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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
600
ADL-018 (Omalizumab) solution for injection 150 mg/mL prefilled syringe (PFS)
XOLAIR (omalizumab) injection is supplied as a single dose PFS. Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution
True Blue Clinical Research
Brandon, Florida, United States
Access Research Institute
Brooksville, Florida, United States
San Marcus research Clinic, Inc
Miami Lakes, Florida, United States
Options Research Group
West Lafayette, Indiana, United States
Change from baseline in the ISS7 at Week 12 between ADL-018 300 mg and XOLAIR 300 mg
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)
Time frame: Change from Baseline at week 12
Relative potency of ADL-018 and XOLAIR
Relative potency ADL-018 to the Xolair defined as the dose of ADL-018 that produces the same biological response as one unit of the dose of the Xolair. The relative potency and its CI will be measured by change in ISS7 at Week 12 using a 4 point assay based on the 300 mg and 150 mg dose levels of each product.
Time frame: Change from Baseline at week 12
Change from baseline in the ISS7 at Week 2, 4, 6, 8, 16, 20, and 24
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).
Time frame: Change from Baseline at Week 2, 4, 6, 8, 16, 20, and 24
Change from baseline in UAS7 at Weeks 2, 4, 6, 8, 12, 16, 20, and 24
Change from baseline in the Urticaria Activity Score (UAS) - sum of the daily number of wheals score and itch severity score over 7 days, range from 0 (minimum) to 6 (maximum)
Time frame: Change from Baseline at Weeks 2, 4, 6, 8, 12, 16, 20, and 24
Change from baseline in weekly number of hives (urticaria) score (HSS7) at Weeks 2, 4, 6, 8, 12, 16, 20, and 24
Change from baseline in the weekly number of wheals score at Week 12
Time frame: Change from Baseline at Weeks 2, 4, 6, 8, 12, 16, 20, and 24.
Percentage of patients with angioedema-free days from Week 4 to Week 12
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Site 001
Mumbai, Maharashtra, India
Al Essra Hospital
Amman, Jordan
Percentage of angioedema-free days from Week 4 to Week 12
Time frame: change from Week 4 to Week 12
Percentage of complete responders (UAS7=0) at Week 12
Percentage of complete responders with weekly Urticaria Activity Score =0 at Week 12
Time frame: change from baseline at week 12
Percentage of patients achieving UAS7 ≤ 6 at Weeks 2, 4, 6, 8, 12, 16, 20, and 24
Percentage of patients with a weekly Urticaria Activity Score ≤6
Time frame: Change from Baseline at Weeks 2, 4, 6, 8, 12, 16, 20, and 24
Change from baseline in the overall Dermatology Life Quality Index (DLQI) score at weeks 4, 8, 12, 16, 20, and 24.
Change from baseline in the overall dermatology life quality index (DLQI) score at Week 12; comparisons of ADL-018 and XOLAIR treatment arms. The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired
Time frame: Change from Baseline at Week 12