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Treatment of Alopecia Areata (AA) With Dupilumab in Patients With and Without Atopic Dermatitis (AD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03359356
Recruitment Status : Completed
First Posted : December 2, 2017
Results First Posted : February 14, 2022
Last Update Posted : February 14, 2022
Sponsor:
Collaborators:
Rockefeller University
Regeneron Pharmaceuticals
Sanofi
Information provided by (Responsible Party):
Emma Guttman, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alopecia Areata
Interventions Drug: Dupilumab
Drug: Placebo
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Then Dupilumab Dupilumab
Hide Arm/Group Description

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.

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.
Period Title: Overall Study
Started 20 40
Completed 20 40
Not Completed 0 0
Arm/Group Title Placebo Then Dupilumab Dupilumab Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 20 40 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 40 participants 60 participants
46.5  (14.4) 41.6  (13.8) 43  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 40 participants 60 participants
Female
13
  65.0%
30
  75.0%
43
  71.7%
Male
7
  35.0%
10
  25.0%
17
  28.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 20 participants 40 participants 60 participants
15
  75.0%
31
  77.5%
46
  76.7%
African American Number Analyzed 20 participants 40 participants 60 participants
2
  10.0%
3
   7.5%
5
   8.3%
Asian Number Analyzed 20 participants 40 participants 60 participants
2
  10.0%
6
  15.0%
8
  13.3%
Other Number Analyzed 20 participants 40 participants 60 participants
1
   5.0%
0
   0.0%
1
   1.7%
Duration since last hair regrowth  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 40 participants 60 participants
3.5  (3) 3.8  (2.9) 3.6  (3)
Severity of alopecia tool (SALT)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 40 participants 60 participants
75.4  (26.1) 70.5  (27.6) 72.1  (27)
[1]
Measure Description: SALT score 0-100 with lower score indicating better health outcomes
Patients with SALT>75  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 40 participants 60 participants
12
  60.0%
20
  50.0%
32
  53.3%
Patients with SALT<75  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 40 participants 60 participants
8
  40.0%
20
  50.0%
28
  46.7%
Patients with Alopecia Totalis/Universalis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 40 participants 60 participants
8
  40.0%
13
  32.5%
21
  35.0%
Alopecia Areata Symptom Impact Scale (AASIS) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 40 participants 60 participants
56.1  (32.86) 48.42  (30.27) 50.9  (31.33)
[1]
Measure Description: AASIS score 0-130 with lower score indicating better health outcomes
Alopecia Areata Quality of Life (AA-QoL) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 40 participants 60 participants
51.75  (13.88) 49.49  (12.56) 50.25  (13.1)
[1]
Measure Description: AA-QoL score 0-100 with higher score indicating better health outcomes
Eyelash assessment   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Very prominent Number Analyzed 19 participants 40 participants 59 participants
6
  31.6%
12
  30.0%
18
  30.5%
Prominent Number Analyzed 19 participants 40 participants 59 participants
2
  10.5%
6
  15.0%
8
  13.6%
Moderate Number Analyzed 19 participants 40 participants 59 participants
1
   5.3%
4
  10.0%
5
   8.5%
Minimal Number Analyzed 19 participants 40 participants 59 participants
6
  31.6%
9
  22.5%
15
  25.4%
None Number Analyzed 19 participants 40 participants 59 participants
4
  21.1%
9
  22.5%
13
  22.0%
[1]
Measure Description: 0 (none) to 4 (prominent) scale to stage hair status in eyelashes.
[2]
Measure Analysis Population Description: One participant had missing eyelash data at baseline because of artificial eyelashes (glued on her real eyelashes)
Eyebrow assessment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Very prominent Number Analyzed 20 participants 40 participants 60 participants
6
  30.0%
10
  25.0%
16
  26.7%
Prominent Number Analyzed 20 participants 40 participants 60 participants
0
   0.0%
5
  12.5%
5
   8.3%
Moderate Number Analyzed 20 participants 40 participants 60 participants
2
  10.0%
6
  15.0%
8
  13.3%
Minimal Number Analyzed 20 participants 40 participants 60 participants
8
  40.0%
9
  22.5%
17
  28.3%
None Number Analyzed 20 participants 40 participants 60 participants
4
  20.0%
10
  25.0%
14
  23.3%
[1]
Measure Description: 0 (none) to 4 (prominent) scale to stage hair status in eyelashes.
Patients with atopic dermatitis (AD) history  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 40 participants 60 participants
6
  30.0%
17
  42.5%
23
  38.3%
Patients with active AD  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 40 participants 60 participants
2
  10.0%
5
  12.5%
7
  11.7%
Eczema area and severity index (EASI) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 40 participants 60 participants
27.4  (11.0) 13.58  (5.68) 17.53  (9.83)
[1]
Measure Description: The EASI index assigns proportionate values to 4 body regions. Each region is assigned a score of 0 to 3, indicating none, mild, moderate, and severe clinical expression. The percentage of area involved is also assigned an eruption proportional score from 0 to 6. The total body score for each body region is obtained by multiplying the sum of the severity scores by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gives the EASI total from 0-72, with higher score indicating more severity.
Patients with family history of atopy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 40 participants 60 participants
9
  45.0%
18
  45.0%
27
  45.0%
IgE  
Mean (Standard Deviation)
Unit of measure:  IU/ml
Number Analyzed 20 participants 40 participants 60 participants
342.5  (826.7) 525.8  (1211.3) 464.7  (1094)
Patients with IgE≥200  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 40 participants 60 participants
5
  25.0%
13
  32.5%
18
  30.0%
1.Primary Outcome
Title Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24
Hide Description 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.
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Then Dupilumab Dupilumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 20 40
Mean (Standard Deviation)
Unit of Measure: score on a scale
-6.3  (4.2) 2.3  (3)
2.Secondary Outcome
Title Change From Week 24 in the SALT Score at Week 48
Hide Description 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. Week 24 minus week 48 value.
Time Frame Week 24 and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Then Dupilumab Dupilumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 20 40
Mean (Standard Error)
Unit of Measure: score on a scale
-6.3  (4.2) 2.3  (3)
3.Secondary Outcome
Title Change From Baseline in the SALT Score at Week 48
Hide Description Change 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.
Time Frame Baseline and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Then Dupilumab Dupilumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 20 40
Mean (Standard Error)
Unit of Measure: score on a scale
-6.3  (4.2) 2.3  (3)
4.Secondary Outcome
Title 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
Hide Description Number 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.
Time Frame weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Then Dupilumab Dupilumab
Hide Arm/Group Description:
Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks, an initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week. A total of 24 doses.
An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week, A total of 24 doses
Overall Number of Participants Analyzed 20 40
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24
0
   0.0%
4
  10.0%
Week 48
3
  15.0%
9
  22.5%
5.Secondary Outcome
Title Number of Patients Achieving at Least 75% Improvement in SALT-75 at Weeks 24 and 48
Hide Description Number 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.
Time Frame Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Then Dupilumab Dupilumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 20 40
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24
0
   0.0%
2
   5.0%
Week 48
1
   5.0%
6
  15.0%
6.Secondary Outcome
Title Number of Patients Achieving at Least 90% Improvement in Severity of Alopecia Tool (SALT) Score (SALT-90) at Weeks 24 and 48
Hide Description The number of patients achieving at least 90% improvement in Severity of Alopecia Tool (SALT) score (SALT-90) at Weeks 24, 48 compared to Baseline
Time Frame Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Then Dupilumab Dupilumab
Hide Arm/Group Description:
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.
An initial dose of 600 mg (two 300 mg subcutaneous 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.), followed by 300 mg given every other week, A total of 24 doses
Overall Number of Participants Analyzed 20 40
Measure Type: Count of Participants
Unit of Measure: Participants
Week 24
0
   0.0%
1
   2.5%
Week 48
1
   5.0%
4
  10.0%
7.Secondary Outcome
Title Change in Alopecia Areata Symptom Impact Scale (AASIS)
Hide Description Change 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.
Time Frame Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dupilumab
Hide Arm/Group Description:
Matching placebo in prefilled syringes identical to the dupilumab syringes. A total of 24 doses
An initial dose of 600 mg (two 300 mg subcutaneous injections), followed by 300 mg given every other week, A total of 24 doses
Overall Number of Participants Analyzed 20 40
Mean (Standard Error)
Unit of Measure: score on a scale
Week 24 10.25  (20.29) 0.64  (22.27)
Week 48 22.6  (35.42) 8.13  (27.65)
8.Secondary Outcome
Title Change in Alopecia Areata Quality of Life Questionnaire
Hide Description Change 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).
