A Phase 3 interventional study of Dupilumab and Placebo in Moderate-to-Severe Atopic Dermatitis, Dermatitis, Dermatitis Atopic and Eczema, Skin Diseases, Skin, sponsored by Regeneron Pharmaceuticals. Completed at 45 sites in 2 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-07-23.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
The primary objective of the study was to demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe atopic dermatitis (AD). The secondary objective of the study was to assess the safety of dupilumab as a monotherapy in participants ≥12 years to \<18 years of age with moderate-to-severe AD.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Participants received placebo matching dupilumab once every 2 weeks (Q2W) (including doubling the amount of placebo on day 1 to match the loading dose). In order to maintain blinding for the study, participants in the \<60 kilogram (kg) weight stratum received, in a 1:1 ratio, either placebo matching 200 milligram (mg) dupilumab (including doubling the amount of placebo on day 1 to match the loading dose) or placebo matching 300 milligram (mg) dupilumab (including doubling the amount of placebo on day 1 to match the loading dose). In the ≥60 kg weight stratum, the participants randomized to the placebo group received placebo matching 300 mg dupilumab (including doubling the amount of placebo on day 1 to match the loading dose).
Drug: Placebo
Participants received once every 4 weeks (Q4W) subcutaneous (SC) injections of 300 milligrams (mg) dupilumab following a loading dose of 600 mg on day 1. In order to maintain blinding, all participants received an injection once every 2 weeks (Q2W) from day 1 to week 14. Participants received placebo 2 milliliter (mL) injection at the weeks dupilumab was not given.
Drug: Dupilumab
Participants with baseline weight \<60 kg received once every 2 weeks (Q2W) subcutaneous (SC) injections of 200 milligrams (mg) dupilumab following a loading dose of 400 mg on day 1. Participants with baseline weight ≥60 kg received Q2W SC injections of 300 mg dupilumab following a loading dose of 600 mg on day 1.
Drug: Dupilumab
Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.
Also known as: REGN668
Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.
Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 (and Reduction From Baseline of ≥2 Points) at Week 16
IGA is an assessment scale used to determine severity of atopic dermatitis (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). Participants with IGA "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported. \[Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder. Participant considered non-responder after rescue treatment use. Efficacy analyses were based on the treatment allocated at randomization (as randomized).\]
Time frame: Baseline and Week 16
Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Improvement From Baseline) at Week 16
The EASI score was used to measure the severity and extent of 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. EASI--75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. \[Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder. Participant considered nonresponder after rescue treatment use. Efficacy analyses were based on the treatment allocated at randomization (as randomized).\]
Time frame: Baseline and Week 16
Percent Change From Baseline in EASI Score at Week 16
The Eczema Area and Severity Index (EASI) score was used to measure the severity and extent of 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. \[Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.\]
Time frame: Baseline and Week 16
Percent Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score at Week 16
Peak Pruritus NRS is an assessment tool used by subjects to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3) /3. \[Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.\]
Time frame: Baseline and Week 16
Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline to Week 16
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" \[For this endpoint, participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.\]
Time frame: Baseline to Week 16
Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline to Week 16
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" \[For this endpoint, participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.\]
Time frame: Baseline to Week 16
Percentage of Participants With 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 at Week 16. \[Values after first rescue treatment used were set to missing. Participants with missing value at Week 16 were considered as a non-responder\].
Time frame: Baseline and Week 16
Percentage of Participants With 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 at Week 16. \[Values after first rescue treatment used were set to missing. Participants with missing value at week 16 were considered as a non-responder.\]
Time frame: Baeline and Week 16
Time to Onset of Effect on Pruritus as Measured by Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" \[For this endpoint, participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.\]
Time frame: Baseline up to week 16
Time to Onset of Effect on Pruritus as Measured by Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" \[For this endpoint, subjects achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.\]
Time frame: Baseline up to Week 16
Change From Baseline in Percent Body Surface Area (BSA) at 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.
Time frame: Baseline and Week 16
Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16
The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. 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).
