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Study on clinical hold by FDA
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Randomized, multi-center, double-blind, placebo-controlled, parallel group, proof of-concept study with RPT193 in subjects with T2-high, moderate-to-severe asthma who are partially controlled on medium or high doses of inhaled corticosteroids (ICS) in combination with long-acting beta 2 agonist (LABA).
Randomized, multi-center, double-blind, placebo-controlled, parallel group, proof of-concept study with RPT193 in subjects with T2-high, moderate-to-severe asthma who are partially controlled on medium or high doses of inhaled corticosteroids (ICS) in combination with long-acting beta 2 agonist (LABA).
After a screening period subjects will receive standardized, inhaled therapy during a run-in period. Subjects will be randomized to receive RPT193 or placebo through Week 14. All enrolled subjects will receive background inhaled therapy with ICS and LABA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RPT193 400 mg | Experimental |
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| Placebo | Placebo Comparator |
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| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed | Participants experiencing LOAC events; ≥ 30% reduction in peak expiratory flow; ≥ 6 additional inhalations of short-acting beta 2 agonist; increase by factor of 4 or more of inhaled corticosteroids; and/or evidence of a severe asthma exacerbation | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1 (L) of Week 14 Compared to Baseline | 14 Weeks | |
| Number of Participants With Non-serious Treatment-Emergent Adverse Events Experienced by ≥5% of Participants - Any TEAEs | 14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurence Cheng, MD, PhD | RAPT Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy and Asthma Associates of Santa Clara Valley Research Center | San Jose | California | 95117 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | RPT193 400 mg | 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 | Placebo |
| 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 | Sep 12, 2023 | Apr 21, 2025 |
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| Placebo | Other | placebo |
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| Bensch Clinical Research LLC |
| Stockton |
| California |
| 95207 |
| United States |
| Allianz Research Institute | Westminster | California | 92683 | United States |
| Allianz Research Institute CO | Aurora | Colorado | 80014 | United States |
| Sonce Medical Research | Miami | Florida | 33133 | United States |
| Coral Research Clinical Corp | Miami | Florida | 33186 | United States |
| San Marcos Research Clinic | Miami Lakes | Florida | 33014 | United States |
| Clinical Research Trials of Florida | Tampa | Florida | 33607 | United States |
| OK Clinical Research LLC | Edmond | Oklahoma | 73034 | United States |
| Velocity Clinical Research Grants Pass | Grants Pass | Oregon | 97527 | United States |
| Western Sky Medical Research | El Paso | Texas | 79903 | United States |
| Metroplex Pulmonary & Sleep Center | McKinney | Texas | 95069 | United States |
| Allergy, Asthma & Sinus Ceneter SC | Greenfield | Wisconsin | 53228 | United States |
| Medical Center "Zadrave-1" | Kozloduy | 3320 | Bulgaria |
| Medical Center Excelsior | Sofia | 1407 | Bulgaria |
| Diagnostic-Consultative Center Convex Ltd. | Sofia | 1680 | Bulgaria |
| University Multiprofile Hospital for Active Treatment | Stara Zagora | 6003 | Bulgaria |
| Medical Center "ResearchExpert" Ltd | Varna | 9000 | Bulgaria |
| Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Vratsa | Vratsa | 3000 | Bulgaria |
| MediTrial s.r.o | Jindřichův Hradec | 377 01 | Czechia |
| Trialmed Sp z. o.o.o CRS Warszawa | Warsaw | Solipska | 02-482 | Poland |
| Centrum Medycyny Oddechowej Mróz Spółka Jawna | Bialystok | 15-044 | Poland |
| NZOZ Poradnie Specjalistyczne Atopia | Krakow | 31-159 | Poland |
| IP Clinic Sp. z.o.o | Lodz | 90-752 | Poland |
| Centrum Diagnostyczno Terapeutyczne MEDICUS Sp. z o.o. - Szpital | Lubin | 59-300 | Poland |
| Trialmed CRS (Piotrków Trybunalski) | Piotrkow Trybunalski | 97-300 | Poland |
| Specjalistyczna Przychodnia Lekarska Alergo-Med sp. z o.o | Poznan | 61-578 | Poland |
| Michal Bogacki - Dobrostan | Wroclaw | 53-301 | Poland |
| Lekarze Specjaliści - J. Małolepszy i Partnerzy | Wroclaw | 54-239 | Poland |
Placebo: placebo
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | RPT193 400 mg | 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 | Placebo | Placebo: placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||||||
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| Primary | Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed | Participants experiencing LOAC events; ≥ 30% reduction in peak expiratory flow; ≥ 6 additional inhalations of short-acting beta 2 agonist; increase by factor of 4 or more of inhaled corticosteroids; and/or evidence of a severe asthma exacerbation | Posted | Count of Participants | Participants | 14 weeks |
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| Secondary | Change in FEV1 (L) of Week 14 Compared to Baseline | Posted | Mean | Standard Deviation | Liters (L) | 14 Weeks |
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| Secondary | Number of Participants With Non-serious Treatment-Emergent Adverse Events Experienced by ≥5% of Participants - Any TEAEs | Posted | Count of Participants | Participants | 14 weeks |
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Approximately 14 weeks. Overall, 18 (47.4%) participants completed the 14-week treatment period (10 [52.6%] in the RPT193 group and 8 [42.1%] in the placebo group). Nineteen (50.0%) participants completed the study including follow-up visits (11 [57.9%] in the RPT193 group and 8 [42.1%] in the placebo group)
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: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17 | 0 | 19 | 0 | 19 | 6 | 19 |
| EG001 | Placebo | Placebo: placebo | 0 | 19 | 0 | 19 | 3 | 19 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA version 25.1 | Systematic Assessment |
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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 | May 1, 2024 | Apr 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| >=65 years |
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| Male |
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| 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 |
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| Unknown or Not Reported |
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| Czechia |
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| Bulgaria |
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| ≥6 additional reliever inhalations of SABA in a 24-hr period relative to baseline on 2 consec. days |
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| Increase by a factor of 4 or more in the most recent dose of ICS |
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| Exacerbation of asthma requiring systemic corticosteroids |
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| Exacerbation of asthma-related AEs requiring Hospitalization or emergency room visit |
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