BP11 Versus EU-Approved Xolair® in Patients With Chronic Spontaneous Urticaria
- Conditions
- Chronic Spontaneous UrticariaMedDRA version: 20.0Level: PTClassification code 10072757Term: Chronic spontaneous urticariaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2022-001745-20-BG
- Lead Sponsor
- CuraTeQ Biologics Private Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 600
- 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
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
- 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
- Proof of a COVID-19 vaccination within the 2 weeks before randomization
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method