Trial Outcomes & Findings for Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in Adult Growth Hormone Deficiency (AGHD) (NCT NCT02719990)
NCT ID: NCT02719990
Last Updated: 2023-04-13
Results Overview
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included 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 participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
From first dose of study drug up to approximately 2 years
Results posted on
2023-04-13
Participant Flow
The study was open to participants completing a Versartis adult growth hormone deficiency (GHD) study (15VR7 \[NCT02526420\]) as well as new somavaratan naïve participants (either recombinant human growth hormone \[rhGH\] treatment naïve or receiving daily rhGH therapy).
Participant milestones
| Measure |
Somavaratan
Participants received once-monthly subcutaneous (SC) somavaratan per Protocol Version 1.0. The dosing regimen was then modified in Protocol Version 2.0 to twice-monthly SC somavaratan. Doses were titrated to each participant's individual IGF-I responses based on the insulin-like growth factor-I (IGF-I) level 7 days postdose until a maintenance dose was achieved. Maintenance dose was defined as an IGF-I value between 0 and 2.0 standard deviation score (SDS) for two consecutive 7-day postdose time points (Day 8, peak level). Participants who received somavaratan once-monthly in this study or in a previous somavaratan study (15VR7), had their dose decreased by half (minimum dose of 20 milligrams \[mg\], 40 mg for women on estrogen, rounded down to the nearest even number) and were titrated based on IGF-I level at Day 8. New participants enrolling in this study received a starting dose of 20 mg twice-monthly (40 mg for women on estrogen) and were titrated based on IGF-I level at Day 8. Maintenance doses were adjusted further based on pharmacodynamic (PD) data at the discretion of the Investigator or Medical Monitor. The maximum allowable dose of somavaratan was 250.0 mg.
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|---|---|
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Overall Study
STARTED
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36
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
36
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Somavaratan
Participants received once-monthly subcutaneous (SC) somavaratan per Protocol Version 1.0. The dosing regimen was then modified in Protocol Version 2.0 to twice-monthly SC somavaratan. Doses were titrated to each participant's individual IGF-I responses based on the insulin-like growth factor-I (IGF-I) level 7 days postdose until a maintenance dose was achieved. Maintenance dose was defined as an IGF-I value between 0 and 2.0 standard deviation score (SDS) for two consecutive 7-day postdose time points (Day 8, peak level). Participants who received somavaratan once-monthly in this study or in a previous somavaratan study (15VR7), had their dose decreased by half (minimum dose of 20 milligrams \[mg\], 40 mg for women on estrogen, rounded down to the nearest even number) and were titrated based on IGF-I level at Day 8. New participants enrolling in this study received a starting dose of 20 mg twice-monthly (40 mg for women on estrogen) and were titrated based on IGF-I level at Day 8. Maintenance doses were adjusted further based on pharmacodynamic (PD) data at the discretion of the Investigator or Medical Monitor. The maximum allowable dose of somavaratan was 250.0 mg.
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|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Study Terminated By Sponsor
|
32
|
Baseline Characteristics
Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in Adult Growth Hormone Deficiency (AGHD)
Baseline characteristics by cohort
| Measure |
Somavaratan
n=36 Participants
Participants received once-monthly SC somavaratan per Protocol Version 1.0. The dosing regimen was then modified in Protocol Version 2.0 to twice-monthly SC somavaratan. Doses were titrated to each participant's individual IGF-I responses based on the IGF-I level 7 days postdose until a maintenance dose was achieved. Maintenance dose was defined as an IGF-I value between 0 and 2.0 SDS for two consecutive 7-day postdose time points (Day 8, peak level). Participants who received somavaratan once-monthly in this study or in a previous somavaratan study (15VR7), had their dose decreased by half (minimum dose of 20 mg, 40 mg for women on estrogen, rounded down to the nearest even number) and were titrated based on IGF-I level at Day 8. New participants enrolling in this study received a starting dose of 20 mg twice-monthly (40 mg for women on estrogen) and were titrated based on IGF-I level at Day 8. Maintenance doses were adjusted further based on PD data at the discretion of the Investigator or Medical Monitor. The maximum allowable dose of somavaratan was 250.0 mg.
