Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dupilumab SAR231893 · 11 trials · 12 indications
The EASI is a composite index with scores ranging from 0 to 72.Higher scores indicates worse condition
The ice cube provocation test is the most frequently used provocation method for cold urticaria (ColdU). A negative ice cube provocation test was defined as the absence of confluent hives/wheal at the entire skin site of exposure after ice cube provocation test. Ice cube was applied on forearm skin for 5 minutes. Provocation test reading time was 10 minutes after removal of ice cube.
The LMK score is used to quantify the degree of opacification of each sinus on CT scan. The CT scan LMK staging system represents the most widely established method of sinus CT scoring. The LMK total score is based on assessment of the CT scan findings for each sinus area (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinus plus the osteomeatal complex on each side). The extent of sinus opacification is rated on a 3-point scale ranging from 0 = normal to 2 = total opacification. In addition, the osteomeatal complex is graded as 0 = not occluded or 2 = occluded. The maximum score is 12 per side; total score ranges from 0 (normal) to 24 (more opacified) corresponding to the sum of all sinuses and the osteomeatal complexes bilaterally. Higher score indicate worse outcome; a negative change from baseline indicate improvement. Baseline was defined as the last available value before the first dose of study drug.
Moderate exacerbations were recorded by the Investigator and defined as acute exacerbation of COPD (AECOPD) event that required either systemic corticosteroids (such as intramuscular, intravenous, or oral) and/or antibiotics. Severe exacerbations were also recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for \>24 hours in an emergency department/urgent care facility or resulted in death. For both moderate and severe events to be counted as separate events, they were separated by at least 14 days. Annualized event rate was the total number of events that occurred during the 52-week treatment period divided by the total number of participant-years followed in the 52-week treatment period.
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with \>=4 points improvement (reduction) from baseline in WI-NRS scores at Week 12 is reported in this outcome measure.
WI-NRS is a validated measure of itch severity. Participants were asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicated more severity. Percentage of participants with improvement (reduction) in WI-NRS scores by \>=4 points from Baseline to Week 24 is reported in this outcome measure.
ISS was recorded in e-diary. The ISS represents severity of itch on a scale ranging from 0 (none) to 3 (intense). The ISS7 score was the sum of daily ISS scores recorded by a participant at the same time each day over 7 days with an overall scale of 0 (no impact) to 21 (severe impact). Higher scores indicated greater intensity of itch. Least squares (LS) mean is presented. Baseline was defined as the sum of daily scores obtained for 7 days prior to randomization.
NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Least squares (LS) means and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model described in Statistical Analysis Overview.
NPS: sum of right, left nostril scores, evaluated by nasal endoscopy. For each nostril, NPS was graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity; lower score = smaller-sized polyps. Total NPS: sum of right and left nostril scores; ranges from 0 (no polyps) to 8 (large polyps), higher score = more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.
The CT scan LMK staging system represented the most widely established method of sinus CT scoring. The LMK total score is based on assessment of the CT scan findings for each sinus area (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinus on each side). The extent of mucosal opacification is rated on a 3-point scale ranging from 0 = normal to 2 = total opacification. In addition, the ostiomeatal complex is graded as 0 = not occluded or 2 = occluded. The maximum score is therefore 12 per side; total score ranges from 0 (normal) to 24 (more opacified), corresponding to the sum of all sinuses and the ostiomeatal unit. Higher score indicated worse outcome. Baseline was defined as the last available value up to randomization date and prior to the first dose of study medication.
