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

A Phase 2 study testing SUN13834 in people with Atopic Dermatitis, run by Daiichi Sankyo at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Atopic Dermatitis
What is being tested?: SUN13834
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 270 participants
Where: 28 sitesUnited States
Study dates: 16 Jul 2008to 9 Apr 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

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

Other trials in United States

About this study

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

Conditions: Atopic Dermatitis
Being tested: SUN13834, Placebo
Keywords: Atopic Dermatitis, SUN13834
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SUN13834Drug
Low dose, orally 3 times a day (tid) for 28 days of SUN13834
PlaceboDrug
Placebo, orally (tid) for 28 days of SUN13834

Study groups in NCT00717769
Study group	Role	What they receive
SUN13834	Experimental	Not described Receives: Drug: SUN13834
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (8)

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).
Measured: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
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).
Measured: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
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.
Measured: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
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.
Measured: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
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.
Measured: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Mean of SUN13834 Plasma Concentrations Over Time Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Measured: Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.
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.
Measured: Baseline up to 0-2.5 h, 2.5-5.0 h, 5.0-10 h, 8-24 h post-dose.
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.
Measured: Baseline up to Week 8 post-dose, up to a total of 36 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jul 20089 Apr 2009

First posted17 Jul 2008 (estimated)
Study start16 Jul 2008
Primary completion9 Apr 2009
Study completion9 Apr 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 270 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00717769
Sponsor's protocol ID: ASBI 404
Status last verified: Mar 2021
First submitted: 16 Jul 2008
Last updated: 21 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of SUN13834 in Adult Subjects With Atopic Dermatitis
ClinicalTrials.gov ID: NCT00717769
Acronym / sponsor ID: ASBI 404
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis, SUN13834
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 270 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: 16 Jul 2008 (actual)
Primary completion: 9 Apr 2009 (actual)
Study completion: 9 Apr 2009 (actual)
First posted: 17 Jul 2008 (estimated)
Results: Posted 21 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SUN13834	Experimental	Drug: SUN13834
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SUN13834Low dose, orally 3 times a day (tid) for 28 days of SUN13834	Drug	SUN13834
PlaceboPlacebo, orally (tid) for 28 days of SUN13834	Drug	Placebo

Primary outcome

Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Time frame: 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 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.
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
Time frame: 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, 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.
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
Time frame: 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, 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.

8 secondary outcomes

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
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
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
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Mean Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Percent Change in Pruritus Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
Mean Change in Insomnia Score From Baseline to Each Visit Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.
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.
Mean of SUN13834 Metabolite 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.
Summary of Treatment-Emergent Adverse Events in ≥2% of Participants Following Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis
Time frame: Baseline up to Week 8 post-dose, up to a total of 36 weeks.

Results and safety

Results posted to the registry on 21 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	120	104
SUN13834 50 mg Tid	120	102
SUN13834 200 mg Tid	30	19

Primary outcome: Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis

Time frame: Pre-dose. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo n = 120	SUN13834 50 mg Tid n = 119	SUN13834 200 mg Tid n = 30
Eczema Area and Severity Index (EASI) Score	12.59 (10.02)	12.45 (8.75)	6.01 (5.98)
Investigator's Global Assessment (IGA) Score	3.0 (0.67)	3.1 (0.69)	2.6 (0.93)
Pruritus Score	2.2 (0.74)	2.2 (0.72)	1.9 (0.80)
Insomnia Score	3.2 (3.16)	4.0 (3.06)	3.0 (3.07)

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

Primary outcome: 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

Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 120	SUN13834 50 mg Tid n = 119
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)

Placebo vs SUN13834 50 mg Tid: p = 0.519, ANCOVA
Placebo vs SUN13834 50 mg Tid: p = 0.032, ANCOVA
Placebo vs SUN13834 50 mg Tid: p = 0.008, ANCOVA

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

Primary outcome: 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

Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.. Mean (Standard Deviation). Unit: percent change

Measure	Placebo n = 120	SUN13834 50 mg Tid n = 119
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)

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

Primary outcome: 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

Time frame: Day 8, Day 15, Day 22, Day 29, Follow Up Week 2 and Week 4 post-dose.. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 93	SUN13834 50 mg Tid n = 87
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)

Placebo vs SUN13834 50 mg Tid: p = 0.533, ANCOVA
Placebo vs SUN13834 50 mg Tid: p = 0.009, ANCOVA
Placebo vs SUN13834 50 mg Tid: p = 0.002, ANCOVA

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

14 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 120 (2.5%)	46 of 120 (38.3%)	0 of 120
SUN13834 50 mg Tid	0 of 120 (0%)	44 of 120 (36.7%)	0 of 120
SUN13834 200 mg Tid	0 of 30 (0%)	11 of 30 (36.7%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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/

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RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Leader study director

Daiichi Sankyo

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SUN13834 in people with Atopic Dermatitis, run by Daiichi Sankyo at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline of Disease Characteristics Before Treatment With SUN13834 or Placebo in Adult Participants With Atopic Dermatitis (time frame: Pre-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00717769.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.