Clinical Trial Results:
Multicenter randomized, double-blind, placebo-controlled parallel clinical trial to assess efficacy and safety of Omalizumab (Xolair®) in a new indication: cholinergic urticaria.
|
Summary
|
|
EudraCT number |
2013-002770-43 |
Trial protocol |
ES |
Global end of trial date |
22 Jun 2017
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
04 Nov 2021
|
First version publication date |
04 Nov 2021
|
Other versions |
|
Summary report(s) |
Final report summary |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
CUN-OMAL-UCOL
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Clínica Universidad de Navarra
|
||
Sponsor organisation address |
Avda. Pío XII, 36, Pamplona, Spain, 31008
|
||
Public contact |
UCEC, Clínica Universidad de Navarra, 34 948255 400, ucicec@unav.es
|
||
Scientific contact |
UCEC, Clínica Universidad de Navarra, 34 948255 400, ucicec@unav.es
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
18 Apr 2018
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
22 Jun 2017
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
22 Jun 2017
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
Our primary endpoint will be the negativization of the exercise challenge test: We will perform the exercise challenge test following the European Guidelines
|
||
Protection of trial subjects |
NA
|
||
Background therapy |
No treatment available. Antihistamines that normally control the symptoms of other types of urticaria partially relieve symptoms in cholinergic urticaria | ||
Evidence for comparator |
NA | ||
Actual start date of recruitment |
19 Dec 2013
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Spain: 22
|
||
Worldwide total number of subjects |
22
|
||
EEA total number of subjects |
22
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
3
|
||
Adults (18-64 years) |
19
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
||||||||||
|
Recruitment
|
||||||||||
Recruitment details |
Recruitment took place over two years to reach 22 evaluable patients | |||||||||
|
Pre-assignment
|
||||||||||
Screening details |
Patients with a clinical diagnosis of cholinergic urticaria by history and a positive exercise challenge test were treated with double license dose of cetirizine (20 mg) for two weeks and the exercise challenge test was repeated. If the test was again positive, they were randomized to start the study. | |||||||||
|
Pre-assignment period milestones
|
||||||||||
Number of subjects started |
22 | |||||||||
Number of subjects completed |
22 | |||||||||
|
Period 1
|
||||||||||
Period 1 title |
Treatment (overall period)
|
|||||||||
Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst | |||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
Arm A (treatment group) | |||||||||
Arm description |
This is a multicenter randomized, double-blind, placebo-controlled Parallel Clinical Trial clinical trial. If the test was positive, patients were randomized to placebo or active treatment for 12 weeks receiving a monthly dose during the blinded period. From week 16th, all patients received omalizumab and performed exercise challenge test in each visit. We followed up patients three months after the last dose performing an exercise challenge test. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Omalizumab
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for injection/infusion in pre-filled syringe
|
|||||||||
Routes of administration |
Subcutaneous use
|
|||||||||
Dosage and administration details |
It is administered subcutaneosly in the deltoid region of the arm. Te dose is 300mg. it is administered as two subcutaneous injections of 150mg in 1ml each.
|
|||||||||
|
Arm title
|
Arm B (placebo group) | |||||||||
Arm description |
This is a multicenter randomized, double-blind, placebo-controlled Parallel Clinical Trial clinical trial. If the test was positive, patients were randomized to placebo or active treatment for 12 weeks receiving a monthly dose during the blinded period. From week 16th, all patients received omalizumab and performed exercise challenge test in each visit. We followed up patients three months after the last dose performing an exercise challenge test. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Solution for injection/infusion in pre-filled syringe
|
|||||||||
Routes of administration |
Subcutaneous use
|
|||||||||
Dosage and administration details |
2ml of Physiological Saline is administered as two injections of 1ml each, subcutaneosly in the deltoid region of the upper arm. The volume to be administered is the same as that of the active treatment.
|
|||||||||
|
||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Arm A (treatment group)
|
||
Reporting group description |
This is a multicenter randomized, double-blind, placebo-controlled Parallel Clinical Trial clinical trial. If the test was positive, patients were randomized to placebo or active treatment for 12 weeks receiving a monthly dose during the blinded period. From week 16th, all patients received omalizumab and performed exercise challenge test in each visit. We followed up patients three months after the last dose performing an exercise challenge test. | ||
Reporting group title |
Arm B (placebo group)
|
||
Reporting group description |
This is a multicenter randomized, double-blind, placebo-controlled Parallel Clinical Trial clinical trial. If the test was positive, patients were randomized to placebo or active treatment for 12 weeks receiving a monthly dose during the blinded period. From week 16th, all patients received omalizumab and performed exercise challenge test in each visit. We followed up patients three months after the last dose performing an exercise challenge test. | ||
|
||||||||||
End point title |
negativization of the exercise challenge test | |||||||||
End point description |
Our primary endpoint will be the negativization of the exercise challenge test: We will perform the exercise challenge test following the European Guidelines
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
To better assess the safety of the medication in the indication under study, the blind clinical trial comprising 4 months will be followed by an open label period of 8 months in which all patients will receive the active drug (pharmacovigilance period)
|
|||||||||
|
||||||||||
Statistical analysis title |
Comparasion of means | |||||||||
Statistical analysis description |
Differences in the distribution of categorical variables were tested using the chi-square test or the Fisher's exact test. The correlation between negativization outcome and visit was quantified using the Spearman’s rank correlation coefficient. Statistical significance was defined using a 2-sided α level of 0.05.
|
|||||||||
Comparison groups |
Arm B (placebo group) v Arm A (treatment group)
|
|||||||||
Number of subjects included in analysis |
22
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
||||||||||
P-value |
≤ 0.05 [1] | |||||||||
Method |
Spearman’s rank correlation coefficient | |||||||||
Confidence interval |
||||||||||
| Notes [1] - We observed a significant correlation between negativization outcomes and visit (Spearman Rho: 0,65; p=0,004). We found an average negativization increase of 2.9 percentage points (IC 95%: 1,5; 4,2) per visit. |
||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
2 years
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
none | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
All the patients
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
05 Feb 2014 |
Adding new centers |
||
07 Aug 2014 |
Adding new centers |
||
26 Jan 2015 |
Adding new centers |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
