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Study on clinical hold by FDA
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Phase 2 study of RPT193 in adults with atopic dermatitis
Randomized, placebo-controlled Phase 2 study of RPT193 in adults with moderate-to-severe atopic dermatitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RPT193 400 mg | Experimental | RPT193 400 mg oral tablet administered daily for 16 weeks |
|
| RPT193 200 mg | Experimental | RPT193 200 mg oral tablet administered daily for 16 weeks |
|
| RPT193 50 mg | Experimental | RPT193 50 mg oral tablet administered daily for 16 weeks |
|
| Placebo | Placebo Comparator | Matching placebo oral tablet administered daily for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPT193 | Drug | RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Clinical Efficacy of RPT193 Administered Orally Once Daily (QD) for 16 Weeks to Participants With Moderate-to-severe AD | % change in Eczema Area Severity Index (EASI) from baseline at Week 16 | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | To evaluate the safety and tolerability of RPT193 administered orally QD for 16 weeks | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Dermatology and Skin Health Center | Birmingham | Alabama | 35244 | United States | ||
| Perseverance Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | RPT193 400 mg | RPT193 400 mg oral tablet administered daily for 16 weeks RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17 |
| FG001 | RPT193 200 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 7, 2023 | May 15, 2025 |
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Double blind
| Placebo | Other | Nonactive placebo tablet |
|
| Scottsdale |
| Arizona |
| 85254 |
| United States |
| Arkansas Research Trials, LLC | North Little Rock | Arkansas | 72117 | United States |
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | United States |
| First OC Dermatology | Fountain Valley | California | 92708 | United States |
| Grimes Center | Los Angeles | California | 90036 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Wallace Medical Group | Los Angeles | California | 90056 | United States |
| Velocity Clinical Research | North Hollywood | California | 91606 | United States |
| Integrative Skin Science and Research | Sacramento | California | 95815 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| Clinical Trials Research Institute | Thousand Oaks | California | 91320 | United States |
| Foxhall Research Center | Washington D.C. | District of Columbia | 20016 | United States |
| Driven Research LLC | Coral Gables | Florida | 33134 | United States |
| Florida Academic Centers Research and Education, LLC | Coral Gables | Florida | 33134 | United States |
| Palm Beach Dermatology Group | Delray Beach | Florida | 33484 | United States |
| GSI Clinical Research | Margate | Florida | 33063 | United States |
| Lenus Research & Medical Group, LLC | Sweetwater | Florida | 33172 | United States |
| Forcare Clinical Research | Tampa | Florida | 33613 | United States |
| Skin Care Physicians of Georgia | Macon | Georgia | 31217 | United States |
| Marietta Dermatology Clinical Research, Inc. | Marietta | Georgia | 30060 | United States |
| Georgia Skin & Cancer Clinic | Savannah | Georgia | 31419 | United States |
| University Dermatology and Vein Clinic | Darien | Illinois | 60561 | United States |
| Indiana Clinical and Translational Sciences Institute (CTSI) Clinical Research Center | Indianapolis | Indiana | 46202 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | United States |
| The Indiana Clinical Trials Center PC | Plainfield | Indiana | 46168 | United States |
| Skin Sciences PLLC | Louisville | Kentucky | 40217' | United States |
| DelRicht Research | Baton Rouge | Louisiana | 70809 | United States |
| Schweiger Dermatology Group, PC Research Division | Columbia | Maryland | 21044 | United States |
| MetroBoston Clinical Partners | Brighton | Massachusetts | 02135 | United States |
| Beacon Clinical Research, LLC | Quincy | Massachusetts | 02169 | United States |
| Fivenson Dermatology | Ann Arbor | Michigan | 48103 | United States |
| St. Joseph Dermatology and Vein Clinic | Saint Joseph | Michigan | 49085 | United States |
| Grekin Skin Institute | Warren | Michigan | 48088 | United States |
| Medisearch Clinical Trials | Saint Joseph | Missouri | 64506 | United States |
| Advanced Dermatology of the Midlands | Omaha | Nebraska | 68144 | United States |
| Skin Specialists PC (Schlessinger MD) | Omaha | Nebraska | 68144 | United States |
| Schweiger Dermatology Group | Verona | New Jersey | 07044 | United States |
| Forest Hills Dermatology Group | Kew Gardens | New York | 11415 | United States |
| JUVA Skin & Laser Center | New York | New York | 10022 | United States |
| Ichan School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Markowitz Medical, PLLC | New York | New York | 10128 | United States |
| Optima Research - Boardman | Boardman | Ohio | 44512 | United States |
| Apex Clinical Research Center | Mayfield Heights | Ohio | 44124 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Arlington Research Center Inc. | Arlington | Texas | 76011 | United States |
| DermResearch | Austin | Texas | 78759 | United States |
| Studies in Dermatology, LLC | Cypress | Texas | 77433 | United States |
| Dermatology Treatment and Research Center | Dallas | Texas | 75230 | United States |
| Clinical Trial Network | Houston | Texas | 77074 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Acclaim Dermatology | Sugar Land | Texas | 77479 | United States |
| Complete Dermatology | Sugar Land | Texas | 77479 | United States |
| Jordan Valley Dermatology Center | South Jordan | Utah | 84095 | United States |
| West End Dermatology Associates | Richmond | Virginia | 23233 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| SimcoDerm Medical and Surgical Dermatology Center | Barrie | Ontario | L4M7G1 | Canada |
| LEADER Research | Hamilton | Ontario | L8L 3C3 | Canada |
| Red Maple Trials Inc. | Ottawa | Ontario | K1H 1E4 | Canada |
RPT193 200 mg oral tablet administered daily for 16 weeks RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17 |
| FG002 | RPT193 50 mg | RPT193 50 mg oral tablet administered daily for 16 weeks RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17 |
| FG003 | Placebo | Matching placebo oral tablet administered daily for 16 weeks Placebo: Nonactive placebo tablet |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RPT193 400 mg | RPT193 400 mg oral tablet administered daily for 16 weeks RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17 |
| BG001 | RPT193 200 mg | RPT193 200 mg oral tablet administered daily for 16 weeks RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17 |
| BG002 | RPT193 50 mg | RPT193 50 mg oral tablet administered daily for 16 weeks RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17 |
| BG003 | Placebo | Matching placebo oral tablet administered daily for 16 weeks Placebo: Nonactive placebo tablet |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Evaluate the Clinical Efficacy of RPT193 Administered Orally Once Daily (QD) for 16 Weeks to Participants With Moderate-to-severe AD | % change in Eczema Area Severity Index (EASI) from baseline at Week 16 | Posted | Mean | Standard Deviation | Percent Change from Baseline to Week 16 | 16 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | To evaluate the safety and tolerability of RPT193 administered orally QD for 16 weeks | Posted | Count of Participants | Participants | 16 weeks |
|
Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RPT193 400 mg | RPT193 400 mg oral tablet administered daily for 16 weeks RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17 | 0 | 59 | 2 | 59 | 12 | 59 |
| EG001 | RPT193 200 mg | RPT193 200 mg oral tablet administered daily for 16 weeks RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17 | 0 | 57 | 0 | 57 | 7 | 57 |
| EG002 | RPT193 50 mg | RPT193 50 mg oral tablet administered daily for 16 weeks RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17 | 0 | 57 | 1 | 57 | 5 | 57 |
| EG003 | Placebo | Matching placebo oral tablet administered daily for 16 weeks Placebo: Nonactive placebo tablet | 0 | 56 | 0 | 56 | 4 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendix Disorder | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment | *Single case of possible SJS reported in the participant with hepatic failure had atypical features including onset >2 weeks after discontinuation of study treatment (RPT193 400 mg) in the setting of hepatic failure and resolution within 5 days |
|
| Hospitalisation | Surgical and medical procedures | MedDRA Version 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
|
A limitation of the study is the small sample size due to the early termination of the study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Nicholson | RAPT Therapeutics | 650-743-8807 | jnicholson@rapt.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2024 | May 15, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
|
| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| United States |
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