Phase 2
N=321
Efficacy and Safety Study of Orally Administered DS107 in Moderate to Severe Atopic Dermatitis Patients
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02864498 ↗Enrolled (actual)
321
Serious AEs
0.6%
Results posted
Oct 2022
Primary outcome: Primary: Proportion of Patients Achieving an Investigators Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population at Week 8. — 0.35; 0.29; 0.33 Proportion of participants — p=0.5570
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DS107 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- DS Biopharma
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Achieving an Investigators Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population at Week 8. |
0.35; 0.29; 0.33 | 0.5570 |
| SECONDARY 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 Placebo Population From Baseline to Weeks 2, 4, 6, and 10. |
0.02; 0.00; 0.01; 0.07; 0.03; 0.06 | — |
| SECONDARY Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, 8, and 10 |
0.03; 0.02; 0.03; 0.08; 0.07; 0.08 | — |
| SECONDARY Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10 |
-3.97; -2.94; -2.62; -7.64; -6.06; -6.86 | — |
| SECONDARY Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10 |
-1.0; -1.3; -1.3; -1.8; -2.2; -2.2 | — |
Summary
The purpose of this study is to determine whether orally administered DS107 (1g and 2g doses) is effective in the treatment of moderate to severe atopic dermatitis.
Oral DS107 capsules will be administered for 8 weeks and will be compared against placebo.
The study will enroll approximately 300 subjects.
Eligibility Criteria
Inclusion Criteria
- Subjects with a clinically confirmed diagnosis of active Atopic Dermatitis according to Hanafin and Rajka criteria
- Subjects with moderate to severe Atopic Dermatitis at baseline as defined by an IGA of minimum 3 at baseline
- Subjects with Atopic Dermatitis covering a minimum 10% of the body surface area at baseline
- Male or female subjects who are aged 18 years and older on the day of signing the informed consent form (ICF)
Exclusion Criteria
- Subjects with other skin conditions that might interfere with Atopic Dermatitis diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and fungal skin infections) as assessed by the Investigator
- Subjects who have used systemic treatments (other than biologics) that could affect Atopic Dermatitis 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 are allowed
- Subjects who have used any topical medicated treatment for Atopic Dermatitis two weeks prior to start of treatment/Baseline (Day 0), including but not limited to, topical corticosteroids, tars and bleach
- Subjects who use topical products containing urea, ceramides or hyaluronic acid two weeks prior to Baseline
- Subjects who have a history of hypersensitivity to any substance in Oral DS107 or placebo capsules
- Subjects who have any clinically significant controlled or uncontrolled medical condition or laboratory abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with the interpretation of study results
- Subjects with significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease, as well as diabetes and arthritis or any other illness that, in the opinion of the investigator, is likely to interfere with completion of the study
- Subjects with chronic infectious disease (e.g. hepatitis B, hepatitis C or infection with human immunodeficiency virus)
Data sourced from ClinicalTrials.gov (NCT02864498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.