Omalizumab in Severe and Refractory Solar Urticaria

NCT02262130 | Completed Phase 2 Results

• 1 other identifier: P/2013/209
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 13

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.

Conditions

Solar Urticaria

Keywords

Omalizumab; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks after the end of treatment

Secondary Outcomes (4)

• 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 With Solar Urticaria Remission Under Experimental Conditions (Phototesting)

  12 weeks after the end of treatment

• Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity

  4 and 12 weeks after the end of treatment

• Proportion of Patients Achieving Clinical Remission of Solar Urticaria

  4 and 12 weeks after the end of treatment

Study Arms (1)

Omalizumab

EXPERIMENTAL

Omalizumab 300 mg W0, W4 and W8

Drug: Omalizumab

Interventions

Omalizumab DRUG

Omalizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Contra indication to omalizumab
• Previous treatment with omalizumab

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Novartis: collaborator

Study Sites (13)

CHU de Angers

Angers, France

Location

Dermatology department, Centre Hospitalier Régional Universitaire

Besançon, France

Location

CHU de Caen

Caen, France

Location

CHU de Dijon

Dijon, France

Location

CHU de Grenoble

Grenoble, France

Location

CHRU de Lille

Lille, France

Location

CHU de Limoges

Limoges, France

Location

CHU de Montpellier

Montpellier, France

Location

CHU de Nancy

Nancy, France

Location

Dermatology department, Hôpital Saint-Louis

Paris, France

Location

CHU de Reims

Reims, France

Location

CHU de Rennes

Rennes, France

Location

CHU de Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Urticaria, Solar

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Photosensitivity Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Chronic Inducible Urticaria; Chronic Urticaria; Urticaria; Skin Diseases, Vascular; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Pr Manuelle Viguier
• Organization: CHU de Reims

mviguier@chu-reims.fr

00333 26 78 43 43

Study Officials

• Manuelle Viguier, MD, PhD

  Assistance Publique-Hôpitaux de Paris, Université Paris 7

  PRINCIPAL INVESTIGATOR

• François AUBIN, Prof.

  Centre hospitalier régional universitaire de Besançon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 10, 2014
• Study Start: September 30, 2014
• Primary Completion: September 29, 2015
• Study Completion: September 29, 2015
• Last Updated: October 12, 2018
• Results First Posted: October 12, 2018

Record last verified: 2018-10

Locations

FR (13)