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Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03568331
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Brief Summary:
This is a multi-center, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Tradipitant Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Efficacy Study of The Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis
Actual Study Start Date : June 30, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Tradipitant Drug: Tradipitant
Oral Capsule

Placebo Comparator: Placebo Drug: Placebo
Oral Capsule




Primary Outcome Measures :
  1. Reduction of worst itch in atopic dermatitis [ Time Frame: 8 weeks ]
    As measured by Numerical Rating Scale (NRS)


Secondary Outcome Measures :
  1. Improvement of disease severity in atopic dermatitis [ Time Frame: 8 weeks ]
    As measured by SCORing Atopic Dermatitis (SCORAD) index

  2. Improvement of disease severity in atopic dermatitis [ Time Frame: 8 weeks ]
    As measured by Eczema Area and Severity Index (EASI)

  3. Improvement of disease severity in atopic dermatitis [ Time Frame: 8 weeks ]
    As measured by Investigator Global Assessment for Atopic Dermatitis (IGA-AD)

  4. Safety and tolerability as measured by spontaneous reporting of adverse events (AEs) [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and non-pregnant, non-lactating female patients aged 18 - 70 years (inclusive);
  • Diagnosed with atopic dermatitis;
  • Suffering from chronic pruritus;
  • Body Mass Index (BMI) of ≥18 and ≤40 kg/m2

Exclusion Criteria:

  • Chronic pruritus due to condition other than atopic dermatitis (AD);
  • A positive test for drugs of abuse at the screening or evaluation visits;
  • Exposure to any investigational medication in the past 60 days

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): NCT03568331


Contacts
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Contact: Vanda Pharmaceuticals 202-734-3400 clinicaltrials@vandapharma.com

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Sponsors and Collaborators
Vanda Pharmaceuticals

Additional Information:
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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03568331     History of Changes
Other Study ID Numbers: VP-VLY-686-3101
EPIONE 1 ( Other Identifier: Vanda Pharmaceuticals, Inc. )
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vanda Pharmaceuticals:
Chronic Pruritus
Eczema

Additional relevant MeSH terms:
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Eczema
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs