Clinical Trial Results:
A multicenter, randomized, double-blind, placebo-controlled 12-week, parallel-group study with a 6 week follow up period to demonstrate efficacy and safety of subcutaneous Omalizumab in patients with urticaria factitia refractory to standard treatment
Summary
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EudraCT number |
2011-005615-87 |
Trial protocol |
DE |
Global end of trial date |
25 Mar 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Sep 2021
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First version publication date |
16 Sep 2021
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Other versions |
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Summary report(s) |
Symptomatic dermographism patients Symptomatic dermographism patients Publication |
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 |
CIGE025EDE17T
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Additional study identifiers
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ISRCTN number |
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US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin
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Sponsor organisation address |
Charitéplatz 1, Berlin, Germany, 10117
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Public contact |
Hesna Gözlükaya, Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin, 49 30450518296, hesna.goezluekaya@charite.de
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Scientific contact |
Hesna Gözlükaya, Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin, 49 30450518296, hesna.goezluekaya@charite.de
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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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Dec 2014
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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 |
25 Mar 2015
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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 |
To assess the effects of 150 and 300 mg omalizumab on wheal development in patients with urticaria factitia
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Protection of trial subjects |
Omalizumab (Xolair®) is a recombinant humanized monoclonal antibody that binds to IgE at its binding site to FcεRI. Omalizumab is currently indicated in patients with moderate to severe allergic asthma, 12 years and older. Up to now, more than 100,000 patients have been treated with omalizumab worldwide. Free IgE levels fall between 89-98% over 16 to 24 weeks of therapy. Associated with the fall in free IgE levels is a down-regulation in the expression of FcεRI receptors on basophils and mast cells. This mechanism of action is postulated to account for the reduction of exacerbations and symptoms of allergic asthma. In the EU, omalizumab is licensed for severe allergic asthma, while there is an expanded indication to moderate allergic asthma in the USA.
Safety parameters were documented at each study visit and reported accordingly. Safety parameters included adverse events, laboratory values, clinical monitoring, and prescribed clinic visits.
There were no significant differences in the frequency of occurrence of adverse events or other unexpected events between the omalizumab groups and the placebo group.
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Background therapy |
No backround therapy | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Jul 2012
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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 |
Germany: 61
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Worldwide total number of subjects |
61
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EEA total number of subjects |
61
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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) |
0
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Adults (18-64 years) |
50
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From 65 to 84 years |
11
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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 3 study centers in Germany, between December 2012 (first patient first visit) and December 2014 (last patient last visit). | ||||||||||||
Pre-assignment
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Screening details |
60 patients with chronic urticaria factitia were planned, 61 were randomized, all 61 were analyzed regarding safety and 55 regarding efficacy. A total of 61 subjects entered the screening period (up to 2 weeks). All 61 subjects were randomized and received at least (two) dose of study drug. | ||||||||||||
Pre-assignment period milestones
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Number of subjects started |
61 | ||||||||||||
Number of subjects completed |
61 | ||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Omalizumab 150mg | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Omalizumab 150mg
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Investigational medicinal product code |
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Other name |
Xolair
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Pharmaceutical forms |
Suspension for emulsion for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Drug: Omalizumab
150mg, s.c., every 4 weeks
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Arm title
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Omalizumab 300mg | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Active comparator | ||||||||||||
Investigational medicinal product name |
Omalizumab
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Investigational medicinal product code |
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Other name |
Xolair
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Omalizumab
150mg, s.c., every 4 weeks
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Arm title
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Placebo | ||||||||||||
Arm description |
- | ||||||||||||
Arm type |
Placebo | ||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Drug: Placebo
Placebo, s.c., every 4 weeks
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Baseline characteristics reporting groups
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Reporting group title |
Omalizumab 150mg
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Omalizumab 300mg
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Omalizumab 150mg
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Reporting group description |
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Reporting group title |
Omalizumab 300mg
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Reporting group description |
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Reporting group title |
Placebo
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Reporting group description |
- |
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End point title |
Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo [1] | ||||||||||||||||
End point description |
every 4 weeks
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End point type |
Primary
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End point timeframe |
70 days
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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: See manuskript |
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No statistical analyses for this end point |
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End point title |
To assess the effects of omalizumab in urticaria factitia patients on quality of life | ||||||||||||||||
End point description |
every 4 weeks
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End point type |
Secondary
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End point timeframe |
70 days
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No statistical analyses for this end point |
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End point title |
To assess the effects of omalizumab in UF patients on physician global assessment of disease severity | ||||||||||||||||
End point description |
every 4 weeks
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End point type |
Secondary
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End point timeframe |
70 days
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Notes [2] - Data were not collected |
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No statistical analyses for this end point |
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End point title |
To assess long-term effects of omalizumab in UF patients, change in friction thresholds from day 70 (week 10) to day 112 (week 16) will be assessed | ||||||||||||||||
End point description |
every 4 weeks
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End point type |
Secondary
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End point timeframe |
112 days
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No statistical analyses for this end point |
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End point title |
Number of Participants with Serious Adverse Events and Adverse Events | ||||||||||||||||
End point description |
every 4 weeks
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End point type |
Secondary
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End point timeframe |
112
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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 |
During the whole trial
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
no dictionary used | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Omalizumab 150mg
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Omalizumab 300mg
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
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 |