Clinical trial NCT02211417: Oral DS107 in Moderate to Severe Atopic Dermatitis
Official title: A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS107G to Patients With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Dignity Sciences Ltd.
Sponsor class: INDUSTRY
First posted: 2014-08-07
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Subjects will come to the clinic on 6 occasions: at screening, baseline, week 2, week 4, week 8 (end of treatment/early termination) and week 10 (follow-up). The primary efficacy variable will be the IGA. Secondary efficacy variables will include IGA (Investigator's Global Assessment), SCORAD (Scoring Atopic Dermatitis) Visual Analog Scale (VAS), EASI, BSA (Body Surface Area), POEM (Patient Orientated Eczema Measure), DLQI (Dermatology Life Quality Index).

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.

Primary outcomes:
measure: 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.
timeFrame: Week 8
Secondary outcomes:
measure: Change From Baseline in IGA at Week 2, 4 and 8.
timeFrame: Baseline, Week 2, Week 4 and Week 8
measure: Change From Baseline in Eczema Area and Severity Index (EASI) at Week 2, 4 and 8.
timeFrame: Baseline, Week 2, Week 4 and Week 8
measure: Proportion of Patients Achieving at Least a 1-point Decrease in IGA at Week 8.
timeFrame: Up to 8 weeks.
measure: Change From Baseline in the Patient Orientated Eczema Measure (POEM) at Week 2, 4 and 8.
timeFrame: Baseline, Week 2, Week 4 and Week 8
measure: Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at Week 2, 4 and 8.
timeFrame: Baseline, Week 2, Week 4 and Week 8
measure: Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 2, 4 and 8.
timeFrame: Baseline, Week 2, Week 4 and Week 8
measure: Change From Baseline in the Patient's Visual Analog Scale (VAS) Pruritus Score at Week 2, 4 and 8.
timeFrame: Baseline, Week 2, Week 4 and Week 8
measure: Change From Baseline in Body Surface Area (BSA) at Week 2, 4 and 8.
timeFrame: Baseline, Week 2, Week 4 and Week 8
measure: Number of Participants With TEAEs in Each Treatment Group
timeFrame: Up to 14 weeks
Other outcomes:
Locations:
city: Arlington Heights
country: United States
facility: Dignity Sciences investigational site
state: Illinois
city: West Dundee
country: United States
facility: Dignity Sciences investigational site
state: Illinois
city: Warren
country: United States
facility: Dignity Sciences investigational site
state: Michigan
city: Verona
country: United States
facility: Dignity Sciences investigational site
state: New Jersey
city: New York
country: United States
facility: Dignity Sciences investigational site
state: New York
city: Rochester
country: United States
facility: Dignity Sciences investigational site
state: New York
city: Hazleton
country: United States
facility: Dignity Sciences investigational site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Dignity Sciences investigational site
state: Pennsylvania
city: Calgary
country: Canada
facility: Dignity Sciences investigational site
state: Alberta
city: Edmonton
country: Canada
facility: Dignity Sciences investigational site
state: Alberta
city: Markham
country: Canada
facility: Dignity Sciences investigational site
state: Ontario
city: Windsor
country: Canada
facility: Dignity Sciences investigational site
state: Ontario
city: Drummondville
country: Canada
facility: Dignity Sciences investigational site
state: Quebec
city: Montreal
country: Canada
facility: Dignity Sciences investigational site
state: Quebec
Study officials:
affiliation: Dignity Sciences Ltd.
name: John Climax, Ph.D.
role: STUDY_CHAIR
References:
citation: Scollan ND, Choi NJ, Kurt E, Fisher AV, Enser M, Wood JD. Manipulating the fatty acid composition of muscle and adipose tissue in beef cattle. Br J Nutr. 2001 Jan;85(1):115-24. doi: 10.1079/bjn2000223.
citation: Kawashima H, Toyoda-Ono Y, Suwa Y, Kiso Y. Subchronic (13-week) oral toxicity study of dihomo-gamma-linolenic acid (DGLA) oil in rats. Food Chem Toxicol. 2009 Jun;47(6):1280-6. doi: 10.1016/j.fct.2009.03.001. Epub 2009 Mar 9.
citation: Makrides M, Simmer K, Neumann M, Gibson R. Changes in the polyunsaturated fatty acids of breast milk from mothers of full-term infants over 30 wk of lactation. Am J Clin Nutr. 1995 Jun;61(6):1231-3. doi: 10.1093/ajcn/61.6.1231.
citation: Teraoka N, Kawashima H, Shiraishi-Tateishi A, Tanaka T, Nakamura J, Kakutani S, Kiso Y. Oral supplementation with dihomo-gamma-linolenic acid-enriched oil altered serum fatty acids in healthy men. Biosci Biotechnol Biochem. 2009 Jun;73(6):1453-5. doi: 10.1271/bbb.90112. Epub 2009 Jun 7.
citation: Tanaka T, Kakutani S, Horikawa C, Kawashima H, Kiso Y. Oral supplementation with dihomo-gamma-linolenic acid (DGLA)-enriched oil increases serum DGLA content in healthy adults. Lipids. 2012 Jun;47(6):643-6. doi: 10.1007/s11745-012-3664-3. Epub 2012 Mar 14.