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BP11 Versus EU-Approved Xolair® in Patients With Chronic Spontaneous Urticaria
EU CTIS ID: 2024-514764-72-00
What this study is testing
To demonstrate therapeutic equivalence between BP11 and Xolair in patients with chronic spontaneous urticaria (CSU) with an inadequate response to H1 antihistamine (H1AH) treatment
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Known history of hypersensitivity or allergic reactions to omalizumab or any of its excipients
- Previous exposure to omalizumab (Xolair or biosimilar omalizumab)
- Clearly defined underlying etiology for chronic urticarias other than CSU. This includes solar, cholinergic, heat, cold, aquagenic, delayed pressure, or contact urticarias
- 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
- Proof of a COVID-19 vaccination within the 2 weeks before randomization
See the full eligibility criteria
Who can join
- 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
What rules you out
- Known history of hypersensitivity or allergic reactions to omalizumab or any of its excipients
- Previous exposure to omalizumab (Xolair or biosimilar omalizumab)
- Clearly defined underlying etiology for chronic urticarias other than CSU. This includes solar, cholinergic, heat, cold, aquagenic, delayed pressure, or contact urticarias
- 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
- Proof of a COVID-19 vaccination within the 2 weeks before randomization
- History of and/or an ongoing use of medications as defined in the protocol
- Any contraindication to use of diphenhydramine
- 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
- 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
- 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
- Inability to comply with the study and follow-up procedures
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Georgia; India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.