🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT07444567
Recruiting Phase 3

Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment

NCT07444567 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2026-07-24
Last updated
2026-08-19

Condition(s) studied

AsthmaEosinophilic Granulomatosis With Polyangiitis (EGPA)Hypereosinophilic Syndrome (HES)

Investigational drug(s) / intervention(s)

Benralizumab

Benralizumab: Accessorized Pre-Filled Syringe (Solution for injection).

Study summary

The rationale of the roll-over study (ROSY) is to provide continuous access to study treatment for participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment, as judged by the Investigator, while monitoring long-term safety and tolerability of benralizumab.

Eligibility

Sex
ALL
Min age
6 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 1\. Provision of signed and dated written ICF. 2\. Participants completing minimum required OLE period of a parent study and judged by the Investigator to benefit from continued treatment. * 3\. Participants must agree to follow the contraception requirements as per their respective parent protocols from study inclusion up to 12 weeks after the last dose of study treatment. * 4\. Participants without childbearing potential at enrolment must agree to start appropriate contraception if childbearing potential develops during the study and up to 12 weeks after the last dose of study treatment. * 5\. Participants who are unable to access commercially available benralizumab and clinically indicated for continuation. Exclusion Criteria: * 1\. Ongoing, unresolved AE requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or closed) that in the Investigator's opinion would prevent restarting benralizumab. * 2\. Participants who are planning to use live/live-attenuated vaccines. * 3\. Participants who are planning to use biologic therapies, including B-cell therapies with the exception for the treatment of co-morbidities where no alternative medicine is available. * 4\. Participants with any medical condition (such as cancer or viral infections \[hepatitis\]) or psychiatric condition that, in the opinion of the Investigator, could jeopardise or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments. * 5\. Concurrently enrolled in any clinical study (other than a parent study). * 6\. Participants who discontinued the parent study prior to completing the minimum OLE or treatment period. * 7\. Local access to commercially available benralizumab.

Primary outcome measure(s)

Trial sites (45)

FacilityCityRegionStatus
Research Site Aurora Colorado Not Yet Recruiting
Research Site Bethesda Maryland Not Yet Recruiting
Research Site Ann Arbor Michigan Not Yet Recruiting
Research Site Northfield New Jersey Not Yet Recruiting
Research Site The Bronx New York Not Yet Recruiting
Research Site Durham North Carolina Not Yet Recruiting
Research Site Cleveland Ohio Not Yet Recruiting
Research Site Salt Lake City Utah Not Yet Recruiting
Research Site Buenos Aires Argentina Not Yet Recruiting
Research Site Florida Argentina Not Yet Recruiting
Research Site Lobos Argentina Not Yet Recruiting
Research Site Mar del Plata Argentina Not Yet Recruiting
Research Site Mendoza Argentina Not Yet Recruiting
Research Site Mendoza Argentina Not Yet Recruiting
Research Site Rosario Argentina Not Yet Recruiting
Research Site San Juan Bautista Argentina Not Yet Recruiting
Research Site Innsbruck Austria Not Yet Recruiting
Research Site Brussels Belgium Not Yet Recruiting
Research Site Edegem Belgium Not Yet Recruiting
Research Site Calgary British Columbia Not Yet Recruiting
Research Site Hamilton Ontario Not Yet Recruiting
Research Site Toronto Ontario Recruiting
Research Site Toronto Ontario Not Yet Recruiting
Research Site Toronto Ontario Not Yet Recruiting
Research Site Bron France Not Yet Recruiting
Research Site Marseille France Not Yet Recruiting
Research Site Montpellier France Not Yet Recruiting
Research Site Nantes France Not Yet Recruiting
Research Site Paris France Not Yet Recruiting
Research Site Paris France Not Yet Recruiting
Research Site Pessac France Not Yet Recruiting
Research Site Suresnes France Not Yet Recruiting
Research Site Ahmedabad India Withdrawn
Research Site Ajmer India Not Yet Recruiting
Research Site Haifa Israel Not Yet Recruiting
Research Site Holon Israel Not Yet Recruiting
Research Site Roma Italy Not Yet Recruiting
Research Site Rotterdam Netherlands Not Yet Recruiting
Research Site Chęciny Poland Not Yet Recruiting
Research Site Gdansk Poland Not Yet Recruiting

+ 5 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07444567 on ClinicalTrials.gov ↗ ← All trials in India