Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis

A Phase 2 study testing DS107 in people with Atopic Dermatitis, run by DS Biopharma at 50 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The objective of this study is to compare the efficacy and safety of orally administered DS107 (2g) versus placebo in the treatment of moderate to severe Atopic Dermatitis (AD). Oral DS107/Placebo capsules will be administered for 16 weeks. The study will enrol approximately 220 subjects. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atopic Dermatitis
What is being tested?: DS107
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 219 participants
Where: 50 sitesin 5 countries
Study dates: 19 Sep 2019to 3 Sep 2020
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with a clinically confirmed diagnosis of active AD according to the American Academy of Dermatology Consensus Criteria that had been present for at least 6 months before the screening visit.
Patients with moderate to severe AD at baseline as defined by a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) score of 3 Or 4 at baseline.
Patients with an Eczema Area and Severity Index (EASI) score of ≥16 at screening and baseline.
Patients with AD covering a minimum 10% of the Body Surface Area (BSA) at baseline.
Patients with a worst itch Numeric Rating Scale (NRS) score in a day of ≥4 (on 11-point NRS) at the screening and baseline visits.
Patients whose pre-study clinical laboratory findings did not interfere with their participation in the study, in the opinion of the investigator.

Show all 12Show fewer

Patients who were able and willing to stop all current treatments for AD throughout the study (except for allowed emollients).
Patients who were on a stable dose of a bland emollient for at least 7 days prior to baseline.
Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF).
Female patients and male patients with female partners of child bearing potential had to use highly effective birth control methods or have a sterilised partner for the duration of the study.
Recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments were otherwise medically inadvisable (e.g. because of important side effects or safety risks).
Patients who were able to communicate well with the investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent prior to initiation of any study specific activities or procedures.

Who cannot join

Patients with other skin conditions that might interfere with AD diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and fungal topical skin infections) as assessed by the investigator.
Patients who had used systemic treatments that could affect AD less than 4 weeks prior to Baseline Visit (Day 0), e.g. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids.
Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions were allowed.
Patients with previous exposure to DS107.
Patients who had used any topical medicated treatment for AD (except for emollients) two weeks prior to start of treatment/Baseline (Day 0) including but not limited to, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and bleach baths.
Patients who used emollients containing urea, ceramides or hyaluronic acid less than 12 weeks prior to Baseline (Day 0).

Show all 20Show fewer

Patients who have had excessive sun exposure, have used tanning booths or other ultraviolet (UV) light sources four weeks prior to Baseline (Day 0) and/or were planning a trip to a sunny climate or to use tanning booths or other UV sources between screening and follow-up visits.
Patients who had a history of hypersensitivity to any substance in DS107 or placebo capsules.
Patients who had a history of hypersensitivity to soy beans or soy lecithin.
Patients who had a white cell count or differential white cell count outside of the normal reference range at screening.
Patients who had any clinically significant controlled or uncontrolled medical condition or laboratory abnormality that would, in the opinion of the investigator, put the patient at undue risk or interfere with interpretation of study results.
Patients who had a clinically significant impairment of renal or hepatic function.
Patients with significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease, as well as uncontrolled diabetes and fluoride arthritis or any other illness that, in the opinion of the investigator, was likely to interfere with completion of the study.
Patients with active infectious diseases (e.g. hepatitis B, hepatitis C or advanced disease secondary to infection with human immunodeficiency virus).
Patients with a history of clinically significant drug or alcohol abuse in the opinion of the investigator in the last year prior to Baseline (Day 0).
Patients who had participated in any other clinical study with an investigational drug within 3 months before the first day of administration of study treatment.
Patients who have had treatment with biologics as follows:
Any cell-depleting agents including but not limited to rituximab: within 6 months before the screening visit, or until lymphocyte count returned to normal, whichever was longer. b. Other biologics influencing cell proliferation: within 6 months before the screening visit. c. Dupilumab or other monoclonal antibodies within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever was longer.
Patients who were pregnant, planning pregnancy, breastfeeding and/or were unwilling to use adequate contraception (as specified in Inclusion Criterion 10) during the trial.
Patients, in the opinion of the investigator, not suitable to participate in the study.

Trial locations and contacts

50 sites in 5 countries.

Country

City, postcode or hospital

50 sites in 5 countries

United States26 sites

DS Investigational Site 509
Arlington, Texas, 76011
DS Investigational Site 506
Austin, Texas, 78745
DS Investigational Site 524
Birmingham, Alabama, 35209
DS Investigational Site 512
Columbus, Georgia, 31904
DS Investigational Site 508
Cypress, Texas, 77433
DS Investigational Site 527
Doral, Florida, 33122
DS Investigational Site 526
Grants Pass, Oregon, 97527
DS Investigational Site 528
Huntington Beach, California, 92647
DS Investigational Site 518
Kenosha, Wisconsin, 53144
DS Investigational Site 502
Los Angeles, California, 90045
DS Investigational Site 513
Louisville, Kentucky, 40241
DS Investigational Site 521
Medford, Oregon, 97504
DS Investigative Site 529
Orem, Utah, 84058
DS Investigational Site 525
Philadelphia, Pennsylvania, 19046
DS Investigational Site 511
Raleigh, North Carolina, 27612
DS Investigational Site 523
Richmond, Virginia, 23224
DS Investigative Site 530
Salt Lake City, Utah, 84117
DS Investigational Site 507
San Antonio, Texas, 78213
DS Investigational Site 504
San Diego, California, 92108
DS Investigational Site 505
San Diego, California, 92123
DS Investigational Site 516
Santa Ana, California, 92705
DS Investigational Site 501
Santa Monica, California, 90404
DS Investigational Site 514
Skokie, Illinois, 60077
DS Investigational Site 510
Sunrise, Florida, 33351
DS Investigational Site 519
Troy, Michigan, 48084
DS Investigational Site 517
Washington D.C., District of Columbia, 20037

Other trials in United States

Germany12 sites

DS Investigational Site 203
Augsburg
DS Investigational Site 202
Berlin
DS Investigational Site 208
Berlin
DS Investigational Site 204
Dresden
DS Investigational Site 206
Essen
DS Investigational Site 201
Frankfurt
DS Investigational Site 207
Gera
DS Investigational Site 211
Leipzig
DS Investigational Site 205
Lübeck
DS Investigational Site 210
Mainz
DS Investigational Site 214
Münster
DS Investigational Site 212
Rostock

Other trials in Germany

Poland6 sites

DS Investigational Site 406
Gdansk
DS Investigational Site 402
Lodz
DS Investigational Site 403
Poznan
DS Investigational Site 405
Warsaw
DS Investigational Site 407
Warsaw
DS Investigational Site 401
Wroclaw

Other trials in Poland

Latvia5 sites

DS Investigational Site 304
Jūrmala
DS Investigational Site 301
Riga
DS Investigational Site 302
Riga
DS Investigational Site 303
Riga
DS Investigational Site 305
Riga

Other trials in Latvia

Austria1 site

DS Investigational Site 101
Graz

Other trials in Austria

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Study to Assess the Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis

The objective of this study is to compare the efficacy and safety of orally administered DS107 (2g) versus placebo in the treatment of moderate to severe Atopic Dermatitis (AD).

Oral DS107/Placebo capsules will be administered for 16 weeks. The study will enrol approximately 220 subjects.

Read the detailed description

This study involves a comparison of 2g DS107 with placebo, administered orally once daily for a total of 16 weeks. Patients will be randomized to one of the two treatment arms in a 1:1 ratio.

The primary endpoint will be the vIGA (Validated Investigator's Global Assessment) and EASI (Eczema Area and Severity Index). Other endpoints include vIGA, EASI, SCORAD, BSA (Body Surface Area) and NRS (Numeric Rating Scale).

Conditions: Atopic Dermatitis
Being tested: DS107, Placebo
Medical subject headings: Dermatitis, Atopic

What participants receive

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

DS107Drug
Also called DS107 500mg DGLA Capsules/DS107 500mg Placebo Capsules
DS107 Capsule
PlaceboDrug
Placebo capsule

Study groups in NCT03817190
Study group	Role	What they receive
2g Oral DS107	Experimental	2g DS107 (4 DS107 capsules) administered once-daily for 16 weeks Receives: Drug: DS107
Placebo	Placebo comparator	Placebo (4 placebo capsules) orally administered once-daily for 16 weeks Receives: Drug: Placebo

What is being measured

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

Proportion of Patients Achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis Score of 0 or 1 and a Decrease of at Least 2 Points in vIGA-ADTM in Treated Population Compared to Placebo Population From Baseline at Week 16.
Proportion of patients achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from Baseline at Week 16 using GLMM.The vIGA-ADTM scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.
Measured: 16 Weeks
Proportion of Patients Achieving EASI-75 in Treated Population Compared to Placebo Population at Week 16.
Proportion of patients achieving EASI-75 (≥75% improvement from Baseline) in treated population compared to placebo population at Week 16 using GLMM.
Measured: 16 Weeks

Secondary outcomes (11)

Proportion of Patients Achieving a vIGA-ADTM Score of 0 or 1 and a Decrease of at Least 2 Points in vIGA-ADTM in Treated Population Compared to Placebo Population From Baseline to Week 4, 8, 12, 18 and 20.
Proportion of patients achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from baseline to Week 4, 8, 12, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.
The vIGA-ADTM scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.
Measured: Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20.
Proportion of Patients Achieving EASI-75 (≥75% Improvement From Baseline) in Treated Population Compared to Placebo Population at Weeks 4, 8, 12, 18 and 20
Proportion of Patients Achieving EASI-75 (≥75% Improvement in Eczema Area and Severity Index from Baseline) in Treated Population Compared to Placebo Population at Weeks 4, 8, 12, 18 and 20 EASI quantifies the severity of a patient's AD based on both lesion severity and the percent of BSA affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.
Measured: Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20.
Change From Baseline in Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) Score in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20.
The Validated Global Investigator Assessment scale for Atopic Dermatitis (vIGA-AD) scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in Validated Global Investigator Assessment scale indicates a positive outcome for the participant.
Measured: 20 Weeks
Change From Baseline in EASI in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20.
Change from Baseline in Eczema Area and Severity Index (EASI) in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected.
The EASI is a composite score ranging from 0 (no lesion severity) to 72 (severe lesions) that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of Body Surface Area (BSA) involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):
- 0 = none
- 1 = mild
- 2 = moderate
- 3 = severe A decrease in EASI indicates a positive outcome for the participant.
Measured: Week 20
Change From Baseline in Worst Itch NRS in Treated Population Compared to Placebo Population to Week 4, 8, 12, 16, 18.
Change from Baseline in worst itch Numeric Rating Scale (NRS) in treated population compared to placebo population to Week 4, 8, 12, 16 and 18. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients will score their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients will complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.
Measured: Week 18
Proportion of Patients Achieving a Decrease of at Least 3 Points in Worst Itch NRS in Treated Population Compared to Placebo Population From Baseline to Week 4, 8, 12, 16, 18 and 20.
Proportion of Patients Achieving a Decrease of at Least 3 Points in Worst Itch Numeric Rating Scale (NRS) in Treated Population Compared to Placebo Population From Baseline to Week 4, 8, 12, 16, 18 and 20.
The Pruritus NRS is a single-question assessment tool that will be used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients score their pruritus due to AD on a scale of 0 - 10, with 0 (no itch) and 10 (worst itch imaginable). Patients will complete the rating scale daily starting at screening through to the last study visit.
Measured: Week 20
Proportion of Patients Achieving a Decrease of at Least 4 Points in Worst Itch NRS in Treated Population Compared to Placebo Population From Baseline to Week 4, 8, 12, 16, 18 and 20,
Proportion of patients achieving a decrease of at least 4 points in worst itch Numeric Rating Scale (NRS) in treated population compared to placebo population from baseline to Week 4, 8, 12, 16, 18 and 20. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that is used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients will score their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients completed the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.
Measured: Week 20
Proportion of Patients Achieving EASI-50 (≥50% Improvement From Baseline) in Treated Population Compared to Placebo Population at Week 4, 8, 12, 16, 18 and 20.
Proportion of Patients Achieving EASI-50 (≥50% Improvement in Eczema Area and Severity Index From Baseline) in Treated Population Compared to Placebo Population at Week 4, 8, 12, 16, 18 and 20.
The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of Body Surface Area (BSA) involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):
- 0 = none
- 1 = mild
- 2 = moderate
- 3 = severe A decrease in EASI indicates a positive outcome for the participant.
Measured: Week 20
Change From Baseline in the Body Surface Area Affected by AD in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18.
Change from Baseline in the Body Surface Area (BSA) affected by AD in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18.
Measured: Week 18
Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18.
The SCORing Atopic Dermatitis (SCORAD) grading system was developed by the European Task Force on Atopic Dermatitis and has been a standard tool to assess atopic dermatitis (AD) severity in clinical studies. Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) will be selected to evaluate the AD severity. The intensity of each item is graded using a 4-point scale:
- 0 = No symptoms
- 1 = Mild
- 2 = Moderate
- 3 = Severe The overall body surface area (BSA) affected by AD is evaluated (from 0 to 100%) and included in the SCORAD scores. Loss of sleep and pruritus will be evaluated by patients on a visual analog scale (0-10).
Measured: 18 Weeks
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Safety Analysis Set.
Measured: 20 Weeks

