Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT01949311 | Dermatitis, Atopic | Number of Treatment Emergent Adverse Events (TEAEs) Up to 272 weeks | Dupilumab | 14717 Number of Events |
| NCT01949311 | Dermatitis, Atopic | OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product Up to 24 Weeks | Dupilumab | 0 Events |
| NCT02134028 | Asthma | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks) | Participants From DRI12544: Dupilumab/Dupilumab | 369 Participants |
| Participants From DRI12544: Dupilumab/Dupilumab | 19 Participants | |||
| Participants From DRI12544: Dupilumab/Dupilumab | 3 Participants | |||
| Participants From DRI12544: Dupilumab/Dupilumab | 42 Participants | |||
| Participants From DRI12544: Placebo/Dupilumab | 88 Participants | |||
| Participants From DRI12544: Placebo/Dupilumab | 3 Participants | |||
| Participants From DRI12544: Placebo/Dupilumab | 0 Participants | |||
| Participants From DRI12544: Placebo/Dupilumab | 14 Participants | |||
| Participants From EFC13579: Dupilumab/Dupilumab | 31 Participants | |||
| Participants From EFC13579: Dupilumab/Dupilumab | 789 Participants | |||
| Participants From EFC13579: Dupilumab/Dupilumab | 106 Participants | |||
| Participants From EFC13579: Dupilumab/Dupilumab | 1 Participants | |||
| Participants From EFC13579: Placebo/Dupilumab | 48 Participants | |||
| Participants From EFC13579: Placebo/Dupilumab | 414 Participants | |||
| Participants From EFC13579: Placebo/Dupilumab | 12 Participants | |||
| Participants From EFC13579: Placebo/Dupilumab | 0 Participants | |||
| Participants From EFC13691: Dupilumab/Dupilumab | 0 Participants | |||
| Participants From EFC13691: Dupilumab/Dupilumab | 70 Participants | |||
| Participants From EFC13691: Dupilumab/Dupilumab | 10 Participants | |||
| Participants From EFC13691: Dupilumab/Dupilumab | 5 Participants | |||
| Participants From EFC13691: Placebo/Dupilumab | 4 Participants | |||
| Participants From EFC13691: Placebo/Dupilumab | 74 Participants | |||
| Participants From EFC13691: Placebo/Dupilumab | 12 Participants | |||
| Participants From EFC13691: Placebo/Dupilumab | 0 Participants | |||
| Participants From PDY14192: Dupilumab/Dupilumab | 0 Participants | |||
| Participants From PDY14192: Dupilumab/Dupilumab | 2 Participants | |||
| Participants From PDY14192: Dupilumab/Dupilumab | 13 Participants | |||
| Participants From PDY14192: Dupilumab/Dupilumab | 4 Participants | |||
| Participants From PDY14192: Placebo/Dupilumab | 18 Participants | |||
| Participants From PDY14192: Placebo/Dupilumab | 1 Participants | |||
| Participants From PDY14192: Placebo/Dupilumab | 0 Participants | |||
| Participants From PDY14192: Placebo/Dupilumab | 0 Participants | |||
| NCT02260986 CHRONOS | Dermatitis, Atopic | Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 Baseline to Week 16 | Dupilumab 300 mg q2w | 38.7 percentage of participants |
| Dupilumab 300 mg qw | 39.2 percentage of participants | |||
| Placebo qw | 12.4 percentage of participants | |||
| NCT02277743 SOLO 1 | Dermatitis, Atopic | Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 Week 16 | Dupilumab 300 mg q2w | 37.9 percentage of participants |
| Dupilumab 300 mg qw | 37.2 percentage of participants | |||
| Placebo | 10.3 percentage of participants | |||
| NCT02277769 SOLO 2 | Dermatitis, Atopic | Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of ≥2 Points at Week 16 Week 16 | Dupilumab 300 mg q2w | 36.1 percentage of participants |
| Dupilumab 300 mg qw | 36.4 percentage of participants | |||
| Placebo | 8.5 percentage of participants | |||
| NCT02395133 SOLO-CONTINUE | Dermatitis, Atopic | Difference Between Current Study Baseline and Week 36 in Percent Change in EASI From Parent Study Baseline (NCT02277743 and NCT02277769) Baseline (Parent Study), Baseline (Current Study) and Week 36 (Current study) | Dupilumab 300 mg Q2W/QW | 0.06 percent change (±1.736 Standard Error) |
| Dupilumab 300 mg Q4W | 3.84 percent change (±2.283 Standard Error) | |||
| Dupilumab 300 mg Q8W | 6.84 percent change (±2.434 Standard Error) | |||
| Placebo QW | 21.67 percent change (±3.134 Standard Error) | |||
| NCT02395133 SOLO-CONTINUE | Dermatitis, Atopic | Percentage of Participants With Eczema Area and Severity Index >= 75% [EASI-75] at Baseline of Current Study Maintaining EASI-75 at Week 36 Week 36 | Dupilumab 300 mg Q2W/QW | 71.6 percentage of participants |
| Dupilumab 300 mg Q4W | 58.3 percentage of participants | |||
| Dupilumab 300 mg Q8W | 54.9 percentage of participants | |||
| Placebo QW | 30.4 percentage of participants | |||
| NCT02414854 | Asthma | Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population Baseline, Week 12 | Dupilumab 200 mg q2w | 1.78 liter (±0.62 Standard Deviation) |
| Dupilumab 200 mg q2w | 0.28 liter (±0.45 Standard Deviation) | |||
| Dupilumab 200 mg q2w | 2.07 liter (±0.76 Standard Deviation) | |||
| Dupilumab 300 mg q2w | 1.78 liter (±0.60 Standard Deviation) | |||
| Dupilumab 300 mg q2w | 0.31 liter (±0.43 Standard Deviation) | |||
| Dupilumab 300 mg q2w | 2.09 liter (±0.70 Standard Deviation) | |||
| Placebo (for Dupilumab 200 mg) q2w | 1.92 liter (±0.70 Standard Deviation) | |||
| Placebo (for Dupilumab 200 mg) q2w | 1.76 liter (±0.61 Standard Deviation) | |||
| Placebo (for Dupilumab 200 mg) q2w | 0.15 liter (±0.36 Standard Deviation) | |||
| Placebo (for Dupilumab 300 mg) q2w | 0.18 liter (±0.39 Standard Deviation) | |||
| Placebo (for Dupilumab 300 mg) q2w | 1.93 liter (±0.68 Standard Deviation) | |||
| Placebo (for Dupilumab 300 mg) q2w | 1.75 liter (±0.57 Standard Deviation) | |||
| NCT02414854 | Asthma | Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population Baseline to Week 52 | Dupilumab 200 mg q2w | 0.456 Exacerbation per participant-year |
| Dupilumab 300 mg q2w | 0.524 Exacerbation per participant-year | |||
| Placebo (for Dupilumab 200 mg) q2w | 0.871 Exacerbation per participant-year | |||
| Placebo (for Dupilumab 300 mg) q2w | 0.970 Exacerbation per participant-year | |||
| NCT02528214 VENTURE | Asthma | Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control Baseline, Week 24 | Dupilumab 300 mg q2w | 70.09 Percentage reduction from baseline (±4.90 Standard Error) |
| Placebo q2w | 41.85 Percentage reduction from baseline (±4.57 Standard Error) | |||
| NCT02528214 VENTURE | Asthma | Supplementary Presentation of Primary Outcome Measure Data: Median Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control Baseline, Week 24 | Dupilumab 300 mg q2w | 100.0 percentage reduction from baseline |
| Placebo q2w | 50.0 percentage reduction from baseline | |||
| NCT02755649 | Dermatitis, Atopic | Percentage of Participants With Eczema Area and Severity Index (EASI) 75 (≥75% Improvement From Baseline) at Week 16 Baseline, Week 16 | Dupilumab 300 mg Q2W + TCS | 62.6 Percentage of Participants |
| Dupilumab 300 mg QW + TCS | 59.1 Percentage of Participants | |||
| Placebo QW + TCS | 29.6 Percentage of Participants | |||
| NCT02898454 SINUS-52 | — | Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score Baseline, Week 24 | Dupilumab 300 mg (24 Weeks Pooled Arm) | -1.25 score on a scale (±0.06 Standard Error) |