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|---|---|
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Age, Continuous
|
50.1 years
STANDARD_DEVIATION 10.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to approximately 2 yearsPopulation: Safety population included all participants who received any amount of study drug.
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included 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 participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Outcome measures
| Measure |
Somavaratan
n=36 Participants
Participants received once-monthly SC somavaratan per Protocol Version 1.0. The dosing regimen was then modified in Protocol Version 2.0 to twice-monthly SC somavaratan. Doses were titrated to each participant's individual IGF-I responses based on the IGF-I level 7 days postdose until a maintenance dose was achieved. Maintenance dose was defined as an IGF-I value between 0 and 2.0 SDS for two consecutive 7-day postdose time points (Day 8, peak level). Participants who received somavaratan once-monthly in this study or in a previous somavaratan study (15VR7), had their dose decreased by half (minimum dose of 20 mg, 40 mg for women on estrogen, rounded down to the nearest even number) and were titrated based on IGF-I level at Day 8. New participants enrolling in this study received a starting dose of 20 mg twice-monthly (40 mg for women on estrogen) and were titrated based on IGF-I level at Day 8. Maintenance doses were adjusted further based on PD data at the discretion of the Investigator or Medical Monitor. The maximum allowable dose of somavaratan was 250.0 mg.
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|---|---|
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Number of Participants With Adverse Events (AEs)
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30 Participants
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SECONDARY outcome
Timeframe: Up to Month 12Population: Safety population included all participants who received any amount of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Total average dose received by a participant during titration/maintenance has been reported.
Outcome measures
| Measure |
Somavaratan
n=33 Participants
Participants received once-monthly SC somavaratan per Protocol Version 1.0. The dosing regimen was then modified in Protocol Version 2.0 to twice-monthly SC somavaratan. Doses were titrated to each participant's individual IGF-I responses based on the IGF-I level 7 days postdose until a maintenance dose was achieved. Maintenance dose was defined as an IGF-I value between 0 and 2.0 SDS for two consecutive 7-day postdose time points (Day 8, peak level). Participants who received somavaratan once-monthly in this study or in a previous somavaratan study (15VR7), had their dose decreased by half (minimum dose of 20 mg, 40 mg for women on estrogen, rounded down to the nearest even number) and were titrated based on IGF-I level at Day 8. New participants enrolling in this study received a starting dose of 20 mg twice-monthly (40 mg for women on estrogen) and were titrated based on IGF-I level at Day 8. Maintenance doses were adjusted further based on PD data at the discretion of the Investigator or Medical Monitor. The maximum allowable dose of somavaratan was 250.0 mg.
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|---|---|
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Average Dose Level During Titration/Maintenance
|
41.60 mg
Standard Deviation 47.398
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SECONDARY outcome
Timeframe: Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12Population: Safety population included all participants who received any amount of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants analyzed at specified timepoint.
The number of participants with a dose adjustment (titrated up/down) at each month are summarized.
Outcome measures
| Measure |
Somavaratan
n=11 Participants
Participants received once-monthly SC somavaratan per Protocol Version 1.0. The dosing regimen was then modified in Protocol Version 2.0 to twice-monthly SC somavaratan. Doses were titrated to each participant's individual IGF-I responses based on the IGF-I level 7 days postdose until a maintenance dose was achieved. Maintenance dose was defined as an IGF-I value between 0 and 2.0 SDS for two consecutive 7-day postdose time points (Day 8, peak level). Participants who received somavaratan once-monthly in this study or in a previous somavaratan study (15VR7), had their dose decreased by half (minimum dose of 20 mg, 40 mg for women on estrogen, rounded down to the nearest even number) and were titrated based on IGF-I level at Day 8. New participants enrolling in this study received a starting dose of 20 mg twice-monthly (40 mg for women on estrogen) and were titrated based on IGF-I level at Day 8. Maintenance doses were adjusted further based on PD data at the discretion of the Investigator or Medical Monitor. The maximum allowable dose of somavaratan was 250.0 mg.
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|---|---|
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Number of Participants With Dose Adjustments
Month 2 · Titrated Up
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11 Participants
|
|
Number of Participants With Dose Adjustments
Month 2 · Titrated Down
|
0 Participants
|
|
Number of Participants With Dose Adjustments
Month 3 · Titrated Up
|
7 Participants
|
|
Number of Participants With Dose Adjustments
Month 3 · Titrated Down
|
0 Participants
|
|
Number of Participants With Dose Adjustments
Month 4 · Titrated Up
|
6 Participants
|
|
Number of Participants With Dose Adjustments
Month 4 · Titrated Down
|
2 Participants
|
|
Number of Participants With Dose Adjustments
Month 5 · Titrated Up
|
3 Participants
|
|
Number of Participants With Dose Adjustments
Month 5 · Titrated Down
|
2 Participants
|
|
Number of Participants With Dose Adjustments
Month 6 · Titrated Up
|
3 Participants
|
|
Number of Participants With Dose Adjustments
Month 6 · Titrated Down
|
0 Participants
|
|
Number of Participants With Dose Adjustments
Month 7 · Titrated Up
|
3 Participants
|
|
Number of Participants With Dose Adjustments
Month 7 · Titrated Down
|
0 Participants
|
|
Number of Participants With Dose Adjustments
Month 8 · Titrated Up
|
3 Participants
|
|
Number of Participants With Dose Adjustments
Month 8 · Titrated Down
|
1 Participants
|
|
Number of Participants With Dose Adjustments
Month 9 · Titrated Up
|
0 Participants
|
|
Number of Participants With Dose Adjustments
Month 9 · Titrated Down
|
0 Participants
|
|
Number of Participants With Dose Adjustments
Month 10 · Titrated Up
|
0 Participants
|
|
Number of Participants With Dose Adjustments
Month 10 · Titrated Down
|
0 Participants
|
|
Number of Participants With Dose Adjustments
Month 11 · Titrated Up
|
1 Participants
|
|
Number of Participants With Dose Adjustments
Month 11 · Titrated Down
|
2 Participants
|
|
Number of Participants With Dose Adjustments
Month 12 · Titrated Up
|
0 Participants
|
|
Number of Participants With Dose Adjustments
Month 12 · Titrated Down
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: Safety population included all participants who received any amount of study drug.
Outcome measures
| Measure |
Somavaratan
n=36 Participants
Participants received once-monthly SC somavaratan per Protocol Version 1.0. The dosing regimen was then modified in Protocol Version 2.0 to twice-monthly SC somavaratan. Doses were titrated to each participant's individual IGF-I responses based on the IGF-I level 7 days postdose until a maintenance dose was achieved. Maintenance dose was defined as an IGF-I value between 0 and 2.0 SDS for two consecutive 7-day postdose time points (Day 8, peak level). Participants who received somavaratan once-monthly in this study or in a previous somavaratan study (15VR7), had their dose decreased by half (minimum dose of 20 mg, 40 mg for women on estrogen, rounded down to the nearest even number) and were titrated based on IGF-I level at Day 8. New participants enrolling in this study received a starting dose of 20 mg twice-monthly (40 mg for women on estrogen) and were titrated based on IGF-I level at Day 8. Maintenance doses were adjusted further based on PD data at the discretion of the Investigator or Medical Monitor. The maximum allowable dose of somavaratan was 250.0 mg.
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|---|---|
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Number of Participants Who Were Anti-drug Antibody (ADA) Positive
|
22 Participants
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SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: Safety population included all participants who received any amount of study drug.
Outcome measures
| Measure |
Somavaratan
n=36 Participants
Participants received once-monthly SC somavaratan per Protocol Version 1.0. The dosing regimen was then modified in Protocol Version 2.0 to twice-monthly SC somavaratan. Doses were titrated to each participant's individual IGF-I responses based on the IGF-I level 7 days postdose until a maintenance dose was achieved. Maintenance dose was defined as an IGF-I value between 0 and 2.0 SDS for two consecutive 7-day postdose time points (Day 8, peak level). Participants who received somavaratan once-monthly in this study or in a previous somavaratan study (15VR7), had their dose decreased by half (minimum dose of 20 mg, 40 mg for women on estrogen, rounded down to the nearest even number) and were titrated based on IGF-I level at Day 8. New participants enrolling in this study received a starting dose of 20 mg twice-monthly (40 mg for women on estrogen) and were titrated based on IGF-I level at Day 8. Maintenance doses were adjusted further based on PD data at the discretion of the Investigator or Medical Monitor. The maximum allowable dose of somavaratan was 250.0 mg.
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|---|---|
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Number of Participants With Positive Neutralizing Antibodies (NABs)
|
15 Participants
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SECONDARY outcome
Timeframe: Baseline, Month 2 Day 1, Month 2 Day 8, Month 3 Day 1, Month 3 Day 8, Month 4 Day 1, Month 4 Day 8, Month 5 Day 1, Month 5 Day 8, Month 6 Day 1, Month 6 Day 8, Month 7 Day 1, Month 7 Day 8, Month 8 Day 1, Month 8 Day 8, Month 10 Day 1, and Month 10 Day 8Population: Safety population included all participants who received any amount of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants analyzed at specified timepoint.
Changes in the IGF-I levels were assessed as Standard Deviation Scores (SDS). The SDS was calculated as the actual value of IGF-I minus mean reference value of IGF-1 divided by reference standard deviation of IGF-I. The mean and the standard deviation (SD) vary depending on the age and sex of the participant. Change in IGF-I level (SDS) at specified timepoints from baseline was assessed. A higher score reflects a better outcome.
Outcome measures
| Measure |
Somavaratan
n=18 Participants
Participants received once-monthly SC somavaratan per Protocol Version 1.0. The dosing regimen was then modified in Protocol Version 2.0 to twice-monthly SC somavaratan. Doses were titrated to each participant's individual IGF-I responses based on the IGF-I level 7 days postdose until a maintenance dose was achieved. Maintenance dose was defined as an IGF-I value between 0 and 2.0 SDS for two consecutive 7-day postdose time points (Day 8, peak level). Participants who received somavaratan once-monthly in this study or in a previous somavaratan study (15VR7), had their dose decreased by half (minimum dose of 20 mg, 40 mg for women on estrogen, rounded down to the nearest even number) and were titrated based on IGF-I level at Day 8. New participants enrolling in this study received a starting dose of 20 mg twice-monthly (40 mg for women on estrogen) and were titrated based on IGF-I level at Day 8. Maintenance doses were adjusted further based on PD data at the discretion of the Investigator or Medical Monitor. The maximum allowable dose of somavaratan was 250.0 mg.
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|---|---|
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Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 4 Day 8
|
1.73 SDS
Standard Deviation 1.221
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|
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 5 Day 1
|
0.18 SDS
Standard Deviation 0.738
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|
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 5 Day 8
|
1.68 SDS
Standard Deviation 0.691
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|
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 2 Day 1
|
0.76 SDS
Standard Deviation 0.639
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|
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 2 Day 8
|
1.83 SDS
Standard Deviation 0.899
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|
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 3 Day 1
|
0.45 SDS
Standard Deviation 0.457
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|
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 3 Day 8
|
1.44 SDS
Standard Deviation 0.915
|
|
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 4 Day 1
|
0.49 SDS
Standard Deviation 0.751
|
|
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 6 Day 1
|
0.74 SDS
Standard Deviation 0.500
|
|
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 6 Day 8
|
1.38 SDS
Standard Deviation 0.777
|
|
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 7 Day 1
|
0.74 SDS
Standard Deviation 0.541
|
|
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 7 Day 8
|
1.82 SDS
Standard Deviation 1.414
|
|
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 8 Day 1
|
0.30 SDS
|
|
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 8 Day 8
|
4.30 SDS
|
|
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 10 Day 1
|
0.91 SDS
Standard Deviation 0.845
|
|
Change From Baseline in Mean Insulin-like Growth Factor 1 (IGF-I) Standard Deviation Score (SDS) at Specified Timepoints During Maintenance Period
Month 10 Day 8
|
1.76 SDS
Standard Deviation 1.539
|
SECONDARY outcome
Timeframe: Baseline up to Month 12Population: Due to early termination of study, no data were collected for this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Somavaratan
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Somavaratan
n=36 participants at risk
Participants received once-monthly SC somavaratan per Protocol Version 1.0. The dosing regimen was then modified in Protocol Version 2.0 to twice-monthly SC somavaratan. Doses were titrated to each participant's individual IGF-I responses based on the IGF-I level 7 days postdose until a maintenance dose was achieved. Maintenance dose was defined as an IGF-I value between 0 and 2.0 SDS for two consecutive 7-day postdose time points (Day 8, peak level). Participants who received somavaratan once-monthly in this study or in a previous somavaratan study (15VR7), had their dose decreased by half (minimum dose of 20 mg, 40 mg for women on estrogen, rounded down to the nearest even number) and were titrated based on IGF-I level at Day 8. New participants enrolling in this study received a starting dose of 20 mg twice-monthly (40 mg for women on estrogen) and were titrated based on IGF-I level at Day 8. Maintenance doses were adjusted further based on PD data at the discretion of the Investigator or Medical Monitor. The maximum allowable dose of somavaratan was 250.0 mg.
|
|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Infections and infestations
Bronchitis
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Metabolism and nutrition disorders
Polydipsia
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
Other adverse events
| Measure |
Somavaratan
n=36 participants at risk
Participants received once-monthly SC somavaratan per Protocol Version 1.0. The dosing regimen was then modified in Protocol Version 2.0 to twice-monthly SC somavaratan. Doses were titrated to each participant's individual IGF-I responses based on the IGF-I level 7 days postdose until a maintenance dose was achieved. Maintenance dose was defined as an IGF-I value between 0 and 2.0 SDS for two consecutive 7-day postdose time points (Day 8, peak level). Participants who received somavaratan once-monthly in this study or in a previous somavaratan study (15VR7), had their dose decreased by half (minimum dose of 20 mg, 40 mg for women on estrogen, rounded down to the nearest even number) and were titrated based on IGF-I level at Day 8. New participants enrolling in this study received a starting dose of 20 mg twice-monthly (40 mg for women on estrogen) and were titrated based on IGF-I level at Day 8. Maintenance doses were adjusted further based on PD data at the discretion of the Investigator or Medical Monitor. The maximum allowable dose of somavaratan was 250.0 mg.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.9%
5/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
8.3%
3/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
General disorders
Hernia
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Infections and infestations
Pharyngitis
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Infections and infestations
Gastroenteritis
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Infections and infestations
Hordeolum
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Nervous system disorders
Headache
|
8.3%
3/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Infections and infestations
Diverticulitis
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Investigations
Very low density lipoprotein increased
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Investigations
Blood triglycerides increased
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Investigations
C-reactive protein increased
|
8.3%
3/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
3/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Infections and infestations
Sinusitis
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Investigations
Blood phosphorus decreased
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Investigations
Blood phosphorus increased
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
3/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Infections and infestations
Viral pharyngitis
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Investigations
Blood potassium decreased
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Investigations
Blood cholesterol increased
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Investigations
Low density lipoprotein increased
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Surgical and medical procedures
Haemangioma removal
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
General disorders
Injection site erythema
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
General disorders
Fatigue
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Macule
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
General disorders
Pain
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Endocrine disorders
Adrenal insufficiency
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Psychiatric disorders
Insomnia
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Infections and infestations
Influenza
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Investigations
White blood cell count increased
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Abdominal wall mass
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Nervous system disorders
Migraine
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Dysuria
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Renal and urinary disorders
Haematuria
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
General disorders
Injection site reaction
|
8.3%
3/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Vascular disorders
Hypertension
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Infections and infestations
Oral candidiasis
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Surgical and medical procedures
Tooth extraction
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Infections and infestations
Oral herpes
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Psychiatric disorders
Depression
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Surgical and medical procedures
Skin lesion excision
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
General disorders
Oedema peripheral
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Eye disorders
Choroidal detachment
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Psychiatric disorders
Stress
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
2/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
|
Investigations
Weight increased
|
2.8%
1/36 • From first dose of study drug up to approximately 2 years
Safety population included all participants who received any amount of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee US Sites: Institution shall cause Principal Investigator to submit a complete copy of the proposed publication to Sponsor at least 60 days prior to presentation or submission to any third party. Non-US sites: The Investigator and the Institution agree that any proposed publication relating to the research and/or Study conducted under this Agreement will be submitted to Sponsor for review at least 90 days prior to submission for publication. Additional agreement conditions apply.
- Publication restrictions are in place
Restriction type: OTHER