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Trial record 19 of 154 for:    Dermatitis, Atopic, 8

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

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ClinicalTrials.gov Identifier: NCT02864498
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
DS Biopharma

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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: DS107 Drug: Placebo Phase 2

Detailed 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),


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Phase 2b Study to Assess the Efficacy and Safety of Orally Administered DS107 in Patients With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : January 2017
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: 1g Oral DS107
1g Oral DS107 to be administered once-daily for 8 weeks.
Drug: DS107
Experimental: 2g Oral DS107
2g Oral DS107 to be administered once daily for 8 weeks.
Drug: DS107
Placebo Comparator: Placebo
Placebo orally administered once-daily for 8 weeks.
Drug: Placebo



Primary Outcome Measures :
  1. An IGA of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients achieving an IGA score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA [ Time Frame: 10 weeks ]
  2. Change from baseline in Eczema Area and Severity Index (EASI) [ Time Frame: 10 weeks ]
  3. Change from baseline in Numeric Rating Scale (NRS) for Pruritus [ Time Frame: 10 weeks ]
  4. Proportion of patients achieving a decrease of at least 2 points in IGA [ Time Frame: 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864498


Locations
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United States, Pennsylvania
DS Biopharma Site
Philadelphia, Pennsylvania, United States
South Africa
DS Biopharma Site
Cape Town, South Africa
Sponsors and Collaborators
DS Biopharma
Investigators
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Study Chair: Markus Weissbach, Ph.D DS Biopharma

Publications:

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Responsible Party: DS Biopharma
ClinicalTrials.gov Identifier: NCT02864498     History of Changes
Other Study ID Numbers: DS107G-03
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases