 2 weeks (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 placebo alternating with single 300 mg injection of Dupilumab 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 of Dupilumab qw from Week 1 to Week 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points 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 response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16 | The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders. |
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Inclusion Criteria:
Exclusion Criteria:
Participation in a prior Dupilumab clinical study.
Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit;
Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
Regular use (more than 2 visits per week) of a tanning booth/ parlor within 4 weeks of the screening visit;
Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit;
History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening;
Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit;
Active chronic or acute infection requiring systemic treatment within 2 weeks before the baseline visit;
Known or suspected history of immunosuppression;
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study;
Women unwilling to use adequate birth control, if of reproductive potential and sexually active.
Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anniston | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27690741 | Result | Simpson EL, Bieber T, Guttman-Yassky E, Beck LA, Blauvelt A, Cork MJ, Silverberg JI, Deleuran M, Kataoka Y, Lacour JP, Kingo K, Worm M, Poulin Y, Wollenberg A, Soo Y, Graham NM, Pirozzi G, Akinlade B, Staudinger H, Mastey V, Eckert L, Gadkari A, Stahl N, Yancopoulos GD, Ardeleanu M; SOLO 1 and SOLO 2 Investigators. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. N Engl J Med. 2016 Dec 15;375(24):2335-2348. doi: 10.1056/NEJMoa1610020. Epub 2016 Sep 30. | |
| 40993471 |
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Out of 962 participants, 708 were randomized and 707 were treated in the study. Participants were randomized in 1:1:1 ratio to receive Dupilumab 300 mg once weekly (qw), Dupilumab 300 mg every 2 weeks (q2w) or Placebo qw.
The study was conducted in 10 countries between 03 December 2014 and 21 January 2016. A total of 962 participants were screened in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Dupilumab 300 mg q2w |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo (for Dupilumab) | Drug | Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms. |
|
| Week 16 |
| Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 | Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders. | Baseline to Week 16 |
| Percentage of Participants With Improvement (Reduction ≥3 Points) in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 | Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders. | Baseline to Week 16 |
| Percent Change From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (NRS) Score to Week 16 | Pruritus NRS was an assessment tool that was used to report the intensity of a 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 |
| Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4 | Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders. | Baseline to Week 4 |
| Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2 | Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders. | Baseline to Week 2 |
| Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16 | Pruritus NRS was an assessment tool that was used to report the intensity of a 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 |
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16 | The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | Baseline to Week 16 |
| Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16 | The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 16 were considered as non-responders. | Week 16 |
| Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 16 | The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-90 scores at Week 16 were considered as non-responders. | Week 16 |
| Change From Baseline in Percent Body Surface Area (BSA) to Week 16 | BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined. | Baseline to Week 16 |
| Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score 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 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16 | The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL. | Baseline to Week 16 |
| Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16 | The 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 |
| Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16 | HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression. | Baseline to Week 16 |
| Percent Change From Baseline in Global Individual Signs Score (GISS) 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 |
| Percent Change From Baseline in Weekly Average of Peak Daily Pruritus NRS Score to Week 2 | Pruritus NRS was an assessment tool that was used to report the intensity of a 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 2 |
| Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment | Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. Statistical significance in the hierarchical testing of secondary hypotheses was broken at this endpoint. Therefore, subsequent secondary efficacy endpoints were not tested for statistical significance. | Baseline up to Week 16 |
| Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16 | Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. | Baseline up to Week 16 |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16 | Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. | Baseline up to Week 16 |
| Birmingham |
| Alabama |
| United States |
| Phoenix | Arizona | United States |
| Bakersfield | California | United States |
| Costa Mesa | California | United States |
| Fremont | California | United States |
| Long Beach | California | United States |
| Los Angeles | California | United States |
| Orange | California | United States |
| Roseville | California | United States |
| Temecula | California | United States |
| Trumbull | Connecticut | United States |
| Miami | Florida | United States |
| Oviedo | Florida | United States |
| Tampa | Florida | United States |
| West Palm Beach | Florida | United States |
| Alpharetta | Georgia | United States |
| Atlanta | Georgia | United States |
| Columbus | Georgia | United States |
| Buffalo Grove | Illinois | United States |
| Plainfield | Indiana | United States |
| West Des Moines | Iowa | United States |
| Overland Park | Kansas | United States |
| Rockville | Maryland | United States |
| Washington Park | Maryland | United States |
| Boston | Massachusetts | United States |
| Farmington Hills | Michigan | United States |
| Minneapolis | Minnesota | United States |
| Plymouth | Minnesota | United States |
| Saint Joseph | Missouri | United States |
| St Louis | Missouri | United States |
| Billings | Montana | United States |
| Bozeman | Montana | United States |
| Las Vegas | Nevada | United States |
| Verona | New Jersey | United States |
| Forest Hills | New York | United States |
| New York | New York | United States |
| Smithtown | New York | United States |
| Chapel Hill | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Tulsa | Oklahoma | United States |
| Portland | Oregon | United States |
| Jenkintown | Pennsylvania | United States |
| Greer | South Carolina | United States |
| Arlington | Texas | United States |
| Austin | Texas | United States |
| Bellaire | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Richmond | Virginia | United States |
| Seattle | Washington | United States |
| Calgary | Alberta | Canada |
| Edmonton | Alberta | Canada |
| Surrey | British Columbia | Canada |
| St. John's | Newfoundland and Labrador | Canada |
| Ajax | Ontario | Canada |
| Mississauga | Ontario | Canada |
| Oakville | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Peterborough | Ontario | Canada |
| Richmond Hill | Ontario | Canada |
| Montreal | Quebec | Canada |
| Lille | France |
| Marseille | France |
| Nantes | France |
| Berlin | Germany |
| Bochum | Germany |
| Darmstadt | Germany |
| Friedrichshafen | Germany |
| Hamburg | Germany |
| Kiel | Germany |
| Hong Kong | Hong Kong |
| Lucca | Italy |
| Pisa | Italy |
| Roma | Italy |
| Kaunas | Lithuania |
| Klaipėda | Lithuania |
| Vilnius | Lithuania |
| Elblag | Poland |
| Gdansk | Poland |
| Katowice | Poland |
| Poznan | Poland |
| Torun | Poland |
| Warsaw | Poland |
| Busan | South Korea |
| Gyeonggi-do | South Korea |
| Incheon | South Korea |
| Seoul | South Korea |
| Stockholm | Sweden |
| London | United Kingdom |
| Plymouth | United Kingdom |
| Derived |
| Langley RG, Gherardi G, Coleman A, Ardeleanu M, Rodriguez-Marco A, Levy S, Bansal A, Chen Z, Rossi AB, Shumel B, Khokhar FA. The Safety Data of Dupilumab for the Treatment of Moderate-to-Severe Atopic Dermatitis in Infants, Children, Adolescents, and Adults. Am J Clin Dermatol. 2025 Nov;26(6):981-1002. doi: 10.1007/s40257-025-00952-w. Epub 2025 Sep 24. |
| 39588375 | Derived | Kamal MA, Kosloski MP, Lai CH, Partridge MA, Rajadhyaksha M, Kanamaluru V, Bansal A, Shabbir A, Shumel B, Ardeleanu M, Richards SM, Yan H, Xu CR, Rodriguez-Marco A, Xiao J, Khokhar FA, Gherardi G, Babilonia E, Maloney J, Mortensen E, Akinlade B, Braunstein N, Stahl N, Torri A, Davis JD, DiCioccio AT. Immunogenicity of dupilumab in adult and pediatric patients with atopic dermatitis. Front Immunol. 2024 Nov 11;15:1466372. doi: 10.3389/fimmu.2024.1466372. eCollection 2024. |
