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

Phase 2

Terminated

• Conditions: Asthma
• Interventions: Drug: RPT193; Other: Placebo

• Registration Number: NCT05935332
• Lead Sponsor: RAPT Therapeutics, Inc.

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).

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 Timeline

• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-07-04
• Study Start: 2023-07-05
• Study First Posted: 2023-07-07
• Primary Completion: 2024-06-21
• Study Completion: 2024-06-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RPT193 400 mg	RPT193	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants with a Loss of Asthma Control event as defined by criteria listed	14 weeks	≥ 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

Secondary Outcome Measures

Name	Time	Method
Frequency of treatment-emergent adverse events as assessed by CTCAE v5.0	20 weeks	Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Trial Locations

Locations (29)

Coral Research Clinical Corp; 🇺🇸 Miami, Florida, United States

NZOZ Poradnie Specjalistyczne Atopia; 🇵🇱 Kraków, Poland

Specjalistyczna Przychodnia Lekarska Alergo-Med sp. z o.o; 🇵🇱 Poznań, Poland

Medical Center "Zadrave-1"; 🇧🇬 Kozloduy, Bulgaria

Centrum Diagnostyczno Terapeutyczne MEDICUS Sp. z o.o. - Szpital; 🇵🇱 Lubin, Poland

Lekarze Specjaliści - J. Małolepszy i Partnerzy; 🇵🇱 Wrocław, Poland

Medical Center Excelsior; 🇧🇬 Sofia, Bulgaria

Diagnostic-Consultative Center Convex Ltd.; 🇧🇬 Sofia, Bulgaria

IP Clinic Sp. z.o.o; 🇵🇱 Łódź, Poland

Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Vratsa; 🇧🇬 Vratsa, Bulgaria

Centrum Medycyny Oddechowej Mróz Spółka Jawna; 🇵🇱 Białystok, Poland

Allergy and Asthma Associates of Santa Clara Valley Research Center; 🇺🇸 San Jose, California, United States

Allianz Research Institute; 🇺🇸 Westminster, California, United States

Bensch Clinical Research LLC; 🇺🇸 Stockton, California, United States

Sonce Medical Research; 🇺🇸 Miami, Florida, United States

San Marcos Research Clinic; 🇺🇸 Miami Lakes, Florida, United States

Velocity Clinical Research Grants Pass; 🇺🇸 Grants Pass, Oregon, United States

Allergy, Asthma & Sinus Ceneter SC; 🇺🇸 Greenfield, Wisconsin, United States

University Multiprofile Hospital for Active Treatment; 🇧🇬 Stara Zagora, Bulgaria

Medical Center "ResearchExpert" Ltd; 🇧🇬 Varna, Bulgaria

MediTrial s.r.o; 🇨🇿 Jindřichův Hradec, Czechia

Trialmed Sp z. o.o.o CRS Warszawa; 🇵🇱 Warsaw, Solipska, Poland

Trialmed CRS (Piotrków Trybunalski); 🇵🇱 Piotrków Trybunalski, Poland

Michal Bogacki - Dobrostan; 🇵🇱 Wrocław, Poland

OK Clinical Research LLC; 🇺🇸 Edmond, Oklahoma, United States

Western Sky Medical Research; 🇺🇸 El Paso, Texas, United States

Metroplex Pulmonary & Sleep Center; 🇺🇸 McKinney, Texas, United States

Allianz Research Institute CO; 🇺🇸 Aurora, Colorado, United States

Clinical Research Trials of Florida; 🇺🇸 Tampa, Florida, United States