BP11 Versus EU-Approved Xolair® in Patients With Chronic Spontaneous Urticaria

Who can take part

• Male or female patients 18 to 75 years of age (inclusive) willing and able to provide informed consent
• A diagnosis of CSU for at least 6 months before randomization
• A diagnosis of CSU refractory to H1AH treatment as defined in the protocol
• Able to provide patient e-diary entries (without missing data) for the last 7 consecutive days before randomization
• Patient must be willing to complete e-diary twice daily (morning and evening). Able to provide e-diary entries for at least 4 consecutive days out of 7 days before randomization
• Females of childbearing potential (FOCBP) and males with a female partner of childbearing potential must be willing to use reliable contraceptive precautions (refer to Appendix 1 for details) throughout the study until 6 months after the last study treatment dose
• If the patient is an FOCBP, they should have a negative pregnancy test result at the Screening and Baseline visits

Who cannot take part

• Previous exposure to omalizumab (Xolair or biosimilar omalizumab)
• Proof of a COVID-19 vaccination within the 2 weeks before randomization
• Contraindication to background therapy and/or rescue therapy with H1AHs or contraindication to epinephrine or other components of these agents as per the investigator's discretion
• To ensure complete systemic elimination of the study drug, any female who is currently pregnant or breastfeeding or plans to become pregnant or breastfeed for 6 months after the last dose of assigned study treatment or any male who is planning to father a child or donate sperm during the study period or for 6 months after the last dose of assigned study treatment
• History of and/or concomitant immune complex disease (including allergic reaction type III), hyperimmunoglobulin E syndrome, autoimmune disease (which impact the study objectives at the discretion of investigator), or bronchopulmonary aspergillosis
• Active infection requiring treatment 4 weeks before Screening
• Known history of hypersensitivity or allergic reactions to omalizumab or any of its excipients
• Any of the following diseases, which may have symptoms of urticaria and/or angioedema: urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer
• History of and/or current disease as defined in the protocol
• History of and/or an ongoing use of medications as defined in the protocol
• Diagnosed with parasitic diseases or colonization on stool evaluation for ova and parasites
• Current or history of drug or alcohol abuse within the past year based on the investigator's judgment
• Presence of clinically significant cardiovascular, neurological, psychiatric, metabolic, hepatic, or other pathological conditions that could interfere with the interpretation of the study results and/or compromise the safety of the patients in the opinion of the investigator
• Clearly defined underlying etiology for chronic urticarias other than CSU. This includes solar, cholinergic, heat, cold, aquagenic, delayed pressure, or contact urticarias
• Any contraindication to use of diphenhydramine
• Inability to comply with the study and follow-up procedures