Atopic Dermatitis Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Efficacy Study of the Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis
Verified date | April 2024 |
Source | Vanda Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.
Status | Terminated |
Enrollment | 87 |
Est. completion date | October 14, 2020 |
Est. primary completion date | October 14, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanda Investigational Site | Alexandria | Virginia |
United States | Vanda Investigational Site | Berlin | New Jersey |
United States | Vanda Investigational Site | Boise | Idaho |
United States | Vanda Investigational Site | Bronx | New York |
United States | Vanda Investigational Site | Charlotte | North Carolina |
United States | Vanda Investigational Site | Chicago | Illinois |
United States | Vanda Investigational Site | Cincinnati | Ohio |
United States | Vanda Investigational Site | Clearwater | Florida |
United States | Vanda Investigational Site | Crowley | Louisiana |
United States | Vanda Investigational Site | Dallas | Texas |
United States | Vanda Investigational Site | Denver | Colorado |
United States | Vanda Investigational Site | Encino | California |
United States | Vanda Investigational Site | Fort Gratiot | Michigan |
United States | Vanda Investigational Site | Fountain Valley | California |
United States | Vanda Investigational Site | Hoboken | New Jersey |
United States | Vanda Investigational Site | Hoover | Alabama |
United States | Vanda Investigational Site | Houston | Texas |
United States | Vanda Investigational Site | Houston | Texas |
United States | Vanda Investigational Site | Johnston | Rhode Island |
United States | Vanda Investigational Site | Kew Gardens | New York |
United States | Vanda Investigational Site | Laguna Hills | California |
United States | Vanda Investigational Site | Las Vegas | Nevada |
United States | Vanda Investigational Site | Lomita | California |
United States | Vanda Investigational Site | Los Angeles | California |
United States | Vanda Investigational Site | Los Angeles | California |
United States | Vanda Investigational Site | Los Angeles | California |
United States | Vanda Investigational Site | Mesquite | Texas |
United States | Vanda Investigational Site | Miami | Florida |
United States | Vanda Investigational Site | New York | New York |
United States | Vanda Investigational Site | New York | New York |
United States | Vanda Investigational Site | Newport News | Virginia |
United States | Vanda Investigational Site | Norfolk | Virginia |
United States | Vanda Investigational Site | Normal | Illinois |
United States | Vanda Investigational Site | Oklahoma City | Oklahoma |
United States | Vanda Investigational Site | Omaha | Nebraska |
United States | Vanda Investigational Site | Philadelphia | Pennsylvania |
United States | Vanda Investigational Site | Plainfield | Indiana |
United States | Vanda Investigational Site | Saint Joseph | Missouri |
United States | Vanda Investigational Site | Saint Louis | Missouri |
United States | Vanda Investigational Site | Savannah | Georgia |
United States | Vanda Investigational Site | Skokie | Illinois |
United States | Vanda Investigational Site | South Burlington | Vermont |
United States | Vanda Investigational Site | South Jordan | Utah |
United States | Vanda Investigational Site | Spartanburg | South Carolina |
United States | Vanda Investigational Site | Spartanburg | South Carolina |
United States | Vanda Investigational Site | Spokane | Washington |
United States | Vanda Investigational Site | Tampa | Florida |
United States | Vanda Investigational Site | Tempe | Arizona |
United States | Vanda Investigational Site | Timonium | Maryland |
United States | Vanda Investigational Site | Tulsa | Oklahoma |
United States | Vanda Investigational Site | Verona | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Vanda Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Worst Itch Numeric Rating Scale (WI-NRS) Responder Rate at Week 2 | The WI-NRS responder is defined as a patient achieving at least 4 points reduction from baseline in weekly average of diary WI-NRS. Responses were measured on a scale of 0 - 10, with 0 being "no itch" and 10 being the "worst itch imaginable". | 2 weeks |
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