Atopic Dermatitis Clinical Trial
Official title:
A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 as Monotherapy in Adults With Moderate-to-Severe Atopic Dermatitis
| Verified date | February 2024 |
| Source | RAPT Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Phase 2 study of RPT193 in adults with atopic dermatitis
| Status | Suspended |
| Enrollment | 268 |
| Est. completion date | September 2024 |
| Est. primary completion date | July 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Clinically confirmed diagnosis of active atopic dermatitis (AD), according to the revised Hanifin and Rajka criteria - 12-month history of AD and had no significant flares in AD for at least 4 weeks before screening - inadequate response to a =1 month treatment with topical medications - Atopic dermatitis covering =10% of the body surface area - EASI score =16 - Validated Investigator Global Assessment (VIGA) =3 - Use of emollient(s) at least 2x daily for 1 week prior to baseline - Negative coronavirus disease (COVID)-19 results at screening Exclusion Criteria: - Uncontrolled moderate-to-severe asthma - Uncontrolled diabetes - Stage III or IV cardiac failure - Severe renal condition - Major surgery within 8 weeks of screening - Immunodeficiency and/or receipt of immunosuppressive drugs within 4 weeks of baseline - Use of systemic Janus kinase (JAK) inhibitor within 8 weeks of baseline - Received live or live-attenuated vaccine within 4 weeks of baseline - Prior receipt of RPT193 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | SimcoDerm Medical and Surgical Dermatology Center | Barrie | Ontario |
| Canada | LEADER Research | Hamilton | Ontario |
| Canada | Red Maple Trials Inc. | Ottawa | Ontario |
| United States | Fivenson Dermatology | Ann Arbor | Michigan |
| United States | Arlington Research Center Inc. | Arlington | Texas |
| United States | DermResearch | Austin | Texas |
| United States | DelRicht Research | Baton Rouge | Louisiana |
| United States | Cahaba Dermatology and Skin Health Center | Birmingham | Alabama |
| United States | Optima Research - Boardman | Boardman | Ohio |
| United States | MetroBoston Clinical Partners | Brighton | Massachusetts |
| United States | Schweiger Dermatology Group, PC Research Division | Columbia | Maryland |
| United States | Driven Research LLC | Coral Gables | Florida |
| United States | Florida Academic Centers Research and Education, LLC | Coral Gables | Florida |
| United States | Studies in Dermatology, LLC | Cypress | Texas |
| United States | Dermatology Treatment and Research Center | Dallas | Texas |
| United States | University Dermatology and Vein Clinic | Darien | Illinois |
| United States | Palm Beach Dermatology Group | Delray Beach | Florida |
| United States | California Dermatology & Clinical Research Institute | Encinitas | California |
| United States | First OC Dermatology | Fountain Valley | California |
| United States | Clinical Trial Network | Houston | Texas |
| United States | Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana |
| United States | Indiana Clinical and Translational Sciences Institute (CTSI) Clinical Research Center | Indianapolis | Indiana |
| United States | Forest Hills Dermatology Group | Kew Gardens | New York |
| United States | Dermatology Research Associates | Los Angeles | California |
| United States | Grimes Center | Los Angeles | California |
| United States | Wallace Medical Group | Los Angeles | California |
| United States | Skin Sciences PLLC | Louisville | Kentucky |
| United States | Skin Care Physicians of Georgia | Macon | Georgia |
| United States | GSI Clinical Research | Margate | Florida |
| United States | Marietta Dermatology Clinical Research, Inc. | Marietta | Georgia |
| United States | Apex Clinical Research Center | Mayfield Heights | Ohio |
| United States | Ichan School of Medicine at Mount Sinai | New York | New York |
| United States | JUVA Skin & Laser Center | New York | New York |
| United States | Markowitz Medical, PLLC | New York | New York |
| United States | Velocity Clinical Research | North Hollywood | California |
| United States | Arkansas Research Trials, LLC | North Little Rock | Arkansas |
| United States | Advanced Dermatology of the Midlands | Omaha | Nebraska |
| United States | Skin Specialists PC (Schlessinger MD) | Omaha | Nebraska |
| United States | The Indiana Clinical Trials Center PC | Plainfield | Indiana |
| United States | Beacon Clinical Research, LLC | Quincy | Massachusetts |
| United States | Health Concepts | Rapid City | South Dakota |
| United States | West End Dermatology Associates | Richmond | Virginia |
| United States | Integrative Skin Science and Research | Sacramento | California |
| United States | Medisearch Clinical Trials | Saint Joseph | Missouri |
| United States | St. Joseph Dermatology and Vein Clinic | Saint Joseph | Michigan |
| United States | Progressive Clinical Research | San Antonio | Texas |
| United States | Clinical Science Institute | Santa Monica | California |
| United States | Georgia Skin & Cancer Clinic | Savannah | Georgia |
| United States | Perseverance Research Center | Scottsdale | Arizona |
| United States | Jordan Valley Dermatology Center | South Jordan | Utah |
| United States | Premier Clinical Research | Spokane | Washington |
| United States | Acclaim Dermatology | Sugar Land | Texas |
| United States | Complete Dermatology | Sugar Land | Texas |
| United States | Lenus Research & Medical Group, LLC | Sweetwater | Florida |
| United States | Forcare Clinical Research | Tampa | Florida |
| United States | Clinical Trials Research Institute | Thousand Oaks | California |
| United States | Schweiger Dermatology Group | Verona | New Jersey |
| United States | Grekin Skin Institute | Warren | Michigan |
| United States | Foxhall Research Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| RAPT Therapeutics, Inc. |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical efficacy | % change in Eczema Area Severity Index (EASI) | 16 weeks | |
| Primary | Safety as measured by adverse events | Incidence of treatment-emergent adverse events | 16 weeks |
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