Time frame: Baseline and Week 16
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Week 16
The CDLQI is a 10-item questionnaire used to measure how much a participant's skin problem had affected the participant's quality of life (QOL) over a recall period of the past week. The questionnaire consists of 10 items. For each item the scale is rated as follows: 0 = Not at all = Not relevant; 1 = Only a little; 2 = Quite a lot; 3 = Very much = Yes = Prevents school. The CDLQI total score is the sum of the score of each question with a maximum of 30 and a minimum of 0. The higher the score, the greater the impact is on the QOL.
Time frame: Baseline and Week 16
Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults with atopic eczema. The format is subject response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on symptom frequency during the past week (ie, 0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day'). The total score is the sum of the 7 items which is ranged from 0 to 28; a high score is indicative of a poor quality of life (QOL).
Time frame: Baseline and Week 16
Change From Baseline in Weekly Average of Daily Peak Pruritus NRS at Week 16
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Particpants were asked the following question for maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3)/ 3.
Time frame: Baseline and Week 16
Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS at Week 4
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question for maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3)/ 3.
Time frame: Baseline and Week 4
Change From Baseline in Total Hospital Anxiety and Depression Scale (HADS) at Week 16
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each item is rated on a 4-point scale (0-3). A person could score between 0 \& 21 for each subscale (anxiety \& depression). A high score is indicative of a poor state. Scores of 11 or more on either subscale are considered a 'definite case' of psychological morbidity, while scores of 8 to 10 represents 'probable case' \& 0 to 7 'not a case'. The total score was the sum of the 2 sub-scores; therefore, the full range of possible values for the reported data is 0-42.
Time frame: Baseline and Week 16
Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline at Week 4
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question for maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3)/ 3.
Time frame: Baseline and Week 4
Percentage of Participants With Skin-infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Through Week 16
Any untoward medical occurrence in a subject 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 16)). 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.
Time frame: Baseline through Week 16
Percentage of Participants With Serious TEAEs 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.
Time frame: Baseline through Week 16
The study was conducted at 45 sites in the United States and Canada between 21 Mar 2017 and 05 Jun 2018. A total of 295 participants were screened, of which, 251 were eligible. The most common causes for screening failures were lack of adequate disease severity and lack of willingness to comply with study visits and procedures.
| Milestone | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Started | 85 | 84 | 82 |
| Completed wk 16 end of treatment (eot) | 80 | 81 | 79 |
| Completed week 28 (end of study) | 2 | 4 | 3 |
| Completed | 2 | 4 | 3 |
| Not completed | 83 | 80 | 79 |
| Withdrew: Physician decision | 0 | 1 | 1 |
| Withdrew: Lack of efficacy | 3 | 1 | 0 |
| Withdrew: Discontinued to enroll in ole: enrolled | 0 | 0 | 1 |
| Withdrew: Discont'd to enroll in ole: not enrolled | 1 | 0 | 0 |
| Withdrew: Transitioned to ole study | 76 | 76 | 73 |
| Withdrew: Withdrawal by subject | 3 | 2 | 3 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
IGA is an assessment scale used to determine severity of atopic dermatitis (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). Participants with IGA "0" or "1" and a reduction from baseline of ≥2 points at Week 16 were reported. \[Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder. Participant considered non-responder after rescue treatment use. Efficacy analyses were based on the treatment allocated at randomization (as randomized).\]
| Percentage of participants | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 (and Reduction From Baseline of ≥2 Points) at Week 16 | 2.4 | 17.9 | 24.4 |
The EASI score was used to measure the severity and extent of 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. EASI--75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. \[Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder. Participant considered nonresponder after rescue treatment use. Efficacy analyses were based on the treatment allocated at randomization (as randomized).\]
| Percentage of participants | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Improvement From Baseline) at Week 16 | 8.2 | 38.1 | 41.5 |
The Eczema Area and Severity Index (EASI) score was used to measure the severity and extent of 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. \[Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.\]
| Percent change | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Percent Change From Baseline in EASI Score at Week 16 | -23.6 ± 5.49 | -64.8 ± 4.51 | -65.9 ± 3.99 |
Peak Pruritus NRS is an assessment tool used by subjects to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3) /3. \[Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.\]
| Percent change | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Percent Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score at Week 16 | -19.0 ± 4.09 | -45.5 ± 3.54 | -47.9 ± 3.43 |
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" \[For this endpoint, participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.\]
| Percentage of participants | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline to Week 16 | 9.4 | 38.6 | 48.8 |
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" \[For this endpoint, participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.\]
| Percentage of participants | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline to Week 16 | 4.8 | 26.5 | 36.6 |
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 at Week 16. \[Values after first rescue treatment used were set to missing. Participants with missing value at Week 16 were considered as a non-responder\].
