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CompletedNCT00717769Updated Apr 21, 2021Results posted

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

A Phase 2 interventional study of SUN13834 and Placebo in Atopic Dermatitis, sponsored by Daiichi Sankyo. Completed at 28 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-04-21.

Sponsored by Daiichi Sankyo · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Atopic Dermatitis
  • SUN13834
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 270 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female participants between 18 and 65 years of age.
  • A diagnosis of Atopic Dermatitis (AD), meeting the Guidelines for Diagnosis of Atopic Dermatitis criteria
  • At least 1 inflammatory lesion Eczema Area and Severity Index (EASI) score ≥5 at Screening and prior to randomization (as per Amendment 2 and 3). Under the original protocol and Amendment 1, no minimum EASI score was required.

Exclusion criteria

Exclusion Criteria:

  • Taking systemic immunosuppressive drugs or biologicals (within 3 months), or systemic corticosteroids therapy (within 4 weeks)prior to Screening(note: inhaled, intranasal or otic corticosteroids are allowed).
  • Use of phototherapy or tanning beds within 6 weeks of screening
  • History of reactive airway disease (asthma) requiring hospitalization in an intensive care unit in the last 5 years.
  • Presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the Clinical Investigator) that will interfere with the interpretation of data from this patient (eg, renal impairment with non-atopic pruritus).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
270 participants (actual)

Study arms

  • Experimental
    SUN13834

    Drug: SUN13834

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugSUN13834

    Low dose, orally 3 times a day (tid) for 28 days of SUN13834

  • DrugPlacebo

    Placebo, orally (tid) for 28 days of SUN13834

06

What researchers measure

Primary outcomes

  1. Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

    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.

    Time frame: Pre-dose

  2. 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

    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.

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

  3. 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

    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.

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

Secondary outcomes

  1. 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

    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).

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

  2. 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

    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).

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

  3. Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

    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.

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

  4. Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

    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.

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

  5. Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

    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.

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

  6. Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

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

  7. Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

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

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

  8. Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

    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.

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

07

Results

Posted Apr 21, 2021

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).

Participant flow — Overall Study
MilestonePlaceboSUN13834 50 mg TidSUN13834 200 mg Tid
Started12012030
Completed10410219
Not completed161811
Withdrew: Adverse event961
Withdrew: Lack of compliance020
Withdrew: Lost to follow-up340
Withdrew: Lack of efficacy120
Withdrew: Protocol violation020
Withdrew: Sponsor decision1010
Withdrew: Withdrew consent220

Outcome measures

PrimaryBaseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

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.

Time frame:
Pre-dose
Reported as:
Mean · score on a scale
Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
score on a scalePlaceboSUN13834 50 mg TidSUN13834 200 mg Tid
Eczema Area and Severity Index (EASI) Score12.59 ± 10.0212.45 ± 8.756.01 ± 5.98
Investigator's Global Assessment (IGA) Score3.0 ± 0.673.1 ± 0.692.6 ± 0.93
Pruritus Score2.2 ± 0.742.2 ± 0.721.9 ± 0.80
Insomnia Score3.2 ± 3.164.0 ± 3.063.0 ± 3.07
PrimaryMean 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

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.

Time frame:
Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Reported as:
Mean · units on a scale
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
units on a scalePlaceboSUN13834 50 mg Tid
Day 8: Change from Baseline-1.66 ± 4.59-1.94 ± 3.36
Day 15: Change from Baseline-2.88 ± 4.82-4.06 ± 4.92
Day 22: Change from Baseline-3.83 ± 6.30-5.67 ± 6.60
Day 29: Change from Baseline-4.70 ± 6.96-6.70 ± 6.82
Follow-up Week 2: Change from Baseline-4.64 ± 6.70-6.41 ± 7.86
Follow-up Week 4: Change from Baseline-4.41 ± 6.95-6.73 ± 7.77
Statistical analysis
  • Placebo vs SUN13834 50 mg Tid · ANCOVA · p = 0.519
  • Placebo vs SUN13834 50 mg Tid · ANCOVA · p = 0.032
  • Placebo vs SUN13834 50 mg Tid · ANCOVA · p = 0.008
  • Placebo vs SUN13834 50 mg Tid · ANCOVA · p = 0.006
PrimaryPercent 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

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.

