Trial Outcomes & Findings for An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis (NCT NCT05399368)
NCT ID: NCT05399368
Last Updated: 2026-03-23
Results Overview
% change in Eczema Area Severity Index (EASI) from baseline at Week 16
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
229 participants
Primary outcome timeframe
16 weeks
Results posted on
2026-03-23
Participant Flow
Participant milestones
| Measure |
RPT193 400 mg
RPT193 400 mg oral tablet administered daily for 16 weeks
RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
|
RPT193 200 mg
RPT193 200 mg oral tablet administered daily for 16 weeks
RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
|
RPT193 50 mg
RPT193 50 mg oral tablet administered daily for 16 weeks
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
Matching placebo oral tablet administered daily for 16 weeks
Placebo: Nonactive placebo tablet
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
57
|
57
|
56
|
|
Overall Study
COMPLETED
|
22
|
29
|
28
|
39
|
|
Overall Study
NOT COMPLETED
|
37
|
28
|
29
|
17
|
Reasons for withdrawal
| Measure |
RPT193 400 mg
RPT193 400 mg oral tablet administered daily for 16 weeks
RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
|
RPT193 200 mg
RPT193 200 mg oral tablet administered daily for 16 weeks
RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
|
RPT193 50 mg
RPT193 50 mg oral tablet administered daily for 16 weeks
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
Matching placebo oral tablet administered daily for 16 weeks
Placebo: Nonactive placebo tablet
|
|---|---|---|---|---|
|
Overall Study
discontinued treatment
|
37
|
28
|
29
|
17
|
Baseline Characteristics
An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
RPT193 400 mg
n=59 Participants
RPT193 400 mg oral tablet administered daily for 16 weeks
RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
|
RPT193 200 mg
n=57 Participants
RPT193 200 mg oral tablet administered daily for 16 weeks
RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
|
RPT193 50 mg
n=57 Participants
RPT193 50 mg oral tablet administered daily for 16 weeks
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=56 Participants
Matching placebo oral tablet administered daily for 16 weeks
Placebo: Nonactive placebo tablet
|
Total
n=229 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
8 Participants
n=10 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=18 Participants
|
12 Participants
n=158 Participants
|
28 Participants
n=3 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=158 Participants
|
2 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=10 Participants
|
53 Participants
n=8 Participants
|
52 Participants
n=18 Participants
|
43 Participants
n=158 Participants
|
199 Participants
n=3 Participants
|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 16.37 • n=10 Participants
|
44.1 years
STANDARD_DEVIATION 15.09 • n=8 Participants
|
42.4 years
STANDARD_DEVIATION 14.99 • n=18 Participants
|
44.1 years
STANDARD_DEVIATION 17.91 • n=158 Participants
|
43.3 years
STANDARD_DEVIATION 16.04 • n=3 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=10 Participants
|
33 Participants
n=8 Participants
|
30 Participants
n=18 Participants
|
30 Participants
n=158 Participants
|
125 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=10 Participants
|
24 Participants
n=8 Participants
|
27 Participants
n=18 Participants
|
26 Participants
n=158 Participants
|
104 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=158 Participants
|
4 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=10 Participants
|
7 Participants
n=8 Participants
|
10 Participants
n=18 Participants
|
7 Participants
n=158 Participants
|
30 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=10 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=158 Participants
|
6 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=10 Participants
|
17 Participants
n=8 Participants
|
15 Participants
n=18 Participants
|
19 Participants
n=158 Participants
|
65 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=10 Participants
|
26 Participants
n=8 Participants
|
29 Participants
n=18 Participants
|
25 Participants
n=158 Participants
|
114 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=10 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=158 Participants
|
5 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=10 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
5 Participants
n=3 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=10 Participants
|
2 participants
n=8 Participants
|
3 participants
n=18 Participants
|
2 participants
n=158 Participants
|
10 participants
n=3 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=10 Participants
|
55 participants
n=8 Participants
|
54 participants
n=18 Participants
|
54 participants
n=158 Participants
|
219 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 16 weeks% change in Eczema Area Severity Index (EASI) from baseline at Week 16
Outcome measures
| Measure |
RPT193 400 mg
n=59 Participants
RPT193 400 mg oral tablet administered daily for 16 weeks
RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
|
RPT193 200 mg
n=57 Participants
RPT193 200 mg oral tablet administered daily for 16 weeks
RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
|
RPT193 50 mg
n=57 Participants
RPT193 50 mg oral tablet administered daily for 16 weeks
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=56 Participants
