Trial Outcomes & Findings for Assessment of BIM23B065, Given as Repeated Subcutaneous Injection in Subjects With Acromegaly (NCT NCT03045302)
NCT ID: NCT03045302
Last Updated: 2019-03-08
Results Overview
A GH responder was defined as a subject with mean serum GH concentration ≤2.5 micrograms per litre (mcg/L) or \>50% reduction from mean baseline GH concentration after a 6-day titration and an 8-day treatment period with BIM23B065. The mean serum concentration of GH was measured over 6 hours at baseline (Day -1) and on Day 14. The number of subjects who were GH responders at Day 14 of the treatment period is presented.
TERMINATED
PHASE2
4 participants
From baseline (Day -1) to Day 14.
2019-03-08
Participant Flow
Subjects with acromegaly were recruited from 26 January 2017 in 4 study centres in 4 countries. Stage 1 of the study consisted of a twice daily (BID) regimen of BIM23B065, and a Stage 2 with a three times daily regimen of BIM23B065 was planned but not conducted due to early termination of the study on 26 May 2017.
7 subjects were screened and 3 failed screening (1 subject did not meet eligibility criteria and 2 subjects did not complete screening procedures due to the early study termination).
Participant milestones
| Measure |
BIM23B065 BID Stage 1
Subjects received twice daily administrations of BIM23B065 (at an interval of 12 +/- 1 hour) as subcutaneous injections in the abdominal region during the Stage 1 treatment period which consisted of a titration phase and a treatment phase.
Titration phase (Days 1 to 6): Subjects received BIM23B065 0.4 milligram (mg) BID (Days 1 and 2, then BIM23B065 0.6 mg BID (Days 3 and 4) and BIM23B065 0.8 mg BID (Days 5 and 6).
Treatment phase (Days 7 to 14): Following titration, a stable target dose of 1.0 mg BID BIM23B065 was planned to be administered from Day 7 to Day 14.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
BIM23B065 BID Stage 1
Subjects received twice daily administrations of BIM23B065 (at an interval of 12 +/- 1 hour) as subcutaneous injections in the abdominal region during the Stage 1 treatment period which consisted of a titration phase and a treatment phase.
Titration phase (Days 1 to 6): Subjects received BIM23B065 0.4 milligram (mg) BID (Days 1 and 2, then BIM23B065 0.6 mg BID (Days 3 and 4) and BIM23B065 0.8 mg BID (Days 5 and 6).
Treatment phase (Days 7 to 14): Following titration, a stable target dose of 1.0 mg BID BIM23B065 was planned to be administered from Day 7 to Day 14.
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|---|---|
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Overall Study
Pre-treatment adverse event
|
1
|
Baseline Characteristics
Assessment of BIM23B065, Given as Repeated Subcutaneous Injection in Subjects With Acromegaly
Baseline characteristics by cohort
| Measure |
BIM23B065 BID Stage 1
n=4 Participants
Subjects received twice daily administrations of BIM23B065 (at an interval of 12 +/- 1 hour) as subcutaneous injections in the abdominal region during the Stage 1 treatment period which consisted of a titration phase and a treatment phase.
Titration phase (Days 1 to 6): Subjects received BIM23B065 0.4 milligram (mg) BID (Days 1 and 2, then BIM23B065 0.6 mg BID (Days 3 and 4) and BIM23B065 0.8 mg BID (Days 5 and 6).
Treatment phase (Days 7 to 14): Following titration, a stable target dose of 1.0 mg BID BIM23B065 was planned to be administered from Day 7 to Day 14.
|
|---|---|
|
Age, Continuous
|
53.0 Years
STANDARD_DEVIATION 15.12 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From baseline (Day -1) to Day 14.Population: The Efficacy Evaluable population consisted of all subjects with at least 1 BIM23B065 administration with available pharmacodynamic (PD) data and no protocol deviations with relevant impact on PD data, who had an evaluable primary efficacy endpoint (mean concentration of GH over 6 hours) at baseline and at Day 14.
A GH responder was defined as a subject with mean serum GH concentration ≤2.5 micrograms per litre (mcg/L) or \>50% reduction from mean baseline GH concentration after a 6-day titration and an 8-day treatment period with BIM23B065. The mean serum concentration of GH was measured over 6 hours at baseline (Day -1) and on Day 14. The number of subjects who were GH responders at Day 14 of the treatment period is presented.
Outcome measures
| Measure |
BIM23B065 BID Stage 1
n=3 Participants
Subjects received twice daily administrations of BIM23B065 (at an interval of 12 +/- 1 hour) as subcutaneous injections in the abdominal region during the Stage 1 treatment period which consisted of a titration phase and a treatment phase.
Titration phase (Days 1 to 6): Subjects received BIM23B065 0.4 milligram (mg) BID (Days 1 and 2, then BIM23B065 0.6 mg BID (Days 3 and 4) and BIM23B065 0.8 mg BID (Days 5 and 6).
Treatment phase (Days 7 to 14): Following titration, a stable target dose of 1.0 mg BID BIM23B065 was planned to be administered from Day 7 to Day 14.
|
|---|---|
|
The Number of Subjects Who Were Growth Hormone (GH) Responders at Day 14 of the Treatment Period
|
1 Participants
|
Adverse Events
BIM23B065 BID Stage 1
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BIM23B065 BID Stage 1
n=4 participants at risk
Subjects received twice daily administrations of BIM23B065 (at an interval of 12 +/- 1 hour) as subcutaneous injections in the abdominal region during the Stage 1 treatment period which consisted of a titration phase and a treatment phase.
Titration phase (Days 1 to 6): Subjects received BIM23B065 0.4 milligram (mg) BID (Days 1 and 2, then BIM23B065 0.6 mg BID (Days 3 and 4) and BIM23B065 0.8 mg BID (Days 5 and 6).
Treatment phase (Days 7 to 14): Following titration, a stable target dose of 1.0 mg BID BIM23B065 was planned to be administered from Day 7 to Day 14.
|
|---|---|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 of the treatment period up to the end of Week 4 (approximately 28 days).
The Safety population consisted of all subjects with at least 1 BIM23B065 administration.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 of the treatment period up to the end of Week 4 (approximately 28 days).
The Safety population consisted of all subjects with at least 1 BIM23B065 administration.
|
|
Cardiac disorders
Bradycardia
|
25.0%
1/4 • Number of events 2 • Treatment emergent adverse events were collected from Day 1 of the treatment period up to the end of Week 4 (approximately 28 days).
The Safety population consisted of all subjects with at least 1 BIM23B065 administration.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
1/4 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 of the treatment period up to the end of Week 4 (approximately 28 days).
The Safety population consisted of all subjects with at least 1 BIM23B065 administration.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 of the treatment period up to the end of Week 4 (approximately 28 days).
The Safety population consisted of all subjects with at least 1 BIM23B065 administration.
|
|
Hepatobiliary disorders
Cholelithiasis
|
25.0%
1/4 • Number of events 1 • Treatment emergent adverse events were collected from Day 1 of the treatment period up to the end of Week 4 (approximately 28 days).
The Safety population consisted of all subjects with at least 1 BIM23B065 administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60