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Based on Interim Analysis results
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2g Oral DS107 | Experimental | 2g DS107 (4 DS107 capsules) administered once-daily for 16 weeks |
|
| Placebo | Placebo Comparator | Placebo (4 placebo capsules) orally administered once-daily for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS107 | Drug | DS107 Capsule |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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).
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.
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| Name | Affiliation | Role |
|---|---|---|
| Markus Weissbach, MD | DS Biopharma | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DS Investigational Site 524 | Birmingham | Alabama | 35209 | United States | ||
| DS Investigational Site 528 |
A total of 219 patients were randomised in a 1:1 ratio.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (4 placebo capsules) orally administered once daily for 16 weeks. |
| FG001 | DS107 2000mg | 2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2020 | Dec 22, 2021 |
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| Placebo | Drug | Placebo capsule |
|
| 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. | 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. | 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):
| 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. | 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. | 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. | 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):
| 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. | 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:
| 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. | 20 Weeks |
| Huntington Beach |
| California |
| 92647 |
| United States |
| DS Investigational Site 502 | Los Angeles | California | 90045 | United States |
| DS Investigational Site 504 | San Diego | California | 92108 | United States |
| DS Investigational Site 505 | San Diego | California | 92123 | United States |
| DS Investigational Site 516 | Santa Ana | California | 92705 | United States |
| DS Investigational Site 501 | Santa Monica | California | 90404 | United States |
| DS Investigational Site 517 | Washington D.C. | District of Columbia | 20037 | United States |
| DS Investigational Site 527 | Doral | Florida | 33122 | United States |
| DS Investigational Site 510 | Sunrise | Florida | 33351 | United States |
| DS Investigational Site 512 | Columbus | Georgia | 31904 | United States |
| DS Investigational Site 514 | Skokie | Illinois | 60077 | United States |
| DS Investigational Site 513 | Louisville | Kentucky | 40241 | United States |
| DS Investigational Site 519 | Troy | Michigan | 48084 | United States |
| DS Investigational Site 511 | Raleigh | North Carolina | 27612 | United States |
| DS Investigational Site 526 | Grants Pass | Oregon | 97527 | United States |
| DS Investigational Site 521 | Medford | Oregon | 97504 | United States |
| DS Investigational Site 525 | Philadelphia | Pennsylvania | 19046 | United States |
| DS Investigational Site 509 | Arlington | Texas | 76011 | United States |
| DS Investigational Site 506 | Austin | Texas | 78745 | United States |
| DS Investigational Site 508 | Cypress | Texas | 77433 | United States |
| DS Investigational Site 507 | San Antonio | Texas | 78213 | United States |
| DS Investigative Site 529 | Orem | Utah | 84058 | United States |
| DS Investigative Site 530 | Salt Lake City | Utah | 84117 | United States |
| DS Investigational Site 523 | Richmond | Virginia | 23224 | United States |
| DS Investigational Site 518 | Kenosha | Wisconsin | 53144 | United States |
| DS Investigational Site 101 | Graz | Austria |
| DS Investigational Site 203 | Augsburg | Germany |
| DS Investigational Site 202 | Berlin | Germany |
| DS Investigational Site 208 | Berlin | Germany |
| DS Investigational Site 204 | Dresden | Germany |
| DS Investigational Site 206 | Essen | Germany |
| DS Investigational Site 201 | Frankfurt | Germany |
| DS Investigational Site 207 | Gera | Germany |
| DS Investigational Site 211 | Leipzig | Germany |
| DS Investigational Site 205 | Lübeck | Germany |
| DS Investigational Site 210 | Mainz | Germany |
| DS Investigational Site 214 | Münster | Germany |
| DS Investigational Site 212 | Rostock | Germany |
| DS Investigational Site 304 | JÅ«rmala | Latvia |
| DS Investigational Site 301 | Riga | Latvia |
| DS Investigational Site 302 | Riga | Latvia |
| DS Investigational Site 303 | Riga | Latvia |
| DS Investigational Site 305 | Riga | Latvia |
| DS Investigational Site 406 | Gdansk | Poland |
| DS Investigational Site 402 | Lodz | Poland |
| DS Investigational Site 403 | Poznan | Poland |
| DS Investigational Site 405 | Warsaw | Poland |
| DS Investigational Site 407 | Warsaw | Poland |
| DS Investigational Site 401 | Wroclaw | Poland |
| COMPLETED |
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| NOT COMPLETED |
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The Randomised Set consists of all patients who are randomised to the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (4 placebo capsules) orally administered once daily for 16 weeks. |
| BG001 | DS107 2000mg | 2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Surface Area Affected | Mean | Standard Deviation | Percentage of body surface area |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | 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. | Posted | Number | Number of participants | 16 Weeks |
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| Primary | 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. | 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. | Posted | Number | participants | 16 Weeks |
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| Secondary | 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. | 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. | Posted | Number | participants | Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20. |
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| Secondary | 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. | 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. | Posted | Number | participants | Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20. |
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| Secondary | 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. | FAS 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | 20 Weeks |
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| Secondary | 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):
| 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. | Posted | Mean | 95% Confidence Interval | Scores on a scale | Week 20 |
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| Secondary | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Week 18 |
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| Secondary | 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. | 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. | Posted | Number | participants | Week 20 |
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| Secondary | 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. | FAS 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. | Posted | Number | participants | Week 20 |
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| Secondary | 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):
| 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. | Posted | Number | participants | Week 20 |
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| Secondary | 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. | 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. | Posted | Mean | 95% Confidence Interval | % Change from Baseline | Week 18 |
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| Secondary | 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:
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 18 Weeks |
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| Secondary | 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. | Safety Analysis set consists of all patients who received at least one dose of the medication. SAS was the analysis population for all safety endpoints. Analysis was done according to the actual treatment patients received. | Posted | Number | Adverse Events | 20 Weeks |
|
|
Up to 20 weeks.
