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Clinical Trial Results:
An Open-Label Study of XOMA 358, with Optional Dose Escalation, in Patients with Congenital Hyperinsulinism

Summary
EudraCT number	2016-001275-80
Trial protocol	DE
Global end of trial date	20 Jan 2017

Results information
Results version number	v1(current)
This version publication date	04 May 2018
First version publication date	04 May 2018
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

X358605

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Xoma (US) LLC

Sponsor organisation address

2200 Powell Street, Suite 310, Emeryville, United States, CA 94608

Public contact

Kirk Jonhson, Xoma (US) LLC, +1 501 204 7439, Kirk.Johnson@xoma.com

Scientific contact

Kirk Jonhson, Xoma (US) LLC, +1 501 204 7439, Kirk.Johnson@xoma.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

31 Oct 2017

Is this the analysis of the primary completion data?

Yes

Primary completion date

20 Jan 2017

Global end of trial reached?

Yes

Global end of trial date

20 Jan 2017

Was the trial ended prematurely?

Main objective of the trial

The objective of this Phase 2 study was to evaluate the safety, pharmacokinetics and pharmacodynamics of XOMA 358 in patients aged 12 years and older with hypoglycemia associated with congenital hyperinsulinism (CHI).

Protection of trial subjects

This study was conducted in accordance with Good Clinical Practice standards, ethical principles stated in the Declaration of Helsinki and applicable local regulatory requirements. Patients were assured that they could withdraw from the study at any time without jeopardizing their medical care. After the subject has ended his/her participation in the trial, the investigator provided appropriate medication and/or arranged access to appropriate care for the patient.

Background therapy

Evidence for comparator

Actual start date of recruitment

22 Sep 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 4

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Subjects with blood glucose < 60 mg/dL or with clinically meaningful decrease in blood glucose in conjunction with symptoms during monitored fasts, who could be safely washed out of background medications used to treat CHI and who met all inclusion/exclusion criteria were enrolled. No subjects failed screening.

Period 1 title

overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Cohort 1

Arm description

All patients were enrolled in Cohort 1 and received a first dose of 3 mg/kg X358 on Day 1 followed by a second dose of 6 mg/kg X358 on Day 4 or 5

Arm type

Experimental

Investigational medicinal product name

X358

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Single 3 mg/kg dose of X358 followed by a single 6 mg/kg dose. Both doses administered as an IV infusion over 30 minutes.

Number of subjects in period 1	Cohort 1
Started	4
Completed	4

Baseline characteristics

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Reporting group title

overall trial

Reporting group description

Reporting group values	overall trial	Total
Number of subjects	4	4
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	2	2
Adults (18-64 years)	2	2
From 65-84 years	0	0
85 years and over	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	24.5 ± 13.87	-
Gender categorical
Units: Subjects
Female	1	1
Male	3	3
K(ATP) mutation
Units: Subjects
Yes	2	2
no	2	2

End points

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Reporting group title

Cohort 1

Reporting group description

All patients were enrolled in Cohort 1 and received a first dose of 3 mg/kg X358 on Day 1 followed by a second dose of 6 mg/kg X358 on Day 4 or 5

Primary: Cumulative time blood glucose < 70 mg/dL (< 3.89 mM)

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End point title

Cumulative time blood glucose < 70 mg/dL (< 3.89 mM) ^[1]

End point description

Duration of hypoglycaemia (blood glucose < 70 mg/dL) is presented for Baseline values collected during the Screening period (where 24-hour CGM was recorded) and Days 1 to D12 post 3 mg/kg X358 and 6 mg/kg X358 administration. Duration of hypoglycaemia is calculated as the sum of the total time in the specified threshold; number of data points < threshold multiplied by 5 minutes.

End point type

Primary

End point timeframe

Glucose was followed via the continuous glucose monitor from check in (5 days prior to dosing) until Day 29 post dose.

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Due to the small sample size, only a descriptive analysis and documentation of data listings of this endpoint was specified.

