Clinical Trials Logo
  1. Home
  2. Asthma
  3. NCT05935332
  4. Details
NCT05935332 Clinical Trial

Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma

Asthma Clinical Trial

Official title:
A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 in Adults With Moderate-to-severe T2-high Asthma Who Are Partially Controlled on Inhaled Corticosteroid and Long-acting Beta 2 Agonist Therapy

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT05935332
Other study ID # RPT193-03
Secondary ID
Status Suspended
Phase Phase 2
First received
Last updated
Start date July 5, 2023
Est. completion date August 2025

Study information
Verified date February 2024
Source RAPT Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility
Status Suspended
Enrollment 100
Est. completion date August 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Physician diagnosis of asthma for =6 months - Pre-bronchodilator FEV1 of >40% and <80% - History of treatment with corticosteroid or hospitalization for worsening asthma - Medium- or high-dose inhaled corticosteroid use Exclusion Criteria: - History of smoking/vaping - History of severe COVID - Serious and/or uncontrolled pulmonary, cardiac, immune system conditions - Requires systemic oral or IV corticosteroids in the month prior to screening

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• RPT193
RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
Other:
• Placebo
placebo

Locations
Country Name City State
Bulgaria Medical Center "Zadrave-1" Kozloduy
Bulgaria Diagnostic-Consultative Center Convex Ltd. Sofia
Bulgaria Medical Center Excelsior Sofia
Bulgaria University Multiprofile Hospital for Active Treatment Stara Zagora
Bulgaria Medical Center "ResearchExpert" Ltd Varna
Bulgaria Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Vratsa Vratsa
Czechia MediTrial s.r.o Jindrichuv Hradec
Poland Centrum Medycyny Oddechowej Mróz Spólka Jawna Bialystok
Poland NZOZ Poradnie Specjalistyczne Atopia Kraków
Poland IP Clinic Sp. z.o.o Lódz
Poland Centrum Diagnostyczno Terapeutyczne MEDICUS Sp. z o.o. - Szpital Lubin
Poland Trialmed CRS (Piotrków Trybunalski) Piotrków Trybunalski
Poland Specjalistyczna Przychodnia Lekarska Alergo-Med sp. z o.o Poznan
Poland Trialmed Sp z. o.o.o CRS Warszawa Warsaw Solipska
Poland Lekarze Specjalisci - J. Malolepszy i Partnerzy Wroclaw
Poland Michal Bogacki - Dobrostan Wroclaw
United States Allianz Research Institute CO Aurora Colorado
United States OK Clinical Research LLC Edmond Oklahoma
United States Western Sky Medical Research El Paso Texas
United States Velocity Clinical Research Grants Pass Grants Pass Oregon
United States Allergy, Asthma & Sinus Ceneter SC Greenfield Wisconsin
United States Metroplex Pulmonary & Sleep Center McKinney Texas
United States Coral Research Clinical Corp Miami Florida
United States Sonce Medical Research Miami Florida
United States San Marcos Research Clinic Miami Lakes Florida
United States Allergy and Asthma Associates of Santa Clara Valley Research Center San Jose California
United States Bensch Clinical Research LLC Stockton California
United States Clinical Research Trials of Florida Tampa Florida
United States Allianz Research Institute Westminster California

Sponsors (1)
Lead Sponsor Collaborator
RAPT Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of participants with a Loss of Asthma Control event as defined by criteria listed = 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
Secondary Frequency of treatment-emergent adverse events as assessed by CTCAE v5.0 Common Terminology Criteria for Adverse Events (CTCAE) v5.0 20 weeks
See also
  Status Clinical Trial Phase
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device