Trial Outcomes & Findings for Open-Label Treatment Extension Study (NCT NCT02896296)

Last Updated: 2018-11-29

Results Overview

TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical or surgical intervention to prevent one of the outcomes listed in this definition.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

208 participants

Primary outcome timeframe

Day 1 up to Week 29

Results posted on

2018-11-29

Participant Flow

A total of 208 subjects were screened across 25 sites, and of those, all 208 subjects entered the treatment period and received at least 1 dose of RBP-6000.

Participant milestones

Participant milestones
Measure	RBP-6000 (100/300 mg Flex) On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time. For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator.
Overall Study STARTED	208
Overall Study COMPLETED	166
Overall Study NOT COMPLETED	42

Reasons for withdrawal

Reasons for withdrawal
Measure	RBP-6000 (100/300 mg Flex) On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time. For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	19
Overall Study Pregnancy	1
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	10
Overall Study Site closing	7
Overall Study Incarceration	1
Overall Study Relocation	1

Baseline Characteristics

Data missing for two participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RBP-6000 (100/300 mg Flex) n=208 Participants On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time. For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator.
Age, Continuous	42.1 years STANDARD_DEVIATION 11.47 • n=208 Participants
Age, Customized >=18 and <30 years	32 Participants n=208 Participants
Age, Customized >= 30 and < 45 years	88 Participants n=208 Participants
Age, Customized >=45 and < 60 years	71 Participants n=208 Participants
Age, Customized >= 60 years	17 Participants n=208 Participants
Sex: Female, Male Female	70 Participants n=208 Participants
Sex: Female, Male Male	138 Participants n=208 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=208 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	198 Participants n=208 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=208 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=208 Participants
Race (NIH/OMB) Asian	0 Participants n=208 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=208 Participants
Race (NIH/OMB) Black or African American	78 Participants n=208 Participants
Race (NIH/OMB) White	129 Participants n=208 Participants
Race (NIH/OMB) More than one race	0 Participants n=208 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=208 Participants
Height	173.26 cm STANDARD_DEVIATION 9.788 • n=206 Participants • Data missing for two participants
Weight	78.41 kg STANDARD_DEVIATION 16.949 • n=208 Participants
Body Mass Index	26.12 kg/m^2 STANDARD_DEVIATION 5.031 • n=206 Participants • Data missing for two participants
Waist-to-Hip Ratio	0.925 ratio STANDARD_DEVIATION 0.0878 • n=207 Participants • Records for one participant were missing baseline waist-to-hip ratio.
Females of Childbearing Potential	40 Participants n=70 Participants • Female participants only

PRIMARY outcome

Timeframe: Day 1 up to Week 29

Population: Safety analysis set

Outcome measures

Outcome measures
Measure	RBP-6000 (100/300 mg Flex) n=208 Participants On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time. For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator.
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period >=1 TEAE	71 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period >=1 TEAE related to study drug	14 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period >=1 serious TEAE	5 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period >=1 serious study treatment-related TEAE	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period Death	0 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period >=1 severe TEAE	8 Participants
Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period TEAE leading to study treatment discontinuation	1 Participants

PRIMARY outcome

Timeframe: Day 1, Week 25

Population: Safety analysis set. Participants with both baseline and Week 25 data are included.

Vital signs include: * systolic blood pressure (mmHg) * diastolic blood pressure (mmHg) * respiratory rate (breaths/minute) * pulse oximetry (%) * pulse rate (beats/min) * temperature (C)

Outcome measures

Outcome measures
Measure	RBP-6000 (100/300 mg Flex) n=208 Participants On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time. For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator.
Percentage Change From Baseline to Week 25 in Vital Signs Systolic blood pressure	1.93 percentage change from baseline Standard Deviation 11.208
Percentage Change From Baseline to Week 25 in Vital Signs Diastolic blood pressure	2.61 percentage change from baseline Standard Deviation 12.397
Percentage Change From Baseline to Week 25 in Vital Signs Pulse oximetry	0.13 percentage change from baseline Standard Deviation 1.377
Percentage Change From Baseline to Week 25 in Vital Signs Pulse rate	6.04 percentage change from baseline Standard Deviation 16.975
Percentage Change From Baseline to Week 25 in Vital Signs Respiratory rate	0.67 percentage change from baseline Standard Deviation 8.360
Percentage Change From Baseline to Week 25 in Vital Signs Temperature	0.02 percentage change from baseline Standard Deviation 1.003

PRIMARY outcome

Timeframe: Day 1 up to Week 25

Population: Safety population

Outcome measures

Outcome measures
Measure	RBP-6000 (100/300 mg Flex) n=208 Participants On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time. For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator.
Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values Aspartate aminotransferase increased	1 Participants
Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values Alanine aminotransferase increased	1 Participants
Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values Blood cholesterol increased	1 Participants
Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values Diabetes mellitus	1 Participants
Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values Hepatic enzyme increased	1 Participants
Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values Liver function test increased	1 Participants

Adverse Events

RBP-6000 (100/300 mg Flex)

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RBP-6000 (100/300 mg Flex) n=208 participants at risk On Day 1 of the study all eligible subjects received a single subcutaneous (SC) injection of RBP-6000. Participants returned to the site for monthly injection visits every 28 days (-2/+7 days) for a total of up to 6 injections. Participants were not required to complete all 6 injections and could choose to terminate from the study at any time. For each injection, participants could receive either a dose of 100 mg RBP-6000 or 300 mg RBP-6000, based on the medical judgement of the investigator.
Infections and infestations Pneumonia	1.4% 3/208 • Day 1 up to Week 29
Nervous system disorders Seizure	0.48% 1/208 • Day 1 up to Week 29
Psychiatric disorders Panic attack	0.48% 1/208 • Day 1 up to Week 29

Other adverse events

Adverse event data not reported

Additional Information

Global Director, Clinical Development

Indivior, Inc.

Phone: 804-379-1090

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Proposed publications shall be submitted to Sponsor 30 days prior to submission for publication, and may be withheld for an additional period, up to 90 days, to allow Sponsor to file patent applications. If a multi-center publication isn't submitted for publication within 12 months of the conclusion of the Study at all sites, or is published in a shorter period, the results from the institution's site may be published individually.
Publication restrictions are in place

Restriction type: OTHER