Omalizumab for Chronic spontaneous urticaria

Inclusion criteria

• {"criterion_text":"- Male or female patients 18 to 75 years of age (inclusive) willing and able to provide informed consent"}
• {"criterion_text":"- A diagnosis of CSU for at least 6 months before randomization"}
• {"criterion_text":"- A diagnosis of CSU refractory to H1AH treatment as defined in the protocol"}
• {"criterion_text":"- Able to provide patient e-diary entries (without missing data) for the last 7 consecutive days before randomization"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- If the patient is an FOCBP, they should have a negative pregnancy test result at the Screening and Baseline visits"}

Exclusion criteria

• {"criterion_text":"- Known history of hypersensitivity or allergic reactions to omalizumab or any of its excipients"}
• {"criterion_text":"- Previous exposure to omalizumab (Xolair or biosimilar omalizumab)"}
• {"criterion_text":"- Clearly defined underlying etiology for chronic urticarias other than CSU. This includes solar, cholinergic, heat, cold, aquagenic, delayed pressure, or contact urticarias"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- History of and/or current disease as defined in the protocol"}
• {"criterion_text":"- Proof of a COVID-19 vaccination within the 2 weeks before randomization"}
• {"criterion_text":"- History of and/or an ongoing use of medications as defined in the protocol"}
• {"criterion_text":"- Any contraindication to use of diphenhydramine"}
• {"criterion_text":"- Diagnosed with parasitic diseases or colonization on stool evaluation for ova and parasites"}
• {"criterion_text":"- Current or history of drug or alcohol abuse within the past year based on the investigator's judgment"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Inability to comply with the study and follow-up procedures"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Active infection requiring treatment 4 weeks before Screening."}

Primary endpoints

• {"endpoint_text":"- Change from Baseline in weekly Itch Severity Score (ISS7) at Week 12","definition_or_measurement_approach":"Change from Baseline in weekly Itch Severity Score (ISS7) measured at Week 12"}

Secondary endpoints

• {"endpoint_text":"- Change from Baseline in ISS7 at Weeks 2, 4, 8, 16, 20, and 24","definition_or_measurement_approach":"Change from Baseline in weekly Itch Severity Score (ISS7) measured at specified weeks"}
• {"endpoint_text":"- Change from Baseline in weekly Urticaria Activity Score (UAS7) at Weeks 2, 4, 8, 12, 16, 20, and 24","definition_or_measurement_approach":"Change from Baseline in weekly Urticaria Activity Score (UAS7) measured at specified weeks"}
• {"endpoint_text":"- Percentage of patients with UAS7 of ≤6 at Weeks 2, 4, 8, 12, 16, 20, and 24","definition_or_measurement_approach":"Proportion of patients with weekly UAS7 score ≤6 at the listed timepoints"}
• {"endpoint_text":"- Percentage of complete responders (UAS7 = 0) in UAS7 at Weeks 2, 4, 8, 12, 16, 20, and 24","definition_or_measurement_approach":"Proportion of patients with UAS7 = 0 at listed timepoints"}
• {"endpoint_text":"- Change from Baseline in weekly Hives Severity Score (HSS7) at Weeks 2, 4, 8, 12, 16, 20, and 24","definition_or_measurement_approach":"Change from Baseline in weekly Hives Severity Score (HSS7) measured at specified weeks"}
• {"endpoint_text":"- Change from Baseline in the overall Dermatology Life Quality Index (DLQI) score at Weeks 4, 8, 12, 16, 20, and 24","definition_or_measurement_approach":"Change from Baseline in DLQI measured at specified weeks"}
• {"endpoint_text":"- Use of rescue medication up to scheduled efficacy time points and over the study (at Weeks 2, 4, 8, and 12, and by treatment period)","definition_or_measurement_approach":"Use (incidence/amount) of rescue medications recorded at specified timepoints and across treatment periods"}
• {"endpoint_text":"- Incidence, nature, and severity of adverse events (AEs) including adverse drug reactions graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 as defined by treatment-emergent AEs (TEAEs), serious AEs (SAEs), AEs of special interest (AESIs), related TEAEs, and related SAEs during Treatment Period 1 (TP1) and Treatment Period 2 (TP2)","definition_or_measurement_approach":"AE collection and grading per NCI CTCAE v5.0; categorised as TEAEs, SAEs, AESIs, related events during TP1 and TP2"}
• {"endpoint_text":"- Injection-site and hypersensitivity reactions at Baseline (Week 0 after first study drug dose) and at Weeks 4, 8, 12, 16, and 20, and throughout the study","definition_or_measurement_approach":"Recording of injection-site and hypersensitivity reactions at listed timepoints and throughout study"}
• {"endpoint_text":"- Physical examinations, vital signs, and 12-lead electrocardiograms (ECGs) throughout the study","definition_or_measurement_approach":"Scheduled physical exams, vital signs, and 12-lead ECG assessments throughout study"}
• {"endpoint_text":"- Laboratory parameters (hematology, serum chemistry, and urinalysis) throughout the study","definition_or_measurement_approach":"Scheduled laboratory assessments throughout the study"}
• {"endpoint_text":"- Incidence of antidrug antibodies (ADAs) and neutralizing antibodies (NAbs) and ADA titers to omalizumab measured during TP1 at Baseline (Week 0) and at Weeks 4 and 12","definition_or_measurement_approach":"ADA and NAb incidence and titers measured at Baseline, Week 4 and Week 12 during TP1"}
• {"endpoint_text":"- Incidence of ADAs and NAbs and ADA titers to omalizumab measured during TP2 at Weeks 20, 24, and 40","definition_or_measurement_approach":"ADA and NAb incidence and titers measured at Weeks 20, 24 and 40 during TP2"}
• {"endpoint_text":"- Trough serum concentration (Ctrough) of omalizumab during TP1 at Baseline and at Weeks 4 and 12","definition_or_measurement_approach":"Ctrough serum concentrations measured at Baseline, Week 4 and Week 12 during TP1"}
• {"endpoint_text":"- Trough serum concentration (Ctrough) of omalizumab during TP2 at Weeks 20, 24, and 40","definition_or_measurement_approach":"Ctrough serum concentrations measured at Weeks 20, 24 and 40 during TP2"}
• {"endpoint_text":"- Total IgE and free IgE levels in serum during TP1 at Baseline (Week 0) and at Weeks 4 and 12","definition_or_measurement_approach":"Total and free IgE measured in serum at Baseline, Week 4 and Week 12 during TP1"}
• {"endpoint_text":"- Total IgE and free IgE levels in serum during TP2 at Weeks 20, 24, and 40","definition_or_measurement_approach":"Total and free IgE measured in serum at Weeks 20, 24 and 40 during TP2"}
• {"endpoint_text":"- Incidence, nature, and severity of AEs including adverse drug reactions graded according to the NCI CTCAE v5.0 as defined by TEAEs, SAEs, AESIs, related TEAEs, and related SAEs during TP2 for patients who switch treatment","definition_or_measurement_approach":"AE collection and grading per NCI CTCAE v5.0 for patients who switch during TP2"}
• {"endpoint_text":"- Injection-site and hypersensitivity reactions during TP2 for patients who switch treatment","definition_or_measurement_approach":"Recording of injection-site and hypersensitivity reactions during TP2 for switch patients"}
• {"endpoint_text":"- Physical examinations, vital signs, and 12-lead ECGs during TP2 for patients who switch treatment","definition_or_measurement_approach":"Scheduled physical exams, vital signs and 12-lead ECGs during TP2 for switch patients"}
• {"endpoint_text":"- Laboratory parameters (hematology, clinical chemistry, and urinalysis) during TP2 for patients who switch treatment","definition_or_measurement_approach":"Scheduled laboratory assessments during TP2 for switch patients"}
• {"endpoint_text":"- Incidence of ADAs and NAbs and ADA titers to omalizumab measured during TP2 for patients who switch treatment","definition_or_measurement_approach":"ADA and NAb incidence and titers measured during TP2 for switch patients"}

Lithuania

Earliest CTIS Part Ii Submission Date

15-08-2024

Latest Decision Or Authorization Date

13-09-2024

Processing Time Days

29

Number Of Participants

24

Latvia

Earliest CTIS Part Ii Submission Date

15-08-2024

Latest Decision Or Authorization Date

27-08-2024

Processing Time Days

12

Number Of Participants

20

Bulgaria

Earliest CTIS Part Ii Submission Date

15-08-2024

Latest Decision Or Authorization Date

16-09-2024

Processing Time Days

32

Number Of Participants

126

Poland

Earliest CTIS Part Ii Submission Date

15-08-2024

Latest Decision Or Authorization Date

23-09-2024

Processing Time Days

39

Number Of Participants

236

Hungary

Earliest CTIS Part Ii Submission Date

15-08-2024

Latest Decision Or Authorization Date

27-08-2024

Processing Time Days

12

Number Of Participants

12

Slovakia

Earliest CTIS Part Ii Submission Date

15-08-2024

Latest Decision Or Authorization Date

28-08-2024

Processing Time Days

13

Number Of Participants

56

Primary sponsor

Full Name

Curateq Biologics Private Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

India

Contract research organisations

Name

Syneos Health Inc.

Responsibilities

Site start-up, project and vendors management, unblinded tasks, medical and scientific management

Name

Syneos Health Clinique Inc.

Responsibilities

Bioanalytical services: PK, PD (Free IgE and Total IgE), ADA, NAb, Analytical chemistry

Name

PPD Global Central Labs

Responsibilities

Clinical pathology testing - COVID, Hepatitis B, Hepatitis C, HIV, stool parasite test, Clinical haematology, Serology/ endocrinology

Third parties

• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Site start-up, project and vendors management, unblinded tasks, medical and scientific management","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"Bioanalytical services: PK, PD (Free IgE and Total IgE), ADA, NAb, Analytical chemistry","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Clinical pathology testing - COVID, Hepatitis B, Hepatitis C, HIV, stool parasite test, Clinical haematology, Serology/ endocrinology","organisation_type":"Pharmaceutical company"}