deltatrials
Terminated PHASE1/PHASE2 INTERVENTIONAL 8-arm NCT05574335

Siplizumab in T1DM (DESIGNATE)

A T Cell Phenotype Signature Driven Dose Finding Study With Siplizumab in Type 1 Diabetes Mellitus (ITN095AI)

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions Type 1 Diabetes Mellitus
Interventions Siplizumab
Updated 21 times since 2022 Last updated: Feb 10, 2026 Started: Apr 26, 2023 Primary completion: May 14, 2025 Completion: Oct 20, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

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.

Other terminated trials from National Institute of Allergy and Infectious Diseases (NIAID)

See all terminations from National Institute of Allergy and Infectious Diseases (NIAID)

Other Type 1 Diabetes Mellitus trials with similar outcome

Browse all Type 1 Diabetes Mellitus trials

Listed as NCT05574335, this PHASE1/PHASE2 trial focuses on Type 1 Diabetes Mellitus and remains terminated or withdrawn. Sponsored by National Institute of Allergy and Infectious Diseases (NIAID), it has been updated 21 times since 2023, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~May 2023 · 3 months · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Jan 2024 · 2 months · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~May 2024 · 3 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jul 2025 · 10 months · monthly snapshot~Jul 2025 – ~Oct 2025 · 3 months · monthly snapshot~Oct 2025 – ~Nov 2025 · 31 days · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – present · 3 months · monthly snapshot

Change History

21 versions recorded

  1. Feb 2026 — Present [monthly]

    Terminated PHASE1/PHASE2

  2. Jan 2026 — Feb 2026 [monthly]

    Terminated PHASE1/PHASE2

  3. Dec 2025 — Jan 2026 [monthly]

    Terminated PHASE1/PHASE2

    Status: Active Not Recruiting → Terminated

  4. Nov 2025 — Dec 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  5. Oct 2025 — Nov 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

▶ Show 16 earlier versions

  1. Jul 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  2. Sep 2024 — Jul 2025 [monthly]

    Active Not Recruiting PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  4. May 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  5. Feb 2024 — May 2024 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: Recruiting → Active Not Recruiting

  6. Jan 2024 — Feb 2024 [monthly]

    Recruiting PHASE1_PHASE2

  7. Nov 2023 — Jan 2024 [monthly]

    Recruiting PHASE1_PHASE2

  8. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE1_PHASE2

  9. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE1_PHASE2

  10. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE1_PHASE2

  11. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE1_PHASE2

  12. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  13. May 2023 — Jun 2023 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  14. Feb 2023 — May 2023 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  15. Dec 2022 — Feb 2023 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  16. Nov 2022 — Dec 2022 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Allergy and Infectious Diseases (NIAID)
Data source: National Institute of Allergy and Infectious Diseases (NIAID)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations