Trial Outcomes & Findings for A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis (NCT NCT00717769)

NCT ID: NCT00717769

Last Updated: 2021-04-21

Results Overview

Eczema Area and Severity Index (EASI) Score is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The total EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). Investigator's Global Assessment (IGA) score consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease). Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). Higher scores indicate a worse outcome and lower scores indicate a better outcome for all scales.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 270 participants
• Primary outcome timeframe: Pre-dose
• Results posted on: 2021-04-21

Participant Flow

A total of 270 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 27 clinic sites in the United States of America (USA).

Washout period for Atopic Dermatitis treatments such as topical corticosteroids, antihistamines, over the counter (OTC) sleep aids, and some FDA approved devices for 3 months up to 1 week prior to screening and for the duration of the study (including follow-up). After the initiation of the study, the protocol was amended to discontinue group 3 (200 mg three times a day [tid]). The efficacy outcomes and analyses were also redefined to compare the 50 mg tid group against the placebo group.

Participant milestones

Measure	Placebo Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Overall Study STARTED	120	120	30
Overall Study COMPLETED	104	102	19
Overall Study NOT COMPLETED	16	18	11

Reasons for withdrawal

Measure	Placebo Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Overall Study Adverse Event	9	6	1
Overall Study Lack of compliance	0	2	0
Overall Study Lost to Follow-up	3	4	0
Overall Study Lack of Efficacy	1	2	0
Overall Study Protocol Violation	0	2	0
Overall Study Sponsor decision	1	0	10
Overall Study Withdrew consent	2	2	0

Baseline Characteristics

A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis

Baseline characteristics by cohort

Measure	Placebo n=120 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=119 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg;(2×50 mg) orally tid for 28 days.	SUN13834 200 mg Tid n=30 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 200 mg (2×100 mg) orally tid for 28 days.	Total n=269 Participants Total of all reporting groups
Age, Continuous	37.2 years STANDARD_DEVIATION 13.14 • n=5 Participants	38.5 years STANDARD_DEVIATION 12.95 • n=7 Participants	37.0 years STANDARD_DEVIATION 10.62 • n=5 Participants	37.8 years STANDARD_DEVIATION 12.77 • n=4 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	60 Participants n=7 Participants	22 Participants n=5 Participants	154 Participants n=4 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	59 Participants n=7 Participants	8 Participants n=5 Participants	115 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	12 Participants n=7 Participants	0 Participants n=5 Participants	23 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	109 Participants n=5 Participants	107 Participants n=7 Participants	30 Participants n=5 Participants	246 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	46 Participants n=5 Participants	50 Participants n=7 Participants	9 Participants n=5 Participants	105 Participants n=4 Participants
Race (NIH/OMB) White	71 Participants n=5 Participants	65 Participants n=7 Participants	21 Participants n=5 Participants	157 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	120 participants n=5 Participants	119 participants n=7 Participants	30 participants n=5 Participants	269 participants n=4 Participants

PRIMARY outcome

Timeframe: Pre-dose

Population: Baseline disease characteristics were assessed using the Intent-to-Treat (ITT) population. All enrolled participants.

Eczema Area and Severity Index (EASI) Score is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The total EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). Investigator's Global Assessment (IGA) score consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease). Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). Higher scores indicate a worse outcome and lower scores indicate a better outcome for all scales.

Outcome measures

Measure	Placebo n=120 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=119 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid n=30 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Eczema Area and Severity Index (EASI) Score	12.59 score on a scale Standard Deviation 10.02	12.45 score on a scale Standard Deviation 8.75	6.01 score on a scale Standard Deviation 5.98
Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Investigator's Global Assessment (IGA) Score	3.0 score on a scale Standard Deviation 0.67	3.1 score on a scale Standard Deviation 0.69	2.6 score on a scale Standard Deviation 0.93
Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Pruritus Score	2.2 score on a scale Standard Deviation 0.74	2.2 score on a scale Standard Deviation 0.72	1.9 score on a scale Standard Deviation 0.80
Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Insomnia Score	3.2 score on a scale Standard Deviation 3.16	4.0 score on a scale Standard Deviation 3.06	3.0 score on a scale Standard Deviation 3.07

PRIMARY outcome

Timeframe: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

Population: EASI score was assessed using the Intent-to-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.

EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.

Outcome measures

Measure	Placebo n=120 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=119 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8: Change from Baseline	-1.66 units on a scale Standard Deviation 4.59	-1.94 units on a scale Standard Deviation 3.36	—
Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 15: Change from Baseline	-2.88 units on a scale Standard Deviation 4.82	-4.06 units on a scale Standard Deviation 4.92	—
Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 22: Change from Baseline	-3.83 units on a scale Standard Deviation 6.30	-5.67 units on a scale Standard Deviation 6.60	—
Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 29: Change from Baseline	-4.70 units on a scale Standard Deviation 6.96	-6.70 units on a scale Standard Deviation 6.82	—
Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 2: Change from Baseline	-4.64 units on a scale Standard Deviation 6.70	-6.41 units on a scale Standard Deviation 7.86	—
Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 4: Change from Baseline	-4.41 units on a scale Standard Deviation 6.95	-6.73 units on a scale Standard Deviation 7.77	—

PRIMARY outcome

Timeframe: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

Population: EASI score was assessed using the Intent-to-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.

EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.

Outcome measures

Measure	Placebo n=120 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=119 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8: % Change from Baseline	-12.62 percent change Standard Deviation 30.45	-15.52 percent change Standard Deviation 27.03	—
Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 15: % Change from Baseline	-23.42 percent change Standard Deviation 33.34	-28.46 percent change Standard Deviation 59.41	—
Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 22: % Change from Baseline	-30.83 percent change Standard Deviation 42.61	-39.11 percent change Standard Deviation 42.83	—
Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 29: % Change from Baseline	-38.33 percent change Standard Deviation 43.89	-47.46 percent change Standard Deviation 39.89	—
Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 2: % Change from Baseline	-37.29 percent change Standard Deviation 56.64	-45.35 percent change Standard Deviation 45.55	—
Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 4: % Change from Baseline	-37.89 percent change Standard Deviation 53.35	-48.06 percent change Standard Deviation 44.46	—

PRIMARY outcome

Timeframe: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

Population: EASI was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.

EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.

Outcome measures

Measure	Placebo n=93 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=87 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8: Change from Baseline	-1.94 units on a scale Standard Deviation 5.08	-2.36 units on a scale Standard Deviation 3.73	—
Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 15: Change from Baseline	-3.28 units on a scale Standard Deviation 5.27	-5.13 units on a scale Standard Deviation 4.95	—
Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 22: Change from Baseline	-4.26 units on a scale Standard Deviation 6.91	-7.08 units on a scale Standard Deviation 6.81	—
Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 29: Change from Baseline	-5.26 units on a scale Standard Deviation 7.55	-8.19 units on a scale Standard Deviation 6.90	—
Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 2: Change from Baseline	-5.38 units on a scale Standard Deviation 7.20	-7.99 units on a scale Standard Deviation 8.29	—
Mean Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 4: Change from Baseline	-5.09 units on a scale Standard Deviation 7.24	-8.49 units on a scale Standard Deviation 7.89	—

PRIMARY outcome

Timeframe: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

Population: EASI score was assessed using the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.

EASI is an overall assessment of the disease severity of the entire body. The EASI is a composite index including an assessment of disease extent and percent of body surface area involved, converted to a proportional factor (scale of 0-6), in 4 body regions (head and neck, lower limbs, upper limbs, and trunk). The EASI also includes an assessment of erythema, induration and/or papulation, excoriation, and lichenification, each on a scale of 0 to 3. The EASI has a minimum score of 0 (clear) and a maximum of 72 (very severe). The algorithm for calculating the EASI requires, for each body region, the sum of the clinical sign scores multiplied by the area, multiplied by the proportional factor. The total EASI score is the sum of the 4 body region scores. A negative value is an indication of a decrease in individual EASI scores and eczema severity. Higher scores indicate a worse outcome and lower scores a better outcome.

Outcome measures

Measure	Placebo n=93 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=87 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 22: % Change from Baseline	-29.29 percent change Standard Deviation 45.21	-44.40 percent change Standard Deviation 35.29	—
Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8: % Change from Baseline	-13.65 percent change Standard Deviation 29.51	-16.03 percent change Standard Deviation 23.94	—
Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 15: % Change from Baseline	-23.67 percent change Standard Deviation 31.94	-33.64 percent change Standard Deviation 31.26	—
Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 29: % Change from Baseline	-37.58 percent change Standard Deviation 46.18	-52.84 percent change Standard Deviation 35.90	—
Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 2: % Change from Baseline	-40.69 percent change Standard Deviation 46.07	-50.86 percent change Standard Deviation 42.50	—
Percent Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 4: % Change from Baseline	-40.16 percent change Standard Deviation 47.42	-54.35 percent change Standard Deviation 40.40	—

SECONDARY outcome

Timeframe: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

Population: IGA Score was assessed from the Intent-To-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.

IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).

Outcome measures

Measure	Placebo n=120 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=119 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 4: Change from Baseline	-0.8 units on a scale Standard Deviation 1.10	-1.1 units on a scale Standard Deviation 1.04	—
Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8: Change from Baseline	-0.2 units on a scale Standard Deviation 0.54	-0.3 units on a scale Standard Deviation 0.57	—
Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 15: Change from Baseline	-0.4 units on a scale Standard Deviation 0.69	-0.6 units on a scale Standard Deviation 0.74	—
Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 22: Change from Baseline	-0.6 units on a scale Standard Deviation 0.77	-0.9 units on a scale Standard Deviation 0.87	—
Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 29: Change from Baseline	-0.8 units on a scale Standard Deviation 0.97	-1.1 units on a scale Standard Deviation 1.00	—
Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 2: Change from Baseline	-0.8 units on a scale Standard Deviation 1.01	-1.1 units on a scale Standard Deviation 1.05	—

SECONDARY outcome

Timeframe: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

Population: IGA Score was assessed from the Intent-To-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.

IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).

Outcome measures

Measure	Placebo n=120 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=119 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8: % Change from Baseline	-6.10 percent change Standard Deviation 18.51	-8.83 percent change Standard Deviation 18.17	—
Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 29: % Change from Baseline	-24.21 percent change Standard Deviation 32.24	-34.93 percent change Standard Deviation 34.42	—
Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 2: % Change from Baseline	-25.91 percent change Standard Deviation 34.47	-34.48 percent change Standard Deviation 36.66	—
Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 4: % Change from Baseline	-27.24 percent change Standard Deviation 37.59	-34.10 percent change Standard Deviation 36.67	—
Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 15: % Change from Baseline	-10.84 percent change Standard Deviation 23.00	-19.99 percent change Standard Deviation 32.34	—
Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 22: % Change from Baseline	-17.95 percent change Standard Deviation 26.13	-28.89 percent change Standard Deviation 30.57	—

SECONDARY outcome

Timeframe: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

Population: IGA Score was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.

IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).

Outcome measures

Measure	Placebo n=93 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=87 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 15: Change from Baseline	-0.4 units on a scale Standard Deviation 0.66	-0.7 units on a scale Standard Deviation 0.69	—
Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8: Change from Baseline	-0.2 units on a scale Standard Deviation 0.54	-0.2 units on a scale Standard Deviation 0.58	—
Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 22: Change from Baseline	-0.5 units on a scale Standard Deviation 0.80	-1.0 units on a scale Standard Deviation 0.83	—
Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 29: Change from Baseline	-0.8 units on a scale Standard Deviation 1.02	-1.2 units on a scale Standard Deviation 0.98	—
Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 2: Change from Baseline	-0.8 units on a scale Standard Deviation 1.05	-1.2 units on a scale Standard Deviation 1.04	—
Mean Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 4: Change from Baseline	-0.8 units on a scale Standard Deviation 1.13	-1.2 units on a scale Standard Deviation 1.05	—

SECONDARY outcome

Timeframe: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

Population: IGA Score was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.

IGA score is used as an overall assessment of disease severity of the entire body, which consists of a 6-point scale from a minimum of 0 (clear) and a maximum of 6 (very severe atopic dermatitis). Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).

Outcome measures

Measure	Placebo n=93 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=87 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 15: % Change from Baseline	-11.09 percent change Standard Deviation 21.72	-20.23 percent change Standard Deviation 20.93	—
Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8: % Change from Baseline	-7.06 percent change Standard Deviation 17.76	-7.33 percent change Standard Deviation 17.38	—
Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 22: % Change from Baseline	-16.02 percent change Standard Deviation 26.71	-30.47 percent change Standard Deviation 24.68	—
Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 29: % Change from Baseline	-23.64 percent change Standard Deviation 33.88	-37.99 percent change Standard Deviation 29.96	—
Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 2: % Change from Baseline	-25.18 percent change Standard Deviation 35.21	-36.51 percent change Standard Deviation 32.98	—
Percent Change in Investigator's Global Assessment (IGA) Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 4: % Change from Baseline	-25.72 percent change Standard Deviation 37.31	-37.43 percent change Standard Deviation 34.26	—

SECONDARY outcome

Timeframe: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

Population: Pruritus score was assessed from the Intent-To-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.

Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.

Outcome measures

Measure	Placebo n=120 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=119 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 29: Change from Baseline	-0.7 units on a scale Standard Deviation 0.85	-0.9 units on a scale Standard Deviation 1.04	—
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 2: Change from Baseline	-0.6 units on a scale Standard Deviation 1.04	-0.8 units on a scale Standard Deviation 1.09	—
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 4: Change from Baseline	-0.6 units on a scale Standard Deviation 0.93	-0.7 units on a scale Standard Deviation 1.09	—
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8: Change from Baseline	-0.3 units on a scale Standard Deviation 0.77	-0.3 units on a scale Standard Deviation 0.88	—
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 15: Change from Baseline	-0.5 units on a scale Standard Deviation 0.83	-0.6 units on a scale Standard Deviation 0.92	—
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 22: Change from Baseline	-0.6 units on a scale Standard Deviation 0.92	-0.7 units on a scale Standard Deviation 1.04	—

SECONDARY outcome

Timeframe: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

Population: Pruritus score was assessed from the Intent-To-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.

Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.

Outcome measures

Measure	Placebo n=120 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=119 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 15: % Change from Baseline	-11.53 percent change Standard Deviation 101.25	-22.22 percent change Standard Deviation 48.74	—
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8: % Change from Baseline	-1.54 percent change Standard Deviation 99.05	-7.68 percent change Standard Deviation 48.73	—
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 22: % Change from Baseline	-13.89 percent change Standard Deviation 104.86	-25.99 percent change Standard Deviation 54.76	—
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 29: % Change from Baseline	-18.75 percent change Standard Deviation 103.37	-33.34 percent change Standard Deviation 51.94	—
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 2: % Change from Baseline	-11.95 percent change Standard Deviation 109.12	-28.11 percent change Standard Deviation 55.80	—
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 4: % Change from Baseline	-15.14 percent change Standard Deviation 106.67	-27.82 percent change Standard Deviation 53.91	—

SECONDARY outcome

Timeframe: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

Population: Pruritus score was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.

Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.

Outcome measures

Measure	Placebo n=93 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=87 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8: Change from Baseline	-0.3 units on a scale Standard Deviation 0.72	-0.3 units on a scale Standard Deviation 0.87	—
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 15: Change from Baseline	-0.5 units on a scale Standard Deviation 0.80	-0.7 units on a scale Standard Deviation 0.95	—
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 22: Change from Baseline	-0.6 units on a scale Standard Deviation 0.91	-0.7 units on a scale Standard Deviation 1.10	—
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 29: Change from Baseline	-0.7 units on a scale Standard Deviation 0.89	-0.9 units on a scale Standard Deviation 1.13	—
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 2: Change from Baseline	-0.6 units on a scale Standard Deviation 1.06	-0.7 units on a scale Standard Deviation 1.16	—
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 4: Change from Baseline	-0.6 units on a scale Standard Deviation 0.91	-0.7 units on a scale Standard Deviation 1.14	—

SECONDARY outcome

Timeframe: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

Population: Pruritus score was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.

Symptoms of pruritus were assessed using the Pruritus score. The Pruritus score consists of a 4-point scale with 0 as the minimum and 3 as the maximum (0 = absent, 1 = mild, 2 = moderate, 3 = severe). A lower score (0) indicates a better outcome and a higher score (3) indicates a worse outcome. A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.

Outcome measures

Measure	Placebo n=93 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=87 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 4: % Change from Baseline	-22.76 percent change Standard Deviation 46.81	-22.41 percent change Standard Deviation 54.15	—
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8: % Change in Baseline	-10.03 percent change Standard Deviation 31.19	-7.45 percent change Standard Deviation 44.81	—
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 15: % Change from Baseline	-17.92 percent change Standard Deviation 38.01	-23.45 percent change Standard Deviation 50.45	—
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 22: % Change from Baseline	-20.25 percent change Standard Deviation 44.70	-22.61 percent change Standard Deviation 57.74	—
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 29: % Change from Baseline	-24.73 percent change Standard Deviation 45.75	-33.34 percent change Standard Deviation 56.78	—
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 2: % Change from Baseline	-21.69 percent change Standard Deviation 55.60	-24.72 percent change Standard Deviation 57.34	—

SECONDARY outcome

Timeframe: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

Population: Insomnia score was assessed from the Intent-To-Treat population. Based on the emended protocol, 50 mg tid and the placebo groups.

The extent of insomnia experienced by the participant was assessed using the Insomnia score. The Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). A lower score (0) indicates a better outcome and a higher score (10) indicates a worse outcome. A negative value indicates a decreasing change in the insomnia score. A negative value is an indication of a decrease in individual scores.

Outcome measures

Measure	Placebo n=120 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=119 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8: Change from Baseline	-0.6 units on a scale Standard Deviation 2.50	-0.7 units on a scale Standard Deviation 2.61	—
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 15: Change from Baseline	-0.7 units on a scale Standard Deviation 2.50	-1.2 units on a scale Standard Deviation 2.69	—
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 22: Change from Baseline	-0.8 units on a scale Standard Deviation 2.48	-1.3 units on a scale Standard Deviation 2.96	—
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 29: Change from Baseline	-0.9 units on a scale Standard Deviation 2.55	-1.4 units on a scale Standard Deviation 3.01	—
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 2: Change from Baseline	-0.9 units on a scale Standard Deviation 2.77	-1.1 units on a scale Standard Deviation 3.12	—
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 4: Change from Baseline	-0.8 units on a scale Standard Deviation 2.88	-1.3 units on a scale Standard Deviation 3.24	—

SECONDARY outcome

Timeframe: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

Population: Insomnia score was assessed from the Efficacy Evaluable population. Based on the emended protocol, 50 mg tid and the placebo groups.

The extent of insomnia experienced by the participant was assessed using the Insomnia score. The Insomnia score is an 11-point scale, ranging from a minimum of no insomnia (score = 0) to a maximum of severe insomnia (score = 10). A lower score (0) indicates a better outcome and a higher score (10) indicates a worse outcome. A negative value indicates a decreasing change in the insomnia score. A negative value is an indication of a decrease in individual scores.

Outcome measures

Measure	Placebo n=93 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=87 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 8: Change from Baseline	-0.6 units on a scale Standard Deviation 2.41	-0.7 units on a scale Standard Deviation 2.78	—
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 15: Change from Baseline	-0.7 units on a scale Standard Deviation 2.20	-1.3 units on a scale Standard Deviation 2.66	—
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 22: Change from Baseline	-0.6 units on a scale Standard Deviation 2.25	-1.4 units on a scale Standard Deviation 2.93	—
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Day 29: Change from Baseline	-0.8 units on a scale Standard Deviation 2.44	-1.5 units on a scale Standard Deviation 2.96	—
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 2: Change from Baseline	-0.9 units on a scale Standard Deviation 2.50	-1.0 units on a scale Standard Deviation 3.09	—
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Follow-up Week 4: Change from Baseline	-0.6 units on a scale Standard Deviation 2.56	-1.3 units on a scale Standard Deviation 3.17	—

SECONDARY outcome

Timeframe: Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.

