A Phase 2 interventional study of DS107 and Vehicle cream in Atopic Dermatitis, sponsored by DS Biopharma. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-22.
Sponsored by DS Biopharma · Phase 2, Interventional, and Treatment
The purpose of this randomized, double blind, placebo controlled, parallel group study is to compare the safety and efficacy of topically applied DS107 cream (1% and 5%) versus vehicle cream, in the treatment of adult patients with mild to moderate Atopic Dermatitis (AD).
This was a randomized, vehicle-controlled, double-blind, parallel-group, multicenter, Phase 2b study to investigate the safety and efficacy of topically administered DS107 cream and the dose-response relationship between DS107 cream and vehicle cream in patients 18 years and older with mild to moderate AD.
Approximately 300 patients (100 per treatment group), with mild to moderate AD were to be included in this study. All patients signed the patient information sheet (PIS)/informed consent form (ICF) and underwent screening for study eligibility. Eligible patients were randomized (1:1:1) to receive 1% DS107 cream, 5% DS107 cream or, vehicle cream:
Treatment Group A: 1% DS107 cream Treatment Group B: 5% DS107 cream Treatment Group C: Vehicle cream Study cream was to be applied topically to all affected or commonly affected areas twice daily (BID) for 8 weeks. To maintain the double-blind conditions, the DS107 and vehicle creams were identical in appearance. During their participation, patients were to come to the clinic on 7 occasions: Screening, Baseline, and at Weeks 2, 4, 6, 8 (end of treatment), and 10 (follow-up).
At the start of the study, areas for treatment were defined, DS107 or vehicle cream was then applied to those areas (and any newly affected areas) throughout the 8-week treatment period. Patients were instructed to apply the study cream liberally to the affected area in the morning and the evening. Emollients could be applied to other areas of dry skin that were not in the defined treatment area. On the days of clinic visits, patients were instructed to abstain from applying study cream for 6 hours prior to the visit and then to apply study cream as soon as possible after the clinic visit.
Once enrolled, patients were restricted from using any other treatment for AD. Any medication (prescription and over-the-counter [OTC] drugs) or therapeutic intervention deemed necessary for the patient, and which in the opinion of the investigator did not interfere with the safety and efficacy evaluations, could be continued unless they were included in the prohibited list of medications and therapeutic regimens.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 327 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →DS Biopharma is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks
Other: Vehicle cream
1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks
Drug: DS107
5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks
Drug: DS107
Also known as: 1%w/w DS107 DGLA Cream & 5%w/w DS107 DGLA Cream
Also known as: DS107 Placebo Cream
Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Vehicle Population at Week 8
Change from baseline in Numeric Rating Scale (NRS) for Pruritus in treated population compared to vehicle population at Week 8. 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 scored their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients were required to 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.
Time frame: Baseline and Week 8
Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Vehicle Population at Week 8
Change from baseline in EASI in treated population compared to vehicle population at Week 8. 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 0-72 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. 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.
Time frame: Baseline and Week 8
Change From Baseline in NRS for Pruritus Intreated Populations Compared to Vehicle Population at Week 2, 4, 6, 10
Change from baseline in NRS for Pruritus in the treated populations compared to vehicle population at Weeks 2, 4, 6, 10. 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 were asked to 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.
Time frame: Baseline, Week 2, Week 6 and Week 10
Proportion of Patients Achieving a Decrease of at Least 2.7 Points in NRS in the Treated Populations Compared to Vehicle Population From Baseline to Weeks 2, 4, 6, 8, and 10.
• Proportion of Patients Achieving a Decrease of at Least 2.7 Points in Numeric Rating Scale (NRS) in Treated Population Compared to Vehicle Population from Baseline to Week 2, 4, 6, 8 and 10. The NRS for Pruritus 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 were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. Patients were to score their pruritus due to AD on a scale of 0-10, with 0 (no itch) and 10 (worst itch imaginable)
Time frame: 10 weeks
Change From Baseline in EASI in Treated Population Compared to Vehicle Population at Weeks 2, 4, 6, 10.
Change from baseline in EASI in the treated populations compared to vehicle population at Weeks 2, 4, 6, 10. 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 0-72 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. 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.
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 10
Proportion of Patients Achieving an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10.
Proportion of patients achieving an IGA score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to vehicle population from baseline to Week 2, 4, 6, 8, 10. 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 0-72 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. 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.
Time frame: 10 weeks
Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10.
Proportion of Patients Achieving a Decrease of at Least 2 Points in Investigator Global Assessment (IGA) in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. The IGA 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). IGA uses clinical characteristics of erythema, infiltration, papulation, and oozing/crusting as scoring guidelines for the overall severity assessment.
