Disclaimer
The elements presented on this page are not an exhaustive list of information relating to the clinical trial. The inclusion and exclusion criteria have been simplified and should be interpreted by a physician. For more information please visit CTIS website for FABULINUS.
Study design
- Study Type: Interventional (Clinical Trial)
- Estimated Enrollment: 192 participants
- Allocation: Randomized
- Purpose: The purpose of this study is to determine safety and efficacy of different dose-levels of frexalimab, by assessment of preservation of endogenous insulin secretion in participants with newly diagnosed T1D aged 12 to 21 years compared with placebo on top of standard insulin therapy, and to determine the dose-response relationship and minimal efficacious dose in Part B.
- Official Title: A 52-week Randomized, Double-blind, Placebo-controlled, Multi-center Phase 2b Study With a 52-week Blinded Extension Assessing Safety and Efficacy of Frexalimab, a CD40L-antagonist Monoclonal Antibody, for Preservation of Pancreatic β-cell Function in Adults and Adolescents With Newly Diagnosed Type 1 Diabetes on Insulin Therapy (Fabulinus)
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Duration of Participation: The treatment duration will be up to 104 weeks, the total study duration will be up to 135 weeks.
Criteria
Recruitment for this study is only open to people who meet these criteria.
Highlighted Inclusion:
- For Part A: age 18-35 years old
- For Part B: age 12-21 years old
- Participants who meet the criteria of T1D according to American Diabetes Association
- Initiated insulin replacement therapy not longer than 90 days prior to screening visit
- Receiving at least one type of standard of care (SOC) insulin hormone replacement therapy
- Participants must be positive for at least 1 of the following T1D autoantibodies confirmed by medical history and/or obtained at study screening:
- Glutamic acid decarboxylase (GAD-65)
- Insulinoma Antigen-2 (IA-2)
- Zinc-transporter 8 (ZnT8) or
- Insulin (if obtained not later than 10 days after exogenous insulin therapy initiation)
- Be vaccinated according to the local vaccination schedule. Any vaccinations should take place at least 28 days prior to randomization for non-live vaccines and at least 3 months prior to randomization for live vaccines.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Highlight Exclusion:
- History of serious systemic viral, bacterial or fungal infection
- History of invasive opportunistic infections or active or latent tuberculosis
- History of a systemic hypersensitivity reaction or significant allergies, other than localized injection site reaction, to any humanized mAb
- History of malignancy within 5 years of screening
- Any live vaccines within 3 months prior to randomization
- Any non-live vaccines administered less than 28 days prior to randomization
- Course of Thymoglobulin®, teplizumab or other immunomodulatory treatments at any time
Outcome measures
Change from baseline to W52 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration (calculated from AUC).
Locations
Interested in more Information? Reach out!
Sites Open to Recruitment
Please note that this list will be updated regularly
UZ Leuven, Leuven, Belgium
Principal Investigator: Prof. Kristina Casteels
Contact: kristina.casteels@uzleuven.beCentre Hospitalier Sud Francilien, Corbeil Essonnes, France
Principal Investigator: Dr. Alfred J. Penfornis
Contact: alfred.penfornis@chsf.frAPHP-Hospital Cochin, Paris, France
Principal Investigator: Dr. Roberto Mallone
Contact: roberto.mallone@inserm.frAzienda Ospedaliero-Universitaria Maggiore Della Carita, Novara, Italy
Principal Investigator: Prof. Dr. Ivana Rabone
Contact: ivana.rabbone@uniupo.itKinder-und Jugendkrankenh aus auf der Bult, Hannover, Germany
Principal Investigator: Dr. Felix Reschke
Contact: felix.reschke@hka.deHospital Universitario Virgen Macarena, Seville, Spain
Principal Investigator: Prof. Dr. María Asunción Martínez Brocca
Contact: masuncion.martinez.sspa@juntadeadalucia.es
Sites Open to Recruitment Soon
Fakultni nemocnice v Motole, Praha 5 Motol, Czechia
Principal Investigator: Prof. Dr. Zdenek Sumnik
Contact: zdenek.sumnik@lfmotol.cuni.czTechnische Universitat Dresden, Dresden, Germany
Principal Investigator: Prof. Dr. Gita Gemulla
Contact: gita.gemulla1@mailbox.tu-dresden.deUniversitätsklinik Für Kinder-Und Jugendmedizin, Ulm, Germany
Principal Investigator: Dr. Martin Wabitsch
Contact: martin.wabitsch@uniklinik-ulm.deSan Raffaele Hospital, Milano, Italy
Principal Investigator: Dr. Sabina Martinenghi
Contact: v.cherubini@univpm.itAOU delle Marche Ospedale G. Salesi, Ancona, Italy
Principal Investigator: Dr. Valentino Cherubini
Contact: v.cherubini@univpm.itFederico II, Naples, Italy
Principal Investigator: Dr. Enza Mozzillo
Contact: enza.mozzillo@unina.itBambino Gesu, Rome, Italy
Principal Investigator: Dr. Riccardo Schiaffini
Contact: riccardo.schiaffini@opbg.netAzienda Ospedaliera Universitaria Integrata Verona, Verona, Italy
Principal Investigator: Prof. Dr. Claudio Maffeis
Contact: claudio.maffeis@univr.itGornoslaskie Centrum Zdrowia Dziecka, Katowice, Poland
Principal Investigator: Prof. Dr. Przemyslawa Jarosz-Chobot
Contact: diabetologia@gczd.katowice.plUniversity of Cambridge, Cambridge, United Kingdom
Principal Investigator: Dr. Loredana Marcovecchio
Contact: mlm45@medschl.cam.ac.ukSteno Diabetes Center, Copenhagen, Denmark
Principal Investigator: Prof. Dr. Jesper Johannesen
Contact: Jesper.Johannesen@regionh.dk
This does not mean that all INNODIA Clinical Trial Sites will participate in this specific study.
Some additional sites that are not part of the INNODIA Network may run this study too.
A complete list of participating sites can be found on CTIS website.
Sponsors and Collaborators
Sanofi