Omalizumab in Severe and Refractory Solar Urticaria

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02262130
• Date of registration: 07/10/2014
• Prospective Registration: No
• Primary sponsor: Centre Hospitalier Universitaire de Besancon
• Public title: Omalizumab in Severe and Refractory Solar Urticaria XOLUS
• Scientific title: Phase 2 Multicentric Study Evaluating the Efficacy of Omalizumab in Idiopathic Severe and Refractory Solar Urticaria
• Date of first enrolment: September 30, 2014
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02262130
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Manuelle Viguier, MD, PhD
• Affiliation: Assistance Publique-Hôpitaux de Paris, Université Paris 7

• Name: François AUBIN, Prof.
• Affiliation: Centre Hospitalier régional Universitaire de Besançon

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Solar Urticaria

Intervention(s)

Drug: Omalizumab

Primary Outcome(s)

Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting) [Time Frame: 4 weeks after the end of treatment]

Secondary Outcome(s)

Proportion of Patients Achieving Clinical Remission of Solar Urticaria [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 for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6 [Time Frame: 4 and 12 weeks after the end of treatment]

Secondary ID(s)

P/2013/209

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis

Results

• Results available: Yes
• Date Posted: 12/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02262130