NCT04711226

Brief Summary

This study will evaluate the safety, tolerability and efficacy of AT-1501 in an immunomodulation regimen in adult patients with T1D undergoing an islet cell transplant.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
1mo left

Started Feb 2021

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Feb 2021Jun 2026

First Submitted

Initial submission to the registry

January 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 19, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

3.3 years

First QC Date

January 10, 2021

Last Update Submit

August 8, 2022

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 DiabetesT1DIslet Cell TransplantAT-1501humanized blocking antibody to CD40LCD40L inhibitormonoclonal antibodyGlucose Metabolism DiseasesDiabetes Mellitus, Type 1Endocrine System DiseasesGraftMetabolic DiseasesImmune System DiseasesAutoimmune DiseasesHypoglycemiaHyperglycemia

Outcome Measures

Primary Outcomes (2)

  • Safety- Adverse Events (AE) and Adverse Events of Special Interest (AEoSI)

    Incidence of adverse events

    Accessed from date of transplant through 1 year post transplant for approximately 2 years

  • Efficacy- Insulin independence

    Change in the proportion of participants that become insulin independent at Days 75 and 365 post-first, and final transplant

    Days 75 , Day 365 post-first transplant, and final transplant and 1 year after discontinuation of AT-1501

Secondary Outcomes (3)

  • Efficacy- Graft failure

    Day 365

  • Efficacy- Durability of insulin independence- long term

    2 and 3 years after discontinuation of AT- 1501

  • Efficacy- HbA1c

    Day 365 and free of serious hypoglycemic events from Day 28 to 365 post-first transplant

Other Outcomes (12)

  • Exploratory- Hypoglycemia unawareness (using the method of Clarke)

    Day 75, 365, and 1, 2 and 3 years after discontinuation of AT-1501

  • Exploratory- Glycemic lability (using CGMS)

    Day 75, 365, and 1, 2 and 3 