Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774639
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2023-02-25
Brief Title:
Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR Omalizumab in Adults With Chronic Idiopathic Urticaria
Sponsor:
Kashiv BioSciences LLC
Organization:
Kashiv BioSciences LLC
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 CIUChronic Spontaneous Urticaria CSU who remain symptomatic on H1 antihistamine treatment
Detailed Description:
This is a multicenter randomized double-blind study to demonstrate similar efficacy and safety of ADL-018 compared to XOLAIR administered sc at doses of 300 mg or 150 mg every 4 weeks for 24 weeks 6 treatments in patients with Chronic Idiopathic Urticaria CIUChronic Spontaneous Urticaria CSU who remain symptomatic despite antihistamine H1 treatment This study will consist of a screening period up to 2 weeks a 24-week treatment period consisting of a 12-week double-blind main treatment period and a 12-week double-blind transition period which is followed by a 16-week follow-up period The total duration of the study is up to 42 weeks
At baseline patients will be randomized in a 2211 ratio to receive the first 3 treatments of ADL-018 300 mg XOLAIR 300 mg ADL-018 150 mg or XOLAIR 150 mg main treatment period At Week 12 prior to receiving their fourth dose of study medication patients in the XOLAIR 300 mg and the XOLAIR 150 mg treatment groups will be randomized 11 to receive 3 additional doses of XOLAIR at the same dose level as prior to randomization or switch to 3 doses of ADL-018 transition period at the same dose level as prior to randomization All patients in the ADL-018 groups will continue to receive ADL-018 at the same dose levels
At baseline patients will be randomized in a 2211 ratio to receive the first 3 treatments of ADL-018 300 mg XOLAIR 300 mg ADL-018 150 mg or XOLAIR 150 mg main treatment period At Week 12 prior to receiving their fourth dose of study medication patients in the XOLAIR 300 mg and the XOLAIR 150 mg treatment groups will be randomized 11 to receive 3 additional doses of XOLAIR at the same dose level as prior to randomization or switch to 3 doses of ADL-018 transition period at the same dose level as prior to randomization All patients in the ADL-018 groups will continue to receive ADL-018 at the same dose levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None