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

Clinical Trial ID: NCT03817190

Description

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 200 subjects.

This study involves a comparison of 2g DS107 with placebo, administered orally once daily for a total of 16 weeks. Patient will be randomized to one of the two treatment arms in a 1:1 ratio. Patients will come to the clinic on 12 occasions: at Screening/Visit 1, Baseline/Visit 2, Week 2/Visit 3, Week 4/Visit 4, Week 6/Visit 5, Week 8/Visit 6, Week 10/Visit 7, Week 12/Visit 8, Week 14/ Visit 9, Week 16/Visit 10 (end of treatment), Week 18/ Visit 11 (follow up) and Week 20/Visit 12 (follow-up). The primary endpoint will be the vIGA (Validated Investigator's Global Assessment) and EASI (Eczema Area and Severity Index). Other endpoints include vIGA, EASI, BSA (Body Surface Area) and NRS (Numeric Rating Scale).


Criteria

Inclusion Criteria: - Patients with a clinically confirmed diagnosis of active AD according to the American Academy of Dermatology Consensus Criteria. - Patients with moderate to severe AD at baseline as defined by a vIGA score of 3 or 4 at baseline. - Patients with an EASI score of ≥16 at screening and baseline. - Patients with AD covering a minimum 10% of the body surface area at baseline. Exclusion Criteria: - Patients with other skin conditions that might interfere with AD diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and fungal skin infections) - Patients who have used systemic treatments that could affect AD less than 4 weeks prior to baseline visit (Day 0). Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed. - Patients who have used any topical medicated treatment for AD two weeks prior to start of treatment/ Baseline (Day 0). - Patients who have had excessive sun exposure, have used tanning booths or other ultraviolet (UV) light sources four weeks prior to Baseline (Day 0) and/or are planning a trip to a sunny climate or to use tanning booths or other UV sources between screening and follow-up visits. - Patients who have a white cell count or differential white cell count (neutrophils, lymphocytes, eosinophils) outside of the normal reference range at screening. - Patients who have a clinically significant impairment of renal or hepatic function. - Patients who are pregnant, planning pregnancy, breastfeeding and/or are unwilling to use adequate contraception (as specified in inclusion criterion 10) during the trial.

  • Start Date

    2019-09-19

  • Last Updated

    2019-12-10

  • Sponsor

    DS Biopharma

  • Condition Name

    Atopic Dermatitis

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