Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis
Public ClinicalTrials.gov record NCT05387707. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Two-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin as Adjunct Therapy to a Topical Corticosteroid for Moderate-to-Severe Pruritus in Adult Subjects With Atopic Dermatitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a two-part, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to a topical corticosteroid (TCS) for moderate-to-severe pruritus in adult subjects with atopic dermatitis (AD).
Study identification
- NCT ID
- NCT05387707
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 287 participants
Conditions and interventions
Conditions
Interventions
- difelikefalin 0.25 mg Drug
- difelikefalin 0.5 mg Drug
- TCS Cream Drug
- Placebo Drug
- Vehicle Cream Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 16, 2022 (Actual)
- Primary completion
- Feb 2, 2024 (Actual)
- Completion
- Feb 2, 2024 (Actual)
- Last update posted
- Feb 22, 2024
2022 – 2024
United States locations
- U.S. sites
- 61
- U.S. states
- 24
- U.S. cities
- 59
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cara Therapeutics Study Site | Scottsdale | Arizona | 85260 | — |
| Cara Therapeutics Study Site | Fort Smith | Arkansas | 72916 | — |
| Cara Therapeutics Study Site | Rogers | Arkansas | 72758 | — |
| Cara Therapeutics Study Site | Fountain Valley | California | 92708 | — |
| Cara Therapeutics Study Site | Lomita | California | 90717 | — |
| Cara Therapeutics Study Site | Los Angeles | California | 90033 | — |
| Cara Therapeutics Study Site | Redwood City | California | 94063 | — |
| Cara Therapeutics Study Site | Sacramento | California | 95815 | — |
| Cara Therapeutics Study Site | San Diego | California | 92123 | — |
| Cara Therapeutics Study Site 2 | Santa Monica | California | 90404 | — |
| Cara Therapeutics Study Site | Santa Monica | California | 90404 | — |
| Cara Therapeutics Study Site | Valencia | California | 91355 | — |
| Cara Therapeutics Study Site | Denver | Colorado | 80210 | — |
| Cara Therapeutics Study Site | Brandon | Florida | 33511 | — |
| Cara Therapeutics Study Site | Coral Gables | Florida | 33134 | — |
| Cara Therapeutics Study Site | Delray Beach | Florida | 33484 | — |
| Cara Therapeutics Study Site | Hollywood | Florida | 33021 | — |
| Cara Therapeutics Study Site | North Miami Beach | Florida | 33162 | — |
| Cara Therapeutics Study Site | Orlando | Florida | 32819 | — |
| Cara Therapeutics Study Site | Saint Augustine | Florida | 32080 | — |
| Cara Therapeutics Study Site | St. Petersburg | Florida | 33709 | — |
| Cara Therapeutics Study Site | Sweetwater | Florida | 33172 | — |
| Cara Therapeutics Study Site | Tampa | Florida | 33607 | — |
| Cara Therapeutics Study Site | Marietta | Georgia | 30060 | — |
| Cara Therapeutics Study Site | Indianapolis | Indiana | 46250 | — |
| Cara Therapeutics Study Site | Plainfield | Indiana | 46168 | — |
| Cara Therapeutics Study Site | South Bend | Indiana | 46617 | — |
| Cara Therapeutics Study Site | Overland Park | Kansas | 66210 | — |
| Cara Therapeutics Study Site | Louisville | Kentucky | 40241 | — |
| Cara Therapeutics Study Site | Baton Rouge | Louisiana | 70809 | — |
| Cara Therapeutics Study Site | Houma | Louisiana | 70364 | — |
| Cara Therapeutics Study Site | Metairie | Louisiana | 70006 | — |
| Cara Therapeutics Study Site | New Orleans | Louisiana | 70115 | — |
| Cara Therapeutics Study Site | Rockville | Maryland | 20850 | — |
| Cara Therapeutics Study Site | Brighton | Massachusetts | 02135 | — |
| Cara Therapeutics Study Site | Auburn Hills | Michigan | 48326 | — |
| Cara Therapeutics Study Site | Clinton Township | Michigan | 48038 | — |
| Cara Therapeutics Study Site | Detroit | Michigan | 48202 | — |
| Cara Therapeutics Study Site | Waterford | Michigan | 48328 | — |
| Cara Therapeutics Study Site | Hackensack | New Jersey | 07601 | — |
| Cara Therapeutics Study Site | Huntersville | North Carolina | 28078 | — |
| Cara Therapeutics Study Site | Raleigh | North Carolina | 27617 | — |
| Cara Therapeutics Study Site | Athens | Ohio | 45701 | — |
| Cara Therapeutics Study Site | Bexley | Ohio | 43209 | — |
| Cara Therapeutics Study Site | Boardman | Ohio | 44512 | — |
| Cara Therapeutics Study Site | Oklahoma City | Oklahoma | 73118 | — |
| Cara Therapeutics Study Site | Oklahoma City | Oklahoma | 73170 | — |
| Cara Therapeutics Study Site | Philadelphia | Pennsylvania | 19103 | — |
| Cara Therapeutics Study Site | Plymouth Meeting | Pennsylvania | 19462 | — |
| Cara Therapeutics Study Site | Sugarloaf | Pennsylvania | 18249 | — |
| Cara Therapeutics Study Site | Charleston | South Carolina | 29407 | — |
| Cara Therapeutics Study Site | Knoxville | Tennessee | 37909 | — |
| Cara Therapeutics Study Site | Thompson's Station | Tennessee | 37179 | — |
| Cara Therapeutics Study Site | Arlington | Texas | 76011 | — |
| Cara Therapeutics Study Site | Austin | Texas | 78759 | — |
| Cara Therapeutics Study Site | Bellaire | Texas | 77401 | — |
| Cara Therapeutics Study Site | Houston | Texas | 77004 | — |
| Cara Therapeutics Study Site | San Antonio | Texas | 78209 | — |
| Cara Therapeutics Study Site | Springville | Utah | 84663 | — |
| Cara Therapeutics Study Site | Spokane | Washington | 99202 | — |
| Cara Therapeutics Study Site | Morgantown | West Virginia | 26505 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05387707, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 22, 2024 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05387707 live on ClinicalTrials.gov.