Study of Tolerability and Safety of Adding Ustekinumab to INGAP Peptide for 12 Weeks in Adult Patients With TD1 Melitis

Sponsor
Jewish General Hospital
Study ID
NCT02204397
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

A proof-of-concept for safety and preliminary clinical efficacy of a combined regimen of INGAP-P for β-cell regeneration and ustekinumab for IL-12-23 autoimmune modulation in patients with established T1DM.

Key Dates

Start date
Nov 30, 2015
Status verified
May 2017
Primary completion
Mar 8, 2017
Completion
Mar 8, 2017

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: INGAP Peptide, Ustekinumab
    INGAP Peptide, Ustekinumab subcutaneous

Primary Outcome Measure

Safety and tolerability [ Time Frame: 6 months ]

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