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Urticaria Facticia Treatment With Omalizumab (UFO) (UFO)

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ClinicalTrials.gov Identifier: NCT02169115
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : January 18, 2016
Last Update Posted : December 20, 2016
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Martin Metz, Charite University, Berlin, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Symptomatic Dermographism
Interventions Drug: Omalizumab
Drug: Placebo
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Omalizumab 150mg Omalizumab 300mg Placebo
Hide Arm/Group Description Omalizumab: 150mg, s.c., every 4 weeks Omalizumab: 300mg, s.c., every 4 weeks Placebo: Placebo, s.c., every 4 weeks
Period Title: Overall Study
Started 19 21 21
Completed 19 21 21
Not Completed 0 0 0
Arm/Group Title Omalizumab 150mg Omalizumab 300mg Placebo Total
Hide Arm/Group Description Omalizumab: 150mg, s.c., every 4 weeks Omalizumab: 300mg, s.c., every 4 weeks Placebo: Placebo, s.c., every 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 19 21 21 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 21 participants 21 participants 61 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
 100.0%
21
 100.0%
21
 100.0%
61
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 21 participants 21 participants 61 participants
Female
13
  68.4%
9
  42.9%
12
  57.1%
34
  55.7%
Male
6
  31.6%
12
  57.1%
9
  42.9%
27
  44.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Germany Number Analyzed 19 participants 21 participants 21 participants 61 participants
19 21 21 61
1.Primary Outcome
Title Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo
Hide Description Patients receive provocation test by FricTest (standardized stroking of the skin). FricTest ratings are from 0 (no wheal development to the longest pin) to 4 (wheal development to all four pins). The development of wheals within 30 minutes after provocation is monitored.
Time Frame 70 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omalizumab 150mg Omalizumab 300mg Placebo
Hide Arm/Group Description:
Omalizumab: 150mg, s.c., every 4 weeks
Omalizumab: 300mg, s.c., every 4 weeks
Placebo: Placebo, s.c., every 4 weeks
Overall Number of Participants Analyzed 19 21 21
Mean (Standard Deviation)
Unit of Measure: wheal development up to four pins
-1.8  (1.7) -2.0  (1.8) -0.6  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omalizumab 150mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.8
Parameter Dispersion
Type: Standard Deviation
Value: 1.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Omalizumab 300mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.0
Parameter Dispersion
Type: Standard Deviation
Value: 1.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.6
Parameter Dispersion
Type: Standard Deviation
Value: 1.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life
Hide Description Change in quality of life scores assessed by Dermatology Life Quality Index (DLQI) and UF specific life quality questions from baseline to day 70 after treatment with omalizumab compared to placebo.
Time Frame 70 days
Outcome Measure Data Not Reported
3.Secondary Outcome
Title To Assess the Effects of Omalizumab in UF Patients on Number of Symptom Free Days
Hide Description Change in number of symptom free days as assessed by a patient diary from baseline to day 70 after treatment with omalizumab compared to placebo
Time Frame 70 days
Outcome Measure Data Not Reported
4.Secondary Outcome
Title To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity
Hide Description Change in physician global assessment of disease severity assessed by visual analogue scale by a physician from baseline to day 70 after treatment with omalizumab compared to placebo.
Time Frame 70 days
Outcome Measure Data Not Reported
5.Secondary Outcome
Title To Assess the Effects of Omalizumab in UF Patients on Patient Global Assessment of Disease Severity
Hide Description Change in patient global assessment of disease severity assessed by visual analogue scale by the patient from baseline to day 70 after treatment with omalizumab compared to placebo.
Time Frame 70 days
Outcome Measure Data Not Reported
6.Secondary Outcome
Title To Assess Long-term Effects of Omalizumab in UF Patients
Hide Description 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
Time Frame 112 days
Outcome Measure Data Not Reported
7.Secondary Outcome
Title To Assess the Safety of Omalizumab in UF Patients
Hide Description Safety of patients treated with omalizumab: This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting
Time Frame 112 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omalizumab 150mg Omalizumab 300mg Placebo
Hide Arm/Group Description Omalizumab: 150mg, s.c., every 4 weeks Omalizumab: 300mg, s.c., every 4 weeks Placebo: Placebo, s.c., every 4 weeks
All-Cause Mortality
Omalizumab 150mg Omalizumab 300mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Omalizumab 150mg Omalizumab 300mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/19 (5.26%)   1/21 (4.76%)   1/21 (4.76%) 
Renal and urinary disorders       
Unspecified renal colic  0/19 (0.00%)  0/21 (0.00%)  1/21 (4.76%) 
Acute cystitis  0/19 (0.00%)  1/21 (4.76%)  0/21 (0.00%) 
Surgical and medical procedures       
inguinal hernia  1/19 (5.26%)  0/21 (0.00%)  0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Omalizumab 150mg Omalizumab 300mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/19 (94.74%)   15/21 (71.43%)   18/21 (85.71%) 
General disorders       
Headache  6/19 (31.58%)  9/21 (42.86%)  10/21 (47.62%) 
Respiratory, thoracic and mediastinal disorders       
Upper respiratory tract  12/19 (63.16%)  6/21 (28.57%)  8/21 (38.10%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Martin Metz
Organization: Charité- Dpt. of Dermatology and Allergy
Phone: +49 30 450 518 159
EMail: martin.metz@charite.de
Layout table for additonal information
Responsible Party: Martin Metz, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02169115     History of Changes
Other Study ID Numbers: CIGE025EDE17T
2011-005615-87 ( EudraCT Number )
First Submitted: June 12, 2014
First Posted: June 20, 2014
Results First Submitted: October 28, 2015
Results First Posted: January 18, 2016
Last Update Posted: December 20, 2016