Omalizumab
Last Updated: 04/28/2026
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines (CLEAR)
Summary: This study aims to evaluate the efficacy and safety of lesigercept in approximately 150 participants with CSU. By enrolling participants with an inadequate response to H1-antihistamines, including those previously treated with omalizumab, this study is expected to provide evidence for the clinical utility of lesigercept and to further characterize its benefit-risk profile in the target participant...
ROLL'YN-OMA : Etude Observationnelle de Cohorte Pour la Prise en Charge Des Patients Atteints de Pathologies Inflammatoires Chroniques traités Par Omlyclo®, un Omalizumab Biosimilaire
Summary: ROLL'YN-OMA is a real-world study in patients receiving standard biologic therapies who have been in control and/or remission of their disease for at least 3 months and whose physician has independently decided, within the framework of a shared medical decision, to switch them to OMLYCLO®. The primary objective of this study is to evaluate the maintenance of this control and/or clinical remission ...
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial of Exl-111 in Healthy Participants
Summary: This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose trial of Exl-111 in healthy participants. The trials consists of 2 parts, as follows: Part A (SAD): Up to 5 dose cohorts, each with 8 participants, randomized into 2 arms: Exl-111 and placebo. Part B (MAD): Up to 3 dose cohorts, each with 10 participants, randomized into 3 arms: Exl-111, placebo, an...
Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (COPD-OMA)
Summary: This research is being done to test if a drug called omalizumab can help people with Chronic Obstructive Pulmonary Disease (COPD) and allergies. Each participant will be in the study for about 16 months, including 1-3 months of screening, 12 months of receiving the study drug at a clinic, and a follow-up call one month after your final clinic visit.
Omalizumab Weight-Based Dosing Efficacy Trial
Summary: This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.
A Multicenter, Randomized, Double-Blind, Active Drug and Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in the Treatment of Patients With Moderate to Severe Persistent Allergic Asthma.
Summary: This is a multicenter, randomized, masked, active and placebo controlled, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetics of LP-003 injection in adult patients with moderate to severe persistent allergic asthma.
A Multicenter, Randomized, Double-Blind, Positive Parallel Controlled Phase III Clinical Trial to Compare Omalizumab α(CMAB007) and Xolair® in Patients With Chronic Spontaneous Urticaria
Summary: This study is a multicenter, randomized, double-blind, positive parallel controlled phase III clinical trial to compare efficacy, immunogenicity, pharmacokinetics, pharmacodynamics and safety of omalizumab α(CMAB007) and Xolair® in patients with refractory chronic spontaneous urticaria
Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC Trial): a Multicentre, Randomized, Open-label, Non-inferiority Trial
Summary: This study is a multicentre, randomized, open-label, non-inferiority clinical trial. The purpose and aim of this study is to investigate if patients with well controlled (UCT score score ≥ 12) chronic spontaneous urticaria (CSU) on omalizumab 300 mg every four weeks can extend treatment intervals and maintain disease control.
Omalizumab Before Onset of Exacerbations
Summary: OBOE is a prospective, pilot, parallel group RCT with the overall aim of examining the effect of a single dose of anti-IgE (omalizumab) vs. placebo administered at the onset of URIs in the fall season among highly exacerbation-prone, urban, and atopic youth aged 6-17 years with persistent asthma. OBOE will recruit and randomize participants over 3 years (3 annual cohorts of participants). Recruitm...
Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels
Summary: In this project, the investigators would like to learn if 24 weeks (about 5 and a half months) of omalizumab injections, given every 2 weeks, will be safe and effective for food allergic people who have a total immunoglobulin E (IgE) above the current FDA approved dosing regimen enabling a person to increase tolerance to the food(s) that the person is allergic to. The investigators would also like...
Effect of Omalizumab in the Skin of Food Allergy Patients
Summary: The goal of this interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC). The main question it aims to answer is whether these skin barrier abnormalities can be reversed by omalizumab. If there is a comparison group: Researchers will compare non-food allergic participants (who do not receive o...
A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Adult Patients with Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines
Summary: This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
Last Updated: 04/28/2026