End point values	Cohort 1
Number of subjects analysed	4
Units: minutes
arithmetic mean (standard deviation)
Baseline; 3 mg/kg Dose	558.44 ± 307.699
Day 1 to 12; 3 mg/kg Dose	703.85 ± 520.096
Baseline; 6 mg/kg Dose	558.44 ± 307.699
Day 1 to 12; 6 mg/kg Dose	483.65 ± 323.573

No statistical analyses for this end point

Primary: Frequency of hypoglycaemic events (< 60 mg/dL)

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End point title

Frequency of hypoglycaemic events (< 60 mg/dL) ^[2]

End point description

The number of hypoglycemic episodes (< 60 mg/dL) over each 24-hour day was reported, and summarised herein for Baseline (taken as average number of episodes for non-fast days during checkin and Screening where 24-hour CGM was recorded, combined) and post-treatment (average number of episodes for all Days D1 to D12 combined). An instance of hypoglycemia was defined as 3 consecutive measurements within a 15 minute window that are < 60 mg/dL.

End point type

Primary

End point timeframe

Glucose was followed via the continuous glucose monitor from check in (5 days prior to dosing) until Day 29 post dose.

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Due to the small sample size, only a descriptive analysis and documentation of data listings of this endpoint was specified.

End point values	Cohort 1
Number of subjects analysed	4
Units: Events
arithmetic mean (standard deviation)
Baseline; 3 mg/kg Dose	2.81 ± 2.569
Day 1 to 12, 3 mg/kg Dose	4.21 ± 3.148
Baseline; 6 mg/kg	2.81 ± 2.569
Day 1 to 12; 6 mg/kg Dose	3.65 ± 2.461

No statistical analyses for this end point

Primary: Concomitant treatment/medications used during rescue

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End point title

Concomitant treatment/medications used during rescue ^[3]

End point description

Rescue medication taken by subjects for hypoglycaemia during the study is presented.

End point type

Primary

End point timeframe

Concomitant treatment used during rescue were reported from Baseline until the end of the study.

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Due to the small sample size, only a descriptive analysis and documentation of data listings of this endpoint was specified.

End point values	Cohort 1
Number of subjects analysed	4
Units: Rescue medication required
Glucose infusion	1
Paracetamol	1

No statistical analyses for this end point

Primary: Glucose area under the curve (AUC24)

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End point title

Glucose area under the curve (AUC24) ^[4]

End point description

Glucose (mg/dL) AUC(0-24) via CGMS is presented for Baseline #1 (average of AUC on non-fast days (during checkin and Screening period where 24 hr CGM was recorded), Baseline #2 (average of AUC on all days (checkin and Screening period where 24hr CGM was recorded) and Days 1 to 11 post-dose, checkout [Day 16) and follow-up visits [Day 29 and 33])

End point type

Primary

End point timeframe

Glucose was followed via the continuous glucose monitor from check in (5 days prior to dosing) until Day 29 post dose.

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Due to the small sample size, only a descriptive analysis and documentation of data listings of this endpoint was specified.

End point values	Cohort 1
Number of subjects analysed	4
Units: mg/dL
arithmetic mean (standard deviation)
Baseline #1; 3 mg/kg Dose	2023.875 ± 283.2190
Baseline #2; 3 mg/kg Dose	1972.454 ± 285.0928
Day 1; 3 mg/kg Dose	1898.10 ± 778.72
Day 2; 3 mg/kg Dose	1911.73 ± 577.06
Day 3; 3 mg/kg Dose	1876.89 ± 450.43
Day 4; 3 mg/kg Dose	2600.35 ± 149.46
Baseline #1; 6 mg/kg Dose	2023.875 ± 283.2190
Baseline #2; 6 mg/kg Dose	1972.454 ± 285.0928
Day 1; 6 mg/kg Dose	2286.32 ± 758.49
Day 2; 6 mg/kg Dose	2288.27 ± 691.35
Day 3; 6 mg/kg Dose	2123.73 ± 710.25
Day 4; 6 mg/kg Dose	2219.66 ± 785.31
Day 5; 6 mg/kg Dose	2196.83 ± 621.43
Day 6; 6 mg/kg Dose	2210.13 ± 517.73
Day 7; 6 mg/kg Dose	2110.61 ± 568.05
Day 8; 6 mg/kg Dose	2184.74 ± 495.83
Day 9; 6 mg/kg Dose	2270.03 ± 976.55
Day 10; 6 mg/kg Dose	2209.28 ± 538.09
Day 11; 6 mg/kg Dose	2412.12 ± 492.44
Check Out; 6 mg/kg Dose	2311.46 ± 461.112
Follow-up; 6 mg/kg Dose	1546.44 ± 538.014

No statistical analyses for this end point

Primary: Fasting and postprandial glucose, insulin, C-peptide

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End point title

Fasting and postprandial glucose, insulin, C-peptide ^[5]

End point description

Glucose measurements via a bedside glucometer, serum insulin and C-peptide measurements are presented for fasting days (0-hour, pre-breakfast) for both Baseline and post-treatment days. Post-prandial measurements are presented for both Baseline (average of 0-hour, pre-breakfast measurements) and post-treatment (average of 2-hour post-breakfast measurements).

