FAsenra Safety Trial in India

NCT05384938 | Completed Phase 4 Results

• 1 other identifier: D3250C00093
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 13

Brief Summary

Benralizumab is a humanised, afucosylated, monoclonal antibody that binds specifically to the human interlukin-5 (IL-5) receptor alpha subunit (IL-5Rα) of target cells such as eosinophils and basophils (Takatsu et al, 1994; Toba et al, 1999; Pelaia et al, 2020). Benralizumab was generally well tolerated by patients in clinical trials, with no apparent safety concerns. This study shall be conducted at 10 centers across India. The primary outcome measures will be

• Percentage of AEs a, SAEs, and TEAEs
• Nature, incidence, and severity of AEs including unexpected adverse drug reactions
• Percentage of patients with AEs that lead to study treatment discontinuations.

Conditions

In Adult Patients of Severe Asthma With Eosinophilic Phenotype in India

Outcome Measures

Primary Outcomes (3)

• Participants With Adverse Events (AEs), Serious AEs, and Treatment-emergent AEs

  The number and percentage of participants who experienced at least one adverse event (AE), serious AE, or treatment-emergent AE experienced are presented

  From study treatment to follow-up (up to 24 weeks)

• Severity of AEs

  Severity of adverse events (AEs) by intensity grade

  From study treatment to follow-up (up to 24 weeks)

• Participants With AEs That Led to Study Treatment Discontinuations or Modifications

  Participants with adverse events (AEs) that led to study treatment discontinuations or modifications

  From study treatment to follow-up (up to 24 weeks)

Secondary Outcomes (5)

• Time to First Asthma Exacerbation

  From study treatment to follow-up (up to 24 weeks)

• Exacerbation Rate: Before and After Treatment

  From study treatment to follow-up (up to 24 weeks)

• Annualized Exacerbation Rate: Overall

  From study treatment to follow-up (up to 24 weeks)

• Overall Investigators Assessment

  From study treatment to follow-up (up to 24 weeks)

• Change in Blood Eosinophil Levels From Baseline at Weeks 4, 16, and 24

  Baseline and Weeks 4, 16, and 24

Study Arms (1)

Benralizumab

OTHER

Single arm, Phase-IV

Biological: Benralizumab

Interventions

Benralizumab BIOLOGICAL

Prospective, Single-arm Study to Assess the Safety of Fasenra® (Benralizumab) in Adult Patients of Severe Asthma with Eosinophilic Phenotype in India

Benralizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients 18 to 75 years of age inclusive, at the time of signing the informed consent
• Patients with physician's confirmed diagnosis of severe asthma with an eosinophilic phenotype, ie, a diagnosis of severe asthma in preceding at least 12 months, with an eosinophil count of ≥300 cells/μL at screening, requiring treatment with high-dose ICS (\>500 μg fluticasone propionate dry powder formulation, or \>800 μg budesonide dry powder formulation, or equivalent total daily dose) and a LABA as maintenance treatment for at least 3 months prior to enrolment
• A decreased lung function with prebronchodilator (Pre-BD) forced expiratory volume in 1 second (FEV1) of \<80% predicted, demonstrated by spirometry at screening
• At least 2 documented asthma exacerbations in the preceeding12 months, except in 30 days before the date of informed consent, that required the use of a systemic corticosteroid or temporary increase from the patient's usual maintenance dose of oral corticosteroid (OCS)
• Documented postbronchodilator (post-BD) reversibility in FEV1 of ≥12% and ≥200 mL in FEV1 within 12 months before first dose. If historical documentation is not available, reversibility must be demonstrated and documented at screening or Day 1 before first dose
• Benralizumab naïve patients who have not previously received benralizumab prior to the start of this study
• Patients who are willing and capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

You may not qualify if:

• Clinically important pulmonary disease other than asthma (eg, active lung infection, chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, cystic fibrosis etc.) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome), which can confound the outcome assessment.
• Patients currently enrolled in an interventional clinical study in parallel including those with any biologic treatment
• Patients who have received any biologic within 30 days prior to the date of informed consent.
• Known history of allergy or reaction to the benralizumab formulation or excipients (L-histidine, L-histidine hydrochloride monohydrate, α-trehalose dihydrate, polysorbate 20, water for injection)
• History of anaphylaxis to any biologic therapy
• A helminth parasitic infection diagnosed within 24 weeks before the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
• Acute asthma exacerbation 30 days before the date informed consent
• Acute asthma exacerbation between screening and first dose of study dose administration.
• Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days before the date informed consent
• Patients with malignancy within 5 years prior to enrolment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal, or squamous cell carcinoma or non-melanomatous skin cancer with active or recent malignancy
• Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis, which, in the opinion of the investigator, may put the participant at risk because of his/her participation in the study
• History of current alcohol, drug, or chemical abuse or past abuse that would impair or risk the participant's full participation in the study, in the opinion of the investigator
• Female patients who are pregnant or lactating or planning a family during the study period.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (13)

Research Site

Bengaluru, 560099, India

Location

Research Site

Chennai, 600035, India

Location

Research Site

Delhi, 110029, India

Location

Research Site

Hyderabad, 500084, India

Location

Research Site

Jaipur, 302039, India

Location

Research Site

Jodhpur, 342005, India

Location

Research Site

Lucknow, 226003, India

Location

Research Site

Mumbai, 400008, India

Location

Research Site

New Delhi, 110060, India

Location

Research Site

Noida, 201 301, India

Location

Research Site

Noida, 201301, India

Location

Research Site

Noida, 201304, India

Location

Research Site

Visakhapatnam, 530002, India

Location

Related Links

• CSR Synopsis

MeSH Terms

Interventions

benralizumab

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-arm, multicentre, interventional, Phase 4 study investigating the safety, tolerability, and effectiveness of Fasenra (benralizumab) in adult patients of severe asthma with eosinophilic phenotype over a period of 24 weeks.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: May 20, 2022
• Study Start: November 19, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: December 11, 2024
• Results First Posted: December 11, 2024

Record last verified: 2024-10

Locations

IN (13)