Efficacy and Safety Study of Orally Administered DS107 in Moderate to Severe Atopic Dermatitis Patients
NCT ID: NCT02864498
Last Updated: 2022-10-10
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
321 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-01-31
Study Completion Date
2018-06-30
Brief Summary
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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.
Oral DS107 capsules will be administered for 8 weeks and will be compared against placebo.
The study will enroll approximately 300 subjects.
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Detailed Description
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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),
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),
Conditions
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Atopic Dermatitis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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1g DS107
1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks.
Group Type
EXPERIMENTAL
DS107
Intervention Type
DRUG
2g DS107
2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks.
Group Type
EXPERIMENTAL
DS107
Intervention Type
DRUG
Placebo
Placebo (4 placebo capsules) orally administered once-daily for 8 weeks.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Interventions
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DS107
Intervention Type
DRUG
Placebo
Intervention Type
DRUG
Eligibility Criteria
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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)
* 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)
* 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)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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DS Biopharma
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Markus Weissbach, Ph.D
Role: STUDY_CHAIR
DS Biopharma
Locations
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DS Biopharma Site
Philadelphia, Pennsylvania, United States
Site Status
DS Biopharma Site
Cape Town, , South Africa
Site Status
Countries
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United States
South Africa
References
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Amagai Y, Oida K, Matsuda A, Jung K, Kakutani S, Tanaka T, Matsuda K, Jang H, Ahn G, Xia Y, Kawashima H, Shibata H, Matsuda H, Tanaka A. Dihomo-gamma-linolenic acid prevents the development of atopic dermatitis through prostaglandin D1 production in NC/Tnd mice. J Dermatol Sci. 2015 Jul;79(1):30-7. doi: 10.1016/j.jdermsci.2015.03.010. Epub 2015 Apr 6.
Reference Type
BACKGROUND
Ashcroft DM, Dimmock P, Garside R, Stein K, Williams HC. Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta-analysis of randomised controlled trials. BMJ. 2005 Mar 5;330(7490):516. doi: 10.1136/bmj.38376.439653.D3. Epub 2005 Feb 24.
Reference Type
BACKGROUND
Bos JD, Kapsenberg ML, Smitt JH. Pathogenesis of atopic eczema. Lancet. 1994 May 28;343(8909):1338-41. doi: 10.1016/s0140-6736(94)92473-2. No abstract available.
Reference Type
BACKGROUND
Charman CR, Venn AJ, Williams HC. The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective. Arch Dermatol. 2004 Dec;140(12):1513-9. doi: 10.1001/archderm.140.12.1513.
Reference Type
BACKGROUND
Desbois AP, Lawlor KC. Antibacterial activity of long-chain polyunsaturated fatty acids against Propionibacterium acnes and Staphylococcus aureus. Mar Drugs. 2013 Nov 13;11(11):4544-57. doi: 10.3390/md11114544.
Reference Type
BACKGROUND
Carpenter JR, Roger JH, Kenward MG. Analysis of longitudinal trials with protocol deviation: a framework for relevant, accessible assumptions, and inference via multiple imputation. J Biopharm Stat. 2013;23(6):1352-71. doi: 10.1080/10543406.2013.834911.
Reference Type
BACKGROUND
Williams H, Flohr C. How epidemiology has challenged 3 prevailing concepts about atopic dermatitis. J Allergy Clin Immunol. 2006 Jul;118(1):209-13. doi: 10.1016/j.jaci.2006.04.043. Epub 2006 Jun 9.
Reference Type
BACKGROUND
Kawashima H, Tateishi N, Shiraishi A, Teraoka N, Tanaka T, Tanaka A, Matsuda H, Kiso Y. Oral administration of dihomo-gamma-linolenic acid prevents development of atopic dermatitis in NC/Nga mice. Lipids. 2008 Jan;43(1):37-43. doi: 10.1007/s11745-007-3129-2. Epub 2007 Nov 6.
Reference Type
BACKGROUND
Silverberg JI, Hanifin JM. Adult eczema prevalence and associations with asthma and other health and demographic factors: a US population-based study. J Allergy Clin Immunol. 2013 Nov;132(5):1132-8. doi: 10.1016/j.jaci.2013.08.031. Epub 2013 Oct 4.
Reference Type
BACKGROUND
Simpson EL. Atopic dermatitis: a review of topical treatment options. Curr Med Res Opin. 2010 Mar;26(3):633-40. doi: 10.1185/03007990903512156.
Reference Type
BACKGROUND
Suarez AL, Feramisco JD, Koo J, Steinhoff M. Psychoneuroimmunology of psychological stress and atopic dermatitis: pathophysiologic and therapeutic updates. Acta Derm Venereol. 2012 Jan;92(1):7-15. doi: 10.2340/00015555-1188.
Reference Type
BACKGROUND
Kapp A. The role of eosinophils in the pathogenesis of atopic dermatitis--eosinophil granule proteins as markers of disease activity. Allergy. 1993 Jan;48(1):1-5. doi: 10.1111/j.1398-9995.1993.tb02167.x.
Reference Type
BACKGROUND
Leung DY, Bieber T. Atopic dermatitis. Lancet. 2003 Jan 11;361(9352):151-60. doi: 10.1016/S0140-6736(03)12193-9.
Reference Type
BACKGROUND
Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.
Reference Type
BACKGROUND
Gutfreund K, Bienias W, Szewczyk A, Kaszuba A. Topical calcineurin inhibitors in dermatology. Part I: Properties, method and effectiveness of drug use. Postepy Dermatol Alergol. 2013 Jun;30(3):165-9. doi: 10.5114/pdia.2013.35619. Epub 2013 Jun 20.
Reference Type
BACKGROUND
Reynolds NJ, Franklin V, Gray JC, Diffey BL, Farr PM. Narrow-band ultraviolet B and broad-band ultraviolet A phototherapy in adult atopic eczema: a randomised controlled trial. Lancet. 2001 Jun 23;357(9273):2012-6. doi: 10.1016/S0140-6736(00)05114-X.
Reference Type
BACKGROUND
Iversen L, Fogh K, Kragballe K. Effect of dihomogammalinolenic acid and its 15-lipoxygenase metabolite on eicosanoid metabolism by human mononuclear leukocytes in vitro: selective inhibition of the 5-lipoxygenase pathway. Arch Dermatol Res. 1992;284(4):222-6. doi: 10.1007/BF00375798.
Reference Type
BACKGROUND
Kawashima H, Toyoda-Ono Y, Suwa Y, Kiso Y. Subchronic (13-week) oral toxicity study of dihomo-gamma-linolenic acid (DGLA) oil in rats. Food Chem Toxicol. 2009 Jun;47(6):1280-6. doi: 10.1016/j.fct.2009.03.001. Epub 2009 Mar 9.
Reference Type
BACKGROUND
Futamura M, Leshem YA, Thomas KS, Nankervis H, Williams HC, Simpson EL. A systematic review of Investigator Global Assessment (IGA) in atopic dermatitis (AD) trials: Many options, no standards. J Am Acad Dermatol. 2016 Feb;74(2):288-94. doi: 10.1016/j.jaad.2015.09.062. Epub 2015 Dec 11.
Reference Type
BACKGROUND
Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8. doi: 10.1034/j.1600-0625.2001.100102.x.
Reference Type
BACKGROUND
Phan NQ, Blome C, Fritz F, Gerss J, Reich A, Ebata T, Augustin M, Szepietowski JC, Stander S. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol. 2012 Sep;92(5):502-7. doi: 10.2340/00015555-1246.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DS107G-03
Identifier Type: -
Identifier Source: org_study_id
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