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

NCT03817190 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: DS107G-05-AD3
• Study Type: interventional
• Target: 219
• Locations: 5 countries
• Sites: 50

Brief Summary

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 220 subjects.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients Achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis Score of 0 or 1 and a Decrease of at Least 2 Points in vIGA-ADTM in Treated Population Compared to Placebo Population From Baseline at Week 16.

  Proportion of patients achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from Baseline at Week 16 using GLMM.The vIGA-ADTM 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). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.

  16 Weeks

• Proportion of Patients Achieving EASI-75 in Treated Population Compared to Placebo Population at Week 16.

  Proportion of patients achieving EASI-75 (≥75% improvement from Baseline) in treated population compared to placebo population at Week 16 using GLMM.

  16 Weeks

Secondary Outcomes (11)

• Proportion of Patients Achieving a vIGA-ADTM Score of 0 or 1 and a Decrease of at Least 2 Points in vIGA-ADTM in Treated Population Compared to Placebo Population From Baseline to Week 4, 8, 12, 18 and 20.

  Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20.

• Proportion of Patients Achieving EASI-75 (≥75% Improvement From Baseline) in Treated Population Compared to Placebo Population at Weeks 4, 8, 12, 18 and 20

  Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20.

• Change From Baseline in Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) Score in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20.

  20 Weeks

• Change From Baseline in EASI in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20.

  Week 20

• Change From Baseline in Worst Itch NRS in Treated Population Compared to Placebo Population to Week 4, 8, 12, 16, 18.

  Week 18

Study Arms (2)

2g Oral DS107

EXPERIMENTAL

2g DS107 (4 DS107 capsules) administered once-daily for 16 weeks

Drug: DS107

Placebo

PLACEBO COMPARATOR

Placebo (4 placebo capsules) orally administered once-daily for 16 weeks

Drug: Placebo

Interventions

DS107 DRUG

DS107 Capsule

Also known as: DS107 500mg DGLA Capsules/DS107 500mg Placebo Capsules

2g Oral DS107

Placebo DRUG

Placebo capsule

Placebo

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 AD according to the American Academy of Dermatology Consensus Criteria that had been present for at least 6 months before the screening visit.
• Patients with moderate to severe AD at baseline as defined by a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) score of 3 Or 4 at baseline.
• Patients with an Eczema Area and Severity Index (EASI) score of ≥16 at screening and baseline.
• Patients with AD covering a minimum 10% of the Body Surface Area (BSA) at baseline.
• Patients with a worst itch Numeric Rating Scale (NRS) score in a day of ≥4 (on 11-point NRS) at the screening and baseline visits.
• Patients whose pre-study clinical laboratory findings did not interfere with their participation in the study, in the opinion of the investigator.
• Patients who were able and willing to stop all current treatments for AD throughout the study (except for allowed emollients).
• Patients who were on a stable dose of a bland emollient for at least 7 days prior to baseline.
• Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF).
• Female patients and male patients with female partners of child bearing potential had to use highly effective birth control methods or have a sterilised partner for the duration of the study.
• Recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments were otherwise medically inadvisable (e.g. because of important side effects or safety risks).
• Patients who were able to communicate well with the investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent prior to initiation of any study specific activities or procedures.

You may not qualify if:

• Patients with other skin conditions that might interfere with AD diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and fungal topical skin infections) as assessed by the investigator.
• Patients who had used systemic treatments that could affect AD 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 were allowed.
• Patients with previous exposure to DS107.
• Patients who had used any topical medicated treatment for AD (except for emollients) two weeks prior to start of treatment/Baseline (Day 0) including but not limited to, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and bleach baths.
• Patients who used emollients containing urea, ceramides or hyaluronic acid less than 12 weeks prior to 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 were planning a trip to a sunny climate or to use tanning booths or other UV sources between screening and follow-up visits.
• Patients who had a history of hypersensitivity to any substance in DS107 or placebo capsules.
• Patients who had a history of hypersensitivity to soy beans or soy lecithin.
• Patients who had a white cell count or differential white cell count outside of the normal reference range at screening.
• Patients who had 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 interpretation of study results.
• Patients who had a clinically significant impairment of renal or hepatic function.
• Patients with significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease, as well as uncontrolled diabetes and fluoride arthritis or any other illness that, in the opinion of the investigator, was likely to interfere with completion of the study.
• Patients with active infectious diseases (e.g. hepatitis B, hepatitis C or advanced disease secondary to infection with human immunodeficiency virus).
• Patients with a history of clinically significant drug or alcohol abuse in the opinion of the investigator in the last year prior to Baseline (Day 0).

Sponsors & Collaborators

• DS Biopharma: lead

Study Sites (50)

DS Investigational Site 524

Birmingham, Alabama, 35209, United States

Location

DS Investigational Site 528

Huntington Beach, California, 92647, United States

Location

DS Investigational Site 502

Los Angeles, California, 90045, United States

Location

DS Investigational Site 504

San Diego, California, 92108, United States

Location

DS Investigational Site 505

San Diego, California, 92123, United States

Location

DS Investigational Site 516

Santa Ana, California, 92705, United States

Location

DS Investigational Site 501

Santa Monica, California, 90404, United States

Location

DS Investigational Site 517

Washington D.C., District of Columbia, 20037, United States

Location

DS Investigational Site 527

Doral, Florida, 33122, United States

Location

DS Investigational Site 510

Sunrise, Florida, 33351, United States

Location

DS Investigational Site 512

Columbus, Georgia, 31904, United States

Location

DS Investigational Site 514

Skokie, Illinois, 60077, United States

Location

DS Investigational Site 513

Louisville, Kentucky, 40241, United States

Location

DS Investigational Site 519

Troy, Michigan, 48084, United States

Location

DS Investigational Site 511

Raleigh, North Carolina, 27612, United States

Location

DS Investigational Site 526

Grants Pass, Oregon, 97527, United States

Location

DS Investigational Site 521

Medford, Oregon, 97504, United States

Location

DS Investigational Site 525

Philadelphia, Pennsylvania, 19046, United States

Location

DS Investigational Site 509

Arlington, Texas, 76011, United States

Location

DS Investigational Site 506

Austin, Texas, 78745, United States

Location

DS Investigational Site 508

Cypress, Texas, 77433, United States

Location

DS Investigational Site 507

San Antonio, Texas, 78213, United States

Location

DS Investigative Site 529

Orem, Utah, 84058, United States

Location

DS Investigative Site 530

Salt Lake City, Utah, 84117, United States

Location

DS Investigational Site 523

Richmond, Virginia, 23224, United States

Location

DS Investigational Site 518

Kenosha, Wisconsin, 53144, United States

Location

DS Investigational Site 101

Graz, Austria

Location

DS Investigational Site 203

Augsburg, Germany

Location

DS Investigational Site 202

Berlin, Germany

Location

DS Investigational Site 208

Berlin, Germany

Location

DS Investigational Site 204

Dresden, Germany

Location

DS Investigational Site 206

Essen, Germany

Location

DS Investigational Site 201

Frankfurt, Germany

Location

DS Investigational Site 207

Gera, Germany

Location

DS Investigational Site 211

Leipzig, Germany

Location

DS Investigational Site 205

Lübeck, Germany

Location

DS Investigational Site 210

Mainz, Germany

Location

DS Investigational Site 214

Münster, Germany

Location

DS Investigational Site 212

Rostock, Germany

Location

DS Investigational Site 304

Jūrmala, Latvia

Location

DS Investigational Site 301

Riga, Latvia

Location

DS Investigational Site 302

Riga, Latvia

Location

DS Investigational Site 303

Riga, Latvia

Location

DS Investigational Site 305

Riga, Latvia

Location

DS Investigational Site 406

Gdansk, Poland

Location

DS Investigational Site 402

Lodz, Poland

Location

DS Investigational Site 403

Poznan, Poland

Location

DS Investigational Site 405

Warsaw, Poland

Location

DS Investigational Site 407

Warsaw, Poland

Location

DS Investigational Site 401

Wroclaw, Poland

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

8,11,14-Eicosatrienoic Acid

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

Intervention Hierarchy (Ancestors)

Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Limitations and Caveats

The decision to terminate the study prematurely was based on the results from an interim analysis.

Results Point of Contact

• Title: Study Director
• Organization: DS Biopharma

info@dsbiopharma.com

+35312933590

Study Officials

• Markus Weissbach, MD

  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: January 23, 2019
• First Posted: January 25, 2019
• Study Start: September 19, 2019
• Primary Completion: September 3, 2020
• Study Completion: September 3, 2020
• Last Updated: November 28, 2022
• Results First Posted: May 6, 2022

Record last verified: 2022-09

Locations

PL (6); DE (12); AU (1); LA (5); US (26)