Health Condition 1: L501- Idiopathic urticaria
Conditions
Interventions
Intervention1: BP11: 150 mg (150 mg/mL) SC injections or
300 mg (150 mg/mL) SC injections
Duration: Week 0,4, 8, 12,16 and 20
Control Intervention1: Xolair®: 150 mg (150 mg/mL) SC injections or
3
Sponsors
CuraTeQ Biologics Private Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients 18 to 60 years of age (inclusive) willing and able to provide informed consent. 2. A diagnosis of CSU for at least 6 months before randomization. 3. 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. 4. Willing and able to complete an e-diary twice daily (morning and evening) up to 24 weeks 5. 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. 6. If the patient is an FOCBP, they should have a negative pregnancy test result at the Screening and Baseline visits
Exclusion criteria
Exclusion criteria: 1. Known history of hypersensitivity or allergic reactions to omalizumab or any of its excipients. 2. Previous exposure to omalizumab (Xolair or biosimilar omalizumab). 3. Clearly defined underlying etiology for chronic urticarias other than CSU. This includes solar, cholinergic, heat, cold, aquagenic, delayed pressure, or contact urticarias. 4. 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. 5. Proof of a COVID-19 vaccination within the 2 weeks before randomization. 6. Current or history of drug or alcohol abuse within the past year based on the investigator’s judgment. 7. 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. 8. 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. 9. 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. 10. Inability to comply with the study and follow-up procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in weekly Itch Severity Score (ISS7) and Relative potency based on change from Baseline in ISS7Timepoint: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| EfficacyTimepoint: Various time points from baseline to week 24;safety and tolerabilityTimepoint: Throughout study duration;ImmunogenicityTimepoint: Various time points from baseline (week 0) to week 40;PharmacokineticsTimepoint: Various time points from baseline (week 0) to week 40;PharmacodynamicsTimepoint: Various time points from baseline (week 0) to week 40 | — |
Countries
Bulgaria, Georgia, Hungary, India, Latvia, Lithuania, Poland, Slovakia
Contacts
Public ContactDr Arpitkumar Prajapati
CuraTeQ Biologics Private Ltd.
Outcome results
None listed