Trial · NCT02169115

Urticaria Facticia Treatment With Omalizumab (UFO)

NCT02169115, Phase 2, Completed, Charite University, Berlin, Germany; results first posted 2016-01-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Urticaria Facticia Treatment With Omalizumab (UFO). Trials, record NCT02169115. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02169115

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Urticaria Facticia Treatment With Omalizumab (UFO)
NCT number: NCT02169115
Status: Completed
Phases: Phase 2
Enrollment: 61 participants, actual
Lead sponsor: Charite University, Berlin, Germany
Conditions: Symptomatic Dermographism
Interventions: Omalizumab, Omalizumab, Placebo
First posted: 2014-06-20
Last updated: 2020-11-03
Other registries' IDs: eudract:2011-005615-87
Results first posted: 2016-01-18

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo	70 days	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.
Secondary	To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life	70 days	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. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percantage of the maximum possible score of 30.
Secondary	To Assess the Effects of Omalizumab in UF Patients on Number of Symptom Free Days	70 days	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
Secondary	To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity	70 days	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. VAS are measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients. The scale ranges from a minimum of 0 and a maximum of 10. The higher the score, the worse the outcome.
Secondary	To Assess the Effects of Omalizumab in UF Patients on Patient Global Assessment of Disease Severity	70 days	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. VAS are measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients. The scale ranges from a minimum of 0 and a maximum of 10. The higher the score, the worse the outcome.
Secondary	To Assess Long-term Effects of Omalizumab in UF Patients	112 days	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
Secondary	Number of Participants With Serious Adverse Events and Adverse Events	112 days	Safety of patients treated with omalizumab: This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo	70 days		wheal development up to four pins	MEAN
SECONDARY	To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life	70 days		Dermatology quality of life score	MEAN
SECONDARY	To Assess the Effects of Omalizumab in UF Patients on Number of Symptom Free Days	70 days	Data were not collected.
SECONDARY	To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity	70 days		units on a sclae	MEAN
SECONDARY	To Assess the Effects of Omalizumab in UF Patients on Patient Global Assessment of Disease Severity	70 days	Data were not collected.
SECONDARY	To Assess Long-term Effects of Omalizumab in UF Patients	112 days		Fric Test grades	MEAN
SECONDARY	Number of Participants With Serious Adverse Events and Adverse Events	112 days		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo	Omalizumab 150mg	-1.8	Standard Deviation 1.7	wheal development up to four pins
Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo	Omalizumab 300mg	-2.0	Standard Deviation 1.8	wheal development up to four pins
Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo	Placebo	-0.6	Standard Deviation 1.4	wheal development up to four pins
To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life	Omalizumab 150mg	-6.611	Standard Error 1.234	Dermatology quality of life score
To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life	Omalizumab 300mg	-5.579	Standard Error 1.478	Dermatology quality of life score
To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life	Placebo	-2.316	Standard Error 0.949	Dermatology quality of life score
To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity	Omalizumab 150mg	21.8	Standard Error 3.63	units on a sclae
To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity	Omalizumab 300mg	28.33	Standard Error 6.23	units on a sclae
To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity	Placebo	40.32	Standard Error 6.162	units on a sclae
To Assess Long-term Effects of Omalizumab in UF Patients	Omalizumab 150mg	-1.0556	Standard Deviation 1.39209	Fric Test grades

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Omalizumab 150mg	19
Overall Study	STARTED	Omalizumab 300mg	21
Overall Study	STARTED	Placebo	21
Overall Study	COMPLETED	Omalizumab 150mg	19
Overall Study	COMPLETED	Omalizumab 300mg	21
Overall Study	COMPLETED	Placebo	21
Overall Study	NOT COMPLETED	Omalizumab 150mg	0
Overall Study	NOT COMPLETED	Omalizumab 300mg	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events15

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	General disorders	Omalizumab 150mg	6	19
other	Headache	General disorders	Omalizumab 300mg	9	21
other	Headache	General disorders	Placebo	10	21
other	Upper respiratory tract	Respiratory, thoracic and mediastinal disorders	Omalizumab 150mg	12	19
other	Upper respiratory tract	Respiratory, thoracic and mediastinal disorders	Omalizumab 300mg	6	21
other	Upper respiratory tract	Respiratory, thoracic and mediastinal disorders	Placebo	8	21
serious	inguinal hernia	Surgical and medical procedures	Omalizumab 150mg	1	19
serious	inguinal hernia	Surgical and medical procedures	Omalizumab 300mg	0	21
serious	inguinal hernia	Surgical and medical procedures	Placebo	0	21
serious	Unspecified renal colic	Renal and urinary disorders	Omalizumab 150mg	0	19

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Omalizumab 150mg
Total, all-cause mortality	Omalizumab 300mg
Total, all-cause mortality	Placebo
Total, other adverse events	Omalizumab 150mg	18	19
Total, other adverse events	Omalizumab 300mg	15	21
Total, other adverse events	Placebo	18	21
Total, serious adverse events	Omalizumab 150mg	1	19
Total, serious adverse events	Omalizumab 300mg	1	21
Total, serious adverse events	Placebo	1	21

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28389391	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02169115

GET https://conductscience.org/api/trials/v1/NCT02169115/registered

API reference For AI assistants