Trial Outcomes & Findings for Urticaria Facticia Treatment With Omalizumab (UFO) (NCT NCT02169115)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

70 days

Results posted on

2020-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	Omalizumab 150mg Omalizumab: 150mg, s.c., every 4 weeks	Omalizumab 300mg Omalizumab: 300mg, s.c., every 4 weeks	Placebo Placebo: Placebo, s.c., every 4 weeks
Overall Study STARTED	19	21	21
Overall Study COMPLETED	19	21	21
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Urticaria Facticia Treatment With Omalizumab (UFO)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Omalizumab 150mg n=19 Participants Omalizumab: 150mg, s.c., every 4 weeks	Omalizumab 300mg n=21 Participants Omalizumab: 300mg, s.c., every 4 weeks	Placebo n=21 Participants Placebo: Placebo, s.c., every 4 weeks	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	21 Participants n=7 Participants	21 Participants n=5 Participants	61 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	34 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	12 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Region of Enrollment Germany	19 participants n=5 Participants	21 participants n=7 Participants	21 participants n=5 Participants	61 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Omalizumab 150mg n=19 Participants Omalizumab: 150mg, s.c., every 4 weeks	Omalizumab 300mg n=21 Participants Omalizumab: 300mg, s.c., every 4 weeks	Placebo n=21 Participants Placebo: Placebo, s.c., every 4 weeks
Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo	-1.8 wheal development up to four pins Standard Deviation 1.7	-2.0 wheal development up to four pins Standard Deviation 1.8	-0.6 wheal development up to four pins Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Omalizumab 150mg n=19 Participants Omalizumab: 150mg, s.c., every 4 weeks	Omalizumab 300mg n=21 Participants Omalizumab: 300mg, s.c., every 4 weeks	Placebo n=21 Participants Placebo: Placebo, s.c., every 4 weeks
To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life	-6.611 Dermatology quality of life score Standard Error 1.234	-5.579 Dermatology quality of life score Standard Error 1.478	-2.316 Dermatology quality of life score Standard Error 0.949

SECONDARY outcome

Timeframe: 70 days

Population: Data were not collected.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Omalizumab 150mg n=18 Participants Omalizumab: 150mg, s.c., every 4 weeks	Omalizumab 300mg n=19 Participants Omalizumab: 300mg, s.c., every 4 weeks	Placebo n=20 Participants Placebo: Placebo, s.c., every 4 weeks
To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity	21.8 units on a sclae Standard Error 3.63	28.33 units on a sclae Standard Error 6.23	40.32 units on a sclae Standard Error 6.162

SECONDARY outcome

Timeframe: 70 days

Population: Data were not collected.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Omalizumab 150mg n=18 Participants Omalizumab: 150mg, s.c., every 4 weeks	Omalizumab 300mg n=19 Participants Omalizumab: 300mg, s.c., every 4 weeks	Placebo n=18 Participants Placebo: Placebo, s.c., every 4 weeks
To Assess Long-term Effects of Omalizumab in UF Patients	-1.0556 Fric Test grades Standard Deviation 1.39209	-0.8421 Fric Test grades Standard Deviation 1.77210	-0.8333 Fric Test grades Standard Deviation 1.50489

SECONDARY outcome

Timeframe: 112 days

Safety of patients treated with omalizumab: This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting

Outcome measures

Outcome measures
Measure	Omalizumab 150mg n=19 Participants Omalizumab: 150mg, s.c., every 4 weeks	Omalizumab 300mg n=21 Participants Omalizumab: 300mg, s.c., every 4 weeks	Placebo n=21 Participants Placebo: Placebo, s.c., every 4 weeks
Number of Participants With Serious Adverse Events and Adverse Events Patients with serious adverse events	1 Participants	1 Participants	1 Participants
Number of Participants With Serious Adverse Events and Adverse Events Patients with adverse events	17 Participants	17 Participants	19 Participants

Adverse Events

Omalizumab 150mg

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Omalizumab 300mg

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Omalizumab 150mg n=19 participants at risk Omalizumab: 150mg, s.c., every 4 weeks	Omalizumab 300mg n=21 participants at risk Omalizumab: 300mg, s.c., every 4 weeks	Placebo n=21 participants at risk Placebo: Placebo, s.c., every 4 weeks
Surgical and medical procedures inguinal hernia	5.3% 1/19	0.00% 0/21	0.00% 0/21
Renal and urinary disorders Unspecified renal colic	0.00% 0/19	0.00% 0/21	4.8% 1/21
Renal and urinary disorders Acute cystitis	0.00% 0/19	4.8% 1/21	0.00% 0/21

Other adverse events

Other adverse events
Measure	Omalizumab 150mg n=19 participants at risk Omalizumab: 150mg, s.c., every 4 weeks	Omalizumab 300mg n=21 participants at risk Omalizumab: 300mg, s.c., every 4 weeks	Placebo n=21 participants at risk Placebo: Placebo, s.c., every 4 weeks
General disorders Headache	31.6% 6/19	42.9% 9/21	47.6% 10/21
Respiratory, thoracic and mediastinal disorders Upper respiratory tract	63.2% 12/19	28.6% 6/21	38.1% 8/21

Additional Information

Professor Martin Metz

Charité- Dpt. of Dermatology and Allergy

Phone: +49 30 450 518 159

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place