| Percentage of participants | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Percentage of Participants With EASI-50 (≥50% Improvement From Baseline) at Week 16 | 12.9 | 54.8 | 61.0 |
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 at Week 16. \[Values after first rescue treatment used were set to missing. Participants with missing value at week 16 were considered as a non-responder.\]
| Percentage of participants | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Percentage of Participants With EASI-90 (≥90% Improvement From Baseline) at Week 16 | 2.4 | 19.0 | 23.2 |
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" \[For this endpoint, participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.\]
| Percentage of participants | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Time to Onset of Effect on Pruritus as Measured by Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline | 11.4 ± 5.63 | 8.4 ± 5.92 | 7.7 ± 5.57 |
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" \[For this endpoint, subjects achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.\]
| Percentage of participants | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Time to Onset of Effect on Pruritus as Measured by Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline | 12.8 ± 4.90 | 9.9 ± 5.87 | 10.6 ± 5.50 |
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.
| Percentage of body surface area | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Change From Baseline in Percent Body Surface Area (BSA) at Week 16 | -11.66 ± 2.720 | -33.41 ± 2.330 | -30.11 ± 2.337 |
The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. 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).
| Percent change | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16 | -17.6 ± 3.76 | -47.5 ± 3.21 | -51.6 ± 3.23 |
The CDLQI is a 10-item questionnaire used to measure how much a participant's skin problem had affected the participant's quality of life (QOL) over a recall period of the past week. The questionnaire consists of 10 items. For each item the scale is rated as follows: 0 = Not at all = Not relevant; 1 = Only a little; 2 = Quite a lot; 3 = Very much = Yes = Prevents school. The CDLQI total score is the sum of the score of each question with a maximum of 30 and a minimum of 0. The higher the score, the greater the impact is on the QOL.
| Scores on a scale | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Week 16 | -5.1 ± 0.62 | -8.8 ± 0.53 | -8.5 ± 0.50 |
The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults with atopic eczema. The format is subject response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on symptom frequency during the past week (ie, 0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day'). The total score is the sum of the 7 items which is ranged from 0 to 28; a high score is indicative of a poor quality of life (QOL).
| Scores on a scale | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16 | -3.8 ± 0.96 | -9.5 ± 0.86 | -10.1 ± 0.76 |
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Particpants were asked the following question for maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3)/ 3.
| Scores on a scale | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Change From Baseline in Weekly Average of Daily Peak Pruritus NRS at Week 16 | -1.54 ± 0.303 | -3.44 ± 0.260 | -3.70 ± 0.250 |
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question for maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3)/ 3.
| Percent change | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS at Week 4 | -12.5 ± 3.06 | -33.1 ± 3.05 | -34.7 ± 2.99 |
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each item is rated on a 4-point scale (0-3). A person could score between 0 \& 21 for each subscale (anxiety \& depression). A high score is indicative of a poor state. Scores of 11 or more on either subscale are considered a 'definite case' of psychological morbidity, while scores of 8 to 10 represents 'probable case' \& 0 to 7 'not a case'. The total score was the sum of the 2 sub-scores; therefore, the full range of possible values for the reported data is 0-42.
| Scores on a scale | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Change From Baseline in Total Hospital Anxiety and Depression Scale (HADS) at Week 16 | -2.5 ± 0.80 | -5.2 ± 0.73 | -3.8 ± 0.68 |
Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question for maximum itch intensity: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3)/ 3.
| Percentage of participants | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline at Week 4 | 4.8 | 20.5 | 22.0 |
Any untoward medical occurrence in a subject 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 16)). 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.
