AsthmaPhase 2NCT05935332
Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma
A Phase 2 study testing RPT193 in people with Asthma, run by RAPT Therapeutics, Inc., a member of the GSK plc group of companies at 29 sites in 4 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- RPT193
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 29 sitesin 4 countries
- Study dates
- 5 Jul 2023to 21 Jun 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
29 sites in 4 countries.
29 sites in 4 countries
United States13 sites
Allianz Research Institute CO
Aurora, Colorado, 80014
OK Clinical Research LLC
Edmond, Oklahoma, 73034
Western Sky Medical Research
El Paso, Texas, 79903
Velocity Clinical Research Grants Pass
Grants Pass, Oregon, 97527
Allergy, Asthma & Sinus Ceneter SC
Greenfield, Wisconsin, 53228
Metroplex Pulmonary & Sleep Center
McKinney, Texas, 95069
Sonce Medical Research
Miami, Florida, 33133
Coral Research Clinical Corp
Miami, Florida, 33186
San Marcos Research Clinic
Miami Lakes, Florida, 33014
Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, 95117
Bensch Clinical Research LLC
Stockton, California, 95207
Clinical Research Trials of Florida
Tampa, Florida, 33607
Allianz Research Institute
Westminster, California, 92683
Poland9 sites
Centrum Medycyny Oddechowej Mróz Spółka Jawna
Bialystok, 15-044
NZOZ Poradnie Specjalistyczne Atopia
Krakow, 31-159
IP Clinic Sp. z.o.o
Lodz, 90-752
Centrum Diagnostyczno Terapeutyczne MEDICUS Sp. z o.o. - Szpital
Lubin, 59-300
Trialmed CRS (Piotrków Trybunalski)
Piotrkow Trybunalski, 97-300
Specjalistyczna Przychodnia Lekarska Alergo-Med sp. z o.o
Poznan, 61-578
Trialmed Sp z. o.o.o CRS Warszawa
Warsaw, Solipska, 02-482
Michal Bogacki - Dobrostan
Wroclaw, 53-301
Lekarze Specjaliści - J. Małolepszy i Partnerzy
Wroclaw, 54-239
Bulgaria6 sites
Medical Center "Zadrave-1"
Kozloduy, 3320
Medical Center Excelsior
Sofia, 1407
Diagnostic-Consultative Center Convex Ltd.
Sofia, 1680
University Multiprofile Hospital for Active Treatment
Stara Zagora, 6003
Medical Center "ResearchExpert" Ltd
Varna, 9000
Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Vratsa
Vratsa, 3000
About this study
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
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).
Read the 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.
- Conditions
- Asthma
- Being tested
- RPT193, Placebo
- Keywords
- asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPT193Drug
RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| RPT193 400 mg | Experimental | Not described Receives: Drug: RPT193 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed
Participants experiencing LOAC events; ≥ 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
Measured: 14 weeks
Secondary outcomes (2)
Change in FEV1 (L) of Week 14 Compared to Baseline
Measured: 14 Weeks
Number of Participants With Non-serious Treatment-Emergent Adverse Events Experienced by ≥5% of Participants - Any TEAEs
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start5 Jul 2023
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Why it stopped: Study on clinical hold by FDA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAPT Therapeutics, Inc., a member of the GSK plc group of companies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurence Cheng, MD, PhD, Study director, RAPT Therapeutics, Inc., a member of the GSK plc group of companies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935332
- Sponsor's protocol ID
- RPT193-03
- Status last verified
- Mar 2026
- First submitted
- 26 Jun 2023
- Last updated
- 23 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05935332
- Acronym / sponsor ID
- RPT193-03
- Conditions
- Asthma
- Keywords
- asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study on clinical hold by FDA
- Enrolment
- 38 participants (actual)
- Lead sponsor
- RAPT Therapeutics, Inc., a member of the GSK plc group of companiesIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Posted 23 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPT193 400 mg | Experimental | Drug: RPT193 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPT193RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17 | Drug | RPT193 400 mg |
| Placeboplacebo | Other | Placebo |
Primary outcome
Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed
Time frame: 14 weeks
Participants experiencing LOAC events; ≥ 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
2 secondary outcomes
Change in FEV1 (L) of Week 14 Compared to Baseline
Time frame: 14 Weeks
Number of Participants With Non-serious Treatment-Emergent Adverse Events Experienced by ≥5% of Participants - Any TEAEs
Time frame: 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Cheng, MD, PhD study director
RAPT Therapeutics, Inc., a member of the GSK plc group of companies
29 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RPT193 in people with Asthma, run by RAPT Therapeutics, Inc., a member of the GSK plc group of companies at 29 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Poland, Bulgaria, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.