Trial Outcomes & Findings for Phase I Study of MOv18 IgE (NCT NCT02546921)
NCT ID: NCT02546921
Last Updated: 2023-06-05
Results Overview
Reported safety information in the form of AEs, categorised according to Medical Dictionary for Regulatory Activities (MedDRA) version (v) 24.0 and graded for severity according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.02. AEs will be assessed by the reporting study doctors for a causal relationship to MOv18 IgE. Count of AEs by arm.
COMPLETED
PHASE1
26 participants
From the date of written informed consent and until the end of safety follow up period for MOv18 IgE, a median of 88.5 days (range: 13 to 181 days).
2023-06-05
Participant Flow
Trial participants were enrolled at four trial sites between 18 November 2015 and 05 August 2021.
Participant milestones
| Measure |
MOv18 IgE Cohort 1
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
8
|
6
|
3
|
3
|
3
|
1
|
|
Overall Study
COMPLETED
|
1
|
2
|
4
|
3
|
2
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
2
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
MOv18 IgE Cohort 1
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
5
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Evidence of Disease Progression
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Patient Choice
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MOv18 IgE Cohort 1
n=2 Participants
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
n=8 Participants
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
n=6 Participants
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
n=3 Participants
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
n=3 Participants
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
n=3 Participants
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
n=1 Participants
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=2 Participants
|
58.5 years
n=8 Participants
|
59.5 years
n=6 Participants
|
65 years
n=3 Participants
|
54 years
n=3 Participants
|
63 years
n=3 Participants
|
75 years
n=1 Participants
|
60 years
n=26 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=2 Participants
|
8 Participants
n=8 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=1 Participants
|
26 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=2 Participants
|
8 participants
n=8 Participants
|
6 participants
n=6 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
1 participants
n=1 Participants
|
26 participants
n=26 Participants
|
PRIMARY outcome
Timeframe: From the date of written informed consent and until the end of safety follow up period for MOv18 IgE, a median of 88.5 days (range: 13 to 181 days).Population: All enrolled participants who received at least one dose of MOv18 IgE by IV infusion, intradermally or as a skin prick test.
Reported safety information in the form of AEs, categorised according to Medical Dictionary for Regulatory Activities (MedDRA) version (v) 24.0 and graded for severity according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.02. AEs will be assessed by the reporting study doctors for a causal relationship to MOv18 IgE. Count of AEs by arm.
Outcome measures
| Measure |
MOv18 IgE Cohort 1
n=2 Participants
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
n=8 Participants
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
n=6 Participants
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
n=3 Participants
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
n=3 Participants
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
n=3 Participants
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
n=1 Participants
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7 After Intra-patient Dose Escalation
MOv18 IgE: after receiving three IV infusions of 6 mg MOv18 IgE in Cycle 1, the dose will be escalated. The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with with 2 μg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|---|
|
Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) Considered to be at Least Possibly Related to MOv18 IgE
No. participants at least one Related SAEs
|
0 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) Considered to be at Least Possibly Related to MOv18 IgE
No. participants at least one Related NSAEs
|
0 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: From first dose onwards until completion of Cycle 1 (3 weeks).Population: All enrolled participants who received at least one dose of MOv18 IgE by IV infusion, intradermally or as a skin prick test.
DLTs graded for severity using the NCI CTCAE v4.02, measured by count of participants per arm. Two DLTs were reported; however, following review of the data, it was determined that events of this nature did not constitute DLTs. The trial protocol was updated so that if further similar events occurred then would not be considered as DLTs but the events already reported remain categorised as DLTs.
Outcome measures
| Measure |
MOv18 IgE Cohort 1
n=2 Participants
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
n=8 Participants
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
n=6 Participants
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
n=3 Participants
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
n=3 Participants
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
n=3 Participants
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
n=1 Participants
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7 After Intra-patient Dose Escalation
MOv18 IgE: after receiving three IV infusions of 6 mg MOv18 IgE in Cycle 1, the dose will be escalated. The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with with 2 μg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From the date of written informed consent and until the end of safety follow up period for MOv18 IgE, a median of 88.5 days (range: 13 to 181 days).Population: All enrolled participants who received at least one dose of MOv18 IgE by IV infusion, intradermally or as a skin prick test.
AEs judged to be due to systemic mast cell degranulation (i.e. anaphylaxis). No dose independent significant toxicities were reported. However, one event of anaphylactic reaction was classified as a DLT at the time of occurrence but, following review of the data, the trial protocol was updated. This meant that any future events of anaphylaxis would have been classified as dose independent toxicities, but the event already reported remained as a DLT.
Outcome measures
| Measure |
MOv18 IgE Cohort 1
n=2 Participants
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
n=8 Participants
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
n=6 Participants
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
n=3 Participants
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
n=3 Participants
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
n=3 Participants
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
n=1 Participants
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7 After Intra-patient Dose Escalation
MOv18 IgE: after receiving three IV infusions of 6 mg MOv18 IgE in Cycle 1, the dose will be escalated. The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with with 2 μg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Dose Independent Significant Toxicities
|
0 Dose Independent Significant Toxicities
|
0 Dose Independent Significant Toxicities
|
0 Dose Independent Significant Toxicities
|
0 Dose Independent Significant Toxicities
|
0 Dose Independent Significant Toxicities
|
0 Dose Independent Significant Toxicities
|
0 Dose Independent Significant Toxicities
|
—
|
PRIMARY outcome
Timeframe: From the date of written informed consent and until the end of safety follow up period for MOv18 IgE, a median of 88.5 days (range: 13 to 181 days).Reported safety information in the form of haematological or biochemical abnormalities that were reported as AEs and graded for severity according to NCI CTCAE v4.02.
Outcome measures
| Measure |
MOv18 IgE Cohort 1
n=2 Participants
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
n=8 Participants
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
n=6 Participants
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
n=3 Participants
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
n=3 Participants
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
n=3 Participants
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
n=1 Participants
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7 After Intra-patient Dose Escalation
MOv18 IgE: after receiving three IV infusions of 6 mg MOv18 IgE in Cycle 1, the dose will be escalated. The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with with 2 μg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade ≥2 Laboratory Parameter AEs Reported
No. participants at least one Haem Grade >=2 AE
|
0 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Grade ≥2 Laboratory Parameter AEs Reported
No. participants at least one Biochem Grade >=2 AE
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Radiological disease response assessment at screening/baseline and every 6 weeks to end of treatment, a median of 56.5 days (range: 38 to 124 days).Population: Eligible participants who received at least one complete IV dose of MOv18 IgE and had a baseline and at least one post-baseline assessment of disease according to RECIST v1.1. Although 13 participants were initially reported to have a best response of SD, 2 of these participants were not evaluable for SD, as the assessment was performed \<6 weeks after the first IV infusion of MOv18 IgE. Therefore, the total number (%) of participants with SD is reported here as 11 (55.0%).
Best radiological response observed according to RECIST v1.1, presented per arm by count of participants. RECIST responses include complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). For a response to be defined as SD, the criteria must have been met at least once at a minimum interval of 6 weeks after study entry.
Outcome measures
| Measure |
MOv18 IgE Cohort 1
n=26 Participants
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7 After Intra-patient Dose Escalation
MOv18 IgE: after receiving three IV infusions of 6 mg MOv18 IgE in Cycle 1, the dose will be escalated. The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with with 2 μg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|---|
|
Antitumour Activity (Best Response) of MOv18 IgE Measured According to the Response Evaluation Criteria in Solid Tumours (RECIST) v 1.1
Not evaluable
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antitumour Activity (Best Response) of MOv18 IgE Measured According to the Response Evaluation Criteria in Solid Tumours (RECIST) v 1.1
Stable disease
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Antitumour Activity (Best Response) of MOv18 IgE Measured According to the Response Evaluation Criteria in Solid Tumours (RECIST) v 1.1
Progressive disease
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Disease response assessment at screening/baseline and every six weeks, if clinically appropriate for tumour type, to end of treatment, for a median of 34 days (range: 5 to 91 days).Population: All eligible participants who received at least one complete IV dose of MOv18 IgE and who had elevated CA125 at baseline (\>35 kU/L).
The percentage change in CA125 levels from baseline to the last measurement taken on-treatment, presented as a median (minimum, maximum) for each arm.
Outcome measures
| Measure |
MOv18 IgE Cohort 1
n=1 Participants
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
n=3 Participants
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
n=4 Participants
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
n=3 Participants
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
n=3 Participants
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
n=3 Participants
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
n=1 Participants
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7 After Intra-patient Dose Escalation
MOv18 IgE: after receiving three IV infusions of 6 mg MOv18 IgE in Cycle 1, the dose will be escalated. The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with with 2 μg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|---|
|
Antitumour Activity Measured by the Percentage Change in Cancer Antigen 125 (CA125) Tumour Marker Levels During the Trial, in Participants With Elevated CA125 at Baseline
|
41.38 % change from baseline CA125 level
Interval 41.38 to 41.38
|
59.04 % change from baseline CA125 level
Interval -14.13 to 227.52
|
52.79 % change from baseline CA125 level
Interval 15.12 to 80.36
|
118.13 % change from baseline CA125 level
Interval -32.31 to 264.9
|
45.41 % change from baseline CA125 level
Interval 14.75 to 100.41
|
15.93 % change from baseline CA125 level
Interval 13.82 to 31.86
|
144.14 % change from baseline CA125 level
Interval 144.14 to 144.14
|
—
|
SECONDARY outcome
Timeframe: Cohorts 1-7: Cycle 1 Day 1 within 24 hours (h) predose, then 30 mins postdose and 2, 4, 6 and 24 h postdose. Cohort 7 only (intrapatient dose escalation): Cycle 2 Day 1 predose, then 30 mins postdose and 2, 4, 6 and 24 h postdose. Each cycle = 21 days.Population: All participants who received a complete IV infusion of MOv18 IgE on Cycle 1, Day 1 and, for Cohort 7 only, Cycle 2 Day 1. For this outcome measure, data for Cohort 7 are reportedly separately by dose level.
Area under the serum concentration-time curve from time 0 to 24 hours after IV MOv18 IgE administration, evaluated using an enzyme linked immunosorbent assay (ELISA) method. Not all participants were analysed at all time points.
Outcome measures
| Measure |
MOv18 IgE Cohort 1
n=2 Participants
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
n=5 Participants
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
n=5 Participants
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
n=2 Participants
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
n=2 Participants
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
n=1 Participants
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
n=1 Participants
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7 After Intra-patient Dose Escalation
n=1 Participants
MOv18 IgE: after receiving three IV infusions of 6 mg MOv18 IgE in Cycle 1, the dose will be escalated. The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with with 2 μg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|---|
|
Measurement of Pharmacokinetic (PK) Parameter Area Under the Concentration-Time Curve From Time 0 to 24 Hours of MOv18 IgE
|
NA ng/mL.h
Standard Deviation NA
In one participant, MOv18 IgE could not be quantified in samples at any time point. In the other participant, MOv18 IgE could only be detected up to 7 hours postdose
|
130 ng/mL.h
Standard Deviation 76
|
303 ng/mL.h
Standard Deviation 159
|
222 ng/mL.h
Standard Deviation 42
|
726 ng/mL.h
Standard Deviation 113
|
761 ng/mL.h
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
2134 ng/mL.h
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
5573 ng/mL.h
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
SECONDARY outcome
Timeframe: Cohorts 1-7: Cycle 1 Day 1 <24 h predose, then 30 mins postdose and 2, 4, 6, 24 and 48 h postdose; Cycle 1 Day 8 predose. Cohort 7 only (intrapatient escalation): Cycle 2 Day 1 predose, then 30 mins and 2, 4, 6 and 24 h postdose. Each cycle = 21 days.Population: All participants who received a complete IV infusion of MOv18 IgE on Cycle 1, Day 1 and, for Cohort 7 only, Cycle 2 Day 1. For this outcome measure, data for Cohort 7 are reportedly separately by dose level.
Cmax in serum following IV MOv18 IgE administration was analysed using an ELISA method. Not all participants were analysed at all time points.
Outcome measures
| Measure |
MOv18 IgE Cohort 1
n=2 Participants
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
n=5 Participants
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
n=5 Participants
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
n=2 Participants
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
n=2 Participants
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
n=1 Participants
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
n=1 Participants
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7 After Intra-patient Dose Escalation
n=1 Participants
MOv18 IgE: after receiving three IV infusions of 6 mg MOv18 IgE in Cycle 1, the dose will be escalated. The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with with 2 μg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|---|
|
Measurement of PK Parameter Maximum Observed Serum Concentration (Cmax) of MOv18 IgE
|
2.3 ng/mL
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
9.4 ng/mL
Standard Deviation 6.8
|
31.8 ng/mL
Standard Deviation 11.4
|
29.7 ng/mL
Standard Deviation 4.6
|
86.8 ng/mL
Standard Deviation 18.3
|
75.7 ng/mL
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
196.7 ng/mL
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
368.2 ng/mL
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
SECONDARY outcome
Timeframe: Cohorts 1-7: Cycle 1 Day 1 <24 h predose, then 30 mins postdose and 2, 4, 6, 24 and 48 h postdose; Cycle 1 Day 8 predose. Cohort 7 only (intrapatient escalation): Cycle 2 Day 1 predose, then 30 mins and 2, 4, 6 and 24 h postdose. Each cycle = 21 days.Population: All participants who received a complete IV infusion of MOv18 IgE on Cycle 1, Day 1 and, for Cohort 7 only, Cycle 2 Day 1. For this outcome measure, data for Cohort 7 are reportedly separately by dose level.
Serum samples were analysed to determine the Tmax of MOv18 IgE following IV administration using an ELISA method. Not all participants were analysed at all time points.
Outcome measures
| Measure |
MOv18 IgE Cohort 1
n=2 Participants
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
n=5 Participants
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
n=5 Participants
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
n=2 Participants
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
n=2 Participants
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
n=1 Participants
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
n=1 Participants
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7 After Intra-patient Dose Escalation
n=1 Participants
MOv18 IgE: after receiving three IV infusions of 6 mg MOv18 IgE in Cycle 1, the dose will be escalated. The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with with 2 μg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|---|
|
Measurement of PK Parameter Time to Reach Maximum Observed Serum Concentration (Tmax) of MOv18 IgE
|
3.5 Hour
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
2.2 Hour
Standard Deviation 0.6
|
2.2 Hour
Standard Deviation 0.5
|
2.2 Hour
Standard Deviation 0.1
|
2.0 Hour
Standard Deviation 0.3
|
2.1 Hour
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
1.0 Hour
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
0.9 Hour
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
SECONDARY outcome
Timeframe: Cohorts 1-7: Cycle 1 Day 1 <24 h predose, then 30 mins postdose and 2, 4, 6, 24 and 48 h postdose; Cycle 1 Day 8 predose. Cohort 7 only (intrapatient escalation): Cycle 2 Day 1 predose, then 30 mins and 2, 4, 6 and 24 h postdose. Each cycle = 21 days.Population: All participants who received a complete IV infusion of MOv18 IgE on Cycle 1, Day 1 and, for Cohort 7 only, Cycle 2 Day 1. For this outcome measure, data for Cohort 7 are reportedly separately by dose level.
Serum samples were analysed to determine the concentrations of MOv18 IgE using a previously developed ELISA method. Not all participants were analysed at all time points.
Outcome measures
| Measure |
MOv18 IgE Cohort 1
n=2 Participants
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
n=5 Participants
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
n=5 Participants
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
n=2 Participants
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
n=2 Participants
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
n=1 Participants
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
n=1 Participants
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7 After Intra-patient Dose Escalation
n=1 Participants
MOv18 IgE: after receiving three IV infusions of 6 mg MOv18 IgE in Cycle 1, the dose will be escalated. The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with with 2 μg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|---|
|
Measurement of PK Parameter Terminal Half Life for MOv18 IgE
|
NA Hour
Standard Deviation NA
In one participant, MOv18 IgE could not be quantified in samples at any time point. In the other participant, MOv18 IgE could only be detected up to 7 hours postdose
|
10.5 Hour
Standard Deviation 0.6
|
9.9 Hour
Standard Deviation 2.4
|
7.4 Hour
Standard Deviation 0.3
|
9.2 Hour
Standard Deviation 0.2
|
15.0 Hour
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
10.0 Hour
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
NA Hour
Standard Deviation NA
Half-life was not calculated for the 12 mg dose level due to a skewed value observed at the 6 h time point
|
SECONDARY outcome
Timeframe: Cohorts 1-7: Cycle 1 Day 1 <24 h predose, then 30 mins postdose and 2, 4, 6, 24 and 48 h postdose; Cycle 1 Day 8 predose. Cohort 7 only (intrapatient escalation): Cycle 2 Day 1 predose, then 30 mins and 2, 4, 6 and 24 h postdose. Each cycle = 21 days.Population: All participants who received a complete IV infusion of MOv18 IgE on Cycle 1, Day 1 and, for Cohort 7 only, Cycle 2 Day 1. For this outcome measure, data for Cohort 7 are reportedly separately by dose level.
Serum samples were analysed to determine the MRT of MOv18 IgE following IV administration, using an ELISA method. Not all participants were analysed at all time points.
Outcome measures
| Measure |
MOv18 IgE Cohort 1
n=2 Participants
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
n=5 Participants
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
n=5 Participants
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
n=2 Participants
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
n=2 Participants
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
n=1 Participants
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
n=1 Participants
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7 After Intra-patient Dose Escalation
n=1 Participants
MOv18 IgE: after receiving three IV infusions of 6 mg MOv18 IgE in Cycle 1, the dose will be escalated. The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with with 2 μg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|---|
|
Measurement of the PK Parameter Mean Residence Time (MRT) of MOv18 IgE
|
NA Hour
Standard Deviation NA
In one participant, MOv18 IgE could not be quantified in samples at any time point. In the other participant, MOv18 IgE could only be detected up to 7 hours postdose
|
13.2 Hour
Standard Deviation 1.1
|
12.5 Hour
Standard Deviation 3.4
|
8.9 Hour
Standard Deviation 0.3
|
11.4 Hour
Standard Deviation 1.0
|
19.9 Hour
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
11.8 Hour
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
NA Hour
Standard Deviation NA
MRT was not calculated for the 12 mg dose level due to a skewed value observed at the 6 h time point
|
SECONDARY outcome
Timeframe: Cohorts 1-7: Cycle 1 Day 1 <24 h predose, then 30 mins postdose and 2, 4, 6, 24 and 48 h postdose; Cycle 1 Day 8 predose. Cohort 7 only (intrapatient escalation): Cycle 2 Day 1 predose, then 30 mins and 2, 4, 6 and 24 h postdose. Each cycle = 21 days.Population: All participants who received a complete IV infusion of MOv18 IgE on Cycle 1, Day 1 and, for Cohort 7 only, Cycle 2 Day 1. For this outcome measure, data for Cohort 7 are reportedly separately by dose level.
Serum samples were analysed to determine the CLT of MOv18 IgE following IV administration, using an ELISA method. Not all participants were analysed at all time points.
Outcome measures
| Measure |
MOv18 IgE Cohort 1
n=2 Participants
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
n=5 Participants
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
n=5 Participants
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
n=2 Participants
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
n=2 Participants
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
n=1 Participants
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
n=1 Participants
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7 After Intra-patient Dose Escalation
n=1 Participants
MOv18 IgE: after receiving three IV infusions of 6 mg MOv18 IgE in Cycle 1, the dose will be escalated. The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with with 2 μg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|---|
|
Measurement of the PK Parameter Total Body Clearance (CLT) of MOv18 IgE
|
NA L/h
Standard Deviation NA
In one participant, MOv18 IgE could not be quantified in samples at any time point. In the other participant, MOv18 IgE could only be detected up to 7 h postdose
|
1.9 L/h
Standard Deviation 0.8
|
1.6 L/h
Standard Deviation 0.6
|
2.8 L/h
Standard Deviation 0.5
|
1.7 L/h
Standard Deviation 0.2
|
2.7 L/h
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
2.3 L/h
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
0.8 L/h
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
SECONDARY outcome
Timeframe: Cohorts 1-7: Cycle 1 Day 1 <24 h predose, then 30 mins postdose and 2, 4, 6, 24 and 48 h postdose; Cycle 1 Day 8 predose. Cohort 7 only (intrapatient escalation): Cycle 2 Day 1 predose, then 30 mins and 2, 4, 6 and 24 h postdose. Each cycle = 21 days.Population: All participants who received a complete IV infusion of MOv18 IgE on Cycle 1, Day 1 and, for Cohort 7 only, Cycle 2 Day 1. For this outcome measure, data for Cohort 7 are reportedly separately by dose level.
Serum samples were analysed to determine the Vss of MOv18 IgE following IV administration, using an ELISA method. Not all participants were analysed at all time points.
Outcome measures
| Measure |
MOv18 IgE Cohort 1
n=2 Participants
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
n=5 Participants
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
n=5 Participants
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
n=2 Participants
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
n=2 Participants
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
n=1 Participants
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
n=1 Participants
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7 After Intra-patient Dose Escalation
n=1 Participants
MOv18 IgE: after receiving three IV infusions of 6 mg MOv18 IgE in Cycle 1, the dose will be escalated. The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with with 2 μg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|---|
|
Measurement of the PK Parameter Volume of Distribution (Vss) of MOv18 IgE
|
NA L
Standard Deviation NA
In one participant, MOv18 IgE could not be quantified in samples at any time point. In the other participant, MOv18 IgE could only be detected up to 7 h postdose
|
24.4 L
Standard Deviation 10.2
|
18.7 L
Standard Deviation 6.2
|
25.9 L
Standard Deviation 5.4
|
20.1 L
Standard Deviation 4.6
|
53.2 L
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
27.3 L
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
38.3 L
Standard Deviation NA
Only one patient had evaluable data at this timepoint
|
Adverse Events
MOv18 IgE Cohort 1
MOv18 IgE Cohort 2
MOv18 IgE Cohort 3
MOv18 IgE Cohort 4
MOv18 IgE Cohort 5
MOv18 IgE Cohort 6
MOv18 IgE Cohort 7
Serious adverse events
| Measure |
MOv18 IgE Cohort 1
n=2 participants at risk
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
n=8 participants at risk
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
n=6 participants at risk
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
n=3 participants at risk
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
n=3 participants at risk
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
n=3 participants at risk
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
n=1 participants at risk
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
2/6 • Number of events 3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
2/6 • Number of events 3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Infections and infestations
Kidney infection
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Investigations
Skin test positive
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
62.5%
5/8 • Number of events 5 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
Other adverse events
| Measure |
MOv18 IgE Cohort 1
n=2 participants at risk
MOv18 IgE: The allocated dose of 70 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution for safety assessment.
|
MOv18 IgE Cohort 2
n=8 participants at risk
MOv18 IgE: The allocated dose of 250 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by either an intradermal injection of 0.1 mL of a 2 µg/mL MOv18 IgE solution or a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 3
n=6 participants at risk
MOv18 IgE: The allocated dose of 500 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 4
n=3 participants at risk
MOv18 IgE: The allocated dose of 700 µg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 5
n=3 participants at risk
MOv18 IgE: The allocated dose of 1.5 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 6
n=3 participants at risk
MOv18 IgE: The allocated dose of 3 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 6 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE. Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
MOv18 IgE Cohort 7
n=1 participants at risk
MOv18 IgE: Cycle 1 - The allocated dose of 6 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks.
Cycle 2 - The allocated dose of 12 mg MOv18 IgE will be diluted in 250 mL saline and administered by IV infusion once weekly for 3 weeks, followed by fortnightly for 6 weeks if the patient appears to be benefiting from MOv18 IgE.
Each IV infusion will be preceded by a skin prick test with 2 µg/mL MOv18 IgE solution, for safety assessment.
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
2/6 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
50.0%
1/2 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
50.0%
1/2 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
62.5%
5/8 • Number of events 5 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Investigations
Blood albumin decreased
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Investigations
Blood uric acid increased
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Infections and infestations
Candida infection
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
General disorders
Chest discomfort
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
100.0%
1/1 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
General disorders
Chills
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
2/6 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
37.5%
3/8 • Number of events 3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
66.7%
2/3 • Number of events 3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Nervous system disorders
Dizziness postural
|
50.0%
1/2 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
100.0%
1/1 • Number of events 5 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
66.7%
2/3 • Number of events 3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
66.7%
2/3 • Number of events 6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
100.0%
1/1 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
General disorders
Fatigue
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
37.5%
3/8 • Number of events 3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
2/6 • Number of events 5 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
66.7%
2/3 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
66.7%
2/3 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
100.0%
1/1 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Infections and infestations
Groin infection
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
25.0%
2/8 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
2/6 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Vascular disorders
Hot flush
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
66.7%
2/3 • Number of events 5 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
100.0%
1/1 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
25.0%
2/8 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
50.0%
3/6 • Number of events 4 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Eye disorders
Orbital oedema
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
General disorders
Pain
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
General disorders
Peripheral swelling
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
37.5%
3/8 • Number of events 7 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
66.7%
2/3 • Number of events 6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
66.7%
2/3 • Number of events 9 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
100.0%
3/3 • Number of events 11 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
100.0%
1/1 • Number of events 4 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
100.0%
1/1 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
66.7%
2/3 • Number of events 10 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
100.0%
1/1 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
2/6 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Immune system disorders
Seasonal allergy
|
50.0%
1/2 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
General disorders
Secretion discharge
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
12.5%
1/8 • Number of events 2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
50.0%
3/6 • Number of events 8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
100.0%
3/3 • Number of events 12 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
100.0%
3/3 • Number of events 12 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
100.0%
3/3 • Number of events 10 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
100.0%
1/1 • Number of events 3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
16.7%
1/6 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
50.0%
3/6 • Number of events 5 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
100.0%
1/1 • Number of events 3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/2 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/8 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/6 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
33.3%
1/3 • Number of events 1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/3 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
0.00%
0/1 • Safety data were collected from the date of written informed consent and continued until 70 days after the last dose of MOv18 IgE, an average (median) of 88.5 days (range: 13-181).
|
Additional Information
Regulatory Affairs Manager
Cancer Research UK Centre for Drug Development
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place