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


DS Biopharma
NCT ID: NCT03817190
Last Updated: December 10, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 2
  • Gender: All
  • Age: 18 Years - N/A
  • Condition: Atopic Dermatitis
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: DS Biopharma
  • Location: Not Provided

Official Title

A Randomised, Double-blind, Placebo-controlled, Study to Assess the Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis

Purpose

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 200 subjects.

Eligibility

Ages Eligible for Study

18 Years to N/A

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Criteria

Inclusion Criteria:

– Patients with a clinically confirmed diagnosis of active AD according to the American
Academy of Dermatology Consensus Criteria.

– Patients with moderate to severe AD at baseline as defined by a vIGA score of 3 or 4
at baseline.

– Patients with an EASI score of ≥16 at screening and baseline.

– Patients with AD covering a minimum 10% of the body surface area at baseline.

Exclusion Criteria:

– Patients with other skin conditions that might interfere with AD diagnosis and/or
evaluation (such as psoriasis or current active viral, bacterial and fungal skin
infections)

– Patients who have used systemic treatments that could affect AD less than 4 weeks
prior to baseline visit (Day 0). Intranasal corticosteroids and inhaled
corticosteroids for stable medical conditions are allowed.

– Patients who have used any topical medicated treatment for AD two weeks prior to start
of treatment/ 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 are
planning a trip to a sunny climate or to use tanning booths or other UV sources
between screening and follow-up visits.

– Patients who have a white cell count or differential white cell count (neutrophils,
lymphocytes, eosinophils) outside of the normal reference range at screening.

– Patients who have a clinically significant impairment of renal or hepatic function.

– Patients who are pregnant, planning pregnancy, breastfeeding and/or are unwilling to
use adequate contraception (as specified in inclusion criterion 10) during the trial.

Additional Information, Locations & Contacts

Sponsors & Collaborators

DS Biopharma

Investigators

Study Chair: Markus Weissbach, MD

DS Biopharma

Please refer to this study by its ClinicalTrials.gov identifier: NCT03817190

Location

Contacts

DS Investigational Site 524

Birmingham, Alabama 35209

United States

DS Investigational Site 502

Los Angeles, California 90045

United States

DS Investigational Site 503

Riverside, California 92503

United States

DS Investigational Site 504

San Diego, California 92108

United States

DS Investigational Site 505

San Diego, California 92123

United States

DS Investigational Site 516

Santa Ana, California 92705

United States

DS Investigational Site 501

Santa Monica, California 90404

United States

DS Investigational Site 515

Aurora, Colorado 080045

United States

DS Investigational Site 517

Washington, District of Columbia 20037

United States

DS Investigational Site 510

Sunrise, Florida 33351

United States

DS Investigational Site 512

Columbus, Georgia 31904

United States

DS Investigational Site 514

Skokie, Illinois 60077

United States

DS Investigational Site 513

Louisville, Kentucky 40241

United States

DS Investigational Site 522

Fort Gratiot, Michigan 48059

United States

DS Investigational Site 519

Troy, Michigan 48084

United States

DS Investigational Site 511

Raleigh, North Carolina 27612

United States

DS Investigational Site 521

Medford, Oregon 97504

United States

DS Investigational Site 525

Philadelphia, Pennsylvania 19046

United States

DS Investigational Site 520

Johnston, Rhode Island 02919

United States

DS Investigational Site 509

Arlington, Texas 76011

United States

DS Investigational Site 506

Austin, Texas 78745

United States

DS Investigational Site 508

Cypress, Texas 77433

United States

DS Investigational Site 507

San Antonio, Texas 78213

United States

DS Investigational Site 523

Richmond, Virginia 23224

United States

DS Investigational Site 518

Kenosha, Wisconsin 53144

United States