NCT07815886|Recruiting
Benralizumab Effectiveness in EGPA
BELONG-EGPA
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BELONG-EGPA
Sponsor study identifier
Secondary identifiers
REGISTRY · Ethics Committee of the Tuscany Region - Central Area (CEAVC)
observational
100
1 country
1
Study Start
February 11, 2026
Actual (reported)Primary Completion
February 11, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 11, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a multicenter, retro-prospective observational study evaluating the effectiveness and safety of benralizumab in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) in a real-world setting. The study will include patients treated with benralizumab 30 mg every 4 weeks at EGPA referral centers participating in the European EGPA Study Group. Clinical, laboratory, lung function, treatment, relapse, and safety data will be collected from medical charts at baseline and during follow-up up to 24 months.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 11, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 11, 2026
Actual (reported)May 27, 2026
Actual (reported)September 11, 2026
Actual (reported)February 11, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 11, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Complete Response
Proportion of patients achieving complete response during follow-up. Complete response is defined as no disease activity (BVAS=0) and oral corticosteroid dose ≤4.0 mg/day.
Baseline and up to 24 months (at 3, 6, 12, 24 months)
Change in Lung Function
Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline to each follow-up time point. Unit of Measure: Milliliters
Baseline, 3, 6, 12, and 24 months
Disease relapse
Proportion of patients experiencing disease relapse after achieving complete response. Relapse is defined as active vasculitis, BVAS \>0, and/or worsening asthma or ear-nose-throat manifestations leading to an increase in oral corticosteroid dose to \>4.0 mg/day, initiation of a new immunosuppressive therapy, or hospitalization.
3, 6, 12, and 24 months
Partial response
Treatment persistence
3, 6, 12, and 24 months
Change in oral corticosteroid dose expressed as prednisone-equivalent dose
Baseline, 3, 6, 12, and 24 months
Oral corticosteroid discontinuation
3, 6, 12, and 24 months
Overall clinical benefit in first-line versus post-mepolizumab patients
Baseline, 3, 6, 12, and 24 months
Effectiveness after benralizumab dosage switching
3 months after dosage switch
Changes in organ manifestations
Baseline, 3, 6, 12, and 24 months
DMARD discontinuation rate
3, 6, 12, and 24 months
Change in ANCA positivity
Baseline, 3, 6, 12, and 24 months
Adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) receiving benralizumab 30 mg every 4 weeks in a real-world setting. Patients may be newly diagnosed or have relapsing or refractory EGPA and must have at least 3 months of available follow-up after starting benralizumab.
Benralizumab administered at a dose of 30 mg every 4 weeks in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) in a real-world setting. Patients may receive benralizumab as first-line biologic therapy or after previous exposure to mepolizumab. Treatment use, persistence, dosage changes, effectiveness outcomes, and safety events will be assessed during follow-up.
Adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) treated with benralizumab 30 mg every 4 weeks at EGPA referral centers participating in the European EGPA Study Group. Patients may be newly diagnosed or have relapsing or refractory EGPA, and will be included if at least 3 months of follow-up data after benralizumab initiation are available.
Edoardo Biancalana
Florence, Italy, 50134, Italy
Mattioli I, Urban ML, Padoan R, Mohammad AJ, Salvarani C, Baldini C, Berti A, Cameli P, Caminati M, Cathebras P, Bianchi FC, Cinetto F, Cohen Tervaert JW, Coppola A, Costanzo G, Cottin V, Crimi C, Del Giacco S, Desaintjean C, Egan A, Espigol-Frigole G, Folci M, Fornaro M, Franceschini F, Govoni M, Groh M, Guarnieri G, Hellmich B, Iannone F, Jones R, Kernder A, Lo Gullo A, Lombardi C, Lopalco G, Losappio L, Marchi MR, Rivera CM, Marvisi C, Maule M, Moi L, Monti S, Moosig F, Moroncini G, Negrini SM, Neumann T, Nolasco S, Novikov P, Roccatello D, Samson M, Schroeder JW, Seeliger B, Sinico RA, Solans R, Tcherakian C, Toniati P, Treppo E, Trivioli G, Vacca A, Jayne D, Bettiol A, Vaglio A, Emmi G; European EGPA Study Group. Mepolizumab versus benralizumab for eosinophilic granulomatosis with polyangiitis (EGPA): A European real-life retrospective comparative study. J Autoimmun. 2025 May;153:103398. doi: 10.1016/j.jaut.2025.103398. Epub 2025 Mar 26.
Wechsler ME, Nair P, Terrier B, Walz B, Bourdin A, Jayne DRW, Jackson DJ, Roufosse F, Borjesson Sjo L, Fan Y, Jison M, McCrae C, Necander S, Shavit A, Walton C, Merkel PA; MANDARA Study Group. Benralizumab versus Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2024 Mar 7;390(10):911-921. doi: 10.1056/NEJMoa2311155. Epub 2024 Feb 23.
Giacomo Emmi, MD/PhD
University of Trieste, Italy
First Submitted
May 27, 2026
First Posted
September 11, 2026
Study Start
February 11, 2026
Actual (reported)Primary Completion
February 11, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab
Proportion of patients achieving complete response during follow-up. Partial response is defined as no disease activity (BVAS=0) and oral corticosteroid dose \>4.0 mg/day.
Baseline and up to 24 months (at 3, 6, 12, 24 months)
Contact the study team to confirm eligibility.
Cottu A, Groh M, Desaintjean C, Marchand-Adam S, Guillevin L, Puechal X, Beaumesnil S, Lazaro E, Samson M, Taille C, Durel CA, Diot E, Nicolas S, Guilleminault L, Ebbo M, Cathebras P, Dupin C, Yildiz H, Belfeki N, Pugnet G, Chauvin P, Jouneau S, Lifermann F, Martellosio JP, Cottin V, Terrier B; French Vasculitis Study Group. Benralizumab for eosinophilic granulomatosis with polyangiitis. Ann Rheum Dis. 2023 Dec;82(12):1580-1586. doi: 10.1136/ard-2023-224624. Epub 2023 Aug 7.
Bettiol A, Urban ML, Padoan R, Groh M, Lopalco G, Egan A, Cottin V, Fraticelli P, Crimi C, Del Giacco S, Losappio L, Moi L, Cinetto F, Caminati M, Novikov P, Berti A, Cameli P, Cathebras P, Coppola A, Durel CA, Folci M, Lo Gullo A, Lombardi C, Monti S, Parronchi P, Rivera CM, Solans R, Vacca A, Espigol-Frigole G, Guarnieri G, Bianchi FC, Marchi MR, Tcherakian C, Kahn JE, Iannone F, Venerito V, Desaintjean C, Moroncini G, Nolasco S, Costanzo GAML, Schroeder JW, Ribi C, Tesi M, Gelain E, Mattioli I, Bello F, Jayne D, Prisco D, Vaglio A, Emmi G; European EGPA Study Group. Benralizumab for eosinophilic granulomatosis with polyangiitis: a retrospective, multicentre, cohort study. Lancet Rheumatol. 2023 Dec;5(12):e707-e715. doi: 10.1016/S2665-9913(23)00243-6. Epub 2023 Nov 6.
Nolasco S, Portacci A, Campisi R, Buonamico E, Pelaia C, Benfante A, Triggiani M, Spadaro G, Caiaffa MF, Scioscia G, Detoraki A, Valenti G, Papia F, Tomasello A, Crimi N, Scichilone N, Pelaia G, Carpagnano GE, Crimi C. Effectiveness and safety of anti-IL-5/Ralpha biologics in eosinophilic granulomatosis with polyangiitis: a two-year multicenter observational study. Front Immunol. 2023 Jun 30;14:1204444. doi: 10.3389/fimmu.2023.1204444. eCollection 2023.
Guntur VP, Manka LA, Denson JL, Dunn RM, Dollin YT, Gill M, Kolakowski C, Strand MJ, Wechsler ME. Benralizumab as a Steroid-Sparing Treatment Option in Eosinophilic Granulomatosis with Polyangiitis. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1186-1193.e1. doi: 10.1016/j.jaip.2020.09.054. Epub 2020 Oct 14.
Bettiol A, Urban ML, Bello F, Fiori D, Mattioli I, Lopalco G, Iannone F, Egan A, Dagna L, Caminati M, Negrini S, Bargagli E, Folci M, Franceschini F, Padoan R, Flossmann O, Solans R, Schroeder J, Andre M, Moi L, Parronchi P, Roccatello D, Sciascia S, Jayne D, Prisco D, Vaglio A, Emmi G; European EGPA Study Group. Sequential rituximab and mepolizumab in eosinophilic granulomatosis with polyangiitis (EGPA): a European multicentre observational study. Ann Rheum Dis. 2022 Dec;81(12):1769-1772. doi: 10.1136/ard-2022-222776. Epub 2022 Jul 18. No abstract available.
Canzian A, Venhoff N, Urban ML, Sartorelli S, Ruppert AM, Groh M, Girszyn N, Taille C, Maurier F, Cottin V, de Moreuil C, Germain V, Samson M, Jachiet M, Denis L, Rieu V, Smets P, Pugnet G, Deroux A, Durel CA, Aouba A, Cathebras P, Deligny C, Faguer S, Gil H, Godeau B, Lifermann F, Phin-Huynh S, Ruivard M, Bonniaud P, Puechal X, Kahn JE, Thiel J, Dagna L, Guillevin L, Vaglio A, Emmi G, Terrier B; French Vasculitis Study Group and the European EGPA Study Group. Use of Biologics to Treat Relapsing and/or Refractory Eosinophilic Granulomatosis With Polyangiitis: Data From a European Collaborative Study. Arthritis Rheumatol. 2021 Mar;73(3):498-503. doi: 10.1002/art.41534. Epub 2021 Jan 23.
Bettiol A, Urban ML, Dagna L, Cottin V, Franceschini F, Del Giacco S, Schiavon F, Neumann T, Lopalco G, Novikov P, Baldini C, Lombardi C, Berti A, Alberici F, Folci M, Negrini S, Sinico RA, Quartuccio L, Lunardi C, Parronchi P, Moosig F, Espigol-Frigole G, Schroeder J, Kernder AL, Monti S, Silvagni E, Crimi C, Cinetto F, Fraticelli P, Roccatello D, Vacca A, Mohammad AJ, Hellmich B, Samson M, Bargagli E, Cohen Tervaert JW, Ribi C, Fiori D, Bello F, Fagni F, Moroni L, Ramirez GA, Nasser M, Marvisi C, Toniati P, Firinu D, Padoan R, Egan A, Seeliger B, Iannone F, Salvarani C, Jayne D, Prisco D, Vaglio A, Emmi G; European EGPA Study Group. Mepolizumab for Eosinophilic Granulomatosis With Polyangiitis: A European Multicenter Observational Study. Arthritis Rheumatol. 2022 Feb;74(2):295-306. doi: 10.1002/art.41943. Epub 2021 Dec 30.
Wechsler ME, Akuthota P, Jayne D, Khoury P, Klion A, Langford CA, Merkel PA, Moosig F, Specks U, Cid MC, Luqmani R, Brown J, Mallett S, Philipson R, Yancey SW, Steinfeld J, Weller PF, Gleich GJ; EGPA Mepolizumab Study Team. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2017 May 18;376(20):1921-1932. doi: 10.1056/NEJMoa1702079.
Emmi G, Bettiol A, Gelain E, Bajema IM, Berti A, Burns S, Cid MC, Cohen Tervaert JW, Cottin V, Durante E, Holle JU, Mahr AD, Del Pero MM, Marvisi C, Mills J, Moiseev S, Moosig F, Mukhtyar C, Neumann T, Olivotto I, Salvarani C, Seeliger B, Sinico RA, Taille C, Terrier B, Venhoff N, Bertsias G, Guillevin L, Jayne DRW, Vaglio A. Evidence-Based Guideline for the diagnosis and management of eosinophilic granulomatosis with polyangiitis. Nat Rev Rheumatol. 2023 Jun;19(6):378-393. doi: 10.1038/s41584-023-00958-w. Epub 2023 May 9.
Hellmich B, Sanchez-Alamo B, Schirmer JH, Berti A, Blockmans D, Cid MC, Holle JU, Hollinger N, Karadag O, Kronbichler A, Little MA, Luqmani RA, Mahr A, Merkel PA, Mohammad AJ, Monti S, Mukhtyar CB, Musial J, Price-Kuehne F, Segelmark M, Teng YKO, Terrier B, Tomasson G, Vaglio A, Vassilopoulos D, Verhoeven P, Jayne D. EULAR recommendations for the management of ANCA-associated vasculitis: 2022 update. Ann Rheum Dis. 2024 Jan 2;83(1):30-47. doi: 10.1136/ard-2022-223764.
Fagni F, Bello F, Emmi G. Eosinophilic Granulomatosis With Polyangiitis: Dissecting the Pathophysiology. Front Med (Lausanne). 2021 Feb 24;8:627776. doi: 10.3389/fmed.2021.627776. eCollection 2021.
Lyons PA, Peters JE, Alberici F, Liley J, Coulson RMR, Astle W, Baldini C, Bonatti F, Cid MC, Elding H, Emmi G, Epplen J, Guillevin L, Jayne DRW, Jiang T, Gunnarsson I, Lamprecht P, Leslie S, Little MA, Martorana D, Moosig F, Neumann T, Ohlsson S, Quickert S, Ramirez GA, Rewerska B, Schett G, Sinico RA, Szczeklik W, Tesar V, Vukcevic D; European Vasculitis Genetics Consortium; Terrier B, Watts RA, Vaglio A, Holle JU, Wallace C, Smith KGC. Genome-wide association study of eosinophilic granulomatosis with polyangiitis reveals genomic loci stratified by ANCA status. Nat Commun. 2019 Nov 12;10(1):5120. doi: 10.1038/s41467-019-12515-9.
Study Completion
February 11, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 11, 2026
Record last verified: 2026-09
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