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

NCT05935332 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: RPT193-03
• Study Type: interventional
• Target: 38
• Locations: 4 countries
• Sites: 29

Brief 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).

Conditions

Asthma

Keywords

asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

RPT193 400 mg

EXPERIMENTAL

Drug: RPT193

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

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

RPT193 400 mg

Placebo OTHER

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RAPT Therapeutics, Inc.: lead

Study Sites (29)

Allergy and Asthma Associates of Santa Clara Valley Research Center

San Jose, California, 95117, United States

Location

Bensch Clinical Research LLC

Stockton, California, 95207, United States

Location

Allianz Research Institute

Westminster, California, 92683, United States

Location

Allianz Research Institute CO

Aurora, Colorado, 80014, United States

Location

Sonce Medical Research

Miami, Florida, 33133, United States

Location

Coral Research Clinical Corp

Miami, Florida, 33186, United States

Location

San Marcos Research Clinic

Miami Lakes, Florida, 33014, United States

Location

Clinical Research Trials of Florida

Tampa, Florida, 33607, United States

Location

OK Clinical Research LLC

Edmond, Oklahoma, 73034, United States

Location

Velocity Clinical Research Grants Pass

Grants Pass, Oregon, 97527, United States

Location

Western Sky Medical Research

El Paso, Texas, 79903, United States

Location

Metroplex Pulmonary & Sleep Center

McKinney, Texas, 95069, United States

Location

Allergy, Asthma & Sinus Ceneter SC

Greenfield, Wisconsin, 53228, United States

Location

Medical Center "Zadrave-1"

Kozloduy, 3320, Bulgaria

Location

Medical Center Excelsior

Sofia, 1407, Bulgaria

Location

Diagnostic-Consultative Center Convex Ltd.

Sofia, 1680, Bulgaria

Location

University Multiprofile Hospital for Active Treatment

Stara Zagora, 6003, Bulgaria

Location

Medical Center "ResearchExpert" Ltd

Varna, 9000, Bulgaria

Location

Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Vratsa

Vratsa, 3000, Bulgaria

Location

MediTrial s.r.o

Jindřichův Hradec, 377 01, Czechia

Location

Trialmed Sp z. o.o.o CRS Warszawa

Warsaw, Solipska, 02-482, Poland

Location

Centrum Medycyny Oddechowej Mróz Spółka Jawna

Bialystok, 15-044, Poland

Location

NZOZ Poradnie Specjalistyczne Atopia

Krakow, 31-159, Poland

Location

IP Clinic Sp. z.o.o

Lodz, 90-752, Poland

Location

Centrum Diagnostyczno Terapeutyczne MEDICUS Sp. z o.o. - Szpital

Lubin, 59-300, Poland

Location

Trialmed CRS (Piotrków Trybunalski)

Piotrkow Trybunalski, 97-300, Poland

Location

Specjalistyczna Przychodnia Lekarska Alergo-Med sp. z o.o

Poznan, 61-578, Poland

Location

Michal Bogacki - Dobrostan

Wroclaw, 53-301, Poland

Location

Lekarze Specjaliści - J. Małolepszy i Partnerzy

Wroclaw, 54-239, Poland

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

A limitation of the study is the small sample size due to the early termination of the study.

Results Point of Contact

• Title: Jennifer Nicholson
• Organization: RAPT Therapeutics

jnicholson@rapt.com

650-743-8807

Study Officials

• Laurence Cheng, MD, PhD

  RAPT Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 7, 2023
• Study Start: July 5, 2023
• Primary Completion: June 21, 2024
• Study Completion: June 21, 2024
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (13); PL (9); BU (6); CZ (1)