FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)

Part of paid clinical trials in San Francisco, California.

Sponsor
Sanofi
Study ID
NCT06111586
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Frexalimab — DRUG
    Intravenous (IV) Infusion at Day 1 and subcutaneous (SC) Injection from W2 to W102
  • Placebo — DRUG
    IV Infusion at Day 1 and SC Injection from W2 to W102
  • Insulin — DRUG
    SC injection, dose and frequency will be established and/or adjusted by investigator

Study Details

This is a randomized, parallel group, double-blind Phase 2 study with a 52-week blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on insulin treatment. Study details include: Screening period: at least 3 weeks and up to 5 weeks Double-blind treatment period (104 weeks): * Main treatment period: 52 weeks * Blinded extension: 52 weeks Optional Open Label Extension: 104 weeks Safety follow-up: up to 26 weeks The treatment duration will be up to 104 weeks, the total study duration will be up to 135 weeks.

Key Dates

Start date
Dec 11, 2023
Status verified
Jun 2026
Primary completion
Apr 28, 2027
Completion
Oct 29, 2030

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Frexalimab Dose 1
  • Experimental: Frexalimab Dose 2
  • Experimental: Frexalimab Dose 3
  • Placebo Comparator: Placebo
    Matching Placebo

Primary Outcome Measure

Change from baseline to W52 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration [ Time Frame: Baseline to Week 52 ]

Central Contacts

  • Trial Transparency email recommended (Toll free number for US & Canada)
    800-633-1610
    [email protected]

Locations (14)

FacilityCityStateZIPSite coordinators
University of California San Francisco - Mission Bay- Site Number : 8400012San FranciscoCalifornia94158-
University of Colorado - Anschutz Medical Campus- Site Number : 8400003AuroraColorado80045-
University of Florida College of Medicine- Site Number : 8400010GainesvilleFlorida32610-
University of Miami Hospital- Site Number : 8400013MiamiFlorida33136-
AdventHealth Orlando- Site Number : 8400002OrlandoFlorida32803-
Rocky Mountain Diabetes and Osteoporosis Center- Site Number : 8400009Idaho FallsIdaho83404-
NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400007SkokieIllinois60077-
Joslin Diabetes Center - Boston- Site Number : 8400015BostonMassachusetts02215-
University at Buffalo - Downtown Campus- Site Number : 8400004BuffaloNew York14203-
University of North Carolina at Chapel Hill- Site Number : 8400001Chapel HillNorth Carolina27514-
Cincinnati Children's Hospital Medical Center- Site Number : 8400019CincinnatiOhio45229-
The Children's Hospital of Philadelphia Site Number : 8400005PhiladelphiaPennsylvania19104-
University of Texas - Southwestern Medical Center- Site Number : 8400011DallasTexas75390-
Benaroya Research Institute at Virginia Mason- Site Number : 8400016SeattleWashington98101-

Find similar trials in San Francisco, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of California San Francisco - Mission Bay· San Francisco, CAUniversity of Colorado - Anschutz Medical Campus· Aurora, COUniversity of Florida College of Medicine· Gainesville, FLUniversity of Miami Hospital· Miami, FLAdventHealth Orlando· Orlando, FLRocky Mountain Diabetes and Osteoporosis Center· Idaho Falls, ID

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