Time frame: 10 weeks
Change From Baseline in IGA Score in the Treated Populations Compared to Vehicle Population at Weeks 2, 4, 6, 8, 10.
The Global Investigator Assessment scale (IGA) 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 IGA indicates a positive outcome for the participant.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10
Approximately 300 patients (100 per treatment group), with mild to moderate Atopic Dermatitis (AD) were to be included in this study.
| Milestone | Vehicle Cream | 1% DS107 Cream | 5% DS107 Cream |
|---|---|---|---|
| Started | 106 | 110 | 111 |
| Completed | 81 | 81 | 83 |
| Not completed | 25 | 29 | 28 |
| Withdrew: Adverse event | 3 | 3 | 6 |
| Withdrew: Withdrawal by subject | 16 | 15 | 13 |
| Withdrew: Investigator discretion | 0 | 1 | 1 |
| Withdrew: Lost to follow-up | 2 | 3 | 1 |
| Withdrew: Lack of efficacy | 2 | 6 | 4 |
| Withdrew: Other: | 2 | 1 | 3 |
Change from baseline in Numeric Rating Scale (NRS) for Pruritus in treated population compared to vehicle population at Week 8. 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 scored their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients were required to 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.
| score on a scale | Vehicle Cream | 1% DS107 Cream | 5% DS107 Cream |
|---|---|---|---|
| Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Vehicle Population at Week 8 | -3.8 ± 2.66 | -2.9 ± 2.66 | -2.9 ± 2.31 |
Change from baseline in EASI in treated population compared to vehicle population at Week 8. 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 0-72 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. 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.
| score on a scale | Vehicle Cream | 1% DS107 Cream | 5% DS107 Cream |
|---|---|---|---|
| Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Vehicle Population at Week 8 | -7.96 ± 8.504 | -7.26 ± 7.287 | -8.44 ± 7.603 |
Change from baseline in NRS for Pruritus in the treated populations compared to vehicle population at Weeks 2, 4, 6, 10. 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 were asked to 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.
| score on a scale | Vehicle Cream | 1% DS107 Cream | 5% DS107 Cream |
|---|---|---|---|
| Week 2 | -1.5 ± 1.88 | -1.1 ± 1.68 | -1.4 ± 1.92 |
| Week 4 | -2.7 ± 1.99 | -2.1 ± 2.45 | -2.1 ± 1.95 |
| Week 8 | -3.3 ± 2.44 | -2.7 ± 2.61 | -2.5 ± 2.08 |
| Week 10 | -3.8 ± 2.74 | -2.9 ± 2.90 | -3.0 ± 2.46 |
• Proportion of Patients Achieving a Decrease of at Least 2.7 Points in Numeric Rating Scale (NRS) in Treated Population Compared to Vehicle Population from Baseline to Week 2, 4, 6, 8 and 10. The NRS for Pruritus 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 were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. Patients were to score their pruritus due to AD on a scale of 0-10, with 0 (no itch) and 10 (worst itch imaginable)
| Proportion of participants | Vehicle Cream | 1% DS107 Cream | 5% DS107 Cream |
|---|---|---|---|
| Week 2 | 0.19 | 0.14 | 0.15 |
| Week 4 | 0.38 | 0.26 | 0.28 |
| Week 6 | 0.41 | 0.31 | 0.39 |
| Week 8 | 0.45 | 0.31 | 0.4 |
| Week 10 | 0.42 | 0.31 | 0.35 |
Change from baseline in EASI in the treated populations compared to vehicle population at Weeks 2, 4, 6, 10. 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 0-72 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. 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.
| score on a scale | Vehicle Cream | 1% DS107 Cream | 5% DS107 Cream |
|---|---|---|---|
| Week 2 | -3.14 ± 4.387 | -3.13 ± 5.390 | -2.72 ± 4.776 |
| Week 4 | -6.19 ± 6.705 | -5.43 ± 6.358 | -5.57 ± 6.765 |
| Week 6 | -7.28 ± 7.518 | -6.45 ± 7.198 | -7.40 ± 7.248 |
| Week 10 | -8.47 ± 8.474 | -7.69 ± 7.143 | -8.74 ± 7.769 |
Proportion of patients achieving an IGA score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to vehicle population from baseline to Week 2, 4, 6, 8, 10. 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 0-72 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. 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.
