Phase 2
N=102
Oral DS107 in Moderate to Severe Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02211417 ↗Enrolled (actual)
102
Serious AEs
1.0%
Results posted
Oct 2022
Primary outcome: Primary: Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8. — 0.12; 0.22 Proportion of participants — p=0.057
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oral DS107 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dignity Sciences Ltd.
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8. |
0.12; 0.22 | 0.057 |
| SECONDARY Change From Baseline in IGA at Week 2, 4 and 8. |
-0.2; -0.4; -0.4; -0.9; -0.9; -1.3 | — |
| SECONDARY Change From Baseline in Eczema Area and Severity Index (EASI) at Week 2, 4 and 8. |
-1.2; -2.8; -5.2; -7.2; -8.4; -9.4 | — |
| SECONDARY Proportion of Patients Achieving at Least a 1-point Decrease in IGA at Week 8. |
0.43; 0.51 | — |
| SECONDARY Change From Baseline in the Patient Orientated Eczema Measure (POEM) at Week 2, 4 and 8. |
-3.5; -5.0; -4.0; -6.9; -5.0; -5.7 | — |
| SECONDARY Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at Week 2, 4 and 8. |
-3.6; -4.2; -5.0; -6.5; -4.9; -5.5 | — |
| SECONDARY Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 2, 4 and 8. |
-5.3; -6.6; -10.6; -16.7; -18.3; -21.1 | — |
| SECONDARY Change From Baseline in the Patient's Visual Analog Scale (VAS) Pruritus Score at Week 2, 4 and 8. |
-0.9; -1.6; -1.1; -2.8; -2.2; -2.8 | — |
| SECONDARY Change From Baseline in Body Surface Area (BSA) at Week 2, 4 and 8. |
-0.9; -1.3; -3.6; -5.2; -7.0; -9.6 | — |
| SECONDARY Number of Participants With TEAEs in Each Treatment Group |
24; 37 | — |
Summary
This study will compare the safety and efficacy of Oral DS107 (2 g) to placebo in patients with moderate to severe atopic dermatitis.
Oral DS107 (2 g) will be orally administered for 8 weeks, and will be compared against placebo.
This study will enroll approximately 100 adult patients.
Eligibility Criteria
Inclusion Criteria
- Male or female subject aged 18 years and older.
- Moderate to severe atopic dermatitis.
Exclusion Criteria
- Clinically significant impairment of renal or hepatic function.
- History of hypersensitivity to any substance in Oral DS107 or placebo capsules.
- Treatment with any experimental drug within 30 days prior to Day 0 visit (baseline).
- Excessive sun exposure, use of tanning booths or other ultraviolet (UV) light sources and/or is planning a trip to sunny climate.
Data sourced from ClinicalTrials.gov (NCT02211417). 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.