Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolescents and Children on Top of Insulin Therapy (FABULINUS)

Conditions

• Type 1 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

6 Years - 35 Years

Healthy Volunteers

Not accepted

Interventions

• Frexalimab — DRUG
  IV Infusion at Day 1 SC Injection from W2 to W102 (part A and part B); SC Injection from W2 to W50(part C)
• Placebo — DRUG
  IV Infusion at Day 1 SC Injection from W2 to W102 (part A and part B); SC Injection from W2 to W50(part C)
• 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 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. Enrollment date of the participant must take into consideration this constraint) Double-blind treatment period (104 weeks for Part A and Part B; 52 weeks for Part C): Main treatment period: 52 weeks for Parts A and B, 26 weeks for Part C Blinded extension: 52 weeks (for Part A and Part B, 26 weeks for Part C) Optional OLE period: 104 weeks for all parts Safety follow-up: 26 weeks The treatment duration will be up to 104 weeks for Part A and Part B or 52 weeks for Part C, the total study duration will be up to 135 weeks for Part A and Part B or 83 weeks for Part C. If participants enter the OLE period, the treatment duration will be up to 208 weeks for Part A and Part B or 156 weeks for Part C, and the total study duration will be 240 weeks approximately for Part A and Part B or 188 weeks for Part C.

Key Dates

First listed

Nov 1, 2023

Start date

Dec 11, 2023

Status verified

Jun 2026

Primary completion

Apr 28, 2027

Completion

Oct 29, 2030

Study Design

Enrollment

197 participants (actual)

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 in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W52 for Part B (12-21 y.o.) [ Time Frame: Baseline to Week 52 ]

Locations (14)

Find similar trials in San Francisco, CA

Related Studies

• Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
  Recruiting · Rodolfo Alejandro · Miami, Florida
• Long Term Follow up of Recipients of Functional Islet Allografts
  Recruiting · Rodolfo Alejandro · Miami, Florida
• Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss
  Recruiting · Rodolfo Alejandro · Miami, Florida
• Type 1 Diabetes Extension Study
  Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · San Francisco, California