Trial Outcomes & Findings for Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea (NCT NCT05150587)
NCT ID: NCT05150587
Last Updated: 2024-04-24
Results Overview
This is a co-primary endpoint. Success of the study will be declared in any of the active treatment groups if both the co-primary efficacy endpoints (here listed as 1 and 2) will be satisfied (note: the two items may not necessarily occur in the same patient): 1. Mean change from Baseline in number of rosacea inflammatory lesions (papules, pustules or plaques) at the end of treatment; 2. Percent of participants showing treatment success defined as IGA (Investigator's Global Assessment) score of 0 or 1 (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe) at the end of treatment.
COMPLETED
PHASE2
216 participants
30 days
2024-04-24
Participant Flow
Participant milestones
| Measure |
Rifaximin 250 mg TID
1 tablet of Rifaximin 250 mg TID (750 mg daily) + 1 tablet of placebo TID
|
Rifaximin 500 mg TID
2 tablets of Rifaximin 250 mg formulation TID (1500 mg daily)
|
Placebo
2 tablets of placebo TID
|
|---|---|---|---|
|
Overall Study
STARTED
|
70
|
80
|
66
|
|
Overall Study
Number of Participants Included in the "Full Analysis Set"
|
65
|
76
|
63
|
|
Overall Study
COMPLETED
|
64
|
73
|
60
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea
Baseline characteristics by cohort
| Measure |
Rifaximin 250 mg TID
n=65 Participants
1 tablet of Rifaximin 250 TID (750 mg daily) + 1 tablet of placebo TID
|
Rifaximin 500 mg TID
n=76 Participants
2 tablets of Rifaximin 250 mg TID (1500 mg daily)
|
Placebo
n=63 Participants
2 tablets of placebo TID
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
179 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
183 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: The primary efficacy outcomes measures are reported on the Full Analysis Set
This is a co-primary endpoint. Success of the study will be declared in any of the active treatment groups if both the co-primary efficacy endpoints (here listed as 1 and 2) will be satisfied (note: the two items may not necessarily occur in the same patient): 1. Mean change from Baseline in number of rosacea inflammatory lesions (papules, pustules or plaques) at the end of treatment; 2. Percent of participants showing treatment success defined as IGA (Investigator's Global Assessment) score of 0 or 1 (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe) at the end of treatment.
Outcome measures
| Measure |
Rifaximin 250 mg TID
n=65 Participants
2 tablets of Rifaximin 250 mg formulation TID (1500 mg daily)
|
Rifaximin 500 mg TID
n=76 Participants
2 tablets of Rifaximin 250 mg formulation TID (1500 mg daily)
|
Placebo
n=63 Participants
2 tablets of placebo TID
|
|---|---|---|---|
|
Co-primary Endpoint: Change From Baseline in Number of Rosacea Inflammatory Lesions
|
-10.0 lesions (rosacea inflammatory)
Standard Deviation 9.24
|
-6.7 lesions (rosacea inflammatory)
Standard Deviation 14.78
|
-9.2 lesions (rosacea inflammatory)
Standard Deviation 10.49
|
PRIMARY outcome
Timeframe: 30 daysPopulation: The primary efficacy outcomes measures are reported on the Full Analysis Set
This is a co-primary endpoint. Success of the study will be declared in any of the active treatment groups if both the co-primary efficacy endpoints (here listed as 1 and 2) will be satisfied (note: the two items may not necessarily occur in the same patient): 1. Mean change from Baseline in number of rosacea inflammatory lesions (papules, pustules or plaques) at the end of treatment; 2. Percent of participants showing treatment success defined as IGA (Investigator's Global Assessment) score of 0 or 1 (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe) at the end of treatment.
Outcome measures
| Measure |
Rifaximin 250 mg TID
n=65 Participants
2 tablets of Rifaximin 250 mg formulation TID (1500 mg daily)
|
Rifaximin 500 mg TID
n=76 Participants
2 tablets of Rifaximin 250 mg formulation TID (1500 mg daily)
|
Placebo
n=63 Participants
2 tablets of placebo TID
|
|---|---|---|---|
|
Co-primary Endpoint: Treatment Success Rate
|
9.23 Percentage of participants
Interval 2.19 to 16.27
|
9.21 Percentage of participants
Interval 2.71 to 15.71
|
11.11 Percentage of participants
Interval 3.35 to 18.87
|
Adverse Events
Rifaximin 250 mg TID
Rifaximin 500 mg TID
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rifaximin 250 mg TID
n=70 participants at risk
1 tablet of Rifaximin 250 mg TID (750 mg daily) + 1 tablet of placebo TID
|
Rifaximin 500 mg TID
n=80 participants at risk
2 tablets of Rifaximin 250 mg formulation TID (1500 mg daily)
|
Placebo
n=66 participants at risk
2 tablets of placebo TID
|
|---|---|---|---|
|
Nervous system disorders
headache
|
5.7%
4/70 • Up to 60 days
|
5.0%
4/80 • Up to 60 days
|
3.0%
2/66 • Up to 60 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/70 • Up to 60 days
|
5.0%
4/80 • Up to 60 days
|
3.0%
2/66 • Up to 60 days
|
|
Gastrointestinal disorders
Constipation
|
1.4%
1/70 • Up to 60 days
|
3.8%
3/80 • Up to 60 days
|
3.0%
2/66 • Up to 60 days
|
|
Gastrointestinal disorders
Abdominal distension
|
2.9%
2/70 • Up to 60 days
|
2.5%
2/80 • Up to 60 days
|
1.5%
1/66 • Up to 60 days
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/70 • Up to 60 days
|
1.2%
1/80 • Up to 60 days
|
3.0%
2/66 • Up to 60 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/70 • Up to 60 days
|
2.5%
2/80 • Up to 60 days
|
1.5%
1/66 • Up to 60 days
|
|
General disorders
Influenza like illness
|
0.00%
0/70 • Up to 60 days
|
1.2%
1/80 • Up to 60 days
|
3.0%
2/66 • Up to 60 days
|
Additional Information
Nicola Gargano - Senior Clinical Scientist
Alfasigma
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place