| Arm | Type | Description |
|---|---|---|
| Dupilumab | EXPERIMENTAL | Double dose on day1 and followed by single dose every 2 weeks or single dose every 4 weeks |
| Placebo | PLACEBO_COMPARATOR | Double dose on day1 and followed by single dose every 2 weeks or single dose every 4 weeks |
| Matched Placebo | PLACEBO_COMPARATOR | Placebo, on top of regular/as needed non-sedating H1-antihistamine |
| Matching placebo | PLACEBO_COMPARATOR | Placebo administered every 2 or 4 weeks based on weights |
| Dupilumab 300 mg Q2W | EXPERIMENTAL | Participants received dupilumab at a loading dose of 600 mg, SC on Day 1 followed by dupilumab 300 mg q2w for 24 weeks added to background therapy of TCS/TCI at stable dose. |
| Study A Dupilumab | EXPERIMENTAL | Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 milligrams (mg) SC injection every 2 weeks (q2w) for adults and those adolescents who weighed \>=60 kilograms (kg) at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection every 4 weeks (q4w) for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1. |
| Study A Placebo | PLACEBO_COMPARATOR | Participants who were omalizumab naïve received placebo matched to dupilumab as subcutaneous (SC) injection including loading dose from Day 1 up to 24 weeks. |
| Study B Dupilumab | EXPERIMENTAL | Participants who were intolerant or incomplete responders to omalizumab received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents weighing \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1 or * 200 mg SC injection q2w for adolescents weighing \<60 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1. |
| Study B Placebo | PLACEBO_COMPARATOR | Participants who were intolerant or incomplete responders to omalizumab received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks. |
| Study C Dupilumab | EXPERIMENTAL | Participants who were omalizumab naïve received dupilumab for 24 weeks as follows: * 300 mg SC injection q2w for adults and those adolescents who weighed \>=60 kg at screening starting from Week 2 following a loading dose of 600 mg (2×300 mg injections) on Day 1, * 200 mg SC injection q2w for adolescents who weighed \<60 kg and children (\>=6 to \<12 years of age) who weighed \>=30 kg at screening starting from Week 2 following a loading dose of 400 mg (2×200 mg injections) on Day 1 and * 300 mg SC injection q4w for children (\>=6 to \<12 years of age) who weighed \<30 kg and \>=15 kg at screening starting from Week 4 following a loading dose of 600 mg (2×300 mg injections) on Day 1. |
| Study C Placebo | PLACEBO_COMPARATOR | Participants who were omalizumab naïve received placebo matched to dupilumab as SC injection including loading dose from Day 1 up to 24 weeks. |
| Dupilumab 300 mg | EXPERIMENTAL | Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 added to background therapy of intranasal MFNS at stable dose. |
| Dupilumab 300 mg q2w then q4w | EXPERIMENTAL | Dupilumab 300 mg SC injection q2w from Day 1 of Week 0 up to Week 24 and then 300 mg q4w until Week 52 added to background therapy of intranasal MFNS at stable dose. After Week 24, Dupilumab administration was alternated with matched placebo injection every other week up to Week 50. |
| Part A and B: Dupilumab | EXPERIMENTAL | Participants received dupilumab 300 milligrams (mg) via SC injection q2w for up to 53.1 weeks. |
| Part A and B: Matching placebo | PLACEBO_COMPARATOR | Participants received matching placebo via SC injection q2w for up to 53.2 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC) |
| Dupilumab SAR231893 | DRUG | Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC) |
| Non sedating H1-antihistamine | DRUG | Pharmaceutical form: Tablet Route of administration: Oral |
| Inhaled Corticosteroid | DRUG | Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation |
| Inhaled Long-Acting Beta Agonist | DRUG | Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation |
| Inhaled Long-Acting Muscarinic Antagonist | DRUG | Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation |
| Moisturizers | DRUG | Pharmaceutical form: Route of administration: Topical |
| Low to medium potent topical corticosteroids | DRUG | Pharmaceutical form: Route of administration: Topical |
| Topical calcineurin inhibitors | DRUG | Pharmaceutical form: Route of administration: Topical |
| Dupilumab SAR231893 (REGN668) | DRUG | Pharmaceutical form: Solution Route of administration: Subcutaneous |
| Mometasone furoate 50 micrograms | DRUG | Pharmaceutical form: Suspension (Nasal spray) Route of administration: Intranasal |
| Mometasone furoate nasal spray | DRUG | Pharmaceutical form: Suspension Route of administration: Intranasal |
Inclusion criteria : Japanese and ≥6 months to \<18 years of age, at the time of signing the informed consent and/or assent. Diagnosis of AD according to the American Academy of Dermatology consensus criteria at screening visit. Chronic AD diagnosed at least 1 year prior to the screening visit (f...
Dupilumab SAR231893 is an investigational drug being studied for allergic fungal rhinosinusitis, chronic rhinosinusitis with nasal polyps (CRSwNP), cold urticaria, atopic dermatitis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease. It is in Phase 3 clinical development for these respiratory and inflammatory conditions.
Dupilumab SAR231893 is being developed by Sanofi, a biopharmaceutical company traded on the stock exchange under the ticker symbol SNY. The drug is currently in Phase 3 clinical trials for multiple indications including chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria.
Dupilumab SAR231893 is in Phase 3 clinical development. It has received FDA designations including Priority Review and Orphan Drug designation. The drug is investigational and not yet approved, with completed Phase 3 trials in chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria.
Dupilumab SAR231893 has completed three Phase 3 trials: NCT02898454 and NCT02912468 for chronic rhinosinusitis with nasal polyps, and NCT04180488 for chronic spontaneous urticaria. These trials enrolled a total of 1,874 participants across multiple countries including the United States, Japan, and European nations.
Yes, Dupilumab SAR231893 is also known as SAR231893. The drug is being developed by Sanofi and is in Phase 3 clinical trials for conditions such as chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria. It has received FDA Priority Review and Orphan Drug designations.