FABULINUS: 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 beta-cell function in adults and adolescents with newly diagnosed type 1 diabetes on insulin therapy.

Study Purpose: The study is aimed to evaluate an investigational drug, frexalimab, for preservation of pancreatic beta cell function in adults and adolescents that have been newly diagnosed with Type 1 Diabetes and started on insulin therapy within 90 days of screening.

To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if
you meet the following criteria:

Study Duration: Up to 135 weeks (about 2.5 years)

Study Commitment: 1 Screening visit, 11 outpatient office visits,2 safety visits after last dose of study medication, optional and mandatory PK sampling visits.

Age: Part A:18-35, Part B:12-21
Sex: Male & Female

Conditions/Eligibility: Newly diagnosed with Type 1 Diabetes & initiated insulin therapy within the 90 days prior to screening visit.

Study Procedures:
-Physical exam, vital signs, height, weight, BMI, eligibility labs, urine testing, measurement of waist and hip circumference
-EKG, DEXA, Mixed Meal Tolerance Test, Continuous Glucose Monitoring
-Pregnancy test for women of childbearing potential
-Investigational Medicinal Product Administration
-Safety labs
- PK Sampling/Exploratory Labs
-AE/SAE/AESI reporting
-eDiary Subject Questionnaires

Compensation: Up to $2950

Please call
Call407-303-7193 or fill out the Contact Form below for more information.