Clinical trial NCT05935332: Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Asthma
Keywords: asthma
Lead sponsor: RAPT Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-07
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with a Loss of Asthma Control event as defined by criteria listed
timeFrame: 14 weeks
Secondary outcomes:
measure: Frequency of treatment-emergent adverse events as assessed by CTCAE v5.0
timeFrame: 20 weeks
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Allergy and Asthma Associates of Santa Clara Valley Research Center
state: California
city: Stockton
country: United States
facility: Bensch Clinical Research LLC
state: California
city: Westminster
country: United States
facility: Allianz Research Institute
state: California
city: Aurora
country: United States
facility: Allianz Research Institute CO
state: Colorado
city: Miami Lakes
country: United States
facility: San Marcos Research Clinic
state: Florida
city: Miami
country: United States
facility: Sonce Medical Research
state: Florida
city: Miami
country: United States
facility: Coral Research Clinical Corp
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida
state: Florida
city: Edmond
country: United States
facility: OK Clinical Research LLC
state: Oklahoma
city: Grants Pass
country: United States
facility: Velocity Clinical Research Grants Pass
state: Oregon
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary & Sleep Center
state: Texas
city: Greenfield
country: United States
facility: Allergy, Asthma & Sinus Ceneter SC
state: Wisconsin
city: Kozloduy
country: Bulgaria
facility: Medical Center "Zadrave-1"
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center Convex Ltd.
city: Stara Zagora
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment
city: Varna
country: Bulgaria
facility: Medical Center "ResearchExpert" Ltd
city: Vratsa
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Vratsa
city: Jindřichův Hradec
country: Czechia
facility: MediTrial s.r.o
city: Warsaw
country: Poland
facility: Trialmed Sp z. o.o.o CRS Warszawa
state: Solipska
city: Białystok
country: Poland
facility: Centrum Medycyny Oddechowej Mróz Spółka Jawna
city: Kraków
country: Poland
facility: NZOZ Poradnie Specjalistyczne Atopia
city: Lubin
country: Poland
facility: Centrum Diagnostyczno Terapeutyczne MEDICUS Sp. z o.o. - Szpital
city: Piotrków Trybunalski
country: Poland
facility: Trialmed CRS (Piotrków Trybunalski)
city: Poznań
country: Poland
facility: Specjalistyczna Przychodnia Lekarska Alergo-Med sp. z o.o
city: Wrocław
country: Poland
facility: Michal Bogacki - Dobrostan
city: Wrocław
country: Poland
facility: Lekarze Specjaliści - J. Małolepszy i Partnerzy
city: Łódź
country: Poland
facility: IP Clinic Sp. z.o.o
Study officials:
affiliation: RAPT Therapeutics, Inc.
name: Laurence Cheng, MD, PhD
role: STUDY_DIRECTOR
References: