Trial Outcomes & Findings for Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma (NCT NCT05935332)
NCT ID: NCT05935332
Last Updated: 2026-03-23
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
14 weeks
Results posted on
2026-03-23
Participant Flow
Participant milestones
| Measure |
RPT193 400 mg
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
Placebo: placebo
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
Reasons for withdrawal
| Measure |
RPT193 400 mg
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
Placebo: placebo
|
|---|---|---|
|
Overall Study
Discontinued treatment
|
9
|
11
|
Baseline Characteristics
Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma
Baseline characteristics by cohort
| Measure |
RPT193 400 mg
n=19 Participants
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
n=19 Participants
Placebo: placebo
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=10 Participants
|
17 Participants
n=8 Participants
|
31 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=10 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=18 Participants
|
|
Age, Continuous
|
60 years
n=10 Participants
|
55 years
n=8 Participants
|
58 years
n=18 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=10 Participants
|
12 Participants
n=8 Participants
|
28 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=10 Participants
|
7 Participants
n=8 Participants
|
10 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=10 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=10 Participants
|
15 Participants
n=8 Participants
|
29 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=10 Participants
|
17 participants
n=8 Participants
|
34 participants
n=18 Participants
|
|
Region of Enrollment
Czechia
|
2 participants
n=10 Participants
|
0 participants
n=8 Participants
|
2 participants
n=18 Participants
|
|
Region of Enrollment
Bulgaria
|
0 participants
n=10 Participants
|
2 participants
n=8 Participants
|
2 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 14 weeksParticipants 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
Outcome measures
| Measure |
RPT193 400 mg
n=19 Participants
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
n=19 Participants
Placebo: placebo
|
|---|---|---|
|
Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed
Exacerbation of asthma requiring systemic corticosteroids
|
1 Participants
|
2 Participants
|
|
Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed
Exacerbation of asthma-related AEs requiring Hospitalization or emergency room visit
|
0 Participants
|
0 Participants
|
|
Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed
Participants experiencing LOAC events
|
3 Participants
|
5 Participants
|
|
Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed
≥30% reduction in morning PEF from baseline on 2 consecutive days
|
2 Participants
|
3 Participants
|
|
Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed
≥6 additional reliever inhalations of SABA in a 24-hr period relative to baseline on 2 consec. days
|
1 Participants
|
0 Participants
|
|
Proportion of Participants With a Loss of Asthma Control Event as Defined by Criteria Listed
Increase by a factor of 4 or more in the most recent dose of ICS
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 14 WeeksOutcome measures
| Measure |
RPT193 400 mg
n=10 Participants
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
n=8 Participants
Placebo: placebo
|
|---|---|---|
|
Change in FEV1 (L) of Week 14 Compared to Baseline
|
0.34 Liters (L)
Standard Deviation 0.461
|
-0.19 Liters (L)
Standard Deviation 0.746
|
SECONDARY outcome
Timeframe: 14 weeksOutcome measures
| Measure |
RPT193 400 mg
n=19 Participants
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
n=19 Participants
Placebo: placebo
|
|---|---|---|
|
Number of Participants With Non-serious Treatment-Emergent Adverse Events Experienced by ≥5% of Participants - Any TEAEs
|
6 Participants
|
3 Participants
|
Adverse Events
RPT193 400 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
RPT193 400 mg
n=19 participants at risk
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
n=19 participants at risk
Placebo: placebo
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
10.5%
2/19 • Approximately 14 weeks. Overall, 18 (47.4%) participants completed the 14-week treatment period (10 [52.6%] in the RPT193 group and 8 [42.1%] in the placebo group). Nineteen (50.0%) participants completed the study including follow-up visits (11 [57.9%] in the RPT193 group and 8 [42.1%] in the placebo group)
Adverse events were reported by the sites into an electronic data capture system
|
5.3%
1/19 • Approximately 14 weeks. Overall, 18 (47.4%) participants completed the 14-week treatment period (10 [52.6%] in the RPT193 group and 8 [42.1%] in the placebo group). Nineteen (50.0%) participants completed the study including follow-up visits (11 [57.9%] in the RPT193 group and 8 [42.1%] in the placebo group)
Adverse events were reported by the sites into an electronic data capture system
|
|
Infections and infestations
Influenza
|
0.00%
0/19 • Approximately 14 weeks. Overall, 18 (47.4%) participants completed the 14-week treatment period (10 [52.6%] in the RPT193 group and 8 [42.1%] in the placebo group). Nineteen (50.0%) participants completed the study including follow-up visits (11 [57.9%] in the RPT193 group and 8 [42.1%] in the placebo group)
Adverse events were reported by the sites into an electronic data capture system
|
10.5%
2/19 • Approximately 14 weeks. Overall, 18 (47.4%) participants completed the 14-week treatment period (10 [52.6%] in the RPT193 group and 8 [42.1%] in the placebo group). Nineteen (50.0%) participants completed the study including follow-up visits (11 [57.9%] in the RPT193 group and 8 [42.1%] in the placebo group)
Adverse events were reported by the sites into an electronic data capture system
|
|
Infections and infestations
Viral upper respiratory tract infection
|
10.5%
2/19 • Approximately 14 weeks. Overall, 18 (47.4%) participants completed the 14-week treatment period (10 [52.6%] in the RPT193 group and 8 [42.1%] in the placebo group). Nineteen (50.0%) participants completed the study including follow-up visits (11 [57.9%] in the RPT193 group and 8 [42.1%] in the placebo group)
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/19 • Approximately 14 weeks. Overall, 18 (47.4%) participants completed the 14-week treatment period (10 [52.6%] in the RPT193 group and 8 [42.1%] in the placebo group). Nineteen (50.0%) participants completed the study including follow-up visits (11 [57.9%] in the RPT193 group and 8 [42.1%] in the placebo group)
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Nausea
|
10.5%
2/19 • Approximately 14 weeks. Overall, 18 (47.4%) participants completed the 14-week treatment period (10 [52.6%] in the RPT193 group and 8 [42.1%] in the placebo group). Nineteen (50.0%) participants completed the study including follow-up visits (11 [57.9%] in the RPT193 group and 8 [42.1%] in the placebo group)
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/19 • Approximately 14 weeks. Overall, 18 (47.4%) participants completed the 14-week treatment period (10 [52.6%] in the RPT193 group and 8 [42.1%] in the placebo group). Nineteen (50.0%) participants completed the study including follow-up visits (11 [57.9%] in the RPT193 group and 8 [42.1%] in the placebo group)
Adverse events were reported by the sites into an electronic data capture system
|
|
Investigations
Blood glucose increased
|
5.3%
1/19 • Approximately 14 weeks. Overall, 18 (47.4%) participants completed the 14-week treatment period (10 [52.6%] in the RPT193 group and 8 [42.1%] in the placebo group). Nineteen (50.0%) participants completed the study including follow-up visits (11 [57.9%] in the RPT193 group and 8 [42.1%] in the placebo group)
Adverse events were reported by the sites into an electronic data capture system
|
5.3%
1/19 • Approximately 14 weeks. Overall, 18 (47.4%) participants completed the 14-week treatment period (10 [52.6%] in the RPT193 group and 8 [42.1%] in the placebo group). Nineteen (50.0%) participants completed the study including follow-up visits (11 [57.9%] in the RPT193 group and 8 [42.1%] in the placebo group)
Adverse events were reported by the sites into an electronic data capture system
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60