Trial Outcomes & Findings for Treatment of Alopecia Areata (AA) With Dupilumab in Patients With and Without Atopic Dermatitis (AD) (NCT NCT03359356)
NCT ID: NCT03359356
Last Updated: 2022-09-13
Results Overview
The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss. Primary Outcome is baseline minus Week 24 value.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline and 24 weeks
Results posted on
2022-09-13
Participant Flow
Participant milestones
| Measure |
Placebo Then Dupilumab
Placebo given Weeks 0-24, then Dupilumab given Weeks 24-48
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
|
Dupilumab
An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
40
|
|
Overall Study
COMPLETED
|
20
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
Baseline characteristics by cohort
| Measure |
Placebo Then Dupilumab
n=20 Participants
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
|
Dupilumab
n=40 Participants
An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 14.4 • n=20 Participants
|
41.6 years
STANDARD_DEVIATION 13.8 • n=40 Participants
|
43 years
STANDARD_DEVIATION 13 • n=60 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=20 Participants
|
30 Participants
n=40 Participants
|
43 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
17 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
46 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
5 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
8 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=60 Participants
|
|
Duration since last hair regrowth
|
3.5 years
STANDARD_DEVIATION 3 • n=20 Participants
|
3.8 years
STANDARD_DEVIATION 2.9 • n=40 Participants
|
3.6 years
STANDARD_DEVIATION 3 • n=60 Participants
|
|
Severity of alopecia tool (SALT)
|
75.4 units on a scale
STANDARD_DEVIATION 26.1 • n=20 Participants
|
70.5 units on a scale
STANDARD_DEVIATION 27.6 • n=40 Participants
|
72.1 units on a scale
STANDARD_DEVIATION 27 • n=60 Participants
|
|
Patients with SALT>75
|
12 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
32 Participants
n=60 Participants
|
|
Patients with SALT<75
|
8 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
28 Participants
n=60 Participants
|
|
Patients with Alopecia Totalis/Universalis
|
8 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
21 Participants
n=60 Participants
|
|
Alopecia Areata Symptom Impact Scale (AASIS) score
|
56.1 units on a scale
STANDARD_DEVIATION 32.86 • n=20 Participants
|
48.42 units on a scale
STANDARD_DEVIATION 30.27 • n=40 Participants
|
50.9 units on a scale
STANDARD_DEVIATION 31.33 • n=60 Participants
|
|
Alopecia Areata Quality of Life (AA-QoL) score
|
51.75 units on a scale
STANDARD_DEVIATION 13.88 • n=20 Participants
|
49.49 units on a scale
STANDARD_DEVIATION 12.56 • n=40 Participants
|
50.25 units on a scale
STANDARD_DEVIATION 13.1 • n=60 Participants
|
|
Eyelash assessment
Very prominent
|
6 Participants
n=19 Participants • One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
|
12 Participants
n=40 Participants • One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
|
18 Participants
n=59 Participants • One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
|
|
Eyelash assessment
Prominent
|
2 Participants
n=19 Participants • One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
|
6 Participants
n=40 Participants • One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
|
8 Participants
n=59 Participants • One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
|
|
Eyelash assessment
Moderate
|
1 Participants
n=19 Participants • One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
|
4 Participants
n=40 Participants • One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
|
5 Participants
n=59 Participants • One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
|
|
Eyelash assessment
Minimal
|
6 Participants
n=19 Participants • One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
|
9 Participants
n=40 Participants • One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
|
15 Participants
n=59 Participants • One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
|
|
Eyelash assessment
None
|
4 Participants
n=19 Participants • One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
|
9 Participants
n=40 Participants • One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
|
13 Participants
n=59 Participants • One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
|
|
Eyebrow assessment
Very prominent
|
6 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
16 Participants
n=60 Participants
|
|
Eyebrow assessment
Prominent
|
0 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
5 Participants
n=60 Participants
|
|
Eyebrow assessment
Moderate
|
2 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
8 Participants
n=60 Participants
|
|
Eyebrow assessment
Minimal
|
8 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
17 Participants
n=60 Participants
|
|
Eyebrow assessment
None
|
4 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
14 Participants
n=60 Participants
|
|
Patients with atopic dermatitis (AD) history
|
6 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
23 Participants
n=60 Participants
|
|
Patients with active AD
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
7 Participants
n=60 Participants
|
|
Eczema area and severity index (EASI) score
|
27.4 units on a scale
STANDARD_DEVIATION 11.0 • n=20 Participants
|
13.58 units on a scale
STANDARD_DEVIATION 5.68 • n=40 Participants
|
17.53 units on a scale
STANDARD_DEVIATION 9.83 • n=60 Participants
|
|
Patients with family history of atopy
|
9 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
27 Participants
n=60 Participants
|
|
IgE
|
342.5 IU/ml
STANDARD_DEVIATION 826.7 • n=20 Participants
|
525.8 IU/ml
STANDARD_DEVIATION 1211.3 • n=40 Participants
|
464.7 IU/ml
STANDARD_DEVIATION 1094 • n=60 Participants
|
|
Patients with IgE≥200
|
5 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
18 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksThe SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time The SALT is a validated instrument for measuring the amount of scalp hair loss at a single point in time SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss. Primary Outcome is baseline minus Week 24 value.
Outcome measures
| Measure |
Placebo Then Dupilumab
n=20 Participants
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
|
Dupilumab
n=40 Participants
An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
|
|---|---|---|
|
Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24
|
-6.3 score on a scale
Standard Deviation 4.2
|
2.3 score on a scale
Standard Deviation 3
|
SECONDARY outcome
Timeframe: Week 24 and 48 weeksSALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. Week 24 minus week 48 value.
Outcome measures
| Measure |
Placebo Then Dupilumab
n=20 Participants
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
|
Dupilumab
n=40 Participants
An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
|
|---|---|---|
|
Change From Week 24 in the SALT Score at Week 48
|
-6.3 score on a scale
Standard Error 4.2
|
2.3 score on a scale
Standard Error 3
|
SECONDARY outcome
Timeframe: Baseline and 48 weeksChange in SALT score at Week 48 compared to Baseline. SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss. Baseline minus week 48 value.
Outcome measures
| Measure |
Placebo Then Dupilumab
n=20 Participants
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
|
Dupilumab
n=40 Participants
An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
|
|---|---|---|
|
Change From Baseline in the SALT Score at Week 48
|
-6.3 score on a scale
Standard Error 4.2
|
2.3 score on a scale
Standard Error 3
|
SECONDARY outcome
Timeframe: weeks 24 and 48Number of subjects achieving SALT-50 score at Weeks 24 and 48 compared to Baseline. SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss.in all areas.
Outcome measures
| Measure |
Placebo Then Dupilumab
n=20 Participants
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
|
Dupilumab
n=40 Participants
An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
|
|---|---|---|
|
Number of Patients Achieving at Least 50% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-50) at Weeks 24 and 48 Compared to Baseline
Week 24
|
0 Participants
|
4 Participants
|
|
Number of Patients Achieving at Least 50% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-50) at Weeks 24 and 48 Compared to Baseline
Week 48
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Number of patients with Severity of Alopecia Tool (SALT) Score (SALT-75) (\> or equal to 75% improvement in SALT score) at Weeks 24 compared to Baseline. SALT - Scalp divided into four areas: vertex (40% of scalp surface area), right profile (18% of scalp surface area), left profile (18% of scalp surface area), and posterior scalp (24% of scalp surface area). Percentage of hair loss in these areas is multiplied by percent surface area of the scalp in that area. SALT score is the sum of percentage of hair loss in all areas. SALT scores range from 0 (no hair loss) to 100 (complete scalp hair loss) with lower score indicating better health outcomes/less hair loss.
