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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The primary objective was to assess the clinical efficacy of repeated subcutaneous (SC) doses of Dupilumab in adult participants with moderate-to-severe atopic dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (for Dupilumab) once weekly for 12 weeks by subcutaneous (SC) injection. |
|
| Dupilumab 300 mg | Experimental | Dupilumab 300 mg once weekly for 12 weeks by SC injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Subcutaneous injection altered between back of arms, abdomen and upper thighs. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 12- Last Observation Carried Forward (LOCF) | 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. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 12- LOCF | 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). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. |
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Inclusion Criteria:
The inclusion criteria included, but were not limited to the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Náchod | Czechia | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25006719 | Result | Beck LA, Thaci D, Hamilton JD, Graham NM, Bieber T, Rocklin R, Ming JE, Ren H, Kao R, Simpson E, Ardeleanu M, Weinstein SP, Pirozzi G, Guttman-Yassky E, Suarez-Farinas M, Hager MD, Stahl N, Yancopoulos GD, Radin AR. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014 Jul 10;371(2):130-9. doi: 10.1056/NEJMoa1314768. | |
| 28845523 |
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Out of 153 participants, 109 were randomized and treated in the study. Participants were randomized in 1:1 ratio to receive either Dupilumab 300 mg or placebo.
The study was conducted at 25 sites in Europe between 3 April 2012 and 25 June 2013. A total of 153 participants were screened in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (for Dupilumab) once weekly for 12 weeks by subcutaneous (SC) injection. |
| FG001 | Dupilumab 300 mg | Dupilumab 300 mg once weekly for 12 weeks by SC injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dupilumab |
| Drug |
Subcutaneous injection altered between back of arms, abdomen and upper thighs. |
|
|
| Week 12 |
| Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI-50) at Week 12- LOCF | 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 12. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. | Week 12 |
| Change From Baseline in EASI Score at Week 12- LOCF | 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. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. | Baseline to Week 12 |
| Percent Change From Baseline in IGA Score at Week 12- LOCF | 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). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. | Baseline to Week 12 |
| Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 12 - LOCF | 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. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. | Baseline to Week 12 |
| Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 12- LOCF | 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). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. | Baseline to Week 12 |
| Change From Baseline in Pruritus Numerical Rating Scale (NRS) to Week 12- LOCF | 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]). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. | Baseline to Week 12 |
| Change From Baseline in 5-D Pruritus Scale at Week 12 | The 5-D Pruritus Scale is a 1-page, 5-question tool used in clinical trials to assess 5 dimensions of background itch: degree, duration, direction, disability, and distribution. Each question corresponds to 1 of the 5 dimensions of itch; participants were to rate their symptoms over the preceding 2-week period on a 1 to 5 scale, with 5 being the most affected. After the summation of individual score, the total score ranges from 5 (least affected) to 25 (most affected). | Baseline to Week 12 |
| Svitavy |
| Czechia |
| Ústí nad Labem | Czechia |
| Nice | France |
| Pierre-Bénite | France |
| Toulouse | France |
| Berlin | Germany |
| Bonn | Germany |
| Frankfurt | Germany |
| Gera | Germany |
| Heidelberg | Germany |
| Kiel | Germany |
| Münster | Germany |
| Kaposvár | Hungary |
| Szeged | Hungary |
| Szekszárd | Hungary |
| Szolnok | Hungary |
| Gdansk | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Warsaw | Poland |
| Tsianakas A, Luger TA, Radin A. Dupilumab treatment improves quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a randomized, placebo-controlled clinical trial. Br J Dermatol. 2018 Feb;178(2):406-414. doi: 10.1111/bjd.15905. Epub 2018 Jan 11. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (for Dupilumab) once weekly for 12 weeks by SC injection. |
| BG001 | Dupilumab 300 mg | Dupilumab 300 mg once weekly for 12 weeks by SC injection. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Eczema Area and Severity Index (EASI) Score | The EASI score is 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 ranges 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 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 was an IGA score of 0 (clear) or 1 (almost clear). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Scoring Atopic Dermatitis (SCORAD) Score | SCORAD is a clinical tool for assessing the severity of atopic dermatitis 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). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Body Surface Area (BSA) | 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 BSA |
| ||||||||||||||
| 5-D Pruritus Scale | The 5-D Pruritus Scale is a 1-page, 5-question tool used in clinical trials to assess 5 dimensions of background itch: degree, duration, direction, disability, and distribution. Each question corresponds to 1 of the 5 dimensions of itch; participants were to rate their symptoms over the preceding 2-week period on a 1 to 5 scale, with 5 being the most affected. After the summation of individual score, the total score ranges from 5 (least affected) to 25 (most affected). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Pruritus Numerical Rating Scale (NRS) Score | 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]). | 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 | Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 12- Last Observation Carried Forward (LOCF) | 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. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. | Full analysis set (FAS) population included all randomized participants who received at least one dose of study drug and had at least 1 post-baseline efficacy assessment. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 12 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 12- LOCF | 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). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. | FAS population. | Posted | Number | percentage of participants | Week 12 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI-50) at Week 12- LOCF | 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 12. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. | FAS population. | Posted | Number | Percentage of participants | Week 12 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EASI Score at Week 12- LOCF | 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. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. | FAS population. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in IGA Score at Week 12- LOCF | 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). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. | FAS population. | Posted | Mean | Standard Deviation | Percent change | Baseline to Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 12 - LOCF | 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. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. | FAS population. | Posted | Mean | Standard Deviation | Percentage of BSA | Baseline to Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 12- LOCF | 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). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. | FAS population. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 12 |
|
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| Secondary | Change From Baseline in Pruritus Numerical Rating Scale (NRS) to Week 12- LOCF | 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]). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF. | FAS population. Number of participants analyzed = participants with available data for this endpoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 12 |
|
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| Secondary | Change From Baseline in 5-D Pruritus Scale at Week 12 | The 5-D Pruritus Scale is a 1-page, 5-question tool used in clinical trials to assess 5 dimensions of background itch: degree, duration, direction, disability, and distribution. Each question corresponds to 1 of the 5 dimensions of itch; participants were to rate their symptoms over the preceding 2-week period on a 1 to 5 scale, with 5 being the most affected. After the summation of individual score, the total score ranges from 5 (least affected) to 25 (most affected). | FAS population. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 12 |
|
|
All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 197) regardless of seriousness or relationship to investigational product.
Reported adverse events (AEs) are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug through the end of study (Day 197).
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 | Placebo (for Dupilumab) once weekly for 12 weeks by SC injection. | 7 | 54 | 31 | 54 | ||
| EG001 | Dupilumab 300 mg | Dupilumab 300 mg once weekly for 12 weeks by SC injection. | 1 | 55 | 38 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Eczema herpeticum | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | 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 |
| 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 |
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