End point type

Primary

End point timeframe

AM fasting: Baseline (Screening period, and prior to dosing on Day 1) and post-treatment (Days 2, 4, 5, 6, 7, 8, and 9) Post-prandial: Baseline (Screening period) and post-treatment (Days 2, 4, 5, 6, 7, 8 and 9)

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Due to the small sample size, only a descriptive analysis and documentation of data listings of this endpoint was specified.

End point values	Cohort 1
Number of subjects analysed	4
Units: mg/dL; mIU/L; (ng/mL
arithmetic mean (standard deviation)
Glucose; AM Fasting; Baseline; 3 mg/kg Dose	66.52 ± 16.282
Glucose; AM Fasting; Post-Treatment; 3 mg/kg Dose	66.22 ± 29.243
Glucose; AM Fasting; Baseline; 6 mg/kg Dose	69.07 ± 18.923
Glucose; AM Fasting; Post-Treatment; 6 mg/kg Dose	73.20 ± 25.810
Glucose; Post-prandial; Baseline; 3 mg/kg Dose	68.24 ± 17.382
Glucose; Post-prandial; Post-Treatment; 3 mg/kg Do	122.75 ± 70.025
Glucose; Post-prandial; Baseline; 6 mg/kg Dose	68.24 ± 17.382
Glucose; Post-prandial; Post-Treatment; 6 mg/kg Do	146.40 ± 39.863
Insulin; AM Fasting; Baseline; 3 mg/kg Dose	12.383 ± 4.4984
Insulin; AM Fasting; Post-Treatment; 3 mg/kg Dose	57.225 ± 43.6895
Insulin; AM Fasting; Baseline; 6 mg/kg Dose	41.800 ± 45.5670
Insulin; AM Fasting; Post-Treatment; 6 mg/kg Dose	114.604 ± 52.2824
Insulin; Post-prandial; Baseline; 3 mg/kg Dose	12.938 ± 5.7387
Insulin; Post-prandial; Post-Treatment; 3 mg/kg Do	296.200 ± 210.6859
Insulin; Post-prandial; Baseline; 6 mg/kg Dose	12.938 ± 5.7387
Insulin; Post-prandial; Post-Treatment; 6 mg/kg Do	559.481 ± 164.0734
C-peptide; AM Fasting; Baseline; 3 mg/kg Dose	1.8458 ± 0.43435
C-peptide; AM Fasting; Post-Treatment; 3 mg/kg Dos	1.3800 ± 0.63038
C-peptide; AM Fasting; Baseline; 6 mg/kg Dose	2.1296 ± 0.77543
C-peptide; AM Fasting; Post-Treatment; 6 mg/kg Dos	2.0569 ± 0.56838
C-peptide; Post-prandial; Baseline; 3 mg/kg Dose	1.8725 ± 0.52122
C-peptide; Post-prandial; Post-Treatment; 3 mg/kg	7.4588 ± 4.75957
C-peptide; Post-prandial; Baseline; 6 mg/kg Dose	1.8725 ± 0.52122
C-peptide; Post-prandial; Post-Treatment; 6 mg/kg	9.7088 ± 2.11836

No statistical analyses for this end point

Primary: Time to hypoglycemia during provocation (< 60 mg/dL [< 3.33 mM])

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End point title

Time to hypoglycemia during provocation (< 60 mg/dL [< 3.33 mM]) ^[6]

End point description

First occurrence of glucose < 60 mg/dL (3.33 mM) from the start of fasting challenge post-dosing of 3 and 6 mg/kg X358 on Day 3 (provocation day) is presented.

End point type

Primary

End point timeframe

Day 3 post dose (Provocation)

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Due to the small sample size, only a descriptive analysis and documentation of data listings of this endpoint was specified.

