Clinical Trial Results:
An open label, single arm study to assess the safety and immunogenicity of omalizumab liquid administered subcutaneously in a pre-filled safety syringe (75 mg or 150 mg) over a period of 6 months to male and female adolescents and adults with moderate to severe persistent allergic asthma.
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Summary
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EudraCT number |
2006-005917-36 |
Trial protocol |
ES DE |
Global end of trial date |
22 Sep 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Jul 2016
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First version publication date |
06 Aug 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CIGE025C2303
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00500539 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Novartis Pharma AG
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Sponsor organisation address |
CH-4002, Basel, Switzerland,
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Public contact |
Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
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Scientific contact |
Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
22 Sep 2008
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Sep 2008
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective was to assess the immunogenic potential of omalizumab liquid when administered over a period of 6 months (24 weeks) to omalizumab naive, moderate to severe persistent allergic asthma subjects aged 12 years or older.
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed and that are consistent with Good Clinical Practice and applicable regulations. Rescue medication, as recommended by the treating physician based on asthma management standard of care, was permitted. Systemic corticosteroids were permitted after the screening visit for the treatment of asthma exacerbations during the study.
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Background therapy |
Patients were allowed to continue using their own standard of care for asthma management. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Jul 2007
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 112
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Country: Number of subjects enrolled |
Spain: 1
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Country: Number of subjects enrolled |
Germany: 42
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Worldwide total number of subjects |
155
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EEA total number of subjects |
43
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
13
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Adults (18-64 years) |
135
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From 65 to 84 years |
7
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted at 42 centres in 3 countries. | ||||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 266 subjects were screened, out of which 155 subjects were enrolled and treated with the study drug. The most common reasons for screening failures were unacceptable test procedure results and unacceptable laboratory values. | ||||||||||||||||||||
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Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||
Blinding implementation details |
As the current study was an open label study, this section was not applicable.
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Arms
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Arm title
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Omalizumab | ||||||||||||||||||||
Arm description |
Subjects received omalizaumab (150 milligrams (mg); 225 mg; 300 mg or 375 mg) through subcutaneous (s.c) route for 2-4 weeks based on their body weight and immunoglobulin E (IgE) levels. Subjects with body-weight between 90-150 kilograms (kg), received 300 mg of omalizumab for 4 weeks (if pre-treatment IgE level was between 30-100 international units per milliltres [IU/mL]) and for 2 weeks (if pre-treatment IgE level was between 200-300 IU/mL). | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Omalizumab
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Investigational medicinal product code |
IGE025
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Omalizumab 150 mg, 225mg, 300 mg or 375 mg was administered in pre-filled syringes containing either 75 mg/0.5 mL or 150 mg/1.0 mL.
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Baseline characteristics reporting groups
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Reporting group title |
Overall study
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Omalizumab
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Reporting group description |
Subjects received omalizaumab (150 milligrams (mg); 225 mg; 300 mg or 375 mg) through subcutaneous (s.c) route for 2-4 weeks based on their body weight and immunoglobulin E (IgE) levels. Subjects with body-weight between 90-150 kilograms (kg), received 300 mg of omalizumab for 4 weeks (if pre-treatment IgE level was between 30-100 international units per milliltres [IU/mL]) and for 2 weeks (if pre-treatment IgE level was between 200-300 IU/mL). | ||
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End point title |
Number of subjects with human anti-human antibody (HAHA) positive result at the end of 16 week follow-up period [1] | ||||||||||||
End point description |
Immunogenic potential of liquid omalizumab injection was assessed based on the results of HAHA assay. HAHA was assessed using two parameters; Fab and Fc and the subjects were considered potentially HAHA positive if either Fab or Fc was greater than (>) 2.0 titer. All values more than 2.0 titer were re-assayed to obtain a confirmatory result. Confirmatory results were used to determine those subjects who were HAHA positive. The analysis was performed in safety set, defined as all subjects who received at least one dose of study drug and had at least one post-baseline safety assessment.
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End point type |
Primary
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End point timeframe |
End of 16 week follow up period (Week 41)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive summary statistics was planned for this primary outcome measure. |
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| Notes [2] - Number of subjects who had follow-up HAHA sample. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of subjects with adverse events (AEs), treatment related AEs, AEs leading to discontinuation, AEs by severity, serious adverse events (SAEs), SAEs leading to discontinuation and death during treatment period | ||||||||||||||||||||||||||
End point description |
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the subject or require medical or surgical intervention to prevent one of the aforementioned outcomes. Based on the severity, AEs were categorised into 3 types as mild, moderate and severe.Treatment related AEs or SAEs were defined as AEs or SAEs that were suspected to be related to study treatment as per investigator. Death was a fatal event leading to permanent cessations of all vital functions of the body. The analysis was performed in safety set.
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End point type |
Secondary
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End point timeframe |
24 weeks treatment period + 4 weeks for following up participants
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Number of subjects with adverse events (AEs), treatment related AEs, AEs leading to discontinuation, AEs by severity, serious adverse events (SAEs), SAEs leading to discontinuation and death during follow-up period | ||||||||||||||||||||||||||
End point description |
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the subject or require medical or surgical intervention to prevent one of the aforementioned outcomes. Based on the severity, AEs were categorised into 3 types as mild, moderate and severe.Treatment related AEs or SAEs were defined as AEs or SAEs that were suspected to be related to study treatment as per investigator. Death was a fatal event leading to permanent cessations of all vital functions of the body. The analysis was performed in safety set.
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End point type |
Secondary
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End point timeframe |
Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
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Adverse event reporting additional description |
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
11.1
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Reporting groups
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Reporting group title |
Omalizumab
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Reporting group description |
Subjects received omalizaumab (150 mg; 225 mg; 300 mg or 375 mg) through s.c route for 2-4 weeks based on their body weight and IgE levels. Subjects with body-weight between 90-150 kg, received 300 mg of omalizumab for 4 weeks (if pre-treatment IgE level was between 30-100 IU/mL) and for 2 weeks (if pre-treatment IgE level was between 200-300 IU/mL). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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15 Jun 2007 |
1. Study procedures were modified to include instructions for use of omalizumab safety syringe and skin prick testing procedures
2.Pharmacokinetic evaluation at the end of the treatment period, prior to the final dosing was added and an electrocardiogram evaluation before first dosing was included. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
