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

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

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).

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Other: Placebo; Drug: RPT193

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Kozloduy, Bulgaria, 3320
    • Medical Center "Zadrave-1"
  • Sofia, Bulgaria, 1407
    • Medical Center Excelsior
  • Sofia, Bulgaria, 1680
    • Diagnostic-Consultative Center Convex Ltd.
  • Stara Zagora, Bulgaria, 6003
    • University Multiprofile Hospital for Active Treatment
  • Varna, Bulgaria, 9000
    • Medical Center "ResearchExpert" Ltd
  • Vratsa, Bulgaria, 3000
    • Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Vratsa
• Czechia
  • Jindřichův Hradec, Czechia, 377 01
    • MediTrial s.r.o
• Poland
  • Bialystok, Poland, 15-044
    • Centrum Medycyny Oddechowej Mróz Spółka Jawna
  • Krakow, Poland, 31-159
    • NZOZ Poradnie Specjalistyczne Atopia
  • Lodz, Poland, 90-752
    • IP Clinic Sp. z.o.o
  • Lubin, Poland, 59-300
    • Centrum Diagnostyczno Terapeutyczne MEDICUS Sp. z o.o. - Szpital
  • Piotrkow Trybunalski, Poland, 97-300
    • Trialmed CRS (Piotrków Trybunalski)
  • Poznan, Poland, 61-578
    • Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o
  • Wroclaw, Poland, 54-239
    • Lekarze Specjaliści - J. Małolepszy I Partnerzy
  • Wroclaw, Poland, 53-301
    • Michal Bogacki - Dobrostan
  • Solipska
    • Warsaw, Solipska, Poland, 02-482
      • Trialmed Sp z. o.o.o CRS Warszawa
• United States
  • California
    • San Jose, California, United States, 95117
      • Allergy and Asthma Associates of Santa Clara Valley Research Center
    • Stockton, California, United States, 95207
      • Bensch Clinical Research LLC
    • Westminster, California, United States, 92683
      • Allianz Research Institute
  • Colorado
    • Aurora, Colorado, United States, 80014
      • Allianz Research Institute CO
  • Florida
    • Miami, Florida, United States, 33133
      • Sonce Medical Research
    • Miami, Florida, United States, 33186
      • Coral Research Clinical Corp
    • Miami Lakes, Florida, United States, 33014
      • San Marcos Research Clinic
    • Tampa, Florida, United States, 33607
      • Clinical Research Trials of Florida
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • OK Clinical Research LLC
  • Oregon
    • Grants Pass, Oregon, United States, 97527
      • Velocity Clinical Research Grants Pass
  • Texas
    • El Paso, Texas, United States, 79903
      • Western Sky Medical Research
    • McKinney, Texas, United States, 95069
      • Metroplex Pulmonary & Sleep Center
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53228
      • Allergy, Asthma & Sinus Ceneter SC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; placebo
Experimental: RPT193 400 mg	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: RAPT Therapeutics, Inc.
• Investigators: Study Director: Laurence Cheng, MD, PhD, RAPT Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Actual): June 21, 2024
• Study Completion (Actual): June 21, 2024

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: asthma
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: RPT193-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No