End point values	Cohort 1
Number of subjects analysed	4
Units: minutes
arithmetic mean (standard deviation)
3 mg/kg Dose	2920.0 ± 3704.70
6 mg/kg Dose	5797.5 ± 943.99

No statistical analyses for this end point

Post-hoc: Subgroup Analysis: Glucose Non-fast days 1-7 and 8-12 vs. Baseline (non-fast)

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End point title

Subgroup Analysis: Glucose Non-fast days 1-7 and 8-12 vs. Baseline (non-fast)

End point description

Percentage change in glucose measurements (mg/dL) via CGM over 24 hours on non-fast Days 1-7 and 8-12 post 6 mg/kg X358 dose versus Baseline glucose values for non-fast days (S-1 to S4 where 24hr CGM is recorded) is presented.

End point type

Post-hoc

End point timeframe

Glucose was followed via the continuous glucose monitor from check in (5 days prior to dosing) until Day 29 post dose.

End point values	Cohort 1
Number of subjects analysed	4
Units: Percent change from baseline
median (full range (min-max))
Days 1-7 (non-fast)	10.226 (-15.70 to 23.81)
Days 8-12 post 6 mg/kg X358 (non-fast)	12.738 (-5.82 to 24.22)

No statistical analyses for this end point

Post-hoc: Subgroup Analysis: Glucose Days 1-8 vs. Baseline (4-5 Days)

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End point title

Subgroup Analysis: Glucose Days 1-8 vs. Baseline (4-5 Days)

End point description

Percentage change in glucose measurements (mg/dL) via CGMS over 24 hours on Days 1-8 post 6 mg/kg X358 dose versus Baseline (4-5 days) is presented.

End point type

Post-hoc

End point timeframe

Glucose was followed via the continuous glucose monitor from check in (5 days prior to dosing) until Day 29 post dose.

End point values	Cohort 1
Number of subjects analysed	4
Units: Percent change from baseline
median (full range (min-max))
Days 1-8 post 6 mng/kg X358	12.216 (-10.36 to 24.19)

No statistical analyses for this end point

Post-hoc: Subgroup Analysis: Fasting Blood Glucose -Days 4 and 5 vs. Baseline (2-days)

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End point title

Subgroup Analysis: Fasting Blood Glucose -Days 4 and 5 vs. Baseline (2-days)

End point description

The change in fasting blood glucose (mg/dL) on Days 4 and 5 versus Baseline ( 2-days) is presented.

End point type

Post-hoc

End point timeframe

Baseline (S3 or S4) to Day 5 post 2nd dose.

End point values	Cohort 1
Number of subjects analysed	4
Units: Change from baseline
median (full range (min-max))
Days 4 and 5 post 2nd dose	-1.351 (-4.50 to 37.84)

No statistical analyses for this end point

Post-hoc: Subgroup Analysis: Fasting Blood Glucose- Days 4 and 5 vs. Baseline (3-days)

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End point title

Subgroup Analysis: Fasting Blood Glucose- Days 4 and 5 vs. Baseline (3-days)

End point description

The change in fasting blood glucose (mg/dL) on Days 4 and 5 post 6 mg/kg X358 dose versus Baseline (average of blood glucose on S3, S4 and Day 1 pre-dose) is presented

End point type

Post-hoc

End point timeframe

Baseline (S3 or S4 and Day pre-dose where fasting blood glucose is recorded) to Day 5 post 2nd dose.

End point values	Cohort 1
Number of subjects analysed	4
Units: Change from baseline(3-days)
median (full range (min-max))
Days 4 and 5 post 2nd dose	2.252 (-2.10 to 36.04)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events were reported from date of informed consent until end of study.

Adverse event reporting additional description

Pre-treatment adverse events were not related to protocol procedures and were related to underlying disease. All Treatment-Emergent Adverse Events were considered unrelated to study treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

X358

Reporting group description

Serious adverse events	X358
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 4 (0.00%)
number of deaths (all causes)	0
number of deaths resulting from adverse events	0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	X358
Total subjects affected by non serious adverse events
subjects affected / exposed	4 / 4 (100.00%)
Investigations
Eosinophil count increased
subjects affected / exposed	1 / 4 (25.00%)
occurrences all number	1
Nervous system disorders
Dizziness
subjects affected / exposed	1 / 4 (25.00%)
occurrences all number	5
Headache
subjects affected / exposed	1 / 4 (25.00%)
occurrences all number	2
General disorders and administration site conditions
Malaise
subjects affected / exposed	1 / 4 (25.00%)
occurrences all number	2
Gastrointestinal disorders
Vomiting
subjects affected / exposed	1 / 4 (25.00%)
occurrences all number	1
Infections and infestations
Gastroenteritis
subjects affected / exposed	1 / 4 (25.00%)
occurrences all number	1
Gastrointestinal infection
subjects affected / exposed	1 / 4 (25.00%)
occurrences all number	1

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Due to the small number of patients enrolled into this study, definitive conclusions cannot be drawn

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Clinical trials

Clinical Trial Results:
An Open-Label Study of XOMA 358, with Optional Dose Escalation, in Patients with Congenital Hyperinsulinism

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Cumulative time blood glucose < 70 mg/dL (< 3.89 mM)

Primary: Cumulative time blood glucose < 70 mg/dL (< 3.89 mM)

Primary: Frequency of hypoglycaemic events (< 60 mg/dL)

Primary: Frequency of hypoglycaemic events (< 60 mg/dL)

Primary: Concomitant treatment/medications used during rescue

Primary: Concomitant treatment/medications used during rescue

Primary: Glucose area under the curve (AUC24)

Primary: Glucose area under the curve (AUC24)

Primary: Fasting and postprandial glucose, insulin, C-peptide

Primary: Fasting and postprandial glucose, insulin, C-peptide

Primary: Time to hypoglycemia during provocation (< 60 mg/dL [< 3.33 mM])

Primary: Time to hypoglycemia during provocation (< 60 mg/dL [< 3.33 mM])

Post-hoc: Subgroup Analysis: Glucose Non-fast days 1-7 and 8-12 vs. Baseline (non-fast)

Post-hoc: Subgroup Analysis: Glucose Non-fast days 1-7 and 8-12 vs. Baseline (non-fast)

Post-hoc: Subgroup Analysis: Glucose Days 1-8 vs. Baseline (4-5 Days)

Post-hoc: Subgroup Analysis: Glucose Days 1-8 vs. Baseline (4-5 Days)

Post-hoc: Subgroup Analysis: Fasting Blood Glucose -Days 4 and 5 vs. Baseline (2-days)

Post-hoc: Subgroup Analysis: Fasting Blood Glucose -Days 4 and 5 vs. Baseline (2-days)

Post-hoc: Subgroup Analysis: Fasting Blood Glucose- Days 4 and 5 vs. Baseline (3-days)

Post-hoc: Subgroup Analysis: Fasting Blood Glucose- Days 4 and 5 vs. Baseline (3-days)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Clinical trials

Clinical Trial Results: An Open-Label Study of XOMA 358, with Optional Dose Escalation, in Patients with Congenital Hyperinsulinism

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Cumulative time blood glucose < 70 mg/dL (< 3.89 mM)

Primary: Cumulative time blood glucose < 70 mg/dL (< 3.89 mM)

Primary: Frequency of hypoglycaemic events (< 60 mg/dL)

Primary: Frequency of hypoglycaemic events (< 60 mg/dL)

Primary: Concomitant treatment/medications used during rescue

Primary: Concomitant treatment/medications used during rescue

Primary: Glucose area under the curve (AUC24)

Primary: Glucose area under the curve (AUC24)

Primary: Fasting and postprandial glucose, insulin, C-peptide

Primary: Fasting and postprandial glucose, insulin, C-peptide

Primary: Time to hypoglycemia during provocation (< 60 mg/dL [< 3.33 mM])

Primary: Time to hypoglycemia during provocation (< 60 mg/dL [< 3.33 mM])

Post-hoc: Subgroup Analysis: Glucose Non-fast days 1-7 and 8-12 vs. Baseline (non-fast)

Post-hoc: Subgroup Analysis: Glucose Non-fast days 1-7 and 8-12 vs. Baseline (non-fast)

Post-hoc: Subgroup Analysis: Glucose Days 1-8 vs. Baseline (4-5 Days)

Post-hoc: Subgroup Analysis: Glucose Days 1-8 vs. Baseline (4-5 Days)

Post-hoc: Subgroup Analysis: Fasting Blood Glucose -Days 4 and 5 vs. Baseline (2-days)

Post-hoc: Subgroup Analysis: Fasting Blood Glucose -Days 4 and 5 vs. Baseline (2-days)

Post-hoc: Subgroup Analysis: Fasting Blood Glucose- Days 4 and 5 vs. Baseline (3-days)

Post-hoc: Subgroup Analysis: Fasting Blood Glucose- Days 4 and 5 vs. Baseline (3-days)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
An Open-Label Study of XOMA 358, with Optional Dose Escalation, in Patients with Congenital Hyperinsulinism