| Percentage of participants | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Percentage of Participants With Skin-infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Through Week 16 | 18.8 | 9.6 | 9.8 |
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.
| Percentage of participants | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W |
|---|---|---|---|
| Percentage of Participants With Serious TEAEs Through Week 16 | 1.2 | 0 | 0 |
Collected over All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Day 197) regardless of seriousness or relationship to investigational product (IP).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/85 (0%) | 1/85 (1.2%) | 40/85 (47.1%) |
| Dupilumab 300 mg Q4W | 0/83 (0%) | 0/83 (0%) | 34/83 (41%) |
| Dupilumab 200 mg or 300 mg | 0/82 (0%) | 0/82 (0%) | 39/82 (47.6%) |
| Event | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg |
|---|---|---|---|
| AppendicitisInfections and infestations | 1/85 | 0/83 | 0/82 |
| Event | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg |
|---|---|---|---|
| Dermatitis atopicSkin and subcutaneous tissue disorders | 21/85 | 16/83 | 15/82 |
| Upper respiratory tract infectionInfections and infestations | 15/85 | 7/83 | 10/82 |
| NasopharyngitisInfections and infestations | 4/85 | 10/83 | 5/82 |
| HeadacheNervous system disorders | 9/85 | 4/83 | 9/82 |
| InfluenzaInfections and infestations | 4/85 | 0/83 | 5/82 |
| Pharyngitis streptococcalInfections and infestations | 0/85 | 5/83 | 2/82 |
| Age, Continuous(years) | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W | Total |
|---|---|---|---|---|
| Mean | 14.5 ± 1.78 | 14.4 ± 1.59 | 14.5 ± 1.74 | 14.5 ± 1.70 |
| Age, Customized(Participants) | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W | Total |
|---|---|---|---|---|
| ≥12 to <15 years of age | 41 | 45 | 43 | 129 |
| ≥15 to <18 years of age | 44 | 39 | 39 | 122 |
| Sex: Female, Male(Participants) | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W | Total |
|---|---|---|---|---|
| Female | 32 | 32 | 39 | 103 |
| Male | 53 | 52 | 43 | 148 |
| Race/Ethnicity, Customized(Participants) | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W | Total |
|---|---|---|---|---|
| White | 48 | 55 | 54 | 157 |
| Black or African American | 15 | 8 | 7 | 30 |
| Asian | 13 | 13 | 12 | 38 |
| Other | 6 | 8 | 7 | 21 |
| Not Reported/ Missing | 3 | 0 | 2 | 5 |
| Race/Ethnicity, Customized(Participants) | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W | Total |
|---|---|---|---|---|
| Not Hispanic or Latino | 72 | 64 | 69 | 205 |
| Hispanic or Latino | 13 | 20 | 13 | 46 |
| Duration of Atopic Dermatitis (AD)(Years) | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W | Total |
|---|---|---|---|---|
| Mean | 12.3 ± 3.44 | 11.9 ± 3.18 | 12.5 ± 2.97 | 12.2 ± 3.20 |
| Eczema Area and Severity Index (EASI) Score(Scores on a scale) | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W | Total |
|---|---|---|---|---|
| Mean | 35.5 ± 13.97 | 35.8 ± 14.82 | 35.3 ± 13.84 | 35.5 ± 14.16 |
| Investigator's Global Assessment (IGA) Score(Participants) | Placebo | Dupilumab 300 mg Q4W | Dupilumab 200 mg or 300 mg Q2W | Total |
|---|---|---|---|---|
| IGA score = 3 (moderate) | 39 | 38 | 39 | 116 |
| IGA score = 4 (severe) | 46 | 46 | 43 | 135 |
6 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Ran from Mar 2017 to primary completion in Apr 2018, 12 months.
Results were first posted in Jul 2019, 1 year 3 months after primary completion.
Of 132 industry-sponsored phase 3 interventional studies under Dermatitis, Atopic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 26. This study's 12 months is below that.
Counting every sponsor, half of 139 studies reached it within 18 months; a quarter within 13 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dupilumab