An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational IMP(s). All Adverse Events (AEs) must be recorded in the CRF, defining relationship to IMP and severity. AEs should also be recorded by the Investigator in the patient file/notes.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo (4 placebo capsules) orally administered once daily for 16 weeks. | 0 | 110 | 5 | 110 | 53 | 110 |
| EG001 | DS107 2000mg | 2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks. | 0 | 109 | 5 | 109 | 57 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis Ulcerative | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Coronavirus Infection | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Staphylococcal Skin Infection | Infections and infestations | Systematic Assessment |
| ||
| Blood Creatine Phosphokinase Increased | Investigations | Systematic Assessment |
| ||
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Ventricular extrasystoles | Cardiac disorders | Systematic Assessment |
| ||
| Conjunctivitis allergic | Eye disorders | Systematic Assessment |
| ||
| Eczema Eyelids | Eye disorders | Systematic Assessment |
| ||
| Eye Pain | Eye disorders | Systematic Assessment |
| ||
| Macular Oedema | Eye disorders | Systematic Assessment |
| ||
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Faeces soft | Gastrointestinal disorders | Systematic Assessment |
| ||
| Functional gastrointestinal disorder | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal disorder | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoids thrombosed | Gastrointestinal disorders | Systematic Assessment |
| ||
| Lip swelling | Gastrointestinal disorders | Systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest Pain | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Feeling abnormal | General disorders | Systematic Assessment |
| ||
| General physical health deterioration | General disorders | Systematic Assessment |
| ||
| Peripheral swelling | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Sluggishness | General disorders | Systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Breast abscess | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Folliculitis | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Herpes simplex | Infections and infestations | Systematic Assessment |
| ||
| Herpes virus infection | Infections and infestations | Systematic Assessment |
| ||
| Hordeolum | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Nasal herpes | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Oral herpes | Infections and infestations | Systematic Assessment |
| ||
| Otitis media | Infections and infestations | Systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Pulpitis dental | Infections and infestations | Systematic Assessment |
| ||
| Pyoderma | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Respiratory tract infection viral | Infections and infestations | Systematic Assessment |
| ||
| Rhinitis | Infections and infestations | Systematic Assessment |
| ||
| Skin infection | Infections and infestations | Systematic Assessment |
| ||
| Superinfection bacterial | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Arthropod bite | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Foot fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Heat stroke | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Sunburn | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Tooth injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| Blood glucose increased | Investigations | Systematic Assessment |
| ||
| Blood pressure increased | Investigations | Systematic Assessment |
| ||
| Blood triglycerides increased | Investigations | Systematic Assessment |
| ||
| White blood cell count increased | Investigations | Systematic Assessment |
| ||
| Gout | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint hyperextension | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Hypoesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Emotional distress | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Sleep disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Urinary tract inflammation | Renal and urinary disorders | Systematic Assessment |
| ||
| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Throat tightness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Alopecia areata | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Diffuse alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythrodermic atopic dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Intertrigo | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Solar dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
The decision to terminate the study prematurely was based on the results from an interim analysis.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | DS Biopharma | +35312933590 | info@dsbiopharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 24, 2020 | Dec 22, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015126 | 8,11,14-Eicosatrienoic Acid |
| ID | Term |
|---|---|
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks. |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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|