Time frame:
Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Reported as:
Mean · percent change
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
percent changePlaceboSUN13834 50 mg Tid
Day 8: % Change from Baseline-12.62 ± 30.45-15.52 ± 27.03
Day 15: % Change from Baseline-23.42 ± 33.34-28.46 ± 59.41
Day 22: % Change from Baseline-30.83 ± 42.61-39.11 ± 42.83
Day 29: % Change from Baseline-38.33 ± 43.89-47.46 ± 39.89
Follow-up Week 2: % Change from Baseline-37.29 ± 56.64-45.35 ± 45.55
Follow-up Week 4: % Change from Baseline-37.89 ± 53.35-48.06 ± 44.46
PrimaryMean 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

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.

Time frame:
Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Reported as:
Mean · units on a scale
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
units on a scalePlaceboSUN13834 50 mg Tid
Day 8: Change from Baseline-1.94 ± 5.08-2.36 ± 3.73
Day 15: Change from Baseline-3.28 ± 5.27-5.13 ± 4.95
Day 22: Change from Baseline-4.26 ± 6.91-7.08 ± 6.81
Day 29: Change from Baseline-5.26 ± 7.55-8.19 ± 6.90
Follow-up Week 2: Change from Baseline-5.38 ± 7.20-7.99 ± 8.29
Follow-up Week 4: Change from Baseline-5.09 ± 7.24-8.49 ± 7.89
Statistical analysis
  • Placebo vs SUN13834 50 mg Tid · ANCOVA · p = 0.533
  • Placebo vs SUN13834 50 mg Tid · ANCOVA · p = 0.009
  • Placebo vs SUN13834 50 mg Tid · ANCOVA · p = 0.002
  • Placebo vs SUN13834 50 mg Tid · ANCOVA · p = 0.003
PrimaryPercent 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

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.

Time frame:
Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Reported as:
Mean · percent change
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
percent changePlaceboSUN13834 50 mg Tid
Day 8: % Change from Baseline-13.65 ± 29.51-16.03 ± 23.94
Day 15: % Change from Baseline-23.67 ± 31.94-33.64 ± 31.26
Day 22: % Change from Baseline-29.29 ± 45.21-44.40 ± 35.29
Day 29: % Change from Baseline-37.58 ± 46.18-52.84 ± 35.90
Follow-up Week 2: % Change from Baseline-40.69 ± 46.07-50.86 ± 42.50
Follow-up Week 4: % Change from Baseline-40.16 ± 47.42-54.35 ± 40.40
SecondaryMean 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

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).

Time frame:
Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Reported as:
Mean · units on a scale
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
units on a scalePlaceboSUN13834 50 mg Tid
Day 8: Change from Baseline-0.2 ± 0.54-0.3 ± 0.57
Day 15: Change from Baseline-0.4 ± 0.69-0.6 ± 0.74
Day 22: Change from Baseline-0.6 ± 0.77-0.9 ± 0.87
Day 29: Change from Baseline-0.8 ± 0.97-1.1 ± 1.00
Follow-up Week 2: Change from Baseline-0.8 ± 1.01-1.1 ± 1.05
Follow-up Week 4: Change from Baseline-0.8 ± 1.10-1.1 ± 1.04
SecondaryPercent 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

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).

Time frame:
Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Reported as:
Mean · percent change
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
percent changePlaceboSUN13834 50 mg Tid
Day 8: % Change from Baseline-6.10 ± 18.51-8.83 ± 18.17
Day 15: % Change from Baseline-10.84 ± 23.00-19.99 ± 32.34
Day 22: % Change from Baseline-17.95 ± 26.13-28.89 ± 30.57
Day 29: % Change from Baseline-24.21 ± 32.24-34.93 ± 34.42
Follow-up Week 2: % Change from Baseline-25.91 ± 34.47-34.48 ± 36.66
Follow-up Week 4: % Change from Baseline-27.24 ± 37.59-34.10 ± 36.67
SecondaryMean 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

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).

Time frame:
Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Reported as:
Mean · units on a scale
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
units on a scalePlaceboSUN13834 50 mg Tid
Day 8: Change from Baseline-0.2 ± 0.54-0.2 ± 0.58
Day 15: Change from Baseline-0.4 ± 0.66-0.7 ± 0.69
Day 22: Change from Baseline-0.5 ± 0.80-1.0 ± 0.83
Day 29: Change from Baseline-0.8 ± 1.02-1.2 ± 0.98
Follow-up Week 2: Change from Baseline-0.8 ± 1.05-1.2 ± 1.04
Follow-up Week 4: Change from Baseline-0.8 ± 1.13-1.2 ± 1.05
SecondaryPercent 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

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).

Time frame:
Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Reported as:
Mean · percent change
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
percent changePlaceboSUN13834 50 mg Tid
Day 8: % Change from Baseline-7.06 ± 17.76-7.33 ± 17.38
Day 15: % Change from Baseline-11.09 ± 21.72-20.23 ± 20.93
Day 22: % Change from Baseline-16.02 ± 26.71-30.47 ± 24.68
Day 29: % Change from Baseline-23.64 ± 33.88-37.99 ± 29.96
Follow-up Week 2: % Change from Baseline-25.18 ± 35.21-36.51 ± 32.98
Follow-up Week 4: % Change from Baseline-25.72 ± 37.31-37.43 ± 34.26
SecondaryMean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

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.

Time frame:
Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Reported as:
Mean · units on a scale
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
units on a scalePlaceboSUN13834 50 mg Tid
Day 8: Change from Baseline-0.3 ± 0.77-0.3 ± 0.88
Day 15: Change from Baseline-0.5 ± 0.83-0.6 ± 0.92
Day 22: Change from Baseline-0.6 ± 0.92-0.7 ± 1.04
Day 29: Change from Baseline-0.7 ± 0.85-0.9 ± 1.04
Follow-up Week 2: Change from Baseline-0.6 ± 1.04-0.8 ± 1.09
Follow-up Week 4: Change from Baseline-0.6 ± 0.93-0.7 ± 1.09
SecondaryPercent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

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.

Time frame:
Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Reported as:
Mean · percent change
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
percent changePlaceboSUN13834 50 mg Tid
Day 8: % Change from Baseline-1.54 ± 99.05-7.68 ± 48.73
Day 15: % Change from Baseline-11.53 ± 101.25-22.22 ± 48.74
Day 22: % Change from Baseline-13.89 ± 104.86-25.99 ± 54.76
Day 29: % Change from Baseline-18.75 ± 103.37-33.34 ± 51.94
Follow-up Week 2: % Change from Baseline-11.95 ± 109.12-28.11 ± 55.80
Follow-up Week 4: % Change from Baseline-15.14 ± 106.67-27.82 ± 53.91
SecondaryMean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

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.

Time frame:
Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Reported as:
Mean · units on a scale
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
units on a scalePlaceboSUN13834 50 mg Tid
Day 8: Change from Baseline-0.3 ± 0.72-0.3 ± 0.87
Day 15: Change from Baseline-0.5 ± 0.80-0.7 ± 0.95
Day 22: Change from Baseline-0.6 ± 0.91-0.7 ± 1.10
Day 29: Change from Baseline-0.7 ± 0.89-0.9 ± 1.13
Follow-up Week 2: Change from Baseline-0.6 ± 1.06-0.7 ± 1.16
Follow-up Week 4: Change from Baseline-0.6 ± 0.91-0.7 ± 1.14
SecondaryPercent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

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.

