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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: Completed Phase 3 study of Chronic Idiopathic Urticaria, sponsored by Kashiv BioSciences.
NCT05774639 is a Phase 3 study of Chronic Idiopathic Urticaria that has completed, run by Kashiv BioSciences. The registered enrollment target is 600 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
ISS 7 is a weekly itch severity score calculated as sum of the daily itch severity score for 7 days, on a scale of 0 to 3 (0=none to 3=intense/severe)
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 |
What the finished NCT05774639 record still lists
NCT05774639 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower).
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 lists 6 locations in 4 states (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.
Learn More About Clinical Trials
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Where NCT05774639's enrollment target sits among peer trials
600 608th of 2000 higher than 1,363 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment
COMPLETED · Phase 3
-
A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
COMPLETED · Phase 3
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