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

NCT02864498 | Completed Phase 2 Results

• 1 other identifier: DS107G-03
• Study Type: interventional
• Target: 321
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Achieving an Investigators Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population at Week 8.

  Proportion of patients achieving an IGA of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to placebo population at Week 8. The IGA scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.

  8 weeks

Secondary Outcomes (4)

• Proportion of Patients Achieving an IGA Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, and 10.

  Baseline, Week 2, Week 4, Week 6 and Week 10

• Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, 8, and 10

  Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10

• Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10

  Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10

• Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10

  Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10

Study Arms (3)

1g DS107

EXPERIMENTAL

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

Drug: DS107

2g DS107

EXPERIMENTAL

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

Drug: DS107

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DS107 DRUG

1g DS107; 2g DS107

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• DS Biopharma: lead

Study Sites (2)

DS Biopharma Site

Philadelphia, Pennsylvania, United States

Location

DS Biopharma Site

Cape Town, South Africa

Location

Related Publications (21)

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MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: DS Biopharma

regulatory.dsbiopharma@DSBiopharma.com

+353 1 2933590

Study Officials

• Markus Weissbach, Ph.D

  DS Biopharma

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 12, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 10, 2022
• Results First Posted: October 10, 2022

Record last verified: 2022-09

Locations

US (1); ZA (1)