At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 44 enrolled
Drug / intervention
CFZ533 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating CFZ533 and Placebo for Type 1 Diabetes Mellitus. Completed, enrolled 44 participants across 12 sites in 6 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesBelgium, Germany, Italy, Slovenia, Spain, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartNov 2019
Primary CompletionJan 2024
Study CompletionJun 2024
TodayJul 2026
First PostedOct 16, 2019
Enrollment StartNov 8, 2019
Primary CompletionJan 15, 2024
Study CompletionJun 4, 2024
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 6.7 years ago
Interventions
CFZ533drug
First dose is administered via intravenous infusion, subsequent doses are administered subcutaneously.
Placeboother
Placebo for active drug