Cold Urticaria Treatment With Xolair (CUTEX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Martin Metz, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01580592
First received: April 18, 2012
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

Urticaria is a very frequent skin condition characterised by transient wheal and flare type skin reactions associated with severe pruritus. Cold contact urticaria (CCU) is a frequent form of physical urticaria that is characterized by the development of wheal and flare type skin reactions due to the release of histamine and other proinflammatory mast cell mediators following exposure of the skin to cold. Among all physical urticaria subtypes the frequency of CCU varies between 5.7% and 33.8% in different studies. Physical urticarias including CCU are known to severely impair the quality of life of affected patients.

The treatment of choice in CCU, as well as in other inducible forms and spontaneous urticaria, are non-sedating H1 antihistamines. Recent data have shown that updosing of H1 blockers is significantly more effective in reducing symptoms in cold urticaria than standard-dose treatment. Thus, patients who cannot be sufficiently controlled with standard-dose antihistamines should receive high-dose H1 blockers up to 4 times the standard dose as recommended by the new international guidelines for the management of urticaria.

Previous phase II studies in patients with chronic spontaneous urticaria have shown favorable results for the treatment with omalizumab (Xolair®). Proof-of-concept data from completed studies suggest that omalizumab improves urticaria in patients with chronic spontaneous urticaria who have failed treatment with H1 antihistamines as well as those who have failed treatment with a combination of H1 and H2 antihistamines and a leukotriene receptor antagonist. In addition, two case reports of patients with severe therapy refractory CCU treated with omalizumab reported a complete response with no urticarial symptoms after cold challenge. In summary, these data suggest that omalizumab may have a beneficial effect in the treatment of CCU.


Condition Intervention Phase
Cold Contact Urticaria
Drug: Omalizumab
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Two-center, Double Blind, Placebo-controlled Study in Parallel Design to Assess the Efficacy and Safety of 150 and 300 mg Omalizumab in Subjects With Antihistamine-resistant Cold Contact Urticaria (CCU)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Change in critical temperature thresholds (CTT) from baseline to day 70 after treatment with omalizumab compared to placebo [ Time Frame: day 70 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of patients treated with omalizumab: This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting [ Time Frame: day 70 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omalizumab 150mg Drug: Omalizumab
150mg, s.c., every 4 weeks
Other Name: Xolair
Experimental: Omalizumab 300mg Drug: Omalizumab
300mg, s.c., every 4 weeks
Other Name: Xolair
Placebo Comparator: Placebo Drug: Placebo
Placebo, s.c., every 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (18 years or older)
  • Informed consent signed and dated
  • Able to read, understand and willing to sign the informed consent form and abide with study procedures
  • Diagnosis of CCU lasting for at least 6 months
  • Willing, committed and able to return for all clinic visits and complete all study-related procedures, including willingness to have SC injections administered by a qualified person
  • In females of childbearing potential: Negative pregnancy test; females willing to use highly effective contraception (Pearl-Index < 1). A woman will be considered not of childbearing potential if she is post-menopausal for greater than two years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
  • No participation in other clinical trials 4 weeks before and after participation in this study

Exclusion Criteria:

  • Patients with acute urticaria
  • Concurrent/ongoing treatment with immunosuppressives (e.g. systemic steroids, cyclosporine, methotrexate, dapsone or others) within 4 weeks or 5 half lives prior to day 0, whichever is longer
  • Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
  • Significant concomitant illness that would adversely affect the subject's participation or evaluation in this study
  • History of malignancies within five years prior to screening other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cancer
  • Presence of clinically significant laboratory abnormalities
  • Lactating females or pregnant females
  • Subjects for whom there is concern about compliance with the protocol procedures
  • Any medical condition which, in the opinion of the Investigator, would interfere with participation in the study or place the subject at risk
  • History of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) within the last 5 years that could limit the subject's ability to comply with study procedures
  • Subjects who are detained officially or legally to an official institute
  • Previous use of omalizumab within the last 6 months
  • Intake of antihistamines or leukotriene antagonists within 7 days prior to visit 1
  • Intake of oral corticosteroids within 14 days prior to visit 1
  • Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study
  • Known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication or drugs related to omalizumab (e.g.: monoclonal antibodies, polyclonal gammaglobulin)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580592

Contacts
Contact: Martin Metz, MD +49 30 450 518 ext 159 martin.metz@charite.de
Contact: Hesna Gözlükaya +49 30 450 618 ext 296 hesna.goezluekaya@charite.de

Locations
Germany
University Aachen Recruiting
Aachen, Germany
Contact: Hans merk, Professor       Hans.Merk@post.rwth-aachen.de   
Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Hautklinik Mainz Recruiting
Mainz, Germany
Contact: Petra Staubach, MD       petra.staubach@unimedizin-mainz.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Novartis Pharmaceuticals
Investigators
Principal Investigator: Martin Metz, MD Charité
  More Information

No publications provided

Responsible Party: Martin Metz, Professor, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01580592     History of Changes
Other Study ID Numbers: CIGE025EDE14T
Study First Received: April 18, 2012
Last Updated: June 11, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on October 16, 2014