Omalizumab Clinical Trials

What Is Omalizumab?

Omalizumab is an FDA-approved medication for allergic asthma. It is a recombinant humanized monoclonal antibody, meaning it is a lab-made protein designed to target a specific substance in the body. Omalizumab works by binding to Immunoglobulin E (IgE), a type of antibody involved in allergic reactions. By binding to IgE, omalizumab prevents it from attaching to certain immune cells, such as basophils and mast cells, which play a key role in releasing chemicals that cause allergic symptoms. This action helps to reduce the body's allergic response.

In addition to its approved use, omalizumab is being investigated in clinical trials for a range of other conditions. These include chronic spontaneous urticaria, various food allergies (such as peanut allergy), chronic idiopathic urticaria, nasal polyps, allergic rhinitis, and atopic dermatitis. Researchers are also exploring its potential in eosinophilic gastroenteritis, idiopathic anaphylaxis, and even certain aspects of the immune response related to COVID-19.

Uses and Conditions Under Study

Omalizumab is primarily studied for allergic and inflammatory conditions, with a focus on those driven by IgE-mediated responses.

• Asthma and Allergic Conditions: Omalizumab is FDA-approved for allergic asthma. It has been studied in 45 trials for asthma and 18 trials for allergic asthma. Research also includes allergic rhinitis (5 trials), peanut allergy (6 trials), and food allergy (13 trials), where it aims to reduce severe allergic reactions. Investigators are also exploring its use in conditions like idiopathic anaphylaxis, aspirin exacerbated respiratory disease (AERD), and animal-induced occupational asthma, where reducing IgE activity may alleviate symptoms.
• Urticaria: This medication is being investigated for chronic spontaneous urticaria (14 trials) and chronic idiopathic urticaria (6 trials). These conditions involve persistent hives and itching, and omalizumab may help by reducing the allergic mediators that contribute to these symptoms.
• Nasal and Sinus Conditions: Omalizumab is studied for nasal polyps (6 trials) and chronic rhinosinusitis (4 trials). These conditions often involve inflammation and swelling in the nasal passages, and omalizumab's anti-inflammatory effects are being evaluated.
• Skin Conditions: Atopic dermatitis, a chronic inflammatory skin condition, is being explored in 5 trials, with omalizumab aiming to reduce skin inflammation and itching.
• Gastrointestinal Conditions: Eosinophilic gastroenteritis, characterized by an increase of eosinophils in the digestive tract, is another area of study. Omalizumab may help by reducing the eosinophil counts and improving gastrointestinal symptoms.
• Other Immune Conditions: Less common areas of investigation include systemic lupus erythematosus and understanding the immune response in COVID-19, reflecting the drug's broad impact on immune system regulation.

Dosing

Omalizumab is typically administered as a subcutaneous injection. This means the medication is injected into the fat layer just under the skin, often in the arm or leg, similar to an insulin injection. After receiving the injection, participants in clinical trials are monitored for any potential side effects.

The dosage and frequency of omalizumab injections can vary depending on the condition being treated and individual patient characteristics. Various strengths have been studied, including doses based on body weight, such as 5 mg/kg and 15 mg/kg. Other studied doses include 75 mg, 150 mg, 300 mg, 450 mg, and 600 mg per injection.

The frequency of administration has also been explored, with injections given every two weeks, every four weeks, or every six weeks. For conditions like chronic idiopathic urticaria, a dose of 300 mg per month has been studied. Dosing regimens are being investigated for both children and adults, particularly in studies for food allergies, where the aim is to help patients safely tolerate allergens.

Side Effects

In clinical trials involving a large number of patients, the overall percentage of participants experiencing at least one adverse event was slightly lower with Omalizumab (90.3%) compared to placebo (93.7%). The most commonly reported side effect for Omalizumab was nasopharyngitis (common cold), which occurred in 11.6% of patients taking the drug, compared to 12.2% on placebo. Other common side effects included:

• Headache: 9.9% of patients taking Omalizumab experienced headache, compared to 7.0% on placebo.
• Upper respiratory tract infection: 8.5% of patients taking Omalizumab experienced an upper respiratory tract infection, compared to 10.8% on placebo.
• Injection site reaction: 5.3% of patients taking Omalizumab experienced a reaction at the injection site, compared to 6.1% on placebo.
• Urticaria (hives): 4.9% of patients taking Omalizumab experienced urticaria, compared to 8.4% on placebo.
• Sinusitis: 4.7% of patients taking Omalizumab experienced sinusitis, compared to 7.4% on placebo.
• Back pain: 4.2% of patients taking Omalizumab experienced back pain, compared to 2.6% on placebo.
• Pyrexia (f

