Safety and Efficacy Study of Topically Applied DS107 Cream in Mild to Moderate Atopic Dermatitis Patients (AD)

NCT02925793 | Completed Phase 2 Results

• 1 other identifier: DS107E-06
• Study Type: interventional
• Target: 327
• Locations: 3 countries
• Sites: 3

Brief Summary

The purpose of this randomized, double blind, placebo controlled, parallel group study is to compare the safety and efficacy of topically applied DS107 cream (1% and 5%) versus vehicle cream, in the treatment of adult patients with mild to moderate Atopic Dermatitis (AD).

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Vehicle Population at Week 8

  Change from baseline in Numeric Rating Scale (NRS) for Pruritus in treated population compared to vehicle population at Week 8. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients scored their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients were required to complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.

  Baseline and Week 8

• Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Vehicle Population at Week 8

  Change from baseline in EASI in treated population compared to vehicle population at Week 8. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted): * 0 = none * 1 = mild * 2 = moderate * 3 = severe A decrease in EASI indicates a positive outcome for the participant.

  Baseline and Week 8

Secondary Outcomes (6)

• Change From Baseline in NRS for Pruritus Intreated Populations Compared to Vehicle Population at Week 2, 4, 6, 10

  Baseline, Week 2, Week 6 and Week 10

• Proportion of Patients Achieving a Decrease of at Least 2.7 Points in NRS in the Treated Populations Compared to Vehicle Population From Baseline to Weeks 2, 4, 6, 8, and 10.

  10 weeks

• Change From Baseline in EASI in Treated Population Compared to Vehicle Population at Weeks 2, 4, 6, 10.

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

• Proportion of Patients Achieving an Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10.

  10 weeks

• Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in the Treated Populations Compared to Vehicle Population From Baseline to Week 2, 4, 6, 8, 10.

  10 weeks

Study Arms (3)

Vehicle Cream

PLACEBO COMPARATOR

Vehicle cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks

Other: Vehicle cream

1% DS107 Cream

EXPERIMENTAL

1% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks

Drug: DS107

5% DS107 Cream

EXPERIMENTAL

5% DS107 cream applied topically to all affected or commonly affected areas twice-daily for 8 weeks

Drug: DS107

Interventions

DS107 DRUG

Also known as: 1%w/w DS107 DGLA Cream & 5%w/w DS107 DGLA Cream

1% DS107 Cream; 5% DS107 Cream

Vehicle cream OTHER

Also known as: DS107 Placebo Cream

Vehicle Cream

Eligibility Criteria

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

You may qualify if:

• Patients with a clinically confirmed diagnosis of active Atopic Dermatitis according to Hanifin and Rajka criteria
• Patients with mild to moderate Atopic Dermatitis at baseline as defined by an Investigator's Global Assessment (IGA) score of 3 or 2 at baseline visit
• Patients with Atopic Dermatitis covering a minimum 5% of the body surface area at baseline
• Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF)

You may not qualify if:

• Patients with other skin conditions that might interfere with Atopic Dermatitis diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and fungal topical skin infections) as assessed by the Investigator
• Patients who have used systemic treatments (other than biologics) that could affect Atopic Dermatitis less that 4 weeks prior to baseline visit (Day 0), e.g. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids. Intranasal corticosteroids for stable medical conditions are allowed
• Patients who have used any topical medicated treatment for Atopic Dermatitis two weeks prior to the start of treatment/baseline (Day 0) including but not limited to, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials, and bleach baths
• Patients who use topical products containing urea, ceramides or hyaluronic acid two weeks prior to Day 0
• Patients who have a history of hypersensitivity to any substance in DS107 cream or vehicle cream
• Patients who have any clinically significant controlled or uncontrolled medical condition or laboratory abnormality that would, in the opinion of the Investigator, put the patient at undue risk or interfere with the interpretation of study results
• Patients with significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease, as well as uncontrolled diabetes and floride arthritis or any other illness that, in the opinion of the Investigator, is likely to interfere with completion of the study
• Patients with chronic infectious diseases (e.g. hepatitis B, hepatitis C, or infection with human immunodeficiency virus)

Sponsors & Collaborators

• DS Biopharma: lead

Study Sites (3)

DS Biopharma Site

East Windsor, New Jersey, 08520, United States

Location

DS Biopharma Site

Markham, L3P 1X2, Canada

Location

DS Biopharma Site

Cape Town, 7700, South Africa

Location

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

+35312933590

Study Officials

• Markus Weissbach, MD, 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: October 5, 2016
• First Posted: October 6, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: November 22, 2022
• Results First Posted: October 7, 2022

Record last verified: 2022-10

Locations

CA (1); ZA (1); US (1)