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New drug aims to help type 1 diabetes patients keep making insulin

NCT ID NCT06111586

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This phase 2b trial tests frexalimab, an antibody that calms the immune system, in 192 adults and teens newly diagnosed with type 1 diabetes. The goal is to see if it can preserve the body's ability to produce insulin, reducing reliance on injections. Participants receive frexalimab or placebo for up to 104 weeks, with regular monitoring of insulin production and blood sugar control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
frexalimab (a monoclonal antibody that blocks CD40L to calm the immune system)
What this could lead to
If it works, this could help people with newly diagnosed type 1 diabetes keep making some of their own insulin longer, reducing how much insulin they need to inject.
What could go wrong
This is a mid-stage trial with only 192 people, so results may not apply to everyone. The drug may not preserve insulin production better than placebo, and there are risks from immune suppression, such as infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

197 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 35 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants who meet the criteria of T1D according to American Diabetes Association * Initiated exogenous insulin replacement therapy not longer than 90 days prior to screening visit at which random C-peptide will be assessed (V1). * Receiving at least one of the following T1D standard of care (SOC), insulin hormone replacement therapy * one or multiple daily injections (MDI) of basal insulin, prandial insulin and/or premixed insulin, or * continuous subcutaneous insulin infusion (CSII) * 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) * Have random C-peptide levels ≥ 0.2 nmol/L determined at screening visit. * 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 * Participants body weight at screening must be at least 20kg. Exclusion Criteria: * Serious systemic viral, bacterial or fungal infection (eg, pneumonia, pyelonephritis), infection requiring hospitalization or IV antibiotics or significant chronic viral (including history of recurrent or active herpes zoster, acute or active cytomegalovirus (CMV), Epstein-Barr Virus (EBV) as determined at screening), bacterial, or fungal infection (eg, osteomyelitis) 30 days before and during screening. * Participants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution. * Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and/or TB testing. Blood testing (eg, QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed. * Evidence of any clinically significant, severe or unstable, acute or chronically progressive, uncontrolled infection, medical or surgical condition (eg, but not limited to, cerebral, cardiac, pulmonary, renal, hepatic, gastrointestinal, neurologic, acquired or inherited bone/skeletal disorders including repeated bone fractures for unknown reason, juvenile osteoporosis, osteogenesis imperfecta, osteochondropathies, or any known immune deficiency), or any condition that may affect participant safety in the judgment of the Investigator (including vaccinations which are not updated based on local regulation). * History or current hypogammaglobulinemia. * History of a systemic hypersensitivity reaction or significant allergies, other than localized injection site reaction, to any humanized mAb. Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis). * Has other autoimmune diseases (eg, rheumatoid arthritis \[RA\], polyarticular juvenile idiopathic arthritis \[pJIA\], psoriatic arthritis \[PsA\], ankylosing spondylitis \[AS\], MS, SLE), that require treatment with biologic drugs (mono or polyclonal antibodies) or systemic corticosteroid therapy (at discretion of investigator). * History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, antiphospholipid syndrome, other prothrombotic disorders and/or participants requiring antithrombotic treatment. * Diabetes of forms other than autoimmune T1D that include but is not limited to genetic forms of diabetes, maturity-onset diabetes of the young (MODY), latent autoimmune diabetes of the adult (LADA), secondary to medications or surgery, type 2 diabetes by judgement of the investigator. * History of malignancy of any organ system, treated or untreated, within 5 years of screening, regardless of whether there is evidence of local recurrence or metastases. * Systemic corticosteroids (duration \> 7 days), adrenocorticotropic hormone 1 month prior to screening. * Any IV, IM or SC administered biologic treatments, \< 3 months or \< than 5 half-lives (whichever is longer), prior to randomization. * Any live (attenuated or viral-vector) vaccine (including but not limited to varicella zoster, oral polio, nasal influenza, rabies) within 3 months prior to randomization. * Any non-live (inactivated, mRNA, recombinant, conjugate, toxoid) vaccine administered less than 28 days prior to randomization. * Other medications not compatible or interfering with IMP at discretion of investigator. * Any immunosuppressive therapy within 12 weeks prior to randomization. * Course of Thymoglobulin®, teplizumab or other immunomodulatory treatments at any time. * Any drugs that may be used for treatment of T1D and type 2 diabetes other than insulin including but not limited to metformin, glucagon-like peptide 1 (GLP-1) agonists and sodium-glucose co-transporter-2 and 1 (SGLT2/1) inhibitor and verapamil within 2 weeks prior to screening. * Abnormal laboratory test(s) at screening. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes mellitus