Population: Mean of SUN13834 Plasma Concentrations were assessed from the Pharmacokinetic-Intent-to-Treat (PK-ITT) population, those with evaluable data.

Outcome measures

Measure	Placebo n=107 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=27 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Predose	0.565 ng/mL Standard Deviation 4.81	0.100 ng/mL Standard Deviation NA Mean plasma SUN13834 at pre-dose for the PK-ITT population is \<0.100. Below the level of detection.	—
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis 0-2.5 h	99.8 ng/mL Standard Deviation 119	452 ng/mL Standard Deviation 691	—
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis 2.5-5.0 h	90.6 ng/mL Standard Deviation 86.7	367 ng/mL Standard Deviation 237	—
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis 5.0-10 h	49.4 ng/mL Standard Deviation 69.8	120 ng/mL Standard Deviation 122	—
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis 8-24 h	27.2 ng/mL Standard Deviation 98.1	29.2 ng/mL Standard Deviation 34.0	—

SECONDARY outcome

Timeframe: Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.

Population: Mean of SUN13834 Plasma Concentrations were assessed from the Pharmacokinetic-Efficacy Evaluable (PK-EE) population, those with evaluable data.

Outcome measures

Measure	Placebo n=77 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=8 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Predose	0.747 ng/mL Standard Deviation 5.68	0.100 ng/mL Standard Deviation NA Mean plasma SUN13834 at pre-dose for the PK-EE population is \<0.100. Below level of detection.	—
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis 0-2.5 h	93.7 ng/mL Standard Deviation 122	741 ng/mL Standard Deviation 1090	—
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis 2.5-5.0 h	87.7 ng/mL Standard Deviation 86.7	508 ng/mL Standard Deviation 270	—
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis 5.0-10 h	50.5 ng/mL Standard Deviation 78.5	103 ng/mL Standard Deviation 76.4	—
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis 8-24 h	18.2 ng/mL Standard Deviation 51.7	11.3 ng/mL Standard Deviation 4.47	—

SECONDARY outcome

Timeframe: Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.

Population: Mean of SUN13834 metabolite plasma concentrations were assessed using the Pharmacokinetic-Intent-to-Treat (PK-ITT) population, those with evaluable data.

Mean concentrations of SUN13834 metabolites M-3, M-5, M-6, M-6G, MG-1, and MG-2 in participant plasma samples were measured.

