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

NCT05774639 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-02-05

No results posted yet for this 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

Conditions

  • Chronic Idiopathic Urticaria

Interventions

DRUG

Omalizumab Injection

ADL-018 (Omalizumab) solution for injection 150 mg/mL prefilled syringe (PFS)

DRUG

Xolair Prefilled Syringe

XOLAIR (omalizumab) injection is supplied as a single dose PFS. Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution

Sponsors & Collaborators

  • COD Research Private Ltd

    collaborator OTHER_GOV

  • Kashiv BioSciences, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-15
Primary Completion
2024-10-03
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States
  • India
  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05774639 on ClinicalTrials.gov