# Siplizumab in T1DM

> **NCT05574335** · PHASE1,PHASE2 · TERMINATED · sponsor: **National Institute of Allergy and Infectious Diseases (NIAID)** · enrollment: 8 (actual)

## Conditions studied

- Type 1 Diabetes Mellitus

## Interventions

- **DRUG:** Siplizumab

## Key facts

- **NCT ID:** NCT05574335
- **Lead sponsor:** National Institute of Allergy and Infectious Diseases (NIAID)
- **Sponsor class:** NIH
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2023-04-26
- **Primary completion:** 2025-05-14
- **Final completion:** 2025-10-20
- **Target enrollment:** 8 (ACTUAL)
- **Why stopped:** Prior to termination the DESIGNATE study was an on enrollment hold due to greater than anticipated lymphodepletion. The pharmaceutical partner decided not to reopen its own T1D trial and ceased development of siplizumab in autoimmunity.
- **Last updated:** 2026-02-11


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05574335

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05574335, "Siplizumab in T1DM". Retrieved via AI Analytics 2026-07-03 from https://api.ai-analytics.org/clinical/NCT05574335. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*