Matching placebo oral tablet administered daily for 16 weeks
Placebo: Nonactive placebo tablet
|
|---|---|---|---|---|
|
To Evaluate the Clinical Efficacy of RPT193 Administered Orally Once Daily (QD) for 16 Weeks to Participants With Moderate-to-severe AD
|
-42.2 Percent Change from Baseline to Week 16
Standard Deviation 7.57
|
-52.3 Percent Change from Baseline to Week 16
Standard Deviation 6.10
|
-53.1 Percent Change from Baseline to Week 16
Standard Deviation 5.56
|
-59.8 Percent Change from Baseline to Week 16
Standard Deviation 5
|
SECONDARY outcome
Timeframe: 16 weeksTo evaluate the safety and tolerability of RPT193 administered orally QD for 16 weeks
Outcome measures
| Measure |
RPT193 400 mg
n=59 Participants
RPT193 400 mg oral tablet administered daily for 16 weeks
RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
|
RPT193 200 mg
n=57 Participants
RPT193 200 mg oral tablet administered daily for 16 weeks
RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
|
RPT193 50 mg
n=57 Participants
RPT193 50 mg oral tablet administered daily for 16 weeks
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=56 Participants
Matching placebo oral tablet administered daily for 16 weeks
Placebo: Nonactive placebo tablet
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
26 Participants
|
29 Participants
|
21 Participants
|
18 Participants
|
Adverse Events
RPT193 400 mg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
RPT193 200 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
RPT193 50 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RPT193 400 mg
n=59 participants at risk
RPT193 400 mg oral tablet administered daily for 16 weeks
RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
|
RPT193 200 mg
n=57 participants at risk
RPT193 200 mg oral tablet administered daily for 16 weeks
RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
|
RPT193 50 mg
n=57 participants at risk
RPT193 50 mg oral tablet administered daily for 16 weeks
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=56 participants at risk
Matching placebo oral tablet administered daily for 16 weeks
Placebo: Nonactive placebo tablet
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Appendix Disorder
|
0.00%
0/59 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
1.8%
1/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/56 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/59 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
1.8%
1/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/56 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
|
Hepatobiliary disorders
Hepatic failure
|
1.7%
1/59 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/56 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
|
Infections and infestations
Pneumonia
|
1.7%
1/59 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/56 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
1.7%
1/59 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/56 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
|
Surgical and medical procedures
Hospitalisation
|
1.7%
1/59 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/56 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
Other adverse events
| Measure |
RPT193 400 mg
n=59 participants at risk
RPT193 400 mg oral tablet administered daily for 16 weeks
RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
|
RPT193 200 mg
n=57 participants at risk
RPT193 200 mg oral tablet administered daily for 16 weeks
RPT193: RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
|
RPT193 50 mg
n=57 participants at risk
RPT193 50 mg oral tablet administered daily for 16 weeks
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=56 participants at risk
Matching placebo oral tablet administered daily for 16 weeks
Placebo: Nonactive placebo tablet
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
5.1%
3/59 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
3.5%
2/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
1.8%
1/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
1.8%
1/56 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
|
Infections and infestations
Covid-19
|
5.1%
3/59 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
1.8%
1/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
3.6%
2/56 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Diarrhoea
|
5.1%
3/59 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
1.8%
1/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
3.5%
2/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/56 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
|
Infections and infestations
Urinary tract infection
|
5.1%
3/59 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
1.8%
1/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
1.8%
1/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
1.8%
1/56 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Nausea
|
6.8%
4/59 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
1.8%
1/56 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/59 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
5.3%
3/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/57 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
Adverse events were reported by the sites into an electronic data capture system
|
0.00%
0/56 • Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.
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