Outcome measures

Measure	Placebo n=107 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=27 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-5: Predose	0.513 ng/mL Standard Deviation 0.132	0.500 ng/mL Standard Deviation NA Mean of SUN13834 metabolite concentration at pre-dose is \<0.500. Below level of detection.	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-5: 8-24 h	8.91 ng/mL Standard Deviation 18.0	16.8 ng/mL Standard Deviation 17.4	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-6: 8-24 h	16.9 ng/mL Standard Deviation 43.8	50.0 ng/mL Standard Deviation 79.1	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis MG-1:5.0-10 h	8.51 ng/mL Standard Deviation 10.7	22.0 ng/mL Standard Deviation 21.4	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-3: Predose	0.500 ng/mL Standard Deviation NA Mean of SUN13834 metabolite concentration at pre-dose is \<0.500. Below level of detection.	0.500 ng/mL Standard Deviation NA Mean of SUN13834 metabolite concentration at pre-dose is \<0.500. Below level of detection.	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-3: 0-2.5 h	7.59 ng/mL Standard Deviation 8.77	32.9 ng/mL Standard Deviation 48.4	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-3: 2.5-5.0 h	8.01 ng/mL Standard Deviation 6.27	41.7 ng/mL Standard Deviation 28.4	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-3:5.0-10 h	4.36 ng/mL Standard Deviation 5.10	13.2 ng/mL Standard Deviation 14.4	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-3: 8-24 h	2.33 ng/mL Standard Deviation 6.79	6.11 ng/mL Standard Deviation 10.0	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-5: 0-2.5 h	16.8 ng/mL Standard Deviation 17.3	76.9 ng/mL Standard Deviation 122	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-5: 2.5-5.0 h	17.0 ng/mL Standard Deviation 13.0	68.1 ng/mL Standard Deviation 70.9	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-5:5.0-10 h	13.0 ng/mL Standard Deviation 11.7	33.3 ng/mL Standard Deviation 19.6	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-6: Predose	0.500 ng/mL Standard Deviation NA Mean of SUN13834 metabolite concentration at pre-dose is \<0.500. Below level of detection.	0.500 ng/mL Standard Deviation NA Mean of SUN13834 metabolite concentration at pre-dose is \<0.500. Below level of detection.	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-6: 0-2.5 h	26.8 ng/mL Standard Deviation 26.8	69.5 ng/mL Standard Deviation 83.7	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-6: 2.5-5.0 h	31.6 ng/mL Standard Deviation 21.5	96.6 ng/mL Standard Deviation 67.4	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-6:5.0-10 h	26.6 ng/mL Standard Deviation 19.6	65.7 ng/mL Standard Deviation 50.9	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-6G: Predose	0.00 ng/mL Standard Deviation NA Mean of SUN13834 metabolite concentration at pre-dose is 0. Below level of detection.	0.00 ng/mL Standard Deviation NA Mean of SUN13834 metabolite concentration at pre-dose is 0. Below level of detection.	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-6G: 0-2.5 h	15.3 ng/mL Standard Deviation 22.8	26.1 ng/mL Standard Deviation 41.3	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-6G: 2.5-5.0 h	18.9 ng/mL Standard Deviation 22.3	85.3 ng/mL Standard Deviation 63.6	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-6G:5.0-10 h	16.2 ng/mL Standard Deviation 17.9	54.4 ng/mL Standard Deviation 61.8	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis M-6G: 8-24 h	12.6 ng/mL Standard Deviation 25.7	34.1 ng/mL Standard Deviation 55.1	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis MG-1: Predose	0.0379 ng/mL Standard Deviation 0.392	0.00 ng/mL Standard Deviation NA Mean of SUN13834 metabolite concentration at pre-dose is 0. Below level of detection.	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis MG-1: 0-2.5 h	12.0 ng/mL Standard Deviation 17.4	17.1 ng/mL Standard Deviation 37.4	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis MG-1: 2.5-5.0 h	12.0 ng/mL Standard Deviation 11.9	50.0 ng/mL Standard Deviation 67.1	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis MG-1: 8-24 h	3.25 ng/mL Standard Deviation 9.36	7.24 ng/mL Standard Deviation 10.1	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis MG-2: Predose	0.0038 ng/mL Standard Deviation 0.039	0.00 ng/mL Standard Deviation NA Mean of SUN13834 metabolite concentration at pre-dose is 0. Below level of detection.	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis MG-2: 0-2.5 h	1.31 ng/mL Standard Deviation 2.84	1.78 ng/mL Standard Deviation 3.70	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis MG-2: 2.5-5.0 h	1.81 ng/mL Standard Deviation 3.58	6.98 ng/mL Standard Deviation 11.6	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis MG-2:5.0-10 h	1.42 ng/mL Standard Deviation 3.40	4.93 ng/mL Standard Deviation 8.26	—
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis MG-2: 8-24 h	1.44 ng/mL Standard Deviation 3.57	1.60 ng/mL Standard Deviation 1.69	—

SECONDARY outcome

Timeframe: Baseline up to Week 8 post-dose, up to a total of 36 weeks.

Population: Treatment-emergent adverse events were assessed using the Safety population. All enrolled participants.

Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.

