Clinical trial • Phase III • Immunology|Rare Disease
INEBILIZUMAB for Immunoglobulin G4-related disease
Phase III trial of INEBILIZUMAB for Immunoglobulin G4-related disease.
Overview
- Trial Therapeutic Area
- Immunology|Rare Disease
- Trial Disease
- Immunoglobulin G4-related disease
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 26-02-2024
- First CTIS Authorization Date
- 27-03-2024
Trial design
Randomised, placebo: 10 ml (nominal) solution containing 20 mm histidine/histidine hydrochloride, 70 mm sodium chloride, 106 mm (4% [w/v]) trehalose dihydrate, and 0.01% (w/v) polysorbate 80 (placebo product described; dose/schedule not specified).-controlled Phase III trial in Netherlands, Germany, France and others.
- Randomised
- Yes
- Comparator
- Placebo: 10 mL (nominal) solution containing 20 mM histidine/histidine hydrochloride, 70 mM sodium chloride, 106 mM (4% [w/v]) trehalose dihydrate, and 0.01% (w/v) polysorbate 80 (placebo product described; dose/schedule not specified).
- Target Sample Size
- 110
- Trial Duration For Participant
- 364
Eligibility
Recruits 110 Vulnerable population selected. Informed consent must be provided by adult participants who have reached the age of consent in the applicable region (e.g., ≥18 years)..
- Pregnancy Exclusion
- 6. Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide (where spermicide is available) from Day 1 through to the end of the study and must agree to continue using such precautions for at least 6 months after the final dose of IP. Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highlyeffective method of contraception.
- Vulnerable Population
- Vulnerable population selected. Informed consent must be provided by adult participants who have reached the age of consent in the applicable region (e.g., ≥18 years).
Inclusion criteria
- {"criterion_text":"- 1.Male or female adults who have reached the age of consent in the applicable region (eg, ≥18 years in the US)\n- 2. Clinical diagnosis of IgG4-RD.\n- 3. Fulfillment of the 2019 ACR/EULAR classification criteria.\n- 4. Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of glucocorticoid (GC) treatment at the time of informed consent.\n- 5. IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD. One organ must meet the requirements for the ACR/EULAR classification criteria; the second organ is as defined by the investigator\n- 6. Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide (where spermicide is available) from Day 1 through to the end of the study and must agree to continue using such precautions for at least 6 months after the final dose of IP. Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highlyeffective method of contraception."}
Exclusion criteria
- {"criterion_text":"- 1. History of solid organ or cell-based transplantation or known immunodeficiency disorder .\n- 2. Active malignancy or history of malignancy that was active within the last 10 years (some specific situations for cervical, skin, prostate or thyroid cancer are acceptable).\n- 3. Receipt of any biologic B cell-depleting therapy or non-depleting Bcell- directed therapy in prior 6 months.\n- 4. Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within prior 4 weeks\n- 5. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection\n- 6. Live vaccine or therapeutic agent in prior 2 weeks\n- 7. Glomerular filtration rate < 30 mL/min/1.73 m2"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Time to disease flare, defined as the time in days from Day 1 (dosing) to the date of the first treated and AC-determined IgG4 RD flare within the 52-week RCP. The date of disease flare is defined as the date of initiation of any flare treatment (new or increased GC treatment, other immunotherapy, or interventional procedure) deemed necessary by the Investigator for the flare.","definition_or_measurement_approach":"Defined as time in days from Day 1 (dosing) to date of first treated and AC-determined IgG4-RD flare within the 52-week RCP. Date of flare = date of initiation of any flare treatment (new or increased GC treatment, other immunotherapy, or interventional procedure) deemed necessary by the Investigator."}
Secondary endpoints
- {"endpoint_text":"- 1. Annualized flare rate for treated and AC-determined flares during the RCP.","definition_or_measurement_approach":"Annualized rate of treated and AC-determined flares during the RCP."}
- {"endpoint_text":"- 2. The proportion of subjects achieving flare-free, treatment-free complete remission at Week 52, defined as the lack of evident disease activity at Week 52, no AC-determined flare during the RCP, and no treatment for flare or disease control except the required 8-week GC taper.","definition_or_measurement_approach":"Proportion of subjects with no evident disease activity at Week 52, no AC-determined flare during RCP, and no treatment for flare/disease control except the required 8-week GC taper."}
- {"endpoint_text":"- 3. The proportion of subjects achieving flare-free, corticosteroid-free complete remission at Week 52, defined as the lack of evident disease activity at Week 52, no AC-determined flare during the RCP, and no corticosteroid treatment for flare or disease control except the required 8-week GC taper.","definition_or_measurement_approach":"Proportion of subjects with no evident disease activity at Week 52, no AC-determined flare during RCP, and no corticosteroid treatment for flare/disease control except required 8-week GC taper."}
- {"endpoint_text":"- 4. Time to initiation of first treatment (medication or procedure) for new or worsening disease activity by the Investigator within the RCP, regardless of AC determination of flare.","definition_or_measurement_approach":"Time in days from baseline to initiation of first treatment for new or worsening disease activity by the Investigator within the RCP (regardless of AC determination)."}
- {"endpoint_text":"- 5. Annualized flare rate for AC-determined flares, whether or not treated, during the RCP.","definition_or_measurement_approach":"Annualized rate of AC-determined flares (treated or untreated) during the RCP."}
- {"endpoint_text":"- 6. Glucocorticoid use, calculated as the cumulative GC dose taken for the purpose of IgG4 RD disease control during the RCP.","definition_or_measurement_approach":"Cumulative glucocorticoid dose taken for disease control during the RCP."}
- {"endpoint_text":"- 7. Incidence of treatment emergent adverse events (TEAEs), serious TESAEs, and TEAEs of special interest (AESIs) during the 52-week RCP and during the OLP.","definition_or_measurement_approach":"Incidence rates of TEAEs, serious TESAEs, and TEAEs of special interest during the 52-week RCP and OLP."}
- {"endpoint_text":"- 8. The incidence of ADAs directed against inebilizumab during the RCP.","definition_or_measurement_approach":"Incidence of anti-drug antibodies (ADAs) against inebilizumab during the RCP."}
Recruitment
- Planned Sample Size
- 110
- Recruitment Window Months
- 99
- Consent Approach
- Informed consent obtained from adult participants who have reached the age of consent in the applicable region (eg, ≥18 years). Subject information and informed consent forms available in multiple languages (documents available in English, French, Dutch, Spanish, Italian, Polish, German).
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 90
Netherlands
- Earliest CTIS Part Ii Submission Date
- 16-01-2024
- Latest Decision Or Authorization Date
- 25-03-2025
- Processing Time Days
- 434
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Clinical Immunology
- Principal Investigator Name
- Jan van Laar
- Principal Investigator Email
- j.vanlaar@erasmusmc.nl
- Contact Person Name
- Jan van Laar
- Contact Person Email
- j.vanlaar@erasmusmc.nl
Germany
- Earliest CTIS Part Ii Submission Date
- 16-01-2024
- Latest Decision Or Authorization Date
- 14-04-2025
- Processing Time Days
- 454
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Klinik und Poliklinik für Innere Medizin II, Klinikum der Universität München
- Principal Investigator Name
- Julia Mayerle
- Principal Investigator Email
- Julia.Mayerle@med.uni-muenchen.de
- Contact Person Name
- Julia Mayerle
- Contact Person Email
- Julia.Mayerle@med.uni-muenchen.de
France
- Earliest CTIS Part Ii Submission Date
- 16-01-2024
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 772
- Number Of Sites
- 4
- Number Of Participants
- 13
Sites
- Site Name
- Hopital Beaujon
- Department Name
- Service de Pancréatologie
- Principal Investigator Name
- Vinciane Rebours
- Principal Investigator Email
- vinciane.rebours@aphp.fr
- Contact Person Name
- Vinciane Rebours
- Contact Person Email
- vinciane.rebours@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service de Médecine Interne
- Principal Investigator Name
- Alexandra Espitia
- Principal Investigator Email
- alexandra.espitiathibault@chu-nantes.fr
- Contact Person Name
- Alexandra Espitia
- Contact Person Email
- alexandra.espitiathibault@chu-nantes.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Service de Médecine Interne
- Principal Investigator Name
- Nicolas Schleinitz
- Principal Investigator Email
- nicolas.schleinitz@ap-hm.fr
- Contact Person Name
- Nicolas Schleinitz
- Contact Person Email
- nicolas.schleinitz@ap-hm.fr
- Site Name
- Hopital Huriez
- Department Name
- Service de Médecine Interne
- Principal Investigator Name
- Eric Hachulla
- Principal Investigator Email
- eric.hachulla@chru-lille.fr
- Contact Person Name
- Eric Hachulla
- Contact Person Email
- eric.hachulla@chru-lille.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 16-01-2024
- Latest Decision Or Authorization Date
- 13-02-2026
- Processing Time Days
- 759
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Careggi University Hospital
- Department Name
- Department of Clinical and Experimental Medicine
- Principal Investigator Name
- Elena Silvestri
- Principal Investigator Email
- elena.silvestri@unifi.it
- Contact Person Name
- Elena Silvestri
- Contact Person Email
- elena.silvestri@unifi.it
- Site Name
- Ospedale San Giovanni Bosco
- Department Name
- SCdU Nephrology and Dyalisis - CMID
- Principal Investigator Name
- Savino Sciascia
- Principal Investigator Email
- savino.sciascia@unito.it
- Contact Person Name
- Savino Sciascia
- Contact Person Email
- savino.sciascia@unito.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR)
- Principal Investigator Name
- Lorenzo Dagna
- Principal Investigator Email
- dagna.lorenzo@unisr.it
- Contact Person Name
- Lorenzo Dagna
- Contact Person Email
- dagna.lorenzo@unisr.it
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- c/o Policlinico GB Rossi
- Principal Investigator Name
- Luca Frulloni
- Principal Investigator Email
- luca.frulloni@univr.it
- Contact Person Name
- Luca Frulloni
- Contact Person Email
- luca.frulloni@univr.it
Spain
- Earliest CTIS Part Ii Submission Date
- 16-01-2024
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 778
- Number Of Sites
- 3
- Number Of Participants
- 30
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Internal Medicine
- Principal Investigator Name
- Irene Calatayud Marin
- Principal Investigator Email
- calatayud_ire@gva.es
- Contact Person Name
- Irene Calatayud Marin
- Contact Person Email
- calatayud_ire@gva.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Internal Medicine
- Principal Investigator Name
- Andres Gonzalez Garcia
- Principal Investigator Email
- andres.gonzalez@salud.madrid.org
- Contact Person Name
- Andres Gonzalez Garcia
- Contact Person Email
- andres.gonzalez@salud.madrid.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Internal Medicine
- Principal Investigator Name
- Fernando Martinez Valle
- Principal Investigator Email
- ferranmartinezvalle@gmail.com
- Contact Person Name
- Fernando Martinez Valle
- Contact Person Email
- ferranmartinezvalle@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 16-01-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 762
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Department Name
- Klinika Wczesnego Zapalenia Stawów
- Principal Investigator Name
- Maria Maślińska
- Principal Investigator Email
- maria.maslinska@spartanska.pl
- Contact Person Name
- Maria Maślińska
- Contact Person Email
- maria.maslinska@spartanska.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Reumatologii i Chorób Wewnętrznych
- Principal Investigator Name
- Piotr Wiland
- Principal Investigator Email
- pwiland1@gmail.com
- Contact Person Name
- Piotr Wiland
- Contact Person Email
- pwiland1@gmail.com
Sponsor
Primary sponsor
- Full Name
- Horizon Therapeutics Ireland Designated Activity Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Medpace Inc.
- Responsibilities
- sponsorDuties codes: 1,12,15 (ePRO),2,3,6,7,9
- Name
- Parexel International Corp.
- Responsibilities
- sponsorDuties: 8
- Name
- Icon Public Limited Company
- Responsibilities
- sponsorDuties: 15 (Safety vendor and Firecrest Training Portal)
Third parties
- {"country":"United States","full_name":"Medpace Inc.","duties_or_roles":"sponsorDuties codes: 1,12,15 (ePRO),2,3,6,7,9","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties: 15 (QP release)","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties: 15 (QP release)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"sponsorDuties: 8","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties: 15 (QP release)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties: 15 (TMF),7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"sponsorDuties: 15 (QP release)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"sponsorDuties: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Public Limited Company","duties_or_roles":"sponsorDuties: 15 (Safety vendor and Firecrest Training Portal)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- INEBILIZUMAB
- Active Substance
- INEBILIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Maximum Dose
- 300 mg (max daily); 3000 mg (max total)
- Investigational Product Name
- 10 mL (nominal) solution containing 20 mM histidine/histidine hydrochloride, 70 mM sodium chloride, 106 mM (4% [w/v]) trehalose dihydrate, and 0.01% (w/v) polysorbate 80
- Modality
- Other
- Combination Treatment
- Yes
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