  Currently Recruiting Trials

  Researchers are actively seeking participants for several clinical trials involving omalizumab, a medication used to treat various allergic and inflammatory conditions. These studies aim to explore new uses, optimize dosing, and compare omalizumab with other potential treatments or biosimilars. One study, NCT07059091, sponsored by Johns Hopkins University, is a Phase 2 trial investigating if omalizumab injections can help individuals with Chronic Obstructive Pulmonary Disease (COPD) and allergies. This trial plans to enroll 334 participants. Another Johns Hopkins University study, NCT06934200, is a Phase 2 project focusing on omalizumab's safety and effectiveness for people with food hypersensitivity and elevated total IgE levels, targeting 32 participants. For food allergies, Massachusetts General Hospital is conducting NCT06943534, a Phase 2 trial to assess the safety and effectiveness of increased omalizumab dosing, with a goal of 30 participants. National Jewish Health is sponsoring NCT06618963, a Phase 4 interventional study to evaluate if omalizumab can reverse skin barrier abnormalities in 40 participants with food allergy, including children. In the area of chronic spontaneous urticaria (CSU), Simon Francis Thomsen is leading NCT05916937, a Phase 4 study to determine if patients with well-controlled CSU on omalizumab 300 mg every four weeks can extend their treatment intervals to every six weeks. This study aims for 40 participants. Celltrion HealthCare France is conducting NCT07425639, an observational study called ROLL'YN-OMA, in 225 patients receiving Omlyclo®, an omalizumab biosimilar, for chronic spontaneous urticaria or allergic asthma. Children's National Research Institute is sponsoring NCT05332067, a Phase 2 trial to examine the effect of a single dose of omalizumab versus placebo at the onset of upper respiratory infections in 300 atopic youth aged 6-17 years with persistent asthma. Several trials are also using omalizumab as a comparator drug. Longbio Pharma's Phase 2 study, NCT07342803, is evaluating LP-003 injection in 200 allergic asthma patients, with an omalizumab group included. Similarly, Jemincare's Phase 2 trial, NCT06509334, is assessing JYB1904 in 135 patients with chronic spontaneous urticaria, also with an omalizumab comparator arm. Excellergy Inc. is sponsoring NCT07356713, a Phase 1 study to find a suitable dose of Exl-111 for further research in allergic disease, enrolling 70 healthy participants and including a comparator arm. Finally, Universitaire Ziekenhuizen KU Leuven is conducting NCT06683261, an observational study to evaluate the real-world efficacy of biologics, including omalizumab, in 300 patients with chronic rhinosinusitis with nasal polyposis.

  Where to Participate

  Clinical trials for omalizumab and related treatments are currently recruiting across a wide geographic area, with studies available in 19 states and 23 cities. In total, there are 28 active sites seeking participants. Some of the top cities with recruiting sites include:
  • Chicago, Illinois (3 sites)
  • New York, New York (3 sites)
  • Baltimore, Maryland (2 sites)
  • Denver, Colorado (2 sites)
  • Jacksonville, Florida (1 site)
  • Iowa City, Iowa (1 site)
  • Kansas City, Kansas (1 site)
  • Boston, Massachusetts (1 site)
  • Ann Arbor, Michigan (1 site)
  • Detroit, Michigan (1 site)
  Eligibility for these studies typically includes individuals aged 1 to 75 years, with participation open to all genders. Many trials also welcome healthy volunteers, and children are eligible for several studies.

  Development Timeline

  The journey of omalizumab in clinical research began on October 4, 2002, marking the start of its extensive development. Since then, a total of 180 trials have been conducted or are ongoing, involving over 42,788 participants. Initial research explored conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the research pipeline significantly expanded, demonstrating the drug's versatility in treating a growing list of allergic and inflammatory conditions. Key areas of expansion included chronic spontaneous urticaria, various food allergies (including peanut allergy), nasal polyps, allergic rhinitis, and atopic dermatitis. The latest trial is projected to conclude on February 23, 2026. The development has progressed through all phases of clinical research:
  • Phase 4: 48 trials
  • Phase 2: 45 trials
  • Phase 3: 37 trials
  • Phase 1: 20 trials
  A diverse group of sponsors has driven this extensive research. Novartis Pharmaceuticals and Genentech, Inc. have been prominent, sponsoring 26 and 16 trials respectively. Johns Hopkins University and the National Institute of Allergy and Infectious Diseases (NIAID) have also played significant roles, sponsoring 10 and 8 trials each. This collaborative effort across academic institutions and pharmaceutical companies has been crucial in understanding and expanding the therapeutic potential of omalizumab.