Trial Outcomes & Findings for Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1 (NCT NCT02600611)

NCT ID: NCT02600611

Last Updated: 2018-06-19

Results Overview

≥20% reduction in lesion size at 48 to 72 hours (Early Time Point \[ETP\]) compared to baseline in all randomized patients (ITT).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 600 participants
• Primary outcome timeframe: Baseline and 48-72 hours after first dose of study drug
• Results posted on: 2018-06-19

Participant Flow

Participant milestones

Measure	Iclaprim iclaprim 80 mg intravenous every 12 hours iclaprim: Experimental treatment	Vancomycin vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance vancomycin: Active comparator
Overall Study STARTED	300	300
Overall Study COMPLETED	298	300
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1

Baseline characteristics by cohort

Measure	Iclaprim n=298 Participants iclaprim 80 mg intravenous every 12 hours iclaprim: Experimental treatment	Vancomycin n=300 Participants vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance vancomycin: Active comparator	Total n=598 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
Age, Categorical Between 18 and 65 years	240 Participants n=5 Participants	240 Participants n=7 Participants	480 Participants n=5 Participants
Age, Categorical >=65 years	58 Participants n=5 Participants	60 Participants n=7 Participants	118 Participants n=5 Participants
Age, Continuous	46.4 years STANDARD_DEVIATION 13.3 • n=5 Participants	48.2 years STANDARD_DEVIATION 14.8 • n=7 Participants	47.8 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	109 Participants n=5 Participants	129 Participants n=7 Participants	238 Participants n=5 Participants
Sex: Female, Male Male	189 Participants n=5 Participants	171 Participants n=7 Participants	360 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	266 Participants n=5 Participants	269 Participants n=7 Participants	535 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	266 Participants n=5 Participants	269 Participants n=7 Participants	535 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	28 Participants n=5 Participants	24 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment Latvia	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Puerto Rico	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	219 Participants n=5 Participants	200 Participants n=7 Participants	419 Participants n=5 Participants
Region of Enrollment Ukraine	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment Bulgaria	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Peru	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 48-72 hours after first dose of study drug

Population: all randomized patients (ITT).

≥20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT).

Outcome measures

Measure	Iclaprim n=298 Participants iclaprim 80 mg intravenous every 12 hours iclaprim: Experimental treatment	Vancomycin n=300 Participants vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance vancomycin: Active comparator
≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients.	80.9 percentage of participants	81.0 percentage of participants

SECONDARY outcome

Timeframe: 7 to14 days after the end of treatment

Population: all randomized patients (ITT population)

Resolution or near resolution of lesion at Test of Cure (TOC) visit

Outcome measures

Measure	Iclaprim n=298 Participants iclaprim 80 mg intravenous every 12 hours iclaprim: Experimental treatment	Vancomycin n=300 Participants vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance vancomycin: Active comparator
Resolution or Near Resolution of Lesion at Test of Cure Visit	248 participants	262 participants

Adverse Events

Iclaprim

Serious events: 9 serious events

Other events: 151 other events

Deaths: 0 deaths

Vancomycin

Serious events: 14 serious events

Other events: 128 other events

Deaths: 2 deaths

Serious adverse events

Measure	Iclaprim n=298 participants at risk iclaprim 80 mg intravenous every 12 hours iclaprim: Experimental treatment	Vancomycin n=300 participants at risk vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance vancomycin: Active comparator
Renal and urinary disorders SAEs	3.0% 9/298 • 1 year	4.7% 14/300 • 1 year

Other adverse events

Measure	Iclaprim n=298 participants at risk iclaprim 80 mg intravenous every 12 hours iclaprim: Experimental treatment	Vancomycin n=300 participants at risk vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance vancomycin: Active comparator
Product Issues Adverse effects	50.7% 151/298 • 1 year	42.7% 128/300 • 1 year

Additional Information

David Huang

Motif BioSciences

Phone: 936-577-5770

Email: david.huang@motifbio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place