| Proportion of participants | Vehicle Cream | 1% DS107 Cream | 5% DS107 Cream |
|---|---|---|---|
| Week 2 | 0.03 | 0.05 | 0.03 |
| Week 4 | 0.07 | 0.10 | 0.08 |
| Week 6 | 0.11 | 0.12 | 0.14 |
| Week 8 | 0.14 | 0.17 | 0.23 |
| Week 10 | 0.12 | 0.15 | 0.25 |
Proportion of Patients Achieving a Decrease of at Least 2 Points in Investigator Global Assessment (IGA) in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10. The IGA 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). IGA uses clinical characteristics of erythema, infiltration, papulation, and oozing/crusting as scoring guidelines for the overall severity assessment.
| Proportion of participants | Vehicle Cream | 1% DS107 Cream | 5% DS107 Cream |
|---|---|---|---|
| Week 2 | 0.03 | 0.05 | 0.03 |
| Week 4 | 0.07 | 0.10 | 0.08 |
| Week 6 | 0.11 | 0.12 | 0.14 |
| Week 8 | 0.14 | 0.17 | 0.23 |
| Week 10 | 0.12 | 0.15 | 0.25 |
The Global Investigator Assessment scale (IGA) 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 IGA indicates a positive outcome for the participant.
| score on a scale | Vehicle Cream | 1% DS107 Cream | 5% DS107 Cream |
|---|---|---|---|
| Week 2 | -0.18 ± 0.562 | -0.27 ± 0.604 | -0.26 ± 0.585 |
| Week 4 | -0.33 ± 0.719 | -0.57 ± 0.737 | -0.44 ± 0.709 |
| Week 6 | -0.49 ± 0.840 | -0.70 ± 0.822 | -0.70 ± 0.827 |
| Week 8 | -0.78 ± 0.871 | -0.85 ± 0.896 | -0.92 ± 0.953 |
| Week 10 | -0.73 ± 0.881 | -0.80 ± 0.858 | -0.98 ± 0.987 |
Collected over Up to 10 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vehicle Cream | 0/106 (0%) | 1/106 (0.9%) | 38/106 (35.8%) |
| 1% DS107 Cream | 0/110 (0%) | 1/110 (0.9%) | 48/110 (43.6%) |
| 5% DS107 Cream | 0/111 (0%) | 0/111 (0%) | 40/111 (36%) |
| Event | Vehicle Cream | 1% DS107 Cream | 5% DS107 Cream |
|---|---|---|---|
| Dermatitis AtopicSkin and subcutaneous tissue disorders | 1/106 | 0/110 | 0/111 |
| Conjunctivitis allergicEye disorders | 0/106 | 1/110 | 0/111 |
| Event | Vehicle Cream | 1% DS107 Cream | 5% DS107 Cream |
|---|---|---|---|
| Viral Upper Respiratory Tract InfectionInfections and infestations | 5/106 | 6/110 | 1/111 |
| Upper Respiratory Tract InfectionInfections and infestations | 5/106 | 4/110 | 1/111 |
| HeadacheNervous system disorders | 5/106 | 4/110 | 2/111 |
| Dermatitis AtopicSkin and subcutaneous tissue disorders | 4/106 | 5/110 | 2/111 |
| EczemaSkin and subcutaneous tissue disorders | 4/106 | 5/110 | 2/111 |
| Application Site PainGeneral disorders | 1/106 | 2/110 | 4/111 |
| PruritusSkin and subcutaneous tissue disorders | 3/106 | 2/110 | 4/111 |
| Back PainMusculoskeletal and connective tissue disorders | 3/106 | 0/110 | 1/111 |
| NauseaGastrointestinal disorders | 0/106 | 2/110 | 0/111 |
| Urinary Tract InfectionInfections and infestations | 1/106 | 2/110 | 0/111 |
Full Analysis Set (FAS): All patients who were randomized to the study and received at least one dose of study cream. FAS was the primary analysis population for efficacy endpoints.
| Age, Continuous(years) | Vehicle Cream | 1% DS107 Cream | 5% DS107 Cream | Total |
|---|---|---|---|---|
| Mean | 40.5 ± 16.54 | 38.2 ± 15.13 | 43.2 ± 16.06 | 40.6 ± 15.91 |
| Sex: Female, Male(Participants) | Vehicle Cream | 1% DS107 Cream | 5% DS107 Cream | Total |
|---|---|---|---|---|
| Female | 63 | 75 | 50 | 188 |
| Male | 43 | 35 | 60 | 138 |
| Race (NIH/OMB)(Participants) | Vehicle Cream | 1% DS107 Cream | 5% DS107 Cream | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 16 | 23 | 22 | 61 |
| Native Hawaiian or Other Pacific Islander | 1 | 3 | 1 | 5 |
| Black or African American | 19 | 25 | 28 | 72 |
| White | 55 | 48 | 50 | 153 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 15 | 11 | 9 | 35 |
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