Outcome measures
| Measure |
Placebo Then Dupilumab
n=20 Participants
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
|
Dupilumab
n=40 Participants
An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
|
|---|---|---|
|
Number of Patients Achieving at Least 75% Improvement in SALT-75 at Weeks 24 and 48
Week 24
|
0 Participants
|
2 Participants
|
|
Number of Patients Achieving at Least 75% Improvement in SALT-75 at Weeks 24 and 48
Week 48
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Weeks 24 and 48The number of patients achieving at least 90% improvement in Severity of Alopecia Tool (SALT) score (SALT-90) at Weeks 24, 48 compared to Baseline
Outcome measures
| Measure |
Placebo Then Dupilumab
n=20 Participants
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
|
Dupilumab
n=40 Participants
An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
|
|---|---|---|
|
Number of Patients Achieving at Least 90% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-90) at Weeks 24 and 48
Week 24
|
0 Participants
|
1 Participants
|
|
Number of Patients Achieving at Least 90% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-90) at Weeks 24 and 48
Week 48
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Change in AASIS at Weeks 24 and 48 compared to Baseline. AASIS is a 13-item instrument, each item scored from 0 to 10 where higher scores correspond to worse symptom impact, full range from 0 to 130.
Outcome measures
| Measure |
Placebo Then Dupilumab
n=20 Participants
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
|
Dupilumab
n=40 Participants
An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
|
|---|---|---|
|
Change in Alopecia Areata Symptom Impact Scale (AASIS)
Week 24
|
10.25 score on a scale
Standard Error 20.29
|
0.64 score on a scale
Standard Error 22.27
|
|
Change in Alopecia Areata Symptom Impact Scale (AASIS)
Week 48
|
22.6 score on a scale
Standard Error 35.42
|
8.13 score on a scale
Standard Error 27.65
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Change in the Alopecia Areata Quality of Life questionnaire (AA-QoL) at Weeks 24 and 48 compared to baseline. AAQoL is a 21-item instrument scored from 0 (poor) to 100 (good).
Outcome measures
| Measure |
Placebo Then Dupilumab
n=20 Participants
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
|
Dupilumab
n=40 Participants
An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
|
|---|---|---|
|
Change in Alopecia Areata Quality of Life Questionnaire
Week 24
|
4.29 score on a scale
Standard Error 9.14
|
2.06 score on a scale
Standard Error 8.49
|
|
Change in Alopecia Areata Quality of Life Questionnaire
Week 48
|
22.6 score on a scale
Standard Error 35.42
|
8.13 score on a scale
Standard Error 27.65
|
SECONDARY outcome
Timeframe: Weeks 12, 24, 36, and 48Population: One participant had missing eyelash data because of artificial eyelashes (glued on her real eyelashes).
Change in eyelash and eyebrow scores at Weeks 12, 24, 36, and 48 compared to baseline. The Eyelash/Eyebrow Assessment score based on a 5-point scale, ranging from 0 (none) to 4 (very prominent eyelashes/eyebrows).
Outcome measures
| Measure |
Placebo Then Dupilumab
n=20 Participants
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
|
Dupilumab
n=40 Participants
An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
|
|---|---|---|
|
Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline
Eyelash Week 12
|
0 score on a scale
Standard Error 0.37
|
0.07 score on a scale
Standard Error 0.24
|
|
Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline
Eyelash Week 24
|
0.37 score on a scale
Standard Error 0.34
|
0.04 score on a scale
Standard Error 0.24
|
|
Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline
Eyelash Week 36
|
-0.15 score on a scale
Standard Error 0.37
|
-0.06 score on a scale
Standard Error 0.27
|
|
Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline
Eyelash Week 48
|
-0.17 score on a scale
Standard Error 0.35
|
0.05 score on a scale
Standard Error 0.26
|
|
Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline
Eyebrow Week 12
|
0.09 score on a scale
Standard Error 0.37
|
0.21 score on a scale
Standard Error 0.25
|
|
Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline
Eyebrow Week 24
|
0.27 score on a scale
Standard Error 0.34
|
0.19 score on a scale
Standard Error 0.24
|
|
Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline
Eyebrow Week 36
|
-0.2 score on a scale
Standard Error 0.34
|
0.17 score on a scale
Standard Error 0.24
|
|
Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline
Eyebrow Week 48
|
-0.03 score on a scale
Standard Error 0.35
|
0.09 score on a scale
Standard Error 0.25
|
SECONDARY outcome
Timeframe: Weeks 24 and 48Population: Data for only those participants with eczema.
Change from baseline in Eczema Area and Severity Index (EASI) at Weeks 24 and 48. EASI scores range from 0 (no symptoms) to 72 (severe eczema) with lower score indicating better health outcomes/less eczema.
Outcome measures
| Measure |
Placebo Then Dupilumab
n=2 Participants
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
|
Dupilumab
n=3 Participants
An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
|
|---|---|---|
|
Change in EASI Scores From Baseline at Week 24 and 48
Week 24
|
-1.45 score on a scale
Standard Error 3.61
|
10.6 score on a scale
Standard Error 3.64
|
|
Change in EASI Scores From Baseline at Week 24 and 48
Week 48
|
23.9 score on a scale
Standard Error 10.61
|
10.53 score on a scale
Standard Error 3.75
|
SECONDARY outcome
Timeframe: 48 weeksSafety profile of dupilumab in subjects with AA by reported adverse effects, physical examinations and laboratory parameters
Outcome measures
| Measure |
Placebo Then Dupilumab
n=20 Participants
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
|
Dupilumab
n=40 Participants
An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 48 Dupilumab doses will be given throughout the clinical trial, including 24 weeks during a randomized period and 24 weeks during an open label period.
|
|---|---|---|
|
Number of Adverse Events
|
24 events
|
9 events
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dupilumab
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=20 participants at risk
Matching placebo in prefilled syringes identical to the dupilumab syringes. 24 weeks of Placebo
|
Dupilumab
n=40 participants at risk
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
|
|---|---|---|
|
Renal and urinary disorders
Bladder Cancer
|
0.00%
0/20 • 48 weeks
|
2.5%
1/40 • Number of events 1 • 48 weeks
|
Other adverse events
| Measure |
Placebo
n=20 participants at risk
Matching placebo in prefilled syringes identical to the dupilumab syringes. 24 weeks of Placebo
|
Dupilumab
n=40 participants at risk
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
0.00%
0/20 • 48 weeks
|
5.0%
2/40 • Number of events 2 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Eosinophilic dermatitis
|
0.00%
0/20 • 48 weeks
|
2.5%
1/40 • Number of events 1 • 48 weeks
|
|
General disorders
Fall
|
5.0%
1/20 • Number of events 1 • 48 weeks
|
0.00%
0/40 • 48 weeks
|
|
General disorders
Fatigue
|
0.00%
0/20 • 48 weeks
|
2.5%
1/40 • Number of events 1 • 48 weeks
|
|
Gastrointestinal disorders
Gastrointestinal symptoms
|
5.0%
1/20 • Number of events 1 • 48 weeks
|
7.5%
3/40 • Number of events 3 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Other orthopedic injuries/procedures
|
5.0%
1/20 • Number of events 1 • 48 weeks
|
12.5%
5/40 • Number of events 5 • 48 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder malignancy
|
0.00%
0/20 • 48 weeks
|
2.5%
1/40 • Number of events 1 • 48 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic hyperplasia
|
0.00%
0/20 • 48 weeks
|
2.5%
1/40 • Number of events 1 • 48 weeks
|
|
Infections and infestations
Facial rash
|
0.00%
0/20 • 48 weeks
|
2.5%
1/40 • Number of events 1 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Conjuctivitis
|
0.00%
0/20 • 48 weeks
|
10.0%
4/40 • Number of events 4 • 48 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
2/20 • Number of events 2 • 48 weeks
|
15.0%
6/40 • Number of events 6 • 48 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • 48 weeks
|
5.0%
2/40 • Number of events 2 • 48 weeks
|
|
Infections and infestations
Oral herpes
|
5.0%
1/20 • Number of events 1 • 48 weeks
|
0.00%
0/40 • 48 weeks
|
Additional Information
Dr. Emma Guttman
Icahn School of Medicine at Mount Sinai
Phone: 212-241-9728
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place