Timeline

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

19 Sep 20193 Sep 2020

First posted25 Jan 2019
Study start19 Sep 2019
Primary completion3 Sep 2020
Study completion3 Sep 2020

Why it stopped: Based on Interim Analysis results

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.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 219 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03817190
Sponsor's protocol ID: DS107G-05-AD3
Status last verified: Sep 2022
First submitted: 23 Jan 2019
Last updated: 28 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Study to Assess the Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT03817190
Acronym / sponsor ID: DS107G-05-AD3
Conditions: Atopic Dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Based on Interim Analysis results
Enrolment: 219 participants (actual)
Lead sponsor: DS BiopharmaIndustry (pharma, biotech, devices)
Study start: 19 Sep 2019 (actual)
Primary completion: 3 Sep 2020 (actual)
Study completion: 3 Sep 2020 (actual)
First posted: 25 Jan 2019 (actual)
Results: Posted 6 May 2022

Clinical summary

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

The objective of this study is to compare the efficacy and safety of orally administered DS107 (2g) versus placebo in the treatment of moderate to severe Atopic Dermatitis (AD).

Oral DS107/Placebo capsules will be administered for 16 weeks. The study will enrol approximately 220 subjects.

Detailed description

This study involves a comparison of 2g DS107 with placebo, administered orally once daily for a total of 16 weeks. Patients will be randomized to one of the two treatment arms in a 1:1 ratio.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
2g Oral DS107	Experimental	Drug: DS1072g DS107 (4 DS107 capsules) administered once-daily for 16 weeks
Placebo	Placebo comparator	Drug: PlaceboPlacebo (4 placebo capsules) orally administered once-daily for 16 weeks

Who may qualify

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

Key inclusion criteria (12 listed)

Patients with a clinically confirmed diagnosis of active AD according to the American Academy of Dermatology Consensus Criteria that had been present for at least 6 months before the screening visit.
Patients with moderate to severe AD at baseline as defined by a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) score of 3 Or 4 at baseline.
Patients with an Eczema Area and Severity Index (EASI) score of ≥16 at screening and baseline.
Patients with AD covering a minimum 10% of the Body Surface Area (BSA) at baseline.
Patients with a worst itch Numeric Rating Scale (NRS) score in a day of ≥4 (on 11-point NRS) at the screening and baseline visits.

Key exclusion criteria (20 listed)

Patients with other skin conditions that might interfere with AD diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and fungal topical skin infections) as assessed by the investigator.
Patients who had used systemic treatments that could affect AD less than 4 weeks prior to Baseline Visit (Day 0), e.g. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids.
Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions were allowed.
Patients with previous exposure to DS107.
Patients who had used any topical medicated treatment for AD (except for emollients) two weeks prior to start of treatment/Baseline (Day 0) including but not limited to, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and bleach baths.

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
DS107Also: DS107 500mg DGLA Capsules/DS107 500mg Placebo CapsulesDS107 Capsule	Drug	2g Oral DS107
PlaceboPlacebo capsule	Drug	Placebo

Primary outcome

Proportion of Patients Achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis Score of 0 or 1 and a Decrease of at Least 2 Points in vIGA-ADTM in Treated Population Compared to Placebo Population From Baseline at Week 16.
Time frame: 16 Weeks
Proportion of patients achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from Baseline at Week 16 using GLMM.The vIGA-ADTM scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.
Proportion of Patients Achieving EASI-75 in Treated Population Compared to Placebo Population at Week 16.
Time frame: 16 Weeks
Proportion of patients achieving EASI-75 (≥75% improvement from Baseline) in treated population compared to placebo population at Week 16 using GLMM.

11 secondary outcomes

Proportion of Patients Achieving a vIGA-ADTM Score of 0 or 1 and a Decrease of at Least 2 Points in vIGA-ADTM in Treated Population Compared to Placebo Population From Baseline to Week 4, 8, 12, 18 and 20.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20.
Proportion of Patients Achieving EASI-75 (≥75% Improvement From Baseline) in Treated Population Compared to Placebo Population at Weeks 4, 8, 12, 18 and 20
Time frame: Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20.
Change From Baseline in Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) Score in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20.
Time frame: 20 Weeks
Change From Baseline in EASI in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20.
Time frame: Week 20
Change From Baseline in Worst Itch NRS in Treated Population Compared to Placebo Population to Week 4, 8, 12, 16, 18.
Time frame: Week 18
Proportion of Patients Achieving a Decrease of at Least 3 Points in Worst Itch NRS in Treated Population Compared to Placebo Population From Baseline to Week 4, 8, 12, 16, 18 and 20.
Time frame: Week 20
Proportion of Patients Achieving a Decrease of at Least 4 Points in Worst Itch NRS in Treated Population Compared to Placebo Population From Baseline to Week 4, 8, 12, 16, 18 and 20,
Time frame: Week 20
Proportion of Patients Achieving EASI-50 (≥50% Improvement From Baseline) in Treated Population Compared to Placebo Population at Week 4, 8, 12, 16, 18 and 20.
Time frame: Week 20
Change From Baseline in the Body Surface Area Affected by AD in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18.
Time frame: Week 18
Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18.
Time frame: 18 Weeks
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Time frame: 20 Weeks

Results and safety

Results posted to the registry on 6 May 2022, 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	110	50
DS107 2000mg	109	50

Primary outcome: Proportion of Patients Achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis Score of 0 or 1 and a Decrease of at Least 2 Points in vIGA-ADTM in Treated Population Compared to Placebo Population From Baseline at Week 16.

Time frame: 16 Weeks. Number. Unit: Number of participants

Measure	Placebo n = 86	DS107 2000mg n = 92
Value	15	14

Placebo vs DS107 2000mg: Proportion of participants: -0.2277 (95% CI -1.0415 to 0.5860), p = 0.6880, GLMM

Population analysed: Full analysis set - consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.

Primary outcome: Proportion of Patients Achieving EASI-75 in Treated Population Compared to Placebo Population at Week 16.

Time frame: 16 Weeks. Number. Unit: participants

Measure	Placebo n = 87	DS107 2000mg n = 93
Value	30	27

Placebo vs DS107 2000mg: Proportion of participants: -0.2760 (95% CI -0.9185 to 0.3665), p = 0.4321, GLMM

Population analysed: Full analysis set consists of all patients who were randomised to the study, received at least one dose of study medication and whom reached week 16. Analysis was done according to the treatment patients were randomised to.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 20 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	5 of 110 (4.5%)	53 of 110 (48.2%)	0 of 110
DS107 2000mg	5 of 109 (4.6%)	57 of 109 (52.3%)	0 of 109

Limitations and caveats (from the sponsor): The decision to terminate the study prematurely was based on the results from an interim analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Markus Weissbach, MD study chair

DS Biopharma

50 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DS107 in people with Atopic Dermatitis, run by DS Biopharma at 50 sites in 5 countries.

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 12 inclusion and 20 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: stopped early, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Germany, Poland, Latvia, Austria. 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 6 May 2022). 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?

Proportion of Patients Achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis Score of 0 or 1 and a Decrease of at Least 2 Points in vIGA-ADTM in Treated Population Compared to Placebo Population From Baseline at Week 16. (time frame: 16 Weeks). The study lists 2 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 NCT03817190.

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 28 Nov 2022.