Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus

• Status: Terminated
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and efficacy of secukinumab on the preservation of pancreatic beta cells in patients with newly-diagnosed type 1 diabetes mellitus.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

Males and females aged 18-35 years initially (subjects aged 8-17 may be included at a later stage, starting with age 12-17 years, followed by age 8-11 years).

Body weight between 40-120 kg initially (subjects weighing 21-39 kg may be included at a later stage).

Recent onset type 1 diabetes mellitus, diagnosed with 100 days of first dose. Peak stimulated C-peptide levels >/= 0.2 pmol/L following mixed meal tolerance test

Exclusion Criteria:

Any form of diabetes other than auto-immune type 1 (eg, type 2 diabetes, maturity onset diabetes of the young, latent autoimmune diabetes of the adult).

Diabetic ketoacidosis within 2 weeks of screening. Pregnancy or lactation. Recent (within 2 weeks of screening), ongoing, chronic or recurrent infectious disease.

Active infection with hepatitis B or C, Epstein-Barr virus, cytomegalovirus, or HIV.

Tuberculosis infection. Other protocol-defined inclusion/exclusion criteria may apply