Solar UrticariaPhase 2IGUSNCT01360658
Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria
A Phase 2 study testing Intravenous immunoglobulins in people with Solar Urticaria, run by Centre Hospitalier Universitaire de Besancon at 12 sites in France.
Trial summary
Solar urticaria is a rare but debilitating disease that can severely impact the quality of life, restricting outdoor activities.Treatment, based on sun protection and anti-histaminic drugs, is efficacious in 2 patients out of 3. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Solar Urticaria
- What is being tested?
- Intravenous immunoglobulins
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 12 sitesFrance
- Study dates
- Jun 2011to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- social insurance
- signed informed consent
- solar urticaria (SU) confirmed with photoexplorations
- SU involving the face or generalized to the whole body or accompanied with bronchospasm or triggered by artificial light or per annual SU
- SU with altered quality of life
- SU resistant to photoprotection
- SU resistant to the association of two different antihistaminics during 3 months
Who cannot join
- Pregnancy
- Heat triggered urticaria
- Contra-indications to IVIG
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Regional University Hospital
Besançon, 25000
University Hospital
Caen, 14033
University Hospital
Grenoble, 38043
Regional University Hospital
Lille, 59037
University hospital
Limoges, 87042
Regional University Hospital
Montpellier, 34295
University Hospital
Nancy, 54035
University Hospital
Nîmes, 30029
Saint louis Hospital
Paris, 75475
University Hospital
Reims, 51092
University Hospital
Rennes, 35033
University Hospital
Toulouse, 31059
About this study
Official title: Phase 2 Multicentric Study Evaluating the Efficacy of Polyvalent Intravenous Immunoglobulins in Idiopathic Severe and Refractory Solar Urticaria
Solar urticaria is a rare but debilitating disease that can severely impact the quality of life, restricting outdoor activities.Treatment, based on sun protection and anti-histaminic drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization or immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7 patients, to dramatically improve 71% of patients. In an open-label prospective multicenter study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10 patients affected with severe and refractory solar urticaria.
- Conditions
- Solar Urticaria
- Being tested
- Intravenous immunoglobulins
- Keywords
- Intravenous immunoglobulins, Solar urticaria, Minimal urticaria dose, Quality of life, 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.
Intravenous immunoglobulinsDrug
Also called CLAIRYG
Single administration of 2 g/kg intravenous immunoglobulins over 2 days
| Study group | Role | What they receive |
|---|---|---|
| Intravenous immunoglobulins | Experimental | Intravenous immunoglobulins Receives: Drug: Intravenous immunoglobulins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
Measured: 3 months
Secondary outcomes (15)
Percentage of patients obtaining 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
Measured: 1 month
Percentage of patients obtaining 1 month after treatment an improvement of quality of life
Measured: 1 month
Percentage of patients obtaining after 1 month of treatment a complete clinical response
Measured: 1 month
Percentage of patients obtaining 1 month after treatment a 50% and a 75% improvement of disease severity
Measured: 1 month
Percentage of patients obtaining 6 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
Measured: 6 months
Percentage of patients obtaining 12 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
Measured: 12 months
Percentage of patients obtaining 3 months after treatment an improvement of quality of life
Measured: 3 months
Percentage of patients obtaining 6 months after treatment an improvement of quality of life
Measured: 6 months
Percentage of patients obtaining 12 months after treatment an improvement of quality of life
Measured: 12 months
Percentage of patients obtaining after 3 months of treatment a complete clinical response
Measured: 3 months
Percentage of patients obtaining after 6 months of treatment a complete clinical response
Measured: 6 months
Percentage of patients obtaining after 12 months of treatment a complete clinical response
Measured: 12 months
Percentage of patients obtaining 3 months after treatment a 50% and a 75% improvement of disease severity
Measured: 3 months
Percentage of patients obtaining 6 months after treatment a 50% and a 75% improvement of disease severity
Measured: 6 months
Percentage of patients obtaining 12 months after treatment a 50% and a 75% improvement of disease severity
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Ministry of Health, France, Saint-Louis Hospital, Paris, France
- Responsible party
- Sponsor
- Investigators
- François Aubin, Pr, Principal investigator, University Hospital of BesançonManuelle Viguier, Dr, Principal investigator, Saint-Louis Hospital, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360658
- Sponsor's protocol ID
- N/2010/57
- Acronym
- IGUS
- Status last verified
- Jul 2013
- First submitted
- 23 May 2011
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Multicentric Study Evaluating the Efficacy of Polyvalent Intravenous Immunoglobulins in Idiopathic Severe and Refractory Solar Urticaria
- ClinicalTrials.gov ID
- NCT01360658
- Acronym / sponsor ID
- IGUS / N/2010/57
- Conditions
- Solar Urticaria
- Keywords
- Intravenous immunoglobulins, Solar urticaria, Minimal urticaria dose, Quality of life, 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
- Ministry of Health, France, Saint-Louis Hospital, Paris, France
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Not posted in the source record
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 but debilitating disease that can severely impact the quality of life, restricting outdoor activities.Treatment, based on sun protection and anti-histaminic drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization or immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7 patients, to dramatically improve 71% of patients. In an open-label prospective multicenter study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10 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 |
|---|---|---|
| Intravenous immunoglobulins | Experimental | Drug: Intravenous immunoglobulinsIntravenous immunoglobulins |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- social insurance
- signed informed consent
- solar urticaria (SU) confirmed with photoexplorations
- SU involving the face or generalized to the whole body or accompanied with bronchospasm or triggered by artificial light or per annual SU
- SU with altered quality of life
Key exclusion criteria (3 listed)
- Pregnancy
- Heat triggered urticaria
- Contra-indications to IVIG
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 |
|---|---|---|
| Intravenous immunoglobulinsAlso: CLAIRYGSingle administration of 2 g/kg intravenous immunoglobulins over 2 days | Drug | Intravenous immunoglobulins |
Primary outcome
Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
Time frame: 3 months
15 secondary outcomes
Percentage of patients obtaining 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
Time frame: 1 month
Percentage of patients obtaining 1 month after treatment an improvement of quality of life
Time frame: 1 month
Percentage of patients obtaining after 1 month of treatment a complete clinical response
Time frame: 1 month
Percentage of patients obtaining 1 month after treatment a 50% and a 75% improvement of disease severity
Time frame: 1 month
Percentage of patients obtaining 6 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
Time frame: 6 months
Percentage of patients obtaining 12 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
Time frame: 12 months
Percentage of patients obtaining 3 months after treatment an improvement of quality of life
Time frame: 3 months
Percentage of patients obtaining 6 months after treatment an improvement of quality of life
Time frame: 6 months
Percentage of patients obtaining 12 months after treatment an improvement of quality of life
Time frame: 12 months
Percentage of patients obtaining after 3 months of treatment a complete clinical response
Time frame: 3 months
Percentage of patients obtaining after 6 months of treatment a complete clinical response
Time frame: 6 months
Percentage of patients obtaining after 12 months of treatment a complete clinical response
Time frame: 12 months
Percentage of patients obtaining 3 months after treatment a 50% and a 75% improvement of disease severity
Time frame: 3 months
Percentage of patients obtaining 6 months after treatment a 50% and a 75% improvement of disease severity
Time frame: 6 months
Percentage of patients obtaining 12 months after treatment a 50% and a 75% improvement of disease severity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
Related trials for Solar Urticaria
RecruitingPhase 2
Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Active, not recruitingPhase 2
A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
Hereditary Angioedema
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.
François Aubin, Pr principal investigator
University Hospital of Besançon
Manuelle Viguier, Dr principal investigator
Saint-Louis Hospital, Paris, France
12 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 Intravenous immunoglobulins in people with Solar Urticaria, run by Centre Hospitalier Universitaire de Besancon at 12 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 7 inclusion and 3 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 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose (time frame: 3 months). 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 30 Jul 2013.