Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
Public ClinicalTrials.gov record NCT05774639. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Multicenter, Double-Blind, 4-Arm, Parallel-Group, Active Controlled, Phase 3 Study to Compare Efficacy, Safety and Immunogenicity of ADL-018 150 mg and 300 mg With US-Licensed Xolair® 150 mg and 300 mg Administered Through Subcutaneous Route Every 4 Weeks in Patients With Chronic Idiopathic Urticaria (CIU) Who Remained Symptomatic Despite Treatment With Approved Doses of H1 Antihistamines
Study identification
- NCT ID
- NCT05774639
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Kashiv BioSciences, LLC
- Industry
- Enrollment
- 600 participants
Conditions and interventions
Conditions
Interventions
- Omalizumab Injection Drug
- Xolair Prefilled Syringe Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 14, 2023
- Primary completion
- Oct 2, 2024
- Completion
- Dec 30, 2024
- Last update posted
- Feb 4, 2025
2023 – 2024
United States locations
- U.S. sites
- 4
- U.S. states
- 2
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| True Blue Clinical Research | Brandon | Florida | 33511 | — |
| Access Research Institute | Brooksville | Florida | 34613 | — |
| San Marcus research Clinic, Inc | Miami Lakes | Florida | 33014 | — |
| Options Research Group | West Lafayette | Indiana | 47906 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05774639, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 4, 2025 · Synced Jul 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05774639 live on ClinicalTrials.gov.