| 36808602 | Derived | Silverberg JI, Lynde CW, Abuabara K, Patruno C, de Benedetto A, Zhang H, Thomas RB, Bego-Le-Bagousse G, Khokhar FA, Vakil J, Marco AR, Levit NA. Efficacy and Safety of Dupilumab Maintained in Adults >/= 60 Years of Age with Moderate-to-Severe Atopic Dermatitis: Analysis of Pooled Data from Four Randomized Clinical Trials. Am J Clin Dermatol. 2023 May;24(3):469-483. doi: 10.1007/s40257-022-00754-4. Epub 2023 Feb 20. |
| 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. |
| 36269503 | Derived | Silverberg JI, Boguniewicz M, Hanifin J, Papp KA, Zhang H, Rossi AB, Levit NA. Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis is Efficacious Regardless of Age of Disease Onset: a Post Hoc Analysis of Two Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2731-2746. doi: 10.1007/s13555-022-00822-x. Epub 2022 Oct 21. |
| 35636689 | Derived | Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28. |
| 34897582 | Derived | Armstrong A, Blauvelt A, Simpson EL, Smith CH, Herranz P, Kataoka Y, Seo SJ, Ferrucci SM, Chao J, Chen Z, Rossi AB, Shumel B, Tomondy P. Continued Treatment with Dupilumab is Associated with Improved Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Not Achieving Optimal Responses with Short-Term Treatment. Dermatol Ther (Heidelb). 2022 Jan;12(1):195-202. doi: 10.1007/s13555-021-00643-4. Epub 2021 Dec 13. |
| 34726270 | Derived | Paller AS, Tan JKL, Bagel J, Rossi AB, Shumel B, Zhang H, Abramova A. IGAxBSA composite for assessing disease severity and response in patients with atopic dermatitis. Br J Dermatol. 2022 Mar;186(3):496-507. doi: 10.1111/bjd.20872. Epub 2022 Feb 25. |
| 34142350 | Derived | Griffiths C, de Bruin-Weller M, Deleuran M, Fargnoli MC, Staumont-Salle D, Hong CH, Sanchez-Carazo J, Foley P, Seo SJ, Msihid J, Chen Z, Cyr SL, Rossi AB. Dupilumab in Adults with Moderate-to-Severe Atopic Dermatitis and Prior Use of Systemic Non-Steroidal Immunosuppressants: Analysis of Four Phase 3 Trials. Dermatol Ther (Heidelb). 2021 Aug;11(4):1357-1372. doi: 10.1007/s13555-021-00558-0. Epub 2021 Jun 18. |
| 34037993 | Derived | Hamilton JD, Harel S, Swanson BN, Brian W, Chen Z, Rice MS, Amin N, Ardeleanu M, Radin A, Shumel B, Ruddy M, Patel N, Pirozzi G, Mannent L, Graham NMH. Dupilumab suppresses type 2 inflammatory biomarkers across multiple atopic, allergic diseases. Clin Exp Allergy. 2021 Jul;51(7):915-931. doi: 10.1111/cea.13954. Epub 2021 Jun 26. |
| 33453450 | Derived | Boguniewicz M, Beck LA, Sher L, Guttman-Yassky E, Thaci D, Blauvelt A, Worm M, Corren J, Soong W, Lio P, Rossi AB, Lu Y, Chao J, Eckert L, Gadkari A, Hultsch T, Ruddy M, Mannent LP, Graham NMH, Pirozzi G, Chen Z, Ardeleanu M. Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1212-1223.e6. doi: 10.1016/j.jaip.2020.12.059. Epub 2021 Jan 13. |
| 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. |
| 31424712 | Derived | Alexis AF, Rendon M, Silverberg JI, Pariser DM, Lockshin B, Griffiths CE, Weisman J, Wollenberg A, Chen Z, Davis JD, Li M, Eckert L, Gadkari A, Shumel B, Rossi AB, Graham NM, Ardeleanu M. Efficacy of Dupilumab in Different Racial Subgroups of Adults With Moderate-to-Severe Atopic Dermatitis in Three Randomized, Placebo-Controlled Phase 3 Trials. J Drugs Dermatol. 2019 Aug 1;18(8):804-813. |
| 31407311 | Derived | Wollenberg A, Beck LA, Blauvelt A, Simpson EL, Chen Z, Chen Q, Shumel B, Khokhar FA, Hultsch T, Rizova E, Rossi AB, Graham NMH, Pirozzi G, Lu Y, Ardeleanu M. Laboratory safety of dupilumab in moderate-to-severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY AD CHRONOS). Br J Dermatol. 2020 May;182(5):1120-1135. doi: 10.1111/bjd.18434. Epub 2019 Dec 1. |
| 31066001 | Derived | Eichenfield LF, Bieber T, Beck LA, Simpson EL, Thaci D, de Bruin-Weller M, Deleuran M, Silverberg JI, Ferrandiz C, Folster-Holst R, Chen Z, Graham NMH, Pirozzi G, Akinlade B, Yancopoulos GD, Ardeleanu M. Infections in Dupilumab Clinical Trials in Atopic Dermatitis: A Comprehensive Pooled Analysis. Am J Clin Dermatol. 2019 Jun;20(3):443-456. doi: 10.1007/s40257-019-00445-7. |
| 30791102 | Derived | Silverberg JI, Simpson EL, Ardeleanu M, Thaci D, Barbarot S, Bagel J, Chen Z, Eckert L, Chao J, Korotzer A, Rizova E, Rossi AB, Lu Y, Graham NMH, Hultsch T, Pirozzi G, Akinlade B. Dupilumab provides important clinical benefits to patients with atopic dermatitis who do not achieve clear or almost clear skin according to the Investigator's Global Assessment: a pooled analysis of data from two phase III trials. Br J Dermatol. 2019 Jul;181(1):80-87. doi: 10.1111/bjd.17791. Epub 2019 Apr 11. |
| 28503712 | Derived | Simpson EL. Dupilumab Improves General Health-Related Quality-of-Life in Patients with Moderate-to-Severe Atopic Dermatitis: Pooled Results from Two Randomized, Controlled Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2017 Jun;7(2):243-248. doi: 10.1007/s13555-017-0181-6. Epub 2017 May 13. |
Two subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1, followed by a placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15.
| FG002 | 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 of Dupilumab qw from Week 1 to Week 15. |
| Treated |
|
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
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Baseline population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 placebo alternating with single 300 mg injection of Dupilumab qw from Week 1 to Week 15. |
| BG002 | 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 of Dupilumab qw from Week 1 to Week 15. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Eczema Area and Severity Index (EASI) Score | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measured 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. | Mean | Standard Deviation | units on a scale |
| |||||||||
| Investigator's Global Assessment (IGA) Score | IGA was 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 response was an IGA score of 0 (clear) or 1 (almost clear). | Mean | Standard Deviation | units on a scale |
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| Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) | Pruritus NRS scale 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]). | Number of participants analyzed = participants with available data for the baseline parameter. | Mean | Standard Deviation | units on a scale |
| ||||||||
| Body Surface Area (BSA) Involvement with AD | Body surface area affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined. | Mean | Standard Deviation | percentage of body surface area |
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| SCORing Atopic Dermatitis (SCORAD) Score | SCORAD was 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.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). | Number of participants analyzed = participants with available data for the baseline parameter. | Mean | Standard Deviation | units on a scale |
| ||||||||
| Dermatology Life Quality Index (DLQI) Score | The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score indicative of a poor QOL. | Mean | Standard Deviation | units on a scale |
| |||||||||
| Patient Oriented Eczema Measure (POEM) | The POEM was a 7-item questionnaire that assessed 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]). | Mean | Standard Deviation | units on a scale |
| |||||||||
| Global Individual Signs Score (GISS) | 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). | Mean | Standard Deviation | units on a scale |
| |||||||||
| Total Hospital Anxiety Depression Scale (HADS) | The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression. | Number of participants analyzed = participants with available data for the baseline parameter. | Mean | Standard Deviation | units on a scale |
|
| 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) Score of "0" or "1" and Reduction From Baseline of ≥2 Points 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 response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders. | Full analysis set included all randomized participants. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16 | The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders. | Full analysis set included all randomized participants. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 | Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders. | Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4. | Posted | Number | percentage of participants | Baseline to Week 16 |
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| Secondary | Percentage of Participants With Improvement (Reduction ≥3 Points) in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16 | Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders. | Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥3. | Posted | Number | percentage of participants | Baseline to Week 16 |
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| Secondary | Percent Change From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (NRS) Score to Week 16 | Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). | Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 16 |
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| Secondary | Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4 | Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders. | Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4. | Posted | Number | percentage of participants | Baseline to Week 4 |
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| Secondary | Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2 | Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders. | Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4. | Posted | Number | percentage of participants | Baseline to Week 2 |
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| Secondary | Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16 | Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). | Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 16 |
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| Secondary | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16 | The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 16 |
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| Secondary | Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16 | The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 16 were considered as non-responders. | Full analysis set (FAS) included all randomized participants. | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 16 | The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-90 scores at Week 16 were considered as non-responders. | Full analysis set (FAS) included all randomized participants. | Posted | Number | percentage of particpants | Week 16 |
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| Secondary | Change From Baseline in Percent Body Surface Area (BSA) to Week 16 | BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined. | Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint. | Posted | Mean | Standard Deviation | percentage of body surface area | Baseline to Week 16 |
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| Secondary | Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score 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). | Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 16 |
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| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16 | The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL. | Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 16 |
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| Secondary | Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16 | The 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]). | Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 16 |
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| Secondary | Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16 | HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression. | Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 16 |
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| Secondary | Percent Change From Baseline in Global Individual Signs Score (GISS) 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). | Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 16 |
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| Secondary | Percent Change From Baseline in Weekly Average of Peak Daily Pruritus NRS Score to Week 2 | Pruritus NRS was an assessment tool that was used to report the intensity of a 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]). | Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 2 |
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| Secondary | Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment | Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. Statistical significance in the hierarchical testing of secondary hypotheses was broken at this endpoint. Therefore, subsequent secondary efficacy endpoints were not tested for statistical significance. | Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated. | Posted | Number | percentage of participants | Baseline up to Week 16 |
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| Secondary | Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16 | Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. | Safety analysis set which included all randomized participants who received any study drug, and was analyzed based on the treatment received. | Posted | Number | percentage of participants | Baseline up to Week 16 |
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| Secondary | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16 | Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. | Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated. | Posted | Number | percentage of participants | Baseline up to Week 16 |
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All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 28) regardless of seriousness or relationship to investigational product.
Reported AEs are treatment-emergent adverse events that developed/worsened during the 'on-treatment period' (time form the first dose of study drug up to the end of study [Week 28]). Analysis was performed on safety population.
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 | Placebo | Participants exposed to Placebo (for Dupilumab) for 16 weeks (mean exposure of 14 weeks) | 0 | 234 | 16 | 234 | 109 | 234 |
| EG001 | Dupilumab 300 mg q2w | Participants exposed to Dupilumab 300 mg alternating with placebo qw for 16 weeks (mean exposure of 15 weeks). | 3 | 236 | 6 | 236 | 84 | 236 |
| EG002 | Dupilumab 300 mg qw | Participants exposed to Dupilumab 300 mg qw for 16 weeks (mean exposure of 15 weeks). | 1 | 237 | 9 | 237 | 90 | 237 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | meddra (18.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | meddra (18.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | meddra (18.0) | Systematic Assessment |
| |
| Angle closure glaucoma | Eye disorders | meddra (18.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra (18.0) | Systematic Assessment |
| |
| Colonic pseudo-obstruction | Gastrointestinal disorders | meddra (18.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | meddra (18.0) | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | meddra (18.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | meddra (18.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | meddra (18.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | meddra (18.0) | Systematic Assessment |
| |
| Septic embolus | Infections and infestations | meddra (18.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | meddra (18.0) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | meddra (18.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | meddra (18.0) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | meddra (18.0) | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | meddra (18.0) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | meddra (18.0) | Systematic Assessment |
| |
| Tetany | Metabolism and nutrition disorders | meddra (18.0) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | meddra (18.0) | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra (18.0) | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra (18.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | meddra (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | meddra (18.0) | Systematic Assessment |
| |
| Hypoxic-Ischaemic encephalopathy | Nervous system disorders | meddra (18.0) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | meddra (18.0) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | meddra (18.0) | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | meddra (18.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | meddra (18.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | meddra (18.0) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | meddra (18.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | meddra (18.0) | Systematic Assessment |
| |
| Schizophrenia, paranoid type | Psychiatric disorders | meddra (18.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | meddra (18.0) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | meddra (18.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | meddra (18.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | meddra (18.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | meddra (18.0) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | meddra (18.0) | Systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | meddra (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | meddra (18.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | meddra (18.0) | Systematic Assessment |
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| Headache | Nervous system disorders | meddra (18.0) | Systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | meddra (18.0) | Systematic Assessment |
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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 |
| 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
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Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity. |
| Cochran-Mantel-Haenszel |
| < 0.0001 |
Threshold for significance at 0.025 level. |
| difference in percentages |
| 27.9 |
| 2-Sided |
| 95 |
| 20.87 |
| 34.99 |
Dupilumab 300 mg qw vs Placebo |
| Superiority |
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 qw from Week 1 to Week 15. |
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| OG002 | 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 of Dupilumab qw from Week 1 to Week 15. |
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| OG002 | 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 of Dupilumab qw from Week 1 to Week 15. |
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| OG002 | 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 of Dupilumab qw from Week 1 to Week 15. |
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| OG002 | 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 of Dupilumab qw from Week 1 to Week 15. |
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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 qw from Week 1 to Week 15. |
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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 qw from Week 1 to Week 15. |
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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 qw from Week 1 to Week 15.
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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 qw from Week 1 to Week 15.
|
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| OG002 | 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 of Dupilumab qw from Week 1 to Week 15. |
|
|
| OG002 | 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 of Dupilumab qw from Week 1 to Week 15. |
|
|
| OG002 | 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 of Dupilumab qw from Week 1 to Week 15. |
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