EUCTR2022-001745-20-BG
Active, not recruiting
Phase 1
Phase 3, Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BP11 Versus EU-Approved Xolair® in Patients With Chronic Spontaneous Urticaria Who Are Resistant to H1 Antagonist - Efficacy, Safety, PD, PK, and Immunogenicity of BP11 Compared With Xolair
CuraTeQ Biologics Private Ltd.0 sites600 target enrollmentApril 3, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CuraTeQ Biologics Private Ltd.
- Enrollment
- 600
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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:
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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