| Placebo | -0.38 score on a scale (±0.07 Standard Error) | |||
| NCT02898454 SINUS-52 | — | Change From Baseline at Week 24 in Nasal Polyp Score Baseline, Week 24 | Dupilumab 300 mg (24 Weeks Pooled Arm) | -1.71 score on a scale (±0.11 Standard Error) |
| Placebo | 0.10 score on a scale (±0.14 Standard Error) | |||
| NCT02912468 SINUS-24 | Nasal Polyps | Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score Baseline, Week 24 | Dupilumab 300 mg | -1.34 score on a scale (±0.07 Standard Error) |
| Placebo | -0.45 score on a scale (±0.07 Standard Error) | |||
| NCT02912468 SINUS-24 | Nasal Polyps | Change From Baseline at Week 24 in Nasal Polyp Score Baseline, Week 24 | Dupilumab 300 mg | -1.89 score on a scale (±0.14 Standard Error) |
| Placebo | 0.17 score on a scale (±0.15 Standard Error) | |||
| NCT02948959 VOYAGE | Asthma | Annualized Rate of Severe Exacerbation Events During the 52-Week Treatment Period: Baseline Blood Eosinophils >=300 Cells Per Microliter Population Baseline to Week 52 | Dupilumab | 0.235 exacerbations per participant-years |
| Placebo | 0.665 exacerbations per participant-years | |||
| NCT02948959 VOYAGE | Asthma | Annualized Rate of Severe Exacerbation Events During the 52-Week Treatment Period: Type 2 Inflammatory Asthma Phenotype Population Baseline to Week 52 | Dupilumab | 0.305 exacerbations per participant-years |
| Placebo | 0.748 exacerbations per participant-years | |||
| NCT03054428 | Dermatitis, Atopic | Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Improvement From Baseline) at Week 16 Baseline and Week 16 | Dupilumab 200 mg or 300 mg Q2W | 41.5 Percentage of participants |
| Dupilumab 300 mg Q4W | 38.1 Percentage of participants | |||
| Placebo | 8.2 Percentage of participants | |||
| NCT03054428 | Dermatitis, Atopic | Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 (and Reduction From Baseline of ≥2 Points) at Week 16 Baseline and Week 16 | Dupilumab 200 mg or 300 mg Q2W | 24.4 Percentage of participants |
| Dupilumab 300 mg Q4W | 17.9 Percentage of participants | |||
| Placebo | 2.4 Percentage of participants | |||
| NCT03345914 | Dermatitis, Atopic | Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 at Week 16 Week 16 | Dupilumab 100 mg or 200 mg Q2W + TCS | 29.5 Percentage of Participants |
| Dupilumab 300 mg Q4W + TCS | 32.8 Percentage of Participants | |||
| Placebo + TCS | 11.4 Percentage of Participants | |||
| NCT03346434 Liberty AD | Dermatitis, Atopic | Part A: Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast) of Dupilumab Post-dose on Days 1, 3, 8, 18, and 29 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | 198 Days*Milligrams per Liter (day*mg/L) (±125 Standard Deviation) |
| Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | 622 Days*Milligrams per Liter (day*mg/L) (±184 Standard Deviation) | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg | 123 Days*Milligrams per Liter (day*mg/L) (±86.0 Standard Deviation) | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg | 493 Days*Milligrams per Liter (day*mg/L) (±294 Standard Deviation) | |||
| NCT03346434 Liberty AD | Dermatitis, Atopic | Part A: Dose Normalized Area Under the Serum Concentration-Time Curve From Time Zero to the Time of the Last Measurable Concentration (AUClast/Dose) of Dupilumab Post-dose on Days 1, 3, 8, 18, and 29 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | 66.0 [day*mg/L]/[mg/kg] (±41.6 Standard Deviation) |
| Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | 104 [day*mg/L]/[mg/kg] (±30.6 Standard Deviation) | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg | 41.0 [day*mg/L]/[mg/kg] (±28.7 Standard Deviation) | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg | 82.1 [day*mg/L]/[mg/kg] (±48.9 Standard Deviation) | |||
| NCT03346434 Liberty AD | Dermatitis, Atopic | Part A: Dose Normalized Maximum Observed Serum Concentration (Cmax/Dose) of Dupilumab Post-dose on Days 1, 3, 8, 18, and 29 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | 8.39 [mg/L]/[mg/kg] (±2.48 Standard Deviation) |
| Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | 8.30 [mg/L]/[mg/kg] (±1.89 Standard Deviation) | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg | 6.70 [mg/L]/[mg/kg] (±2.27 Standard Deviation) | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg | 7.68 [mg/L]/[mg/kg] (±1.86 Standard Deviation) | |||
| NCT03346434 Liberty AD | Dermatitis, Atopic | Part A: Last Quantifiable Serum Concentration (Clast) of Dupilumab Post-dose on Days 1, 3, 8, 18, and 29 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | 6.64 mg/L (±6.16 Standard Deviation) |
| Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | 6.14 mg/L (±4.69 Standard Deviation) | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg | 5.64 mg/L (±4.52 Standard Deviation) | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg | 15.1 mg/L (±9.48 Standard Deviation) | |||
| NCT03346434 Liberty AD | Dermatitis, Atopic | Part A: Maximum Observed Serum Concentration (Cmax) of Functional Dupilumab Post-dose on Days 1, 3, 8, 18, and 29 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | 25.2 Milligrams per Liter (mg/L) (±7.44 Standard Deviation) |
| Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | 49.8 Milligrams per Liter (mg/L) (±11.3 Standard Deviation) | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg | 20.1 Milligrams per Liter (mg/L) (±6.81 Standard Deviation) | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg | 46.1 Milligrams per Liter (mg/L) (±11.1 Standard Deviation) | |||
| NCT03346434 Liberty AD | Dermatitis, Atopic | Part A: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) Baseline up to Week 4 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | 3 Participants |
| Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | 2 Participants | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg | 7 Participants | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg | 7 Participants | |||
| NCT03346434 Liberty AD | Dermatitis, Atopic | Part A: Number of Participants With TEAEs by Severity According to Qualitative Toxicity Scale Baseline up to Week 4 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | 2 Participants |
| Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | 1 Participants | |||
| Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | 0 Participants | |||
| Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | 0 Participants | |||
| Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | 0 Participants | |||
| Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | 2 Participants | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg | 4 Participants | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg | 2 Participants | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg | 1 Participants | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg | 0 Participants | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg | 2 Participants | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg | 5 Participants | |||
| NCT03346434 Liberty AD | Dermatitis, Atopic | Part A: Time of the Last Quantifiable Serum Concentration (Tlast) of Dupilumab Post-dose on Days 1, 3, 8, 18, and 29 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | 14.8 Days (±6.79 Full Range) |
| Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | 26.5 Days (±15.0 Full Range) | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg | 8.56 Days (±6.88 Full Range) | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg | 16.0 Days (±6.95 Full Range) | |||
| NCT03346434 Liberty AD | Dermatitis, Atopic | Part A: Time to Reach the Maximum Serum Concentration (Tmax) of Dupilumab Post-dose on Days 1, 3, 8, 18, and 29 | Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 3 mg/kg | 1.92 Days (±1.72 Full Range) |
| Part A: Cohort 1 (≥2 to <6 Years Old): Dupilumab 6 mg/kg | 1.97 Days (±1.87 Full Range) | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 3 mg/kg | 1.95 Days (±1.75 Full Range) | |||
| Part A: Cohort 2 (≥6 Months to <2 Years): Dupilumab 6 mg/kg | 2.10 Days (±1.80 Full Range) | |||
| NCT03346434 Liberty AD | Dermatitis, Atopic | Part B: Percentage of Participants With Eczema Area and Severity Index (EASI) -75 (EASI-75) (≥75% Improvement From Baseline) at Week 16 Week 16 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | 53.0 Percentage of Participants (±41.74 95% Confidence Interval) |
| Part B: Placebo + TCS | 10.7 Percentage of Participants (±3.65 95% Confidence Interval) | |||
| NCT03346434 Liberty AD | Dermatitis, Atopic | Part B: Percentage of Participants With Investigator's Global Assessment (IGA) Score 0 or 1 at Week 16 Week 16 | Part B: Dupilumab 200 mg or 300 mg Q4W + TCS | 27.7 Percentage of Participants (±18.45 95% Confidence Interval) |
| Part B: Placebo + TCS | 3.9 Percentage of Participants (±-0.42 95% Confidence Interval) | |||
| NCT03560466 | Asthma | Japan Sub-study: Change From Baseline to Week 12 in Pre-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Baseline (Day 1) to Week 12 | Japan Sub-study: Dupilumab | 7.08 percent predicted FEV1 (±6.78 Standard Deviation) |
| NCT03560466 | Asthma | Main Study: Number of Participants With Any Treatment-Emergent Adverse Events (TEAEs) From first dose of study treatment (Day 1) up to 112 days post last dose of study treatment, approximately 64 weeks | Main Study: Dupilumab-Dupilumab | 147 Participants |
| Main Study: Placebo-Dupilumab | 85 Participants | |||
| NCT03620747 | Asthma | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks) | Dupilumab | 54.5 percentage of participants |
| NCT03620747 | Asthma | Treatment-emergent Adverse Event Rate (Event Per 100 Participant-years) From first dose of IMP up to 12 weeks after last dose of IMP (maximum duration: up to 144 Weeks) | Dupilumab | 171.4 events per 100 participant-years |
| NCT03633617 | Eosinophilic Esophagitis | Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24 Baseline and week 24 | Part A: Dupilumab 300 mg SC QW | -21.92 Score on a Scale |
| Part A: Placebo | -9.60 Score on a Scale | |||
| Part B: Dupilumab 300 mg SC Q2W | -14.37 Score on a Scale | |||
| Part B: Dupilumab 300 mg SC QW | -23.78 Score on a Scale | |||
| Part B: Placebo | -13.86 Score on a Scale | |||
| NCT03633617 | Eosinophilic Esophagitis | Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils Per High-power Field (Eos/Hpf) in All Three Regions at Week 24 At week 24 | Part A: Dupilumab 300 mg SC QW | 59.5 Percentage of Participants |
| Part A: Placebo | 5.1 Percentage of Participants | |||
| Part B: Dupilumab 300 mg SC Q2W | 60.5 Percentage of Participants | |||
| Part B: Dupilumab 300 mg SC QW | 58.8 Percentage of Participants | |||
| Part B: Placebo | 6.3 Percentage of Participants | |||
| NCT03720470 JADE Compare | Dermatitis, Atopic | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12 Baseline, Week 12 | Dupilumab 300 mg + Oral Placebo up to Week 16 | 58.1 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | 58.7 Percentage of participants | |||
| PF-04965842 200 mg + Placebo Injection up to Week 16 | 70.3 Percentage of participants | |||
| Placebo up to Week 16 | 27.1 Percentage of participants | |||
| NCT03720470 JADE Compare | Dermatitis, Atopic | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Week 12 Baseline (the last measurement prior to first dosing on Day 1), Week 12 | Dupilumab 300 mg + Oral Placebo up to Week 16 | 36.5 Percentage of participants |
| PF-04965842 100 mg + Placebo Injection up to Week 16 | 36.6 Percentage of participants | |||
| PF-04965842 200 mg + Placebo Injection up to Week 16 | 48.4 Percentage of participants | |||
| Placebo up to Week 16 | 14.0 Percentage of participants | |||
| NCT03738397 Heads Up | Dermatitis, Atopic | Percentage of Participants Achieving a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 16 Baseline and Week 16 | Dupilumab 300 mg EOW | 62.6 percentage of participants |
| Upadacitinib 30 mg QD | 72.4 percentage of participants | |||
| NCT03912259 | Dermatitis, Atopic | Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of Greater Than or Equal to (>=) 2 Points at Week 16 Baseline, Week 16 | Dupilumab 300 mg Q2W | 22 Participants |
| Placebo Q2W | 4 Participants | |||
| NCT03930732 BOREAS | Pulmonary Disease, Chronic Obstructive | Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 52-Week Treatment Period Baseline (Day 1) to Week 52 | Dupilumab 300 mg q2w | 0.776 exacerbation per participant-year |
| Placebo | 1.01 exacerbation per participant-year | |||
| NCT04180488 | Chronic Urticaria | Change From Baseline in Weekly Itch Severity Score at Week 24 Baseline (Day 1) and Week 24 | Study A: Dupilumab | -10.24 score on a scale (±0.91 Standard Error) |
| Study A: Placebo | -6.01 score on a scale (±0.94 Standard Error) | |||
| Study B: Dupilumab | -7.68 score on a scale (±1.10 Standard Error) | |||
| Study B: Placebo | -4.81 score on a scale (±1.08 Standard Error) | |||
| Study C: Dupilumab | -8.64 score on a scale (±1.41 Standard Error) | |||
| Study C: Placebo | -6.10 score on a scale (±1.40 Standard Error) | |||
| NCT04183335 | Neurodermatitis | Percentage of Participants With Improvement (Reduction) in Worst Itch Numeric Rating Scale (WI-NRS) Scores by Greater Than or Equal to (>=) 4 Points From Baseline to Week 24 Baseline, Week 24 | Dupilumab 300 mg Q2W | 60.0 percentage of participants |
| Placebo | 18.4 percentage of participants | |||
| NCT04202679 | Neurodermatitis | Percentage of Participants With Greater Than or Equal to (>=) 4 Points Improvement (Reduction) From Baseline in Worst-Itch Numeric Rating Scale (WI-NRS) Scores at Week 12 Baseline, Week 12 | Dupilumab 300 mg Q2W | 37.2 percentage of participants |
| Placebo | 22.0 percentage of participants | |||
| NCT04206553 LIBERTY-BP | Pemphigoid, Bullous | Percent of Participants Achieving Sustained Remission at Week 36 At Week 36 | Dupilumab Q2W | 18.2 Estimated Percentage of Participants |
| Placebo | 4.0 Estimated Percentage of Participants | |||
| NCT04345367 | Dermatitis, Atopic | Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 4 Week 4 | Abrocitinib 200 mg QD | 28.5 Percentage of participants |
| Dupilumab 300 mg Q2W | 14.6 Percentage of participants | |||
