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

NCT ID: NCT05935332

Last Updated: 2024-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2024-06-21

Brief Summary

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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).

Detailed Description

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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).

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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RPT193 400 mg

Group Type EXPERIMENTAL

RPT193

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo

Interventions

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RPT193

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

Intervention Type DRUG

Placebo

placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RAPT Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurence Cheng, MD, PhD

Role: STUDY_DIRECTOR

RAPT Therapeutics, Inc.

Locations

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Allergy and Asthma Associates of Santa Clara Valley Research Center

San Jose, California, United States

Site Status

Bensch Clinical Research LLC

Stockton, California, United States

Site Status

Allianz Research Institute

Westminster, California, United States

Site Status

Allianz Research Institute CO

Aurora, Colorado, United States

Site Status

Sonce Medical Research

Miami, Florida, United States

Site Status

Coral Research Clinical Corp

Miami, Florida, United States

Site Status

San Marcos Research Clinic

Miami Lakes, Florida, United States

Site Status

Clinical Research Trials of Florida

Tampa, Florida, United States

Site Status

OK Clinical Research LLC

Edmond, Oklahoma, United States

Site Status

Velocity Clinical Research Grants Pass

Grants Pass, Oregon, United States

Site Status

Western Sky Medical Research

El Paso, Texas, United States

Site Status

Metroplex Pulmonary & Sleep Center

McKinney, Texas, United States

Site Status

Allergy, Asthma & Sinus Ceneter SC

Greenfield, Wisconsin, United States

Site Status

Medical Center "Zadrave-1"

Kozloduy, , Bulgaria

Site Status

Medical Center Excelsior

Sofia, , Bulgaria

Site Status

Diagnostic-Consultative Center Convex Ltd.

Sofia, , Bulgaria

Site Status

University Multiprofile Hospital for Active Treatment

Stara Zagora, , Bulgaria

Site Status

Medical Center "ResearchExpert" Ltd

Varna, , Bulgaria

Site Status

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

Vratsa, , Bulgaria

Site Status

MediTrial s.r.o

Jindřichův Hradec, , Czechia

Site Status

Trialmed Sp z. o.o.o CRS Warszawa

Warsaw, Solipska, Poland

Site Status

Centrum Medycyny Oddechowej Mróz Spółka Jawna

Bialystok, , Poland

Site Status

NZOZ Poradnie Specjalistyczne Atopia

Krakow, , Poland

Site Status

IP Clinic Sp. z.o.o

Lodz, , Poland

Site Status

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

Lubin, , Poland

Site Status

Trialmed CRS (Piotrków Trybunalski)

Piotrkow Trybunalski, , Poland

Site Status

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

Poznan, , Poland

Site Status

Michal Bogacki - Dobrostan

Wroclaw, , Poland

Site Status

Lekarze Specjaliści - J. Małolepszy i Partnerzy

Wroclaw, , Poland

Site Status

Countries

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United States Bulgaria Czechia Poland

Other Identifiers

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RPT193-03

Identifier Type: -

Identifier Source: org_study_id

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