Solar UrticariaPhase 2XOLUSNCT02262130
Omalizumab in Severe and Refractory Solar Urticaria
A Phase 2 study testing Omalizumab in people with Solar Urticaria, run by Centre Hospitalier Universitaire de Besancon at 13 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solar Urticaria
- What is being tested?
- Omalizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 13 sitesFrance
- Study dates
- 30 Sep 2014to 29 Sep 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Contra indication to omalizumab
- Previous treatment with omalizumab
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU de Angers
Angers
Dermatology department, Centre Hospitalier Régional Universitaire
Besançon
CHU de Caen
Caen
CHU de Dijon
Dijon
CHU de Grenoble
Grenoble
CHRU de Lille
Lille
CHU de Limoges
Limoges
CHU de Montpellier
Montpellier
CHU de Nancy
Nancy
Dermatology department, Hôpital Saint-Louis
Paris
CHU de Reims
Reims
CHU de Rennes
Rennes
CHU de Toulouse
Toulouse
About this study
Official title: Phase 2 Multicentric Study Evaluating the Efficacy of Omalizumab in Idiopathic Severe and Refractory Solar Urticaria
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.
Read the 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.
- Conditions
- Solar Urticaria
- Being tested
- Omalizumab
- Keywords
- Omalizumab, Efficacy, Safety
- Medical subject headings
- Urticaria, Solar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Experimental | Omalizumab 300 mg W0, W4 and W8 Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after the end of treatment
Secondary outcomes (4)
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
Measured: 4 and 12 weeks after the end of treatment
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.
Measured: 12 weeks after the end of treatment
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)
Measured: 4 and 12 weeks after the end of treatment
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
Measured: 4 and 12 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study start30 Sep 2014
- Primary completion29 Sep 2015
- Study completion29 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solar UrticariaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Manuelle Viguier, MD, PhD, Principal investigator, Assistance Publique-Hôpitaux de Paris, Université Paris 7François AUBIN, Prof., Principal investigator, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262130
- Sponsor's protocol ID
- P/2013/209
- Acronym
- XOLUS
- Status last verified
- Oct 2018
- First submitted
- 7 Oct 2014
- Last updated
- 12 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Multicentric Study Evaluating the Efficacy of Omalizumab in Idiopathic Severe and Refractory Solar Urticaria
- ClinicalTrials.gov ID
- NCT02262130
- Acronym / sponsor ID
- XOLUS / P/2013/209
- Conditions
- Solar Urticaria
- Keywords
- Omalizumab, Efficacy, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 30 Sep 2014 (actual)
- Primary completion
- 29 Sep 2015 (actual)
- Study completion
- 29 Sep 2015 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Posted 12 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | Experimental | Drug: OmalizumabOmalizumab 300 mg W0, W4 and W8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Refractory criteria:
Key exclusion criteria (2 listed)
- Contra indication to omalizumab
- Previous treatment with omalizumab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omalizumab | Drug | Omalizumab |
Primary outcome
Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)
Time frame: 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.
4 secondary outcomes
Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6
Time frame: 4 and 12 weeks after the end of treatment
Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)
Time frame: 12 weeks after the end of treatment
Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity
Time frame: 4 and 12 weeks after the end of treatment
Proportion of Patients Achieving Clinical Remission of Solar Urticaria
Time frame: 4 and 12 weeks after the end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Active, not recruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuelle Viguier, MD, PhD principal investigator
Assistance Publique-Hôpitaux de Paris, Université Paris 7
François AUBIN, Prof. principal investigator
Centre Hospitalier Universitaire de Besancon
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omalizumab in people with Solar Urticaria, run by Centre Hospitalier Universitaire de Besancon at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting) (time frame: 4 weeks after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.