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NCT05774639 · ClinicalTrials.gov registry record · Phase 3
Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
A Phase 3 study of Chronic Idiopathic Urticaria, sponsored by Kashiv BioSciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
- 6
- Study locations
NCT05774639 is a Phase 3 study of Chronic Idiopathic Urticaria that has completed, run by Kashiv BioSciences. The registered enrollment target is 600 participants. The trial reports 6 study locations across 4 states.
The verdict
NCT05774639, a Phase 3 study of Chronic Idiopathic Urticaria, has completed, sponsored by Kashiv BioSciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of the study is to compare the efficacy, safety, tolerability, and immunogenicity of ADL-018 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic on H1 antihistamine treatment
Conditions Studied
Interventions
- DRUG Omalizumab Injection
- DRUG Xolair Prefilled Syringe
Study Locations (6)
Florida
- True Blue Clinical Research - Brandon
- Access Research Institute - Brooksville
- San Marcus research Clinic, Inc - Miami Lakes
Indiana
- Options Research Group - West Lafayette
Maharashtra
- Site 001 - Mumbai
Other
- Al Essra Hospital - Amman
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2023-08-15 |
| Est. Completion | 2024-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05774639
The ClinicalTrials.gov registry entry for NCT05774639 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kashiv BioSciences, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Idiopathic Urticaria appearing as the primary indexed condition, and to 2 interventions - of which Omalizumab Injection is the first listed.
NCT05774639 reports 6 study locations spanning 4 distinct geographic areas - top geographies include Florida, Indiana, Maharashtra.
Frequently Asked Questions
What is clinical trial NCT05774639 about?
NCT05774639 is a clinical study titled "Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria". The purpose of the study is to compare the efficacy, safety, tolerability, and immunogenicity of ADL-018 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic on H1 antihistamine treatment
What is the current status of trial NCT05774639?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2023-08-15. Estimated completion is 2024-12-31.
What conditions does trial NCT05774639 study?
This clinical trial studies the following conditions: Chronic Idiopathic Urticaria.
What interventions are being tested in trial NCT05774639?
The interventions under investigation include: Omalizumab Injection (DRUG), Xolair Prefilled Syringe (DRUG).
Who is sponsoring clinical trial NCT05774639?
This trial is sponsored by Kashiv BioSciences, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05774639 being conducted?
This trial has 6 study locations across Florida, Indiana, Maharashtra. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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