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
• Status: Suspended
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Asthma

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