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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the medication omalizumab (Xolair) works for people with Chronic Idiopathic Urticaria (CIU), a condition causing frequent itchy hives. Researchers aim to identify specific differences in participants' blood and skin that predict who will benefit from the treatment. Individuals who have experienced itchy hives for over six weeks without relief from common antihistamines might be suitable for this study. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment benefits more patients.

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 is the safety track record for this treatment?

Research has shown that omalizumab is a safe treatment for people with chronic hives. Studies have found it effective and generally well-tolerated, with most people experiencing no serious side effects. In one study, patients received omalizumab every two weeks, and it proved safe and effective. Another study confirmed its safety for long-term use. Overall, omalizumab maintains a strong safety record for treating chronic hives. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Omalizumab is unique because it targets a specific part of the immune system known as IgE, which plays a key role in allergic reactions. Most treatments for chronic urticaria, like antihistamines, focus on relieving symptoms rather than targeting the underlying cause. Omalizumab works differently by blocking IgE, potentially providing more effective and longer-lasting relief from hives. Researchers are excited about this treatment because it offers a new way to manage chronic urticaria, especially for those who don't respond well to conventional therapies.

What is the effectiveness track record for omalizumab in treating chronic urticaria?

Research has shown that omalizumab effectively treats chronic hives. In one study, 36% of patients experienced no itching or hives after using omalizumab. Another study found that by week 28, omalizumab significantly improved the quality of life for patients with chronic hives compared to those who took a placebo. Real-world evidence also supports its effectiveness in managing symptoms. This treatment has proven effective for chronic hives, making it a reliable option for those dealing with this condition. ^{2 6 7 8 9}

Who Is on the Research Team?

Jenny Stitt, M.D.

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10613187/

Omalizumab for Patients with Chronic Spontaneous Urticaria The X-ACT study (N = 91) found that by week 28, omalizumab was superior to placebo for improvement in Chronic Urticaria Quality of Life ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38513629/

Real-World Effectiveness of Omalizumab in Chronic Urticaria Conclusion: Omalizumab demonstrates efficacy in the management of CU among Chinese patients by exerting effective symptom control and ...

3. xolairhcp.com xolairhcp.com/chronic-spontaneous-urticaria/efficacy/clinical-trial-results.html

Chronic Spontaneous Urticaria (CSU) Treatment Clinical Trial ... *In Study 1, 36% of patients achieved zero itch and zero hives with XOLAIR 300 mg. In Study 2, 44% of patients achieved zero itch and zero hives with XOLAIR 300 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0365059624001910

Comparison of long term efficacy and cost-effectiveness ... The authors aimed to compare the long-term (60 months) efficacy and side effects of 150 mg and 300 mg doses of omalizumab in patients with CSU.

5. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2821286

Multinational Drug Survival Study of Omalizumab in ... This study primarily confirms the effectiveness of omalizumab in chronic urticaria by demonstrating that omalizumab discontinuation occurs ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11317055/

Omalizumab in Chronic Spontaneous Urticaria: A Real- ... In conclusion, this retrospective study suggests that omalizumab is an effective and safe treatment option for antihistamine-refractory CSU.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37634098/

Efficacy and Safety of Omalizumab Updosing in Chronic ... Treatment with omalizumab 300 mg every 2 weeks for 12 weeks led to CR in 41 patients (75.9%). Our results confirmed the efficacy and safety of ...

8. mdpi.com mdpi.com/2673-8449/5/4/33

Real-World Long-Term Management of Chronic Urticaria ... Conclusions: Omalizumab is a safe and effective treatment for chronic urticaria. Total serum IgE levels may help identify complete responders. Long-term low- ...

9. cda-amc.ca cda-amc.ca/sites/default/files/pdf/htis/2024/RE0043_CIU.pdf

Efficacy and Safety of Long-Term Use of Omalizumab for ... This study was designed to explore the impact of omalizumab on measures of quality of life (QoL), and the frequency and severity of angioedema ...