San Marcus Research Clinic | Miami Lakes, FL
Status and phase
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About
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
Full 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 (CIU)/Chronic 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 2:2:1:1 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 1:1 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.
Enrollment
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Volunteers
Inclusion criteria
Capable of providing written informed consent, adhering to all visit schedules, and meeting study requirements.
Male or female patients 18 to 75 years of age (both inclusive) at the time of screening.
Diagnosis of CIU refractory to H1 antihistamines at the time of randomization, as defined by all of the following:
Willing and able to complete a daily symptom diary for the duration of the study and must not have any missing diary entries in the 7 days prior to randomization.
Females of childbearing potential must be willing to use acceptable contraceptive methods throughout the study and for 6 months thereafter.
Females of non-childbearing potential must have undergone sterilization procedures, at least 6 months prior to the first dose or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle stimulating hormone serum levels consistent with postmenopausal status.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
600 participants in 10 patient groups
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Central trial contact
Dr Prayag N shah, MD, MBA
Data sourced from clinicaltrials.gov
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