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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The purpose of this study is to assess the safety and tolerability of repeated subcutaneous (SC) doses of Dupilumab in participants with moderate-to-severe atopic dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | Placebo (for Dupilumab) as a single subcutaneous (SC) injection on Day 1, 8, 15, and 22 |
|
| Dupilumab 150 mg | Experimental | Dupilumab 150 mg as a single SC injection on Day 1, 8, 15, and 22 |
|
| Dupilumab 300 mg | Experimental | Dupilumab 300 mg as a single SC injection on Day 1, 8, 15, and 22 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | A total of 4 doses were administered. |
| |
| Dupilumab |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was considered as medically important event. 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 visit [Day 85]). Any TEAE included participants with both serious and non-serious AEs. | Baseline up to end of study (up to Day 85) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Dupilumab: Peak Plasma Concentration (Cmax) | Maximum Plasma Concentration of functional Dupilumab observed following the fourth (last) dose. | Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85 |
| Pharmacokinetics of Dupilumab: Last Positive (Quantifiable) Concentration (Clast) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Investigator's Global Assessment (IGA) Score of "0" or "1" at Day 29/ Week 4 (End of Treatment Period) | 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" at Week 4 are reported. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kogarah | New South Wales | Australia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25482871 | Result | Hamilton JD, Suarez-Farinas M, Dhingra N, Cardinale I, Li X, Kostic A, Ming JE, Radin AR, Krueger JG, Graham N, Yancopoulos GD, Pirozzi G, Guttman-Yassky E. Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2014 Dec;134(6):1293-1300. doi: 10.1016/j.jaci.2014.10.013. | |
| 25006719 |
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| Drug |
A total of 4 doses were administered. |
|
|
| Background treatment | Other | Participants were required to apply stable doses of an additive-free, basic bland emollient on the affected areas of the skin twice daily throughout the study. |
|
Last Positive (Quantifiable) Concentration of Dupilumab. |
| Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85 |
| Pharmacokinetics of Dupilumab: Time of the Last Positive (Quantifiable) Concentration (Tlast) | Mean time of last measurable concentration of Dupilumab in actual days. | Day 22 (pre-dose), 25, 29, 36, 43, 50, 57, 64, 71 and Day 85 |
| At Day 29/ Week 4 |
| Percent Change From Baseline in Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 4 | 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 Day 29/ Week 4 |
| Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 4 | 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 Day 29/ Week 4 |
| Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 4 | 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.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). | Baseline to Day 29/ Week 4 |
| Percent Change From Baseline in 5-D Pruritus Scale to Week 4 | The 5-D Pruritus was a 5-question tool used in clinical trials to assess 5 dimensions of background itch: degree, duration, direction, disability, and distribution. Each question corresponded to 1 of the 5 dimensions of itch. Participants rated their symptoms over the preceding 2-week period on a scale of 1 (least affected) to 5 (most affected). Total score ranges from 1 (least affected) to 25 (most affected). | Baseline to Day 29/ Week 4 |
| Change From Baseline in Average Weekly Pruritus Numerical Rating Scale (NRS) Score 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]). | Baseline to Day 29/ Week 4 |
| Woolloongabba |
| Queensland |
| Australia |
| Carlton | Victoria | Australia |
| Nedlands | Western Australia | Australia |
| Hanover | Lower Saxony | Germany |
| Bonn | North Rhine-Westphalia | Germany |
| Berlin | 10117 | Germany |
| Berlin | 10827 | Germany |
| Gera | Germany |
| Münster | Germany |
| Sydenham | Christchurch | New Zealand |
| Caversham | Dunedin | New Zealand |
| Auckland | New Zealand |
| 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. |
| 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 |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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