| NCT04345367 | Dermatitis, Atopic | Percentage of Participants Achieving Greater Than or Equal to (>=) 4 Points Improvement in Peak Pruritus Numerical Rating Scale (PP-NRS4) From Baseline at Week 2 Week 2 | Abrocitinib 200 mg QD | 48.2 Percentage of participants |
| Dupilumab 300 mg Q2W | 25.5 Percentage of participants | |||
| NCT04394351 EoE KIDS | Eosinophilic Esophagitis | Part A: Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of Less Than or Equal to (≤) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16 At Week 16 | Part A: Dupilumab High Dose | 67.6 percentage of participants |
| Part A: Dupilumab Low Dose | 58.1 percentage of participants | |||
| Part A: Pooled Placebo | 2.9 percentage of participants | |||
| NCT04417894 | — | Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16 At week 16 | Dupilumab Q2W | 40.3 Percentage of participants |
| Matching Placebo | 16.7 Percentage of participants | |||
| NCT04456673 NOTUS | Pulmonary Disease, Chronic Obstructive | Annualized Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Over the 52-week Treatment Period Baseline (Day 1) to Week 52 | Dupilumab 300 mg q2w | 0.859 Exacerbation per participant-year |
| Placebo | 1.295 Exacerbation per participant-year | |||
| NCT04678856 Liberty CRSsNP | Sinusitis | Change From Baseline to Week 24 in Opacification of Sinuses Assessed by Computed Tomography (CT) Scan Using the Lund Mackay (LMK) Score in Dupilumab Group Baseline (Day 1) and Week 24 | Dupilumab 300 mg q2w | -6.63 Score on a scale (±3.91 Standard Deviation) |
| NCT04681729 | Cold Urticaria | Percentage of Participants With Negative Ice Cube Provocation Test at Week 24 Week 24 | Dupilumab | 40.5 percentage of participants |
| Placebo | 37.5 percentage of participants | |||
| NCT04684524 | Allergic Fungal Sinusitis | Change From Baseline to Week 52 in Opacification of Sinuses Assessed by CT Scan Using the LMK Score Baseline (Day 1) and Week 52 | Dupilumab | -9.17 score on a scale (±0.74 Standard Error) |
| Placebo | -1.81 score on a scale (±0.81 Standard Error) | |||
| NCT05526521 | Chronic Urticaria | Serum Concentration of Dupilumab at Weeks 12 and 24 Weeks 12 and 24 | Dupilumab 200 mg Q2W, 400 mg Loading Dose | 78500 nanogram/milliliter (±31600 Standard Deviation) |
| Dupilumab 200 mg Q2W, 400 mg Loading Dose | 91600 nanogram/milliliter (±23000 Standard Deviation) | |||
| Dupilumab 200 mg Q4W | 67700 nanogram/milliliter | |||
| Dupilumab 200 mg Q4W | 116000 nanogram/milliliter | |||
| Dupilumab 300 mg Q4W | 141000 nanogram/milliliter (±30100 Standard Deviation) | |||
| Dupilumab 300 mg Q4W | 105000 nanogram/milliliter | |||
| Dupilumab 300 mg Q4W, 600 mg Loading Dose | 45800 nanogram/milliliter (±12400 Standard Deviation) | |||
| Dupilumab 300 mg Q4W, 600 mg Loading Dose | 51100 nanogram/milliliter (±20100 Standard Deviation) | |||
| NCT05545072 ADAPT | Allergic Fungal Sinusitis | Incidence of Oral/Topical Corticosteroid Utilization Per Participant Baseline and End of Treatment at Week 52 | Dupilumab | 0 Participants |
| Dupilumab | 0 Participants | |||
| Dupilumab | 3 Participants | |||
| Placebo | 2 Participants | |||
| Placebo | 0 Participants | |||
| NCT05601882 Level Up | Dermatitis, Atopic | Percentage of Participants Achieving a ≥ 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 16 Baseline and Week 16 | Dupilumab (Period 1) | 8.9 percentage of participants |
| Upadacitinib (Period 1) | 19.9 percentage of participants | |||
| NCT05878093 | — | Change From Baseline in Nasal Polyps Score at Week 24 Baseline (Day 1) and Week 24 | Dupilumab 300 mg q2w | -2.34 score on a scale (±0.30 Standard Error) |
| Placebo | -0.50 score on a scale (±0.30 Standard Error) |