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

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.

Timeline

Start

2019-09-19

Primary completion

2020-09-03

Completion

2020-09-03

Outcome

Missed primary endpoint

Stopped: “Based on Interim Analysis results”

registry analysis (superiority test); Placebo vs DS107 2000mg; p = 0.6880; Proportion of participants -0.2277 (95% CI -1.0415 to 0.5860); GLMM NCT03817190 ↗

registry analysis (superiority test); Placebo vs DS107 2000mg; p = 0.4321; Proportion of participants -0.2760 (95% CI -0.9185 to 0.3665); GLMM NCT03817190 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DIHOMO-GAMMA-LINOLENIC ACID	Small molecule	2 g	Oral

Indications