Outcome measures

Measure	Placebo n=120 Participants Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=120 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) orally tid for 28 days.	SUN13834 200 mg Tid n=30 Participants Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 100 mg; 200 mg (2×100 mg) orally tid for 28 days.
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Nausea	5 Participants	6 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Vomiting	3 Participants	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Blood creatine phosphokinase increased	6 Participants	5 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Seasonal allergy	0 Participants	1 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Number of participants with at least 1 Adverse Event	82 Participants	68 Participants	14 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Bronchitis	1 Participants	2 Participants	2 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Carbuncle	0 Participants	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Influenza	3 Participants	1 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Nasopharyngitis	9 Participants	11 Participants	2 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Pneumonia	0 Participants	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Sinusitis	4 Participants	2 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Upper respiratory tract infection	12 Participants	8 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Urinary tract infection	0 Participants	1 Participants	2 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Diarrhea	2 Participants	6 Participants	2 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Cyst drainage	0 Participants	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Blood IgE increased	0 Participants	1 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Blood pressure increased	0 Participants	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Headache	11 Participants	5 Participants	3 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Paresthesia	0 Participants	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Dermatitis atopic	3 Participants	2 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Pruritus	2 Participants	2 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Rash	0 Participants	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Oropharyngeal pain	3 Participants	1 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Pulmonary Congestion	0 Participants	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Fatigue	0 Participants	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Joint injury	0 Participants	1 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Pregnancy	1 Participants	4 Participants	0 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Accelerated hypertension	0 Participants	0 Participants	1 Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Paranoia	0 Participants	0 Participants	1 Participants

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 46 other events

Deaths: 0 deaths

SUN13834 50 mg Tid

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

SUN13834 200 mg Tid

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=120 participants at risk Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=120 participants at risk Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) tid orally 3 times a day (tid) for 28 days.	SUN13834 200 mg Tid n=30 participants at risk Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 200 mg (2×100 mg) tid orally 3 times a day (tid) for 28 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.83% 1/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	0.00% 0/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	0.00% 0/30 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.
Hepatobiliary disorders Cholelithiasis	0.83% 1/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	0.00% 0/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	0.00% 0/30 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.83% 1/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	0.00% 0/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	0.00% 0/30 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.

Other adverse events

Measure	Placebo n=120 participants at risk Participants with atopic dermatitis who were administered 2 SUN13834-matching placebo tablets orally 3 times a day (tid) for 28 days.	SUN13834 50 mg Tid n=120 participants at risk Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 25 mg; 50 mg (2×25 mg) tid orally 3 times a day (tid) for 28 days.	SUN13834 200 mg Tid n=30 participants at risk Participants with atopic dermatitis who were administered 2 SUN13834 tablets of 200 mg (2×100 mg) tid orally 3 times a day (tid) for 28 days.
Infections and infestations Upper respiratory tract infection	10.0% 12/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	6.7% 8/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	0.00% 0/30 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.
Nervous system disorders Headache	9.2% 11/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	4.2% 5/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	10.0% 3/30 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.
Infections and infestations Nasopharyngitis	7.5% 9/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	9.2% 11/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	6.7% 2/30 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.
Investigations Blood creatine phosphokinase increased	5.0% 6/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	4.2% 5/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	0.00% 0/30 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.
Gastrointestinal disorders Nausea	4.2% 5/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	5.0% 6/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	0.00% 0/30 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.
Gastrointestinal disorders Diarrhea	1.7% 2/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	5.0% 6/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	6.7% 2/30 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.
Infections and infestations Bronchitis	0.83% 1/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	1.7% 2/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	6.7% 2/30 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.
Infections and infestations Urinary tract infection	0.00% 0/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	0.83% 1/120 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.	6.7% 2/30 • Treatment-emergent adverse events (TEAEs) data were collected from Baseline (Day 1) up to 8 weeks post-dose, up to a total of 36 weeks. Treatment-emergent adverse events (TEAEs) were defined as Adverse Events (AEs) that occurred from the time treatment was administered on Day 1 through the last follow-up visit or a worsening of a pre-existing condition.

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 908-992-6400

Email: CTRinfo@dsi.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place