Contacts and locations

Locations

  • AOU delle Marche - Ospedale G. Salesi-Site Number : 3800008

    Torette, Ancona, 60020, Italy

  • AdventHealth Orlando- Site Number : 8400002

    Orlando, Florida, 32803, United States

  • Azienda Ospedaliera Universitaria 'Federico II'-Site Number : 3800009

    Naples, Napoli, 80131, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona - Centro regionale di Diabetologia Pediatrica-Site Number : 3800004

    Verona, 37126, Italy

  • Azienda Ospedaliera Universitaria Meyer IRCCS-Site Number : 3800003

    Florence, Firenze, 50139, Italy

  • Azienda Ospedaliero-Universitaria Maggiore Della Carità-Site Number : 3800001

    Novara, 28100, Italy

  • Azienda Socio Sanitaria Territoriale Dei Sette Laghi - Ospedale Filippo del Ponte-Site Number : 3800002

    Varese, 21100, Italy

  • Benaroya Research Institute at Virginia Mason- Site Number : 8400016

    Seattle, Washington, 98101, United States

  • Cincinnati Children's Hospital Medical Center- Site Number : 8400019

    Cincinnati, Ohio, 45229, United States

  • IRCCS Ospedale San Raffaele-Site Number : 3800006

    Milan, Milano, 20132, Italy

  • Investigational Site Number : 0400001

    Vienna, 1090, Austria

  • Investigational Site Number : 0400002

    Graz, 8036, Austria

  • Investigational Site Number : 0400004

    Linz, 4020, Austria

  • Investigational Site Number : 0560001

    Leuven, 3000, Belgium

  • Investigational Site Number : 0560002

    Brussels, 1090, Belgium

  • Investigational Site Number : 1240001

    Vancouver, British Columbia, V5Y 3W2, Canada

  • Investigational Site Number : 1240003

    Montreal, Quebec, H4A 3T2, Canada

  • Investigational Site Number : 1240004

    Montreal, Quebec, H4a 3j1, Canada

  • Investigational Site Number : 1240005

    Montreal, Quebec, H3T 1C5, Canada

  • Investigational Site Number : 1240007

    London, Ontario, N6a 4l6, Canada

  • Investigational Site Number : 2030001

    Prague, 150 06, Czechia

  • Investigational Site Number : 2030002

    Prague, 100 34, Czechia

  • Investigational Site Number : 2030003

    Ostrava, 708 52, Czechia

  • Investigational Site Number : 2080005

    Herlev, 2730, Denmark

  • Investigational Site Number : 2460001

    Helsinki, 00029, Finland

  • Investigational Site Number : 2460002

    Turku, 20521, Finland

  • Investigational Site Number : 2460003

    Tampere, 33520, Finland

  • Investigational Site Number : 2460004

    Oulu, 90220, Finland

  • Investigational Site Number : 2500003

    Saint-Herblain, 44800, France

  • Investigational Site Number : 2500004

    Corbeil-Essonnes, 91106, France

  • Investigational Site Number : 2500005

    Mont-de-Marsan, 40024, France

  • Investigational Site Number : 2500006

    Paris, 75679, France

  • Investigational Site Number : 2500007

    Pontoise, 95300, France

  • Investigational Site Number : 2760001

    Hanover, 30173, Germany

  • Investigational Site Number : 2760002

    Oldenburg in Holstein, 23758, Germany

  • Investigational Site Number : 2760003

    Dresden, 01307, Germany

  • Investigational Site Number : 2760004

    Ulm, 89081, Germany

  • Investigational Site Number : 3480001

    Balatonfüred, 8230, Hungary

  • Investigational Site Number : 3480002

    Nyíregyháza, 4400, Hungary

  • Investigational Site Number : 3480003

    Nyíregyháza, 4400, Hungary

  • Investigational Site Number : 3480004

    Budapest, 1089, Hungary

  • Investigational Site Number : 3480006

    Székesfehérvár, 8000, Hungary

