Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria

Conditions

• Chronic Idiopathic Urticaria

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Omalizumab Injection — DRUG
  ADL-018 (Omalizumab) solution for injection 150 mg/mL prefilled syringe (PFS)
• Xolair Prefilled Syringe — DRUG
  XOLAIR (omalizumab) injection is supplied as a single dose PFS. Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution

Study Details

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

Key Dates

Start date

Aug 15, 2023

Status verified

Feb 2025

Primary completion

Oct 3, 2024

Completion

Dec 31, 2024

Study Design

Enrollment

600 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ADL-018 300 mg Main Treatment period
  ADL-018 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8
• Active Comparator: Xolair-300 mg Main Treatment Period
  XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 0, 4, 8
• Experimental: ADL-018 150 mg Main Treatment period
  ADL-018 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8
• Active Comparator: Xolair-150 mg Main Treatment Period
  XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 0, 4, 8
• Experimental: ADL-018 300 mg Main / ADL-018 300 mg Transition Period
  ADL-018 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 12,16,20 in patients that were randomized to ADL-018 300 mg in the Main Treatment period.
• Experimental: Xolair-300 mg Main / ADL-018 300 mg Transition Period
  ADL-018 (Omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 12,16,20 in patients that were randomized to Xolair-300 mg in the main treatment period.
• Active Comparator: Xolair-300 mg Main / Xolair-300 mg Transition Period
  XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered twice (total dosage 300 mg) at week 12,16,20 in patients that were randomized to Xolair-300 mg in the main treatment period.
• Experimental: ADL-018 150 mg Main / ADL-018 150 mg Transition Period
  ADL-018 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 12,16,20 in patients that were randomized to ADL-018150 mg in the main treatment period.
• Experimental: Xolair-150 mg Main / ADL-018150 mg Transition Period
  ADL-018 (Omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 12,16,20 in patients that were randomized to XOLAIR-150 mg in the main treatment period.
• Active Comparator: Xolair-150 mg Main / Xolair-150 mg Transition Period
  XOLAIR (omalizumab) injection 150 mg/mL pre-filled syringe administered with one placebo injection at week 12,16,20 in patients that were randomized to XOLAIR -150 mg in the main treatment period.

Primary Outcome Measure

Change from baseline in the ISS7 at Week 12 between ADL-018 300 mg and XOLAIR 300 mg [ Time Frame: Change from Baseline at week 12 ]

Locations (4)

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