Time frame:
Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Reported as:
Mean · percent change
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
percent changePlaceboSUN13834 50 mg Tid
Day 8: % Change in Baseline-10.03 ± 31.19-7.45 ± 44.81
Day 15: % Change from Baseline-17.92 ± 38.01-23.45 ± 50.45
Day 22: % Change from Baseline-20.25 ± 44.70-22.61 ± 57.74
Day 29: % Change from Baseline-24.73 ± 45.75-33.34 ± 56.78
Follow-up Week 2: % Change from Baseline-21.69 ± 55.60-24.72 ± 57.34
Follow-up Week 4: % Change from Baseline-22.76 ± 46.81-22.41 ± 54.15
SecondaryMean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

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.

Time frame:
Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Reported as:
Mean · units on a scale
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
units on a scalePlaceboSUN13834 50 mg Tid
Day 8: Change from Baseline-0.6 ± 2.50-0.7 ± 2.61
Day 15: Change from Baseline-0.7 ± 2.50-1.2 ± 2.69
Day 22: Change from Baseline-0.8 ± 2.48-1.3 ± 2.96
Day 29: Change from Baseline-0.9 ± 2.55-1.4 ± 3.01
Follow-up Week 2: Change from Baseline-0.9 ± 2.77-1.1 ± 3.12
Follow-up Week 4: Change from Baseline-0.8 ± 2.88-1.3 ± 3.24
SecondaryMean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

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.

Time frame:
Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Reported as:
Mean · units on a scale
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
units on a scalePlaceboSUN13834 50 mg Tid
Day 8: Change from Baseline-0.6 ± 2.41-0.7 ± 2.78
Day 15: Change from Baseline-0.7 ± 2.20-1.3 ± 2.66
Day 22: Change from Baseline-0.6 ± 2.25-1.4 ± 2.93
Day 29: Change from Baseline-0.8 ± 2.44-1.5 ± 2.96
Follow-up Week 2: Change from Baseline-0.9 ± 2.50-1.0 ± 3.09
Follow-up Week 4: Change from Baseline-0.6 ± 2.56-1.3 ± 3.17
SecondaryMean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Time frame:
Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.
Reported as:
Mean · ng/mL
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
ng/mLSUN13834 50 mg TidSUN13834 200 mg Tid
Predose0.565 ± 4.810.100 ± NA
0-2.5 h99.8 ± 119452 ± 691
2.5-5.0 h90.6 ± 86.7367 ± 237
5.0-10 h49.4 ± 69.8120 ± 122
8-24 h27.2 ± 98.129.2 ± 34.0
SecondaryMean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Time frame:
Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.
Reported as:
Mean · ng/mL
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
ng/mLSUN13834 50 mg TidSUN13834 200 mg Tid
Predose0.747 ± 5.680.100 ± NA
0-2.5 h93.7 ± 122741 ± 1090
2.5-5.0 h87.7 ± 86.7508 ± 270
5.0-10 h50.5 ± 78.5103 ± 76.4
8-24 h18.2 ± 51.711.3 ± 4.47
SecondaryMean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

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

Time frame:
Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.
Reported as:
Mean · ng/mL
Mean of SUN13834 Metabolite Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
ng/mLSUN13834 50 mg TidSUN13834 200 mg Tid
M-3: Predose0.500 ± NA0.500 ± NA
M-3: 0-2.5 h7.59 ± 8.7732.9 ± 48.4
M-3: 2.5-5.0 h8.01 ± 6.2741.7 ± 28.4
M-3:5.0-10 h4.36 ± 5.1013.2 ± 14.4
M-3: 8-24 h2.33 ± 6.796.11 ± 10.0
M-5: Predose0.513 ± 0.1320.500 ± NA
M-5: 0-2.5 h16.8 ± 17.376.9 ± 122
M-5: 2.5-5.0 h17.0 ± 13.068.1 ± 70.9
M-5:5.0-10 h13.0 ± 11.733.3 ± 19.6
M-5: 8-24 h8.91 ± 18.016.8 ± 17.4
M-6: Predose0.500 ± NA0.500 ± NA
M-6: 0-2.5 h26.8 ± 26.869.5 ± 83.7
M-6: 2.5-5.0 h31.6 ± 21.596.6 ± 67.4
M-6:5.0-10 h26.6 ± 19.665.7 ± 50.9
M-6: 8-24 h16.9 ± 43.850.0 ± 79.1
M-6G: Predose0.00 ± NA0.00 ± NA
M-6G: 0-2.5 h15.3 ± 22.826.1 ± 41.3
M-6G: 2.5-5.0 h18.9 ± 22.385.3 ± 63.6
M-6G:5.0-10 h16.2 ± 17.954.4 ± 61.8
M-6G: 8-24 h12.6 ± 25.734.1 ± 55.1
MG-1: Predose0.0379 ± 0.3920.00 ± NA
MG-1: 0-2.5 h12.0 ± 17.417.1 ± 37.4
MG-1: 2.5-5.0 h12.0 ± 11.950.0 ± 67.1
MG-1:5.0-10 h8.51 ± 10.722.0 ± 21.4
MG-1: 8-24 h3.25 ± 9.367.24 ± 10.1
MG-2: Predose0.0038 ± 0.0390.00 ± NA
MG-2: 0-2.5 h1.31 ± 2.841.78 ± 3.70
MG-2: 2.5-5.0 h1.81 ± 3.586.98 ± 11.6
MG-2:5.0-10 h1.42 ± 3.404.93 ± 8.26
MG-2: 8-24 h1.44 ± 3.571.60 ± 1.69
SecondarySummary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

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.

Time frame:
Baseline up to Week 8 post-dose, up to a total of 36 weeks.
Reported as:
Count of participants · Participants
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
ParticipantsPlaceboSUN13834 50 mg TidSUN13834 200 mg Tid
Number of participants with at least 1 Adverse Event826814
Bronchitis122
Carbuncle001
Influenza310
Nasopharyngitis9112
Pneumonia001
Sinusitis421
Upper respiratory tract infection1280
Urinary tract infection012
Diarrhea262
Nausea560
Vomiting301
Blood creatine phosphokinase increased650
Blood IgE increased011
Blood pressure increased001
Headache1153
Paresthesia001
Dermatitis atopic321
Pruritus221
Rash001
Oropharyngeal pain310
Pulmonary Congestion001
Fatigue001
Joint injury011
Pregnancy140
Accelerated hypertension001
Paranoia001
Seasonal allergy011
Cyst drainage001

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/120 (0%)3/120 (2.5%)46/120 (38.3%)
SUN13834 50 mg Tid0/120 (0%)0/120 (0%)44/120 (36.7%)
SUN13834 200 mg Tid0/30 (0%)0/30 (0%)11/30 (36.7%)
Most frequent serious events
Most frequent serious events
EventPlaceboSUN13834 50 mg TidSUN13834 200 mg Tid
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1200/1200/30
CholelithiasisHepatobiliary disorders1/1200/1200/30
Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1200/1200/30
Most frequent other events
Most frequent other events
EventPlaceboSUN13834 50 mg TidSUN13834 200 mg Tid
Upper respiratory tract infectionInfections and infestations12/1208/1200/30
HeadacheNervous system disorders11/1205/1203/30
NasopharyngitisInfections and infestations9/12011/1202/30
DiarrheaGastrointestinal disorders2/1206/1202/30
BronchitisInfections and infestations1/1202/1202/30
Urinary tract infectionInfections and infestations0/1201/1202/30
Blood creatine phosphokinase increasedInvestigations6/1205/1200/30
NauseaGastrointestinal disorders5/1206/1200/30

Baseline characteristics

Baseline characteristics were assessed using the Intent-to-treat (ITT) population.

