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

• ClinicalTrials.gov Identifier: NCT03359356
• Recruitment Status: Completed
• First Posted: December 2, 2017
• Results First Posted: February 14, 2022
• Last Update Posted: September 13, 2022
• Sponsor: Icahn School of Medicine at Mount Sinai
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Placebo Then Dupilumab	Dupilumab
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

Baseline Characteristics

Arm/Group Title		Placebo Then Dupilumab	Dupilumab	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in the Severity of Alopecia Tool (SALT) Score at Week 24
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Then Dupilumab	Dupilumab
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Then Dupilumab	Dupilumab
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Then Dupilumab	Dupilumab
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Then Dupilumab	Dupilumab
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Then Dupilumab	Dupilumab
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Then Dupilumab	Dupilumab
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Dupilumab
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Then Dupilumab	Dupilumab
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

Data for only those participants with eczema.

Arm/Group Title	Placebo Then Dupilumab	Dupilumab
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
Description	Safety profile of dupilumab in subjects with AA by reported adverse effects, physical examinations and laboratory parameters
Time Frame	48 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Then Dupilumab	Dupilumab
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

Adverse Events

Time Frame	48 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Placebo		Dupilumab
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Emma Guttman
• Organization: Icahn School of Medicine at Mount Sinai
• Phone: 212-241-9728
• EMail: emma.guttman@mountsinai.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Guttman-Yassky E, Renert-Yuval Y, Bares J, Chima M, Hawkes JE, Gilleaudeau P, Sullivan-Whalen M, Singer GK, Garcet S, Pavel AB, Lebwohl MG, Krueger JG. Phase 2a randomized clinical trial of dupilumab (anti-IL-4Ralpha) for alopecia areata patients. Allergy. 2022 Mar;77(3):897-906. doi: 10.1111/all.15071. Epub 2021 Sep 6.

• 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: September 13, 2022