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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502854-16-00
Acronym
RPT193-03
Enrollment
71
Registered
2023-10-09
Start date
2023-11-26
Completion date
2024-06-21
Last updated
2024-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

Proportion of subjects who satisfy any of the following LOAC criteria: - ≥30% reduction in morning PEF from baseline on 2 consecutive days - ≥6 additional reliever inhalations of SABA in a 24-hour period relative to abseline on 2 consecutive days - Increase by a factor of 4 or more in the most recent dose of ICS - Exacerbation of asthma requiring systemic CS. - Exacerbation of asthma - related AE that requires a hospitalization or emergency room visit

Detailed description

Frequency of treatment-emergent adverse events, Time to a LOAC event, Change in forced expiratory volume in 1 second (FEV1) at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in Questionnaire score at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in PEF at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in reliever bronchodilator use at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in fractional exhaled nitric oxide (FeNO) at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in Questionnaire at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in FEV1 from Day 99 to 140 (Weeks 14 to 20), Change in FEV1 from Day 43 to 98 (Weeks 6 to 14)

Interventions

DRUGRPT193
DRUGFlixotide 50 micrograms Evohaler
DRUGSeretide Diskus 50 Mikrogramm/250 Mikrogramm/Dosis
DRUGeinzeldosiertes Pulver zur Inhalation
DRUGFlixotide 250 micrograms Evohaler
DRUGFlixotide 125 micrograms Evohaler
DRUGTablet without active substance
DRUGSeretide Diskus 50 Mikrogramm/100 Mikrogramm/Dosis
DRUGSeretide Diskus 50 Mikrogramm/500 Mikrogramm/Dosis

Sponsors

Rapt Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of subjects who satisfy any of the following LOAC criteria: - ≥30% reduction in morning PEF from baseline on 2 consecutive days - ≥6 additional reliever inhalations of SABA in a 24-hour period relative to abseline on 2 consecutive days - Increase by a factor of 4 or more in the most recent dose of ICS - Exacerbation of asthma requiring systemic CS. - Exacerbation of asthma - related AE that requires a hospitalization or emergency room visit

Secondary

MeasureTime frame
Frequency of treatment-emergent adverse events, Time to a LOAC event, Change in forced expiratory volume in 1 second (FEV1) at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in Questionnaire score at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in PEF at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in reliever bronchodilator use at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in fractional exhaled nitric oxide (FeNO) at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in Questionnaire at Day 99 (Week 14) and at each interval visit after treatment with RPT193 compared to baseline, Change in FEV1 from Day 99 to 140 (Weeks 14 to 20), Change in FEV1 from Day 43 to 98 (Weeks 6 to 14)

Countries

Bulgaria, Czechia, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026