NCT04129528

Study of Safety and Efficacy of CFZ533 in Type 1 Diabetes Pediatric and Young Adult Subjects

Investigator- and Subject-blinded, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy Trial of CFZ533 in Pediatric and Young Adult Subjects With New Onset Type 1 Diabetes (T1DM)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The study was a Phase 2, multicounty, multicenter, non-confirmatory, investigator- and subject masked, randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CFZ533 on preservation of residual pancreatic β-cell function in new onset T1DM in pediatric and young adult subjects.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	CFZ533	First dose is administered via intravenous infusion, subsequent doses are administered subcutaneously.
OTHER	Placebo	Placebo for active drug

Timeline

• Start date: 2019-11-08
• Primary completion: 2024-01-15
• Completion: 2024-06-04
• First posted: 2019-10-16
• Last updated: 2025-04-08
• Results posted: 2025-01-17

Locations

12 sites across 6 countries: Belgium, Germany, Italy, Slovenia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study