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

Primary Purpose

Asthma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RPT193
Placebo
Sponsored by
RAPT Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Allergy and Asthma Associates of Santa Clara Valley Research CenterRecruiting
  • Allianz Research InstituteRecruiting
  • Allianz Research Institute CORecruiting
  • San Marcos Research ClinicRecruiting
  • Sonce Medical ResearchRecruiting
  • Coral Research Clinical CorpRecruiting
  • Clinical Research Trials of FloridaRecruiting
  • OK Clinical Research LLCRecruiting
  • Velocity Clinical Research Grants PassRecruiting
  • Western Sky Medical ResearchRecruiting
  • Metroplex Pulmonary & Sleep CenterRecruiting
  • Allergy, Asthma & Sinus Ceneter SCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RPT193 400 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2023
Last Updated
September 11, 2023
Sponsor
RAPT Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05935332
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAPT Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RPT193 400 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
RPT193
Intervention Description
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
Other
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Proportion of participants with a Loss of Asthma Control event as defined by criteria listed
Description
≥ 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
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Frequency of treatment-emergent adverse events as assessed by CTCAE v5.0
Description
Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence Cheng, MD, PhD
Phone
650-489-9000
Email
clinical.trials@rapt.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Cheng, MD, PhD
Organizational Affiliation
RAPT Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Allergy and Asthma Associates of Santa Clara Valley Research Center
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Sanchez-Lang
Phone
408-553-0708
Email
lsanchez@allergycare.com
Facility Name
Allianz Research Institute
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Pham, MD
Phone
714-887-0400
Email
David.pham@allianzresearch.com
Facility Name
Allianz Research Institute CO
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Pham, MD
Phone
720-795-9898
Email
David.pham@allianzresearch.com
Facility Name
San Marcos Research Clinic
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Peralta
Phone
305-424-7420
Email
mperalta@sanmarusrc.com
Facility Name
Sonce Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nestor Cancio Morales, MD
Phone
305-815-0055
Email
nestorcanciomd@sonesmedicalresearch.com
Facility Name
Coral Research Clinical Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edel Abreu, MD
Phone
786-362-6114
Email
abreuedel@gmail.com
Facility Name
Clinical Research Trials of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priscel Sosa
Phone
813-873-8102
Email
psosa@crtfi.com
First Name & Middle Initial & Last Name & Degree
Ricardo Alpizar
Phone
813-873-8102
Email
ralpizar@crtfi.com
Facility Name
OK Clinical Research LLC
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Ireland
Phone
402-285-6811
Email
mireland@okclinicalresearch.org
First Name & Middle Initial & Last Name & Degree
Tammy Ernst
Phone
405-285-6811
Email
ternst@okclinicalresearch.org
Facility Name
Velocity Clinical Research Grants Pass
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Delgado, MD
Phone
541-237-0323
Email
jdelgado@velocityclinical.com
Facility Name
Western Sky Medical Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Huerta
Phone
915-544-2557
Email
mhuerta@westernskymed.com
Facility Name
Metroplex Pulmonary & Sleep Center
City
McKinney
State/Province
Texas
ZIP/Postal Code
95069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rup Krishna
Phone
972-838-1892
Email
rkrishna@mpsleepcenter.com
Facility Name
Allergy, Asthma & Sinus Ceneter SC
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Steven, MD
Phone
414-529-8519
Email
gsteven@myaasc.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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