Age, Continuous
Age, Continuous(years)PlaceboSUN13834 50 mg TidSUN13834 200 mg TidTotal
Mean37.2 ± 13.1438.5 ± 12.9537.0 ± 10.6237.8 ± 12.77
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboSUN13834 50 mg TidSUN13834 200 mg TidTotal
Female726022154
Male48598115
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboSUN13834 50 mg TidSUN13834 200 mg TidTotal
Hispanic or Latino1112023
Not Hispanic or Latino10910730246
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboSUN13834 50 mg TidSUN13834 200 mg TidTotal
American Indian or Alaska Native0000
Asian2305
Native Hawaiian or Other Pacific Islander0000
Black or African American46509105
White716521157
More than one race0000
Unknown or Not Reported1102
Region of Enrollment
Region of Enrollment(participants)PlaceboSUN13834 50 mg TidSUN13834 200 mg TidTotal
United States12011930269
08

Study locations

28 sites
  • Radiant Research, Inc.
    Birmingham, Alabama 35209, United States
  • Pivotal Research Center
    Mesa, Arizona 85210, United States
  • Pivotal Research Center
    Peoria, Arizona 85381, United States
  • Burke Pharmaceutical Research
    Hot Springs, Arkansas 71913, United States
  • Therapeutics Clinical Research
    San Diego, California 92123, United States
  • Horizons Clinical Research Center, LLC
    Denver, Colorado 80220, United States
  • Miami Research Associates
    Miami, Florida 33143, United States
  • Advanced Dermatology and Cosmetic Surgery
    Ormond Beach, Florida 32174, United States
  • Stedman Clinical Trials
    Tampa, Florida 33613, United States
  • Northwest Clinical Trials
    Boise, Idaho 83704, United States
  • Deaconess Clinic Downtown Research Institute
    Evansville, Indiana 47713, United States
  • DermResearch, PLLC
    Louisville, Kentucky 40217, United States
  • Michigan Center for Skin Care Research
    Clinton Township, Michigan 48038, United States
  • Academic Dermatology
    Albuquerque, New Mexico 87106, United States
  • Derm Research Center of New York, Inc.
    Stony Brook, New York 11790, United States
  • Wake Research Associates, LLC
    Raleigh, North Carolina 27612, United States
  • Wake Forest University Health Sciences - Dermatology Studies
    Winston-Salem, North Carolina 27157, United States
  • Toledo Center for Clinical Research
    Sylvania, Ohio 43560, United States
  • Oklahoma University Health Sciences Center, Dermatology Dept
    Oklahoma City, Oklahoma 73104, United States
  • Paddington Testing Co, Inc.
    Philadelphia, Pennsylvania 19103, United States
  • Clinical Partners, LLC
    Johnston, Rhode Island 02919, United States
  • Radiant Research, Inc
    Greer, South Carolina 29651, United States
  • J & S Studies, Inc
    College Station, Texas 77845, United States
  • Baylor Research Institute of Dermatology Department
    Dallas, Texas 75246, United States
  • Dermatology Associates of San Antonio
    San Antonio, Texas 78258, United States
  • Intermountain Clinical Research
    Draper, Utah 84020, United States
  • Commonwealth Clinical Research Specialists, Inc.
    Richmond, Virginia 23233, United States
  • Premier Clinical Research
    Spokane, Washington 99204, United States
09

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00717769
Lead sponsor
Daiichi Sankyo
Responsible party
Sponsor
First posted
Jul 17, 2008
Start date
Jul 16, 2008
Primary completion
Apr 9, 2009
Completion
Apr 9, 2009
Results posted
Apr 21, 2021
Last update
Apr 21, 2021

Study contacts

Global Clinical Leader
study director · Daiichi Sankyo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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