  • Investigational Site Number : 6160002

    Katowice, Silesian Voivodeship, 40-752, Poland

  • Investigational Site Number : 6160004

    Warsaw, Masovian Voivodeship, 02-117, Poland

  • Investigational Site Number : 6160005

    Lodz, Lódzkie, 92-213, Poland

  • Investigational Site Number : 6160006

    Warsaw, Masovian Voivodeship, 02-097, Poland

  • Investigational Site Number : 6160007

    Warsaw, Masovian Voivodeship, 04-746, Poland

  • Investigational Site Number : 6160008

    Bialystok, Podlaskie Voivodeship, 15-274, Poland

  • Investigational Site Number : 6160009

    Szczecin, West Pomeranian Voivodeship, 71-252, Poland

  • Investigational Site Number : 7050001

    Ljubljana, 1000, Slovenia

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240002

    Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

  • Investigational Site Number : 7240003

    Seville, Sevilla, 41009, Spain

  • Investigational Site Number : 7240004

    Málaga, 29010, Spain

  • Investigational Site Number : 7240005

    Oviedo, Principality of Asturias, 33011, Spain

  • Investigational Site Number : 7240006

    Valencia, 46010, Spain

  • Investigational Site Number : 7240007

    Vitoria-Gasteiz, Álava, 01009, Spain

  • Investigational Site Number : 7520001

    Stockholm, 113 65, Sweden

  • Investigational Site Number : 7520002

    Solna, 171 64, Sweden

  • Investigational Site Number : 7520003

    Stockholm, 118 83, Sweden

  • Investigational Site Number : 8260001

    Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

  • Investigational Site Number : 8260003

    Birmingham, England, B15 2TH, United Kingdom

  • Investigational Site Number : 8260004

    Leicester, Leicestershire, LE5 4PW, United Kingdom

  • Investigational Site Number : 8260006

    Harrow, London, City of, HA1 3UJ, United Kingdom

  • Investigational Site Number : 8260007

    Birmingham, England, B4 6NH, United Kingdom

  • Investigational Site Number : 8260009

    Dundee, Dundee City, DD1 9SY, United Kingdom

  • Investigational Site Number : 8260010

    Glasgow, Glasgow City, G51 4TF, United Kingdom

  • Joslin Diabetes Center - Boston- Site Number : 8400015

    Boston, Massachusetts, 02215, United States

  • NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400007

    Skokie, Illinois, 60077, United States

  • Ospedale Pediatrico Bambin Gesu IRCCS-Site Number : 3800007

    Rome, Roma, 00165, Italy

  • Rocky Mountain Diabetes and Osteoporosis Center- Site Number : 8400009

    Idaho Falls, Idaho, 83404, United States

  • The Children's Hospital of Philadelphia Site Number : 8400005

    Philadelphia, Pennsylvania, 19104, United States

  • University at Buffalo - Downtown Campus- Site Number : 8400004

    Buffalo, New York, 14203, United States

  • University of California San Francisco - Mission Bay- Site Number : 8400012

    San Francisco, California, 94158, United States

  • University of Colorado - Anschutz Medical Campus- Site Number : 8400003

    Aurora, Colorado, 80045, United States

  • University of Florida College of Medicine- Site Number : 8400010

    Gainesville, Florida, 32610, United States

  • University of Miami Hospital- Site Number : 8400013

    Miami, Florida, 33136, United States

  • University of North Carolina at Chapel Hill- Site Number : 8400001

    Chapel Hill, North Carolina, 27514, United States

  • University of Texas - Southwestern Medical Center- Site Number : 8400011

    Dallas, Texas, 75390, United States

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