Solar Urticaria
Conditions
Keywords
Omalizumab, Efficacy, Safety
Brief summary
Solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and with anti H1 histamines. Nevertheless, some cases can be severe and refractory to this usual treatment, leading to a large impact on quality of life. New treatment options are warranted. The investigators aim to test the efficacy and the safety of omalizumab, an anti-IgE antibody recently approved in chronic spontaneous urticaria, in this setting.
Detailed description
This is an open-labelled multicentric phase II study testing the efficacy and the safety of omalizumab 300 mg (W0, W4 and W8) in patients affected with severe and refractory solar urticaria.
Interventions
DRUGOmalizumab
Sponsors
Novartis
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> or equal to 18 years, * Appearance of wheals within 15 min after sun exposure and lasting \< 2 hr in the shade, * Wheals reproducible with phototesting: appearance after exposure to UVB, UVA or visible light less than 30 min after exposure and lasting \< 2 hr, * Severity criteria: * Very large effect on quality of life, with Dermatology Life Quality Index (DLQI) \> 10, and * At least 1 of the following: involvement of the face, per annual eruption, extension of wheals on the non-photoexposed skin, SU triggered by artificial light, SU flares accompanied by bronchospasm or syncope. * Refractory criteria: * Resistance to photoprotection with sunscreen with sun protection factor ≥ 50, and * Resistance to administration of an association of 2 different antihistamines during 3 months or to photodesensitization.
Exclusion criteria
* Contra indication to omalizumab * Previous treatment with omalizumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting) | 4 weeks after the end of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6 | 4 and 12 weeks after the end of treatment | 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 |
| Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting) | 12 weeks after the end of treatment | 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. |
| Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity | 4 and 12 weeks after the end of treatment | Proportion of patients achieving 50% improvement in solar urticaria intensity, compared to baseline, assessed by Visual Analogic Scale (scale extending from 0 to 10) |
| Proportion of Patients Achieving Clinical Remission of Solar Urticaria | 4 and 12 weeks after the end of treatment | Proportion of patients showing no or less clinical signs or solar urticaria compared to baseline, under experimental conditions |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omalizumab Omalizumab 300 mg W0, W4 and W8
Omalizumab | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Omalizumab |
|---|---|
| Age, Continuous | 42.9 years STANDARD_DEVIATION 10.52 |
| Region of Enrollment France | 10 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 10 |
| serious Total, serious adverse events | 2 / 10 |
Outcome results
Primary
Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)
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.
Time frame: 4 weeks after the end of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Omalizumab | Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting) | 2 Participants |
Secondary
Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity
Proportion of patients achieving 50% improvement in solar urticaria intensity, compared to baseline, assessed by Visual Analogic Scale (scale extending from 0 to 10)
Time frame: 4 and 12 weeks after the end of treatment
Population: 1 patient withdrawn between week 12 and week 20 (discontinuation)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Omalizumab | Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity | 4 weeks after the end of treatment | 4 Participants |
| Omalizumab | Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity | 12 weeks after the end of treatment | 0 Participants |
Secondary
Proportion of Patients Achieving Clinical Remission of Solar Urticaria
Proportion of patients showing no or less clinical signs or solar urticaria compared to baseline, under experimental conditions
Time frame: 4 and 12 weeks after the end of treatment
Population: 1 patient withdrawn between week 12 and week 20 (discontinuation)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Omalizumab | Proportion of Patients Achieving Clinical Remission of Solar Urticaria | 4 weeks after the end of treatment | 3 Participants |
| Omalizumab | Proportion of Patients Achieving Clinical Remission of Solar Urticaria | 12 weeks after the end of treatment | 1 Participants |
Secondary
Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6
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
Time frame: 4 and 12 weeks after the end of treatment
Population: 1 patient withdrawn between week 12 and week 20 (discontinuation)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Omalizumab | Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6 | 12 weeks after the end of treatment | 1 Participants |
| Omalizumab | Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6 | 4 weeks after the end of treatment | 4 Participants |
Secondary
Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)
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.
Time frame: 12 weeks after the end of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Omalizumab | Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting) | 0 Participants |