NCT00717769

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

Completed Phase 2 Results posted Last updated 21 April 2021

What this trial tests

Phase 2 trial testing SUN13834 in Atopic Dermatitis in 270 participants. Completed in 9 April 2009.

Timeline

16 July 2008

Primary endpoint
9 April 2009

9 April 2009

Quick facts

Lead sponsor	Daiichi Sankyo
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	270
Start date	16 July 2008
Primary completion	9 April 2009
Estimated completion	9 April 2009
Sites	28 locations across United States

Drugs / interventions tested

• SUN13834 — full drug profile →
• Placebo

Conditions studied

• Atopic Dermatitis — all drugs for Atopic Dermatitis →

Sponsor

Daiichi Sankyo — full company profile →

Who can join

Adults 18 to 65, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Primary · Pre-dose

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 seve

Eczema Area and Severity Index (EASI) Score

Group	Value	95% CI
Placebo	12.59	± 10.02
SUN13834 50 mg Tid	12.45	± 8.75
SUN13834 200 mg Tid	6.01	± 5.98

Investigator's Global Assessment (IGA) Score

Group	Value	95% CI
Placebo	3.0	± 0.67
SUN13834 50 mg Tid	3.1	± 0.69
SUN13834 200 mg Tid	2.6	± 0.93

Pruritus Score

Group	Value	95% CI
Placebo	2.2	± 0.74
SUN13834 50 mg Tid	2.2	± 0.72
SUN13834 200 mg Tid	1.9	± 0.80

Insomnia Score

Group	Value	95% CI
Placebo	3.2	± 3.16
SUN13834 50 mg Tid	4.0	± 3.06
SUN13834 200 mg Tid	3.0	± 3.07

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

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,

Day 8: Change from Baseline

Group	Value	95% CI
Placebo	-1.66	± 4.59
SUN13834 50 mg Tid	-1.94	± 3.36

Day 15: Change from Baseline

Group	Value	95% CI
Placebo	-2.88	± 4.82
SUN13834 50 mg Tid	-4.06	± 4.92

Day 22: Change from Baseline

Group	Value	95% CI
Placebo	-3.83	± 6.30
SUN13834 50 mg Tid	-5.67	± 6.60

Day 29: Change from Baseline

Group	Value	95% CI
Placebo	-4.70	± 6.96
SUN13834 50 mg Tid	-6.70	± 6.82

Follow-up Week 2: Change from Baseline

Group	Value	95% CI
Placebo	-4.64	± 6.70
SUN13834 50 mg Tid	-6.41	± 7.86

Follow-up Week 4: Change from Baseline

Group	Value	95% CI
Placebo	-4.41	± 6.95
SUN13834 50 mg Tid	-6.73	± 7.77

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

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,

Day 8: % Change from Baseline

Group	Value	95% CI
Placebo	-12.62	± 30.45
SUN13834 50 mg Tid	-15.52	± 27.03

Day 15: % Change from Baseline

Group	Value	95% CI
Placebo	-23.42	± 33.34
SUN13834 50 mg Tid	-28.46	± 59.41

Day 22: % Change from Baseline

Group	Value	95% CI
Placebo	-30.83	± 42.61
SUN13834 50 mg Tid	-39.11	± 42.83

Day 29: % Change from Baseline

Group	Value	95% CI
Placebo	-38.33	± 43.89
SUN13834 50 mg Tid	-47.46	± 39.89

Follow-up Week 2: % Change from Baseline

Group	Value	95% CI
Placebo	-37.29	± 56.64
SUN13834 50 mg Tid	-45.35	± 45.55

Follow-up Week 4: % Change from Baseline

Group	Value	95% CI
Placebo	-37.89	± 53.35
SUN13834 50 mg Tid	-48.06	± 44.46

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

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,

Day 8: Change from Baseline

Group	Value	95% CI
Placebo	-1.94	± 5.08
SUN13834 50 mg Tid	-2.36	± 3.73

Day 15: Change from Baseline

Group	Value	95% CI
Placebo	-3.28	± 5.27
SUN13834 50 mg Tid	-5.13	± 4.95

Day 22: Change from Baseline

Group	Value	95% CI
Placebo	-4.26	± 6.91
SUN13834 50 mg Tid	-7.08	± 6.81

Day 29: Change from Baseline

Group	Value	95% CI
Placebo	-5.26	± 7.55
SUN13834 50 mg Tid	-8.19	± 6.90

Follow-up Week 2: Change from Baseline

Group	Value	95% CI
Placebo	-5.38	± 7.20
SUN13834 50 mg Tid	-7.99	± 8.29

Follow-up Week 4: Change from Baseline

Group	Value	95% CI
Placebo	-5.09	± 7.24
SUN13834 50 mg Tid	-8.49	± 7.89

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

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,

Day 8: % Change from Baseline

Group	Value	95% CI
Placebo	-13.65	± 29.51
SUN13834 50 mg Tid	-16.03	± 23.94

Day 15: % Change from Baseline

Group	Value	95% CI
Placebo	-23.67	± 31.94
SUN13834 50 mg Tid	-33.64	± 31.26

Day 22: % Change from Baseline

Group	Value	95% CI
Placebo	-29.29	± 45.21
SUN13834 50 mg Tid	-44.40	± 35.29

Day 29: % Change from Baseline

Group	Value	95% CI
Placebo	-37.58	± 46.18
SUN13834 50 mg Tid	-52.84	± 35.90

Follow-up Week 2: % Change from Baseline

Group	Value	95% CI
Placebo	-40.69	± 46.07
SUN13834 50 mg Tid	-50.86	± 42.50

Follow-up Week 4: % Change from Baseline

Group	Value	95% CI
Placebo	-40.16	± 47.42
SUN13834 50 mg Tid	-54.35	± 40.40

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

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).

Day 8: Change from Baseline

Group	Value	95% CI
Placebo	-0.2	± 0.54
SUN13834 50 mg Tid	-0.3	± 0.57

Day 15: Change from Baseline

Group	Value	95% CI
Placebo	-0.4	± 0.69
SUN13834 50 mg Tid	-0.6	± 0.74

Day 22: Change from Baseline

Group	Value	95% CI
Placebo	-0.6	± 0.77
SUN13834 50 mg Tid	-0.9	± 0.87

Day 29: Change from Baseline

Group	Value	95% CI
Placebo	-0.8	± 0.97
SUN13834 50 mg Tid	-1.1	± 1.00

Follow-up Week 2: Change from Baseline

Group	Value	95% CI
Placebo	-0.8	± 1.01
SUN13834 50 mg Tid	-1.1	± 1.05

Follow-up Week 4: Change from Baseline

Group	Value	95% CI
Placebo	-0.8	± 1.10
SUN13834 50 mg Tid	-1.1	± 1.04

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

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).

Day 8: % Change from Baseline

Group	Value	95% CI
Placebo	-6.10	± 18.51
SUN13834 50 mg Tid	-8.83	± 18.17

Day 15: % Change from Baseline

Group	Value	95% CI
Placebo	-10.84	± 23.00
SUN13834 50 mg Tid	-19.99	± 32.34

Day 22: % Change from Baseline

Group	Value	95% CI
Placebo	-17.95	± 26.13
SUN13834 50 mg Tid	-28.89	± 30.57

Day 29: % Change from Baseline

Group	Value	95% CI
Placebo	-24.21	± 32.24
SUN13834 50 mg Tid	-34.93	± 34.42

Follow-up Week 2: % Change from Baseline

Group	Value	95% CI
Placebo	-25.91	± 34.47
SUN13834 50 mg Tid	-34.48	± 36.66

Follow-up Week 4: % Change from Baseline

Group	Value	95% CI
Placebo	-27.24	± 37.59
SUN13834 50 mg Tid	-34.10	± 36.67

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

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).

Day 8: Change from Baseline

Group	Value	95% CI
Placebo	-0.2	± 0.54
SUN13834 50 mg Tid	-0.2	± 0.58

Day 15: Change from Baseline

Group	Value	95% CI
Placebo	-0.4	± 0.66
SUN13834 50 mg Tid	-0.7	± 0.69

Day 22: Change from Baseline

Group	Value	95% CI
Placebo	-0.5	± 0.80
SUN13834 50 mg Tid	-1.0	± 0.83

Day 29: Change from Baseline

Group	Value	95% CI
Placebo	-0.8	± 1.02
SUN13834 50 mg Tid	-1.2	± 0.98

Follow-up Week 2: Change from Baseline

Group	Value	95% CI
Placebo	-0.8	± 1.05
SUN13834 50 mg Tid	-1.2	± 1.04

Follow-up Week 4: Change from Baseline

Group	Value	95% CI
Placebo	-0.8	± 1.13
SUN13834 50 mg Tid	-1.2	± 1.05

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

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).