Time Frame Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Then Dupilumab Dupilumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 20 40
Mean (Standard Error)
Unit of Measure: score on a scale
Week 24 4.29  (9.14) 2.06  (8.49)
Week 48 22.6  (35.42) 8.13  (27.65)
9.Secondary Outcome
Title Eyelash/Eyebrow Assessment Score Weeks 12, 24, 36, and 48 Compared to Baseline
Hide Description 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).
Time Frame Weeks 12, 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
One participant had missing eyelash data because of artificial eyelashes (glued on her real eyelashes).
Arm/Group Title Placebo Then Dupilumab Dupilumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 20 40
Mean (Standard Error)
Unit of Measure: score on a scale
Eyelash Week 12 Number Analyzed 19 participants 40 participants
0  (0.37) 0.07  (0.24)
Eyelash Week 24 Number Analyzed 19 participants 40 participants
0.37  (0.34) 0.04  (0.24)
Eyelash Week 36 Number Analyzed 19 participants 40 participants
-0.15  (0.37) -0.06  (0.27)
Eyelash Week 48 Number Analyzed 19 participants 40 participants
-0.17  (0.35) 0.05  (0.26)
Eyebrow Week 12 Number Analyzed 20 participants 40 participants
0.09  (0.37) 0.21  (0.25)
Eyebrow Week 24 Number Analyzed 20 participants 40 participants
0.27  (0.34) 0.19  (0.24)
Eyebrow Week 36 Number Analyzed 20 participants 40 participants
-0.2  (0.34) 0.17  (0.24)
Eyebrow Week 48 Number Analyzed 20 participants 40 participants
-0.03  (0.35) 0.09  (0.25)
10.Secondary Outcome
Title Change in EASI Scores From Baseline at Week 24 and 48
Hide Description 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.
Time Frame Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Data for only those participants with eczema.
Arm/Group Title Placebo Then Dupilumab Dupilumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 2 3
Mean (Standard Error)
Unit of Measure: score on a scale
Week 24 -1.45  (3.61) 10.6  (3.64)
Week 48 23.9  (10.61) 10.53  (3.75)
11.Secondary Outcome
Title Number of Adverse Events
Hide Description Safety profile of dupilumab in subjects with AA by reported adverse effects, physical examinations and laboratory parameters
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Then Dupilumab Dupilumab
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 20 40
Measure Type: Number
Unit of Measure: events
24 9
Time Frame 48 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Dupilumab
Hide Arm/Group Description Matching placebo in prefilled syringes identical to the dupilumab syringes. 24 weeks of Placebo 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.
All-Cause Mortality
Placebo Dupilumab
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/40 (0.00%)    
Hide Serious Adverse Events
Placebo Dupilumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      1/40 (2.50%)    
Renal and urinary disorders     
Bladder Cancer   0/20 (0.00%)  0 1/40 (2.50%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Dupilumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/20 (20.00%)      22/40 (55.00%)    
Gastrointestinal disorders     
Gastrointestinal symptoms   1/20 (5.00%)  1 3/40 (7.50%)  3
General disorders     
Fall   1/20 (5.00%)  1 0/40 (0.00%)  0
Fatigue   0/20 (0.00%)  0 1/40 (2.50%)  1
Infections and infestations     
Facial rash   0/20 (0.00%)  0 1/40 (2.50%)  1
Upper respiratory tract infection   2/20 (10.00%)  2 6/40 (15.00%)  6
Urinary tract infection   0/20 (0.00%)  0 2/40 (5.00%)  2
Oral herpes   1/20 (5.00%)  1 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Other orthopedic injuries/procedures   1/20 (5.00%)  1 5/40 (12.50%)  5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder malignancy   0/20 (0.00%)  0 1/40 (2.50%)  1
Prostatic hyperplasia   0/20 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders     
Injection site reaction   0/20 (0.00%)  0 2/40 (5.00%)  2
Eosinophilic dermatitis   0/20 (0.00%)  0 1/40 (2.50%)  1
Conjuctivitis   0/20 (0.00%)  0 4/40 (10.00%)  4
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Emma Guttman
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-241-9728
EMail: emma.guttman@mountsinai.org
Layout table for additonal information
Responsible Party: Emma Guttman, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03359356    
Other Study ID Numbers: GCO 17-1084
First Submitted: November 27, 2017
First Posted: December 2, 2017
Results First Submitted: August 17, 2021
Results First Posted: February 14, 2022
Last Update Posted: February 14, 2022