Omalizumab for Chronic Urticaria

Overseen By Jenny Stitt, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Colorado, Denver

Must be taking: Antihistamines

Must not be taking: Immunomodulators, Steroids, Omalizumab, Investigational agents

Disqualifiers: Severe asthma, Flushing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to understand why some people with Chronic Idiopathic Urticaria (CIU) respond to omalizumab (Xolair). Omalizumab is a medication that helps reduce allergic reactions by blocking a specific protein. The study will test patients' blood and skin before treatment to find predictors of response. Omalizumab (Xolair) was first approved for the treatment of this condition in 2014.

Will I have to stop taking my current medications?

The trial requires that you stop using immunomodulatory drugs, systemic steroids, and omalizumab for a certain period before starting. However, you can continue taking standard dose antihistamines.

What data supports the effectiveness of the drug Omalizumab for chronic urticaria?

Research shows that Omalizumab significantly improves symptoms and quality of life for patients with chronic urticaria, especially those who do not respond to standard treatments. Studies have found that many patients experience complete or partial relief from symptoms after a few months of treatment with Omalizumab. ^{1 2 3 4 5}

Is Omalizumab safe for treating chronic urticaria?

Omalizumab is generally considered safe for treating chronic urticaria, with most studies reporting only minor side effects. However, rare cases of allergic reactions and heart-related events have been noted. ^{3 6 7 8 9}

How is the drug omalizumab different from other treatments for chronic urticaria?

Omalizumab is unique because it is a monoclonal antibody that targets IgE, a protein involved in allergic reactions, making it effective for chronic urticaria that doesn't respond to standard antihistamines. It is particularly useful for patients with severe, antihistamine-resistant cases and has a good safety profile, although it is more expensive than other options. ^{2 3 5 9 10}

Research Team

Jenny Stitt, M.D.

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for people who have had frequent hives for at least 6 weeks and haven't seen improvement with standard allergy pills. They should be starting treatment with omalizumab (Xolair) as part of their usual care because other treatments didn't work.

Inclusion Criteria

I am starting Xolair for my severe hives that don't improve with antihistamines.

My allergy symptoms are not managed by standard antihistamines.

I have had hives for 6 weeks or more.

Exclusion Criteria

I have not used omalizumab in the last 3 months.

I have not taken any steroids in the last month.

Use of any investigational agent in the past 30 days

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants undergo baseline testing to assess innate immune markers in blood and skin before treatment

1 week

Treatment

Participants receive omalizumab (Xolair) as part of standard care to assess response

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Omalizumab

Trial Overview The study is looking into why some patients with Chronic Idiopathic Urticaria (CIU) get better when treated with omalizumab. It involves examining participants' blood and skin before they start taking the medication to find patterns predicting a good response.

Participant Groups

Group I: Omalizumab Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

In a study of 878 French patients with chronic urticaria, omalizumab (OMA) showed a longer drug survival rate compared to previous studies, with 50% of patients still on treatment 2.4 years after starting.

The main reason for discontinuing OMA was achieving well-controlled disease in 50% of patients, but many were able to restart treatment, indicating its effectiveness in managing chronic urticaria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab Drug Survival in Chronic Urticaria: A Retrospective Multicentric French Study. Litovsky, J., Hacard, F., Tétart, F., et al.[2023]

Omalizumab is an effective treatment for spontaneous chronic urticaria, demonstrating a high efficacy and excellent safety profile, but rare adverse effects can occur, including allergic reactions and cardiovascular events.

This case report highlights the first documented instance of Takotsubo syndrome occurring after omalizumab administration, suggesting a potential, albeit rare, cardiovascular risk associated with this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab induced Takotsubo syndrome: case report. Aguiar-Ricardo, I., Nunes-Ferreira, A., Roda, Â., et al.[2022]

In a study of 23 patients with chronic urticaria who were unresponsive to standard treatments, omalizumab resulted in complete or significant remission in 83% of cases, with nearly half experiencing remission within 72 hours of the first injection.

While 52% of patients reported non-serious side effects, only one patient had to stop treatment due to adverse events, indicating that omalizumab is generally safe and effective for managing chronic urticaria in real-life settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Omalizumab for the treatment of chronic urticaria: Real-life findings]. Hamelin, A., Amsler, E., Mathelier-Fusade, P., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Omalizumab Drug Survival in Chronic Urticaria: A Retrospective Multicentric French Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Omalizumab in chronic urticaria: a retrospective series of 15 cases. [2015]

3. Spain pubmed.ncbi.nlm.nih.gov

Omalizumab in the treatment of chronic urticaria. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term efficacy of fixed-dose omalizumab for patients with severe chronic spontaneous urticaria. [2015]

5. Spain pubmed.ncbi.nlm.nih.gov

Omalizumab is efficacious for management of recalcitrant, antihistamine-resistant chronic urticaria. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Omalizumab induced Takotsubo syndrome: case report. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Omalizumab for the Treatment of Chronic Idiopathic Urticaria: Systematic Review of the Literature. [2018]

8. France pubmed.ncbi.nlm.nih.gov

[Omalizumab for the treatment of chronic urticaria: Real-life findings]. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Omalizumab for chronic urticaria: a case series and overview of the literature. [2022]

10. Iran pubmed.ncbi.nlm.nih.gov

Adverse Reaction to Omalizumab in Patients with Chronic Urticaria: Flare Up or Ineffectiveness? [2022]