Day 8: % Change from Baseline

Group	Value	95% CI
Placebo	-7.06	± 17.76
SUN13834 50 mg Tid	-7.33	± 17.38

Day 15: % Change from Baseline

Group	Value	95% CI
Placebo	-11.09	± 21.72
SUN13834 50 mg Tid	-20.23	± 20.93

Day 22: % Change from Baseline

Group	Value	95% CI
Placebo	-16.02	± 26.71
SUN13834 50 mg Tid	-30.47	± 24.68

Day 29: % Change from Baseline

Group	Value	95% CI
Placebo	-23.64	± 33.88
SUN13834 50 mg Tid	-37.99	± 29.96

Follow-up Week 2: % Change from Baseline

Group	Value	95% CI
Placebo	-25.18	± 35.21
SUN13834 50 mg Tid	-36.51	± 32.98

Follow-up Week 4: % Change from Baseline

Group	Value	95% CI
Placebo	-25.72	± 37.31
SUN13834 50 mg Tid	-37.43	± 34.26

Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Secondary · Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

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.

Day 8: Change from Baseline

Group	Value	95% CI
Placebo	-0.3	± 0.77
SUN13834 50 mg Tid	-0.3	± 0.88

Day 15: Change from Baseline

Group	Value	95% CI
Placebo	-0.5	± 0.83
SUN13834 50 mg Tid	-0.6	± 0.92

Day 22: Change from Baseline

Group	Value	95% CI
Placebo	-0.6	± 0.92
SUN13834 50 mg Tid	-0.7	± 1.04

Day 29: Change from Baseline

Group	Value	95% CI
Placebo	-0.7	± 0.85
SUN13834 50 mg Tid	-0.9	± 1.04

Follow-up Week 2: Change from Baseline

Group	Value	95% CI
Placebo	-0.6	± 1.04
SUN13834 50 mg Tid	-0.8	± 1.09

Follow-up Week 4: Change from Baseline

Group	Value	95% CI
Placebo	-0.6	± 0.93
SUN13834 50 mg Tid	-0.7	± 1.09

Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Secondary · Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

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.

Day 8: % Change from Baseline

Group	Value	95% CI
Placebo	-1.54	± 99.05
SUN13834 50 mg Tid	-7.68	± 48.73

Day 15: % Change from Baseline

Group	Value	95% CI
Placebo	-11.53	± 101.25
SUN13834 50 mg Tid	-22.22	± 48.74

Day 22: % Change from Baseline

Group	Value	95% CI
Placebo	-13.89	± 104.86
SUN13834 50 mg Tid	-25.99	± 54.76

Day 29: % Change from Baseline

Group	Value	95% CI
Placebo	-18.75	± 103.37
SUN13834 50 mg Tid	-33.34	± 51.94

Follow-up Week 2: % Change from Baseline

Group	Value	95% CI
Placebo	-11.95	± 109.12
SUN13834 50 mg Tid	-28.11	± 55.80

Follow-up Week 4: % Change from Baseline

Group	Value	95% CI
Placebo	-15.14	± 106.67
SUN13834 50 mg Tid	-27.82	± 53.91

Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis Secondary · Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.

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.

Day 8: Change from Baseline

Group	Value	95% CI
Placebo	-0.3	± 0.72
SUN13834 50 mg Tid	-0.3	± 0.87

Day 15: Change from Baseline

Group	Value	95% CI
Placebo	-0.5	± 0.80
SUN13834 50 mg Tid	-0.7	± 0.95

Day 22: Change from Baseline

Group	Value	95% CI
Placebo	-0.6	± 0.91
SUN13834 50 mg Tid	-0.7	± 1.10

Day 29: Change from Baseline

Group	Value	95% CI
Placebo	-0.7	± 0.89
SUN13834 50 mg Tid	-0.9	± 1.13

Follow-up Week 2: Change from Baseline

Group	Value	95% CI
Placebo	-0.6	± 1.06
SUN13834 50 mg Tid	-0.7	± 1.16

Follow-up Week 4: Change from Baseline

Group	Value	95% CI
Placebo	-0.6	± 0.91
SUN13834 50 mg Tid	-0.7	± 1.14

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 3/120 (3%)

Deaths: 0/120

SUN13834 50 mg Tid

Serious: 0/120 (0%)

Deaths: 0/120

SUN13834 200 mg Tid

Serious: 0/30 (0%)

Deaths: 0/30

Serious adverse events (3 terms)

Reaction	System	Placebo	SUN13834 50 mg Tid	SUN13834 200 mg Tid
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	Placebo	SUN13834 50 mg Tid	SUN13834 200 mg Tid
Upper respiratory tract infection	Infections and infestations	—	—	—
Headache	Nervous system disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Bronchitis	Infections and infestations	—	—	—
Urinary tract infection	Infections and infestations	—	—	—

Most-reported serious reactions: Basal cell carcinoma, Cholelithiasis, Squamous cell carcinoma.

Data from ClinicalTrials.gov NCT00717769 adverse events section.

Sponsor's own description

The purpose of the study is to explore the efficacy and safety of SUN13834 vs placebo in adult participants with atopic dermatitis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.