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

DS Biopharma

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: DS107

Study type: Interventional

Funder types: Industry

Identifiers

NCT02864498

DS107G-03

Details and patient eligibility

About

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.

Full description

The study will consist of 3 treatment arms, each consisting of approximately 100 subjects.

Treatment Arm 1 will receive 1g Oral DS107 daily. Treatment Arm 2 will receive 2g Oral DS107 daily. Treatment Arm 3 will receive placebo daily.

The primary objective of the study is to assess the efficacy and safety of daily 1g and 2g doses of Oral DS107 versus placebo.

Subjects will come to the clinic on 7 occasions: Screening, Baseline, Week 2, Week 4, Week 6, Week 8 (end of treatment/early termination) and Week 10 (follow-up). The primary efficacy variable will be the IGA (Investigator's Global Assessment). Secondary efficacy variables will include IGA, EASI (Eczema Area and Severity Index), and NRS (Numeric Rating Scale),

Enrollment: 321 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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321 participants in 3 patient groups, including a placebo group

1g DS107

Experimental group

Description:

1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks.

Treatment:

Drug: DS107

2g DS107

Experimental group

Description:

2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks.

Treatment:

Drug: DS107

Placebo

Placebo Comparator group

Description:

Placebo (4 placebo capsules) orally administered once-daily for 8 weeks.

Treatment:

Drug: Placebo