Trial Outcomes & Findings for Omalizumab in Severe and Refractory Solar Urticaria (NCT NCT02262130)
NCT ID: NCT02262130
Last Updated: 2018-10-12
Results Overview
Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting). A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD.
COMPLETED
PHASE2
10 participants
4 weeks after the end of treatment
2018-10-12
Participant Flow
Participant milestones
| Measure |
Omalizumab
Omalizumab 300 mg W0, W4 and W8
Omalizumab
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Omalizumab in Severe and Refractory Solar Urticaria
Baseline characteristics by cohort
| Measure |
Omalizumab
n=10 Participants
Omalizumab 300 mg W0, W4 and W8
Omalizumab
|
|---|---|
|
Age, Continuous
|
42.9 years
STANDARD_DEVIATION 10.52 • n=85 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=85 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=85 Participants
|
|
Region of Enrollment
France
|
10 participants
n=85 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after the end of treatmentProportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting). A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD.
Outcome measures
| Measure |
Omalizumab
n=10 Participants
Omalizumab 300 mg W0, W4 and W8
Omalizumab
|
|---|---|
|
Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)
|
2 Participants
|
SECONDARY outcome
Timeframe: 4 and 12 weeks after the end of treatmentPopulation: 1 patient withdrawn between week 12 and week 20 (discontinuation)
Proportion of patients for whom the treatment with omalizumab allowed achieving DLQI \< 6. The index extends from 0 to 30: 0 - 1 = no effect at all on patient's life / 2 - 5 = small effect on patient's life / 6 - 10 = moderate effect on patient's life / 11 - 20 = very large effect on patient's life / 21 - 30 = extremely large effect on patient's life
Outcome measures
| Measure |
Omalizumab
n=10 Participants
Omalizumab 300 mg W0, W4 and W8
Omalizumab
|
|---|---|
|
Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6
4 weeks after the end of treatment
|
4 Participants
|
|
Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6
12 weeks after the end of treatment
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after the end of treatmentProportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting). A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD.
Outcome measures
| Measure |
Omalizumab
n=9 Participants
Omalizumab 300 mg W0, W4 and W8
Omalizumab
|
|---|---|
|
Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 and 12 weeks after the end of treatmentPopulation: 1 patient withdrawn between week 12 and week 20 (discontinuation)
Proportion of patients achieving 50% improvement in solar urticaria intensity, compared to baseline, assessed by Visual Analogic Scale (scale extending from 0 to 10)
Outcome measures
| Measure |
Omalizumab
n=10 Participants
Omalizumab 300 mg W0, W4 and W8
Omalizumab
|
|---|---|
|
Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity
4 weeks after the end of treatment
|
4 Participants
|
|
Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity
12 weeks after the end of treatment
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 and 12 weeks after the end of treatmentPopulation: 1 patient withdrawn between week 12 and week 20 (discontinuation)
Proportion of patients showing no or less clinical signs or solar urticaria compared to baseline, under experimental conditions
Outcome measures
| Measure |
Omalizumab
n=10 Participants
Omalizumab 300 mg W0, W4 and W8
Omalizumab
|
|---|---|
|
Proportion of Patients Achieving Clinical Remission of Solar Urticaria
4 weeks after the end of treatment
|
3 Participants
|
|
Proportion of Patients Achieving Clinical Remission of Solar Urticaria
12 weeks after the end of treatment
|
1 Participants
|
Adverse Events
Omalizumab
Serious adverse events
| Measure |
Omalizumab
n=10 participants at risk
Omalizumab 300 mg W0, W4 and W8
Omalizumab
|
|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
10.0%
1/10 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystectomy
|
10.0%
1/10 • Number of events 1
|
Other adverse events
| Measure |
Omalizumab
n=10 participants at risk
Omalizumab 300 mg W0, W4 and W8
Omalizumab
|
|---|---|
|
Nervous system disorders
Headache
|
60.0%
6/10 • Number of events 37
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
4/10 • Number of events 16
|
|
General disorders
Asthenia
|
30.0%
3/10 • Number of events 5
|
|
General disorders
Injection site reaction
|
20.0%
2/10 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
10.0%
1/10 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Odynophagia
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Influenza
|
20.0%
2/10 • Number of events 3
|
|
Ear and labyrinth disorders
Vertigo
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • Number of events 3
|
|
Infections and infestations
Zona
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Faintness
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Iron deficiency
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Solar urticaria relapse
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Rhinitis
|
10.0%
1/10 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place