Trial Outcomes & Findings for SUBLOCADE Rapid Initiation Extension Study (NCT NCT04060654)
NCT ID: NCT04060654
Last Updated: 2025-03-25
Results Overview
Study will report the number of participants with the occurrence of any TEAE during the treatment period.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
17 participants
Primary outcome timeframe
From time of informed consent at Day 1 until EOT, assessed up until Day 141
Results posted on
2025-03-25
Participant Flow
A total of 17 participants who completed the INDV-6000-403 study were screened and enrolled into this extension study.
Participant milestones
| Measure |
SUBLOCADE
All subjects will receive SUBLOCADE 300mg on Day 1, followed by injections every 4 weeks at a dose determined by the Investigator for up to 5 total injections
Sublocade: SUBLOCADE to be administered approximately every 4 weeks per local standard of care
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
SUBLOCADE
All subjects will receive SUBLOCADE 300mg on Day 1, followed by injections every 4 weeks at a dose determined by the Investigator for up to 5 total injections
Sublocade: SUBLOCADE to be administered approximately every 4 weeks per local standard of care
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
Baseline Characteristics
SUBLOCADE Rapid Initiation Extension Study
Baseline characteristics by cohort
| Measure |
SUBLOCADE
n=17 Participants
All subjects will receive SUBLOCADE 300mg on Day 1, followed by injections every 4 weeks at a dose determined by the Investigator (either 100mg or 300mg) for up to 5 total injections
Sublocade: SUBLOCADE to be administered approximately every 4 weeks per local standard of care
|
|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 12.68 • n=99 Participants
|
|
Age, Customized
≥18 to <30
|
4 Participants
n=99 Participants
|
|
Age, Customized
≥30 to <45
|
6 Participants
n=99 Participants
|
|
Age, Customized
≥45 to <60
|
5 Participants
n=99 Participants
|
|
Age, Customized
≥60 to ≤ 65
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=99 Participants
|
|
Screening body mass index (BMI)
|
22.81 kg/m^2
STANDARD_DEVIATION 4.181 • n=99 Participants
|
|
Screening BMI Group
0 to <18.5 (Underweight)
|
2 Participants
n=99 Participants
|
|
Screening BMI Group
≥18.5 and <25 (Normal)
|
12 Participants
n=99 Participants
|
|
Screening BMI Group
≥25 and <30 (Overweight)
|
1 Participants
n=99 Participants
|
|
Screening BMI Group
≥30 (Obesity)
|
2 Participants
n=99 Participants
|
|
Tobacco Use
Never
|
2 Participants
n=99 Participants
|
|
Tobacco Use
Current
|
15 Participants
n=99 Participants
|
|
Caffeine Use
Never
|
2 Participants
n=99 Participants
|
|
Caffeine Use
Current
|
15 Participants
n=99 Participants
|
|
Opioids - Lifetime Use
|
16.16 years
STANDARD_DEVIATION 15.246 • n=99 Participants
|
|
Opioids - Last 30 Days Prior to INDV-6000-403 Screening Visit
|
29.29 Days
STANDARD_DEVIATION 2.910 • n=99 Participants
|
|
Opioids - Use via Intravenous Route in Last 30 Days
|
5 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From time of informed consent at Day 1 until EOT, assessed up until Day 141Population: The safety population was used for the safety analysis, and consisted of all participants who received at least 1 dose of SUBLOCADE
Study will report the number of participants with the occurrence of any TEAE during the treatment period.
Outcome measures
| Measure |
SUBLOCADE
n=17 Participants
Participants who completed the INDV-6000-403 study and met study inclusion and exclusion criteria were given the option to enroll in this study. Baseline measures from the INDV-6000-403 study served also as baseline measures for this study. A total of 17 participants were screened and a total of 17 (100%) were enrolled into the study and received SUBLOCADE 300 mg at injection 1; subsequent doses could be reduced to 100 mg at the discretion of the investigator. Participants returned to the clinic approximately every 4 weeks for injection site assessments, urinary drug screens, pregnancy tests if applicable, subsequent injections and were assessed for the occurrence of any TEAEs. All other interventions were per clinic standard of care.
|
|---|---|
|
Treatment Emergent Adverse Event (TEAE) Occurrence
|
0 Participants
|
Adverse Events
SUBLOCADE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI will not disseminate, present or publish any of the study data without the prior written approval from Indivior to do so.
- Publication restrictions are in place
Restriction type: OTHER