Efficacy Study of Omalizumab in Cholinergic Urticaria

NCT02012387 | Completed Phase 2 DMC

• 1 other identifier: CUN-OMAL-UCOL
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate the efficacy and safety of Omalizumab in a new indication, that is cholinergic urticaria.

Conditions

Cholinergic Urticaria

Keywords

Cholinergic urticaria; Omalizumab

Outcome Measures

Primary Outcomes (1)

• Negativization of the exercise challenge test

  a. Our primary endpoint will be the negativization of the exercise challenge test: We will perform the exercise challenge test following the European Guidelines\[14\] for cholinergic urticaria. According with such guidelines, all centers will follow the same center standardized protocol. The patient will exercise in treadmill or running to the point of sweating and following for 15 more minutes, wearing warm clothing in a warm room. The test will be considered positive if exercise challenge leads to the typical rash over 10 minutes.

  It will be assessed prior to the study, and subsequently each 4 weeks up to 12 months.

Secondary Outcomes (3)

• Chonic Urticaria Quality of life

  It will be evaluated up to 48 weeks.

• Patients' card

  It will be assessed up to 48 weeks.

• Treatment drop offs in each sequence

  Up to 48 weeks.

Study Arms (3)

Active

ACTIVE COMPARATOR

Omalizumab 300 mg Subcutaneous route 300 mg dose (independent from total IgE, weight or high)

Biological: Active

Placebo

PLACEBO COMPARATOR

Placebo Saline serum Subcutaneous route 0.6 ml saline serum with same volume as an active treatment

Biological: Placebo

Open labeled

ACTIVE COMPARATOR

After the double blinded period, all patients from both arms will receive the active drug for 8 more months.

Biological: Open labeled

Interventions

Active BIOLOGICAL

Two injections will be administered every four weeks for four months, we will administer 4 doses within 16 weeks

Also known as: Biological/Vaccine: Omalizumab, Other Names:, Xolair

Active

Placebo BIOLOGICAL

Two injections will be administered every four weeks for four months, we will administer 4 doses within 16 weeks

Also known as: Biological/Vaccine: Placebo, Other Names: Saline serum

Placebo

Open labeled BIOLOGICAL

Two injections will be administered every four weeks for 8 months, we will administer 4 doses within 32 weeks

Also known as: Biological: Omalizumab, Other Names:, Xolair

Open labeled

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult female and male patients (age 14 years or older). Diagnosis of cholinergic urticaria trough clinical history and positive challenge test.
• Non-respondent to supra therapeutic doses of antihistamines (defined as 2x the maximal dose included in the drug labeling) Written informed consent.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Hospital Clinic of Barcelona: collaborator
• Hospital Universitari Joan XXIII de Tarragona.: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator
• Complejo Hospitalario de Navarra: collaborator
• Hospital Universitario Central de Asturias: collaborator
• Hospital Clínico Universitario Lozano Blesa: collaborator
• Hospital Vall d'Hebron: collaborator

Study Sites (1)

Departamento de Alergología. Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (14)

• Abajian M, Mlynek A, Maurer M. Physical urticaria. Curr Allergy Asthma Rep. 2012 Aug;12(4):281-7. doi: 10.1007/s11882-012-0269-0.

  PMID: 22653630 BACKGROUND

• Hirschmann JV, Lawlor F, English JS, Louback JB, Winkelmann RK, Greaves MW. Cholinergic urticaria. A clinical and histologic study. Arch Dermatol. 1987 Apr;123(4):462-7. doi: 10.1001/archderm.123.4.462.

  PMID: 3827277 BACKGROUND

• O'Donnell BF, Lawlor F, Simpson J, Morgan M, Greaves MW. The impact of chronic urticaria on the quality of life. Br J Dermatol. 1997 Feb;136(2):197-201.

  PMID: 9068731 BACKGROUND

• Baiardini I, Giardini A, Pasquali M, Dignetti P, Guerra L, Specchia C, Braido F, Majani G, Canonica GW. Quality of life and patients' satisfaction in chronic urticaria and respiratory allergy. Allergy. 2003 Jul;58(7):621-3. doi: 10.1034/j.1398-9995.2003.00091.x.

  PMID: 12823121 BACKGROUND

• Tlougan BE, Mancini AJ, Mandell JA, Cohen DE, Sanchez MR. Skin conditions in figure skaters, ice-hockey players and speed skaters: part II - cold-induced, infectious and inflammatory dermatoses. Sports Med. 2011 Nov 1;41(11):967-84. doi: 10.2165/11592190-000000000-00000.

  PMID: 21985216 BACKGROUND

• Zuberbier T, Munzberger C, Haustein U, Trippas E, Burtin B, Mariz SD, Henz BM. Double-blind crossover study of high-dose cetirizine in cholinergic urticaria. Dermatology. 1996;193(4):324-7. doi: 10.1159/000246281.

  PMID: 8993958 BACKGROUND

• Nakamizo S, Egawa G, Miyachi Y, Kabashima K. Cholinergic urticaria: pathogenesis-based categorization and its treatment options. J Eur Acad Dermatol Venereol. 2012 Jan;26(1):114-6. doi: 10.1111/j.1468-3083.2011.04017.x. Epub 2011 Mar 4.

  PMID: 21371134 BACKGROUND

• Haas N, Toppe E, Henz BM. Microscopic morphology of different types of urticaria. Arch Dermatol. 1998 Jan;134(1):41-6. doi: 10.1001/archderm.134.1.41.

  PMID: 9449908 BACKGROUND

• Kozaru T, Fukunaga A, Taguchi K, Ogura K, Nagano T, Oka M, Horikawa T, Nishigori C. Rapid desensitization with autologous sweat in cholinergic urticaria. Allergol Int. 2011 Sep;60(3):277-81. doi: 10.2332/allergolint.10-OA-0269. Epub 2011 Feb 25.

  PMID: 21364312 BACKGROUND

• Morales AR, Shah N, Castells M. Antigen-IgE desensitization in signal transducer and activator of transcription 6-deficient mast cells by suboptimal doses of antigen. Ann Allergy Asthma Immunol. 2005 May;94(5):575-80. doi: 10.1016/S1081-1206(10)61136-2.

  PMID: 15945561 BACKGROUND

• Metz M, Altrichter S, Ardelean E, Kessler B, Krause K, Magerl M, Siebenhaar F, Weller K, Zuberbier T, Maurer M. Anti-immunoglobulin E treatment of patients with recalcitrant physical urticaria. Int Arch Allergy Immunol. 2011;154(2):177-80. doi: 10.1159/000320233. Epub 2010 Aug 24.

  PMID: 20733327 BACKGROUND

• Sabroe RA. Failure of omalizumab in cholinergic urticaria. Clin Exp Dermatol. 2010 Jun;35(4):e127-9. doi: 10.1111/j.1365-2230.2009.03748.x. Epub 2009 Nov 19.

  PMID: 19925484 BACKGROUND

• Baiardini I, Pasquali M, Braido F, Fumagalli F, Guerra L, Compalati E, Braga M, Lombardi C, Fassio O, Canonica GW. A new tool to evaluate the impact of chronic urticaria on quality of life: chronic urticaria quality of life questionnaire (CU-QoL). Allergy. 2005 Aug;60(8):1073-8. doi: 10.1111/j.1398-9995.2005.00833.x.

  PMID: 15969690 BACKGROUND

• Gaig P, Olona M, Munoz Lejarazu D, Caballero MT, Dominguez FJ, Echechipia S, Garcia Abujeta JL, Gonzalo MA, Lleonart R, Martinez Cocera C, Rodriguez A, Ferrer M. Epidemiology of urticaria in Spain. J Investig Allergol Clin Immunol. 2004;14(3):214-20.

  PMID: 15552715 BACKGROUND

MeSH Terms

Interventions

Exercise; Biological Products; Omalizumab

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Complex Mixtures; Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: December 16, 2013
• Study Start: January 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: June 1, 2017
• Last Updated: February 12, 2019

Record last verified: 2017-04

Locations

ES (1)