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

Sponsor

RAPT Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05935332

Collaborator

(none)

100

Enrollment

Locations

Arms

24.9

Anticipated Duration (Months)

16.7

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: RPT193 Other: Placebo	Phase 2

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 5, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RPT193 400 mg	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
Placebo Comparator: Placebo	Other: Placebo placebo

Arm

Intervention/Treatment

Experimental: RPT193 400 mg

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

Placebo Comparator: Placebo

Other: Placebo

placebo

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allergy and Asthma Associates of Santa Clara Valley Research Center	San Jose	California	United States	95117
2	Allianz Research Institute	Westminster	California	United States	92683
3	Allianz Research Institute CO	Aurora	Colorado	United States	80014
4	San Marcos Research Clinic	Miami Lakes	Florida	United States	33014
5	Clinical Research Trials of Florida	Tampa	Florida	United States	33607
6	OK Clinical Research LLC	Edmond	Oklahoma	United States	73034

Sponsors and Collaborators

RAPT Therapeutics, Inc.

Investigators

Study Director: Laurence Cheng, MD, PhD, RAPT Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

RAPT Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT05935332

Other Study ID Numbers:

RPT193-03

First Posted:

Jul 7, 2023

Last Update Posted:

Jul 14, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by RAPT Therapeutics, Inc.

asthma

Additional relevant MeSH terms:

Asthma

Study Results

No Results Posted as of Jul 14, 2023