BP11 Versus EU-Approved Xolair® in Patients With Chronic Spontaneous Urticaria

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Curateq Biologics Private Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

27 Sep 2023 → 11 Mar 2026

Decision date (initial)

2024-09-16

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

CuraTeQ Biologics Private Ltd., India

External identifiers

EU CT number

2024-514764-72-00

EudraCT number

2022-001745-20

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Bioequivalence, Efficacy, Dose response, Pharmacokinetic, Therapy, Pharmacodynamic, Others, Safety

To demonstrate therapeutic equivalence between BP11 and Xolair in
patients with chronic spontaneous urticaria (CSU) with an inadequate
response to H1 antihistamine (H1AH) treatment

Secondary objectives 5

1. To assess and compare other efficacy parameters between BP11 and Xolair over time;
2. To assess and compare safety and tolerability between BP11 and Xolair over the entire study period;
3. To assess and compare immunogenicity between BP11 and Xolair over the study;
4. To assess and compare the PK between BP11 and Xolair over the study;
5. To assess and compare the PD between BP11 and Xolair.

Conditions and MedDRA coding

Chronic Urticaria

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Male or female patients 18 to 75 years of age (inclusive) willing and able to provide informed consent
2. A diagnosis of CSU for at least 6 months before randomization
3. A diagnosis of CSU refractory to H1AH treatment as defined in the protocol
4. Able to provide patient e-diary entries (without missing data) for the last 7 consecutive days before randomization
5. 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.
6. 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.
7. If the patient is an FOCBP, they should have a negative pregnancy test result at the Screening and Baseline visits

Exclusion criteria 16

1. Known history of hypersensitivity or allergic reactions to omalizumab or any of its excipients
2. Diagnosed with parasitic diseases or colonization on stool evaluation for ova and parasites
3. Current or history of drug or alcohol abuse within the past year based on the investigator's judgment
4. 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
5. 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
6. 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
7. Inability to comply with the study and follow-up procedures
8. 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.
9. Active infection requiring treatment 4 weeks before Screening.
10. Previous exposure to omalizumab (Xolair or biosimilar omalizumab)
11. Clearly defined underlying etiology for chronic urticarias other than CSU. This includes solar, cholinergic, heat, cold, aquagenic, delayed pressure, or contact urticarias
12. 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
13. History of and/or current disease as defined in the protocol
14. Proof of a COVID-19 vaccination within the 2 weeks before randomization
15. History of and/or an ongoing use of medications as defined in the protocol
16. Any contraindication to use of diphenhydramine

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from Baseline in weekly Itch Severity Score (ISS7) at Week 12

Secondary endpoints 22

1. Change from Baseline in ISS7 at Weeks 2, 4, 8, 16, 20, and 24
2. Change from Baseline in weekly Urticaria Activity Score (UAS7) at Weeks 2, 4, 8, 12, 16, 20, and 24
3. Percentage of patients with UAS7 of ≤6 at Weeks 2, 4, 8, 12, 16, 20, and 24
4. Percentage of complete responders (UAS7 = 0) in UAS7 at Weeks 2, 4, 8, 12, 16, 20, and 24
5. Change from Baseline in weekly Hives Severity Score (HSS7) at Weeks 2, 4, 8, 12, 16, 20, and 24
6. Change from Baseline in the overall Dermatology Life Quality Index (DLQI) score at Weeks 4, 8, 12, 16, 20, and 24
7. 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)
8. 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)
9. 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
10. Physical examinations, vital signs, and 12-lead electrocardiograms (ECGs) throughout the study
11. Laboratory parameters (hematology, serum chemistry, and urinalysis) throughout the study
12. 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
13. Incidence of ADAs and NAbs and ADA titers to omalizumab measured during TP2 at Weeks 20, 24, and 40
14. Trough serum concentration (Ctrough) of omalizumab during TP1 at Baseline and at Weeks 4 and 12
15. Trough serum concentration (Ctrough) of omalizumab during TP2 at Weeks 20, 24, and 40
16. Total IgE and free IgE levels in serum during TP1 at Baseline (Week 0) and at Weeks 4 and 12
17. Total IgE and free IgE levels in serum during TP2 at Weeks 20, 24, and 40
18. 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
19. Injection-site and hypersensitivity reactions during TP2 for patients who switch treatment
20. Physical examinations, vital signs, and 12-lead ECGs during TP2 for patients who switch treatment
21. Laboratory parameters (hematology, clinical chemistry, and urinalysis) during TP2 for patients who switch treatment
22. Incidence of ADAs and NAbs and ADA titers to omalizumab measured during TP2 for patients who switch treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Curateq Biologics Private Limited

Sponsor organisation

Curateq Biologics Private Limited

Address

Galaxy Floors 22-24 Plot No 1, Survey No 83/1, Hyderabad Knowledge City Survey No 83/1 Hyderabad Knowledge City

City

Raidurg

Postcode

500081

Country

India

Scientific contact point

Organisation

Curateq Biologics Private Limited

Contact name

Arpitkumar Prajapati

Public contact point

Organisation

Curateq Biologics Private Limited

Contact name

Arpitkumar Prajapati

Third parties 3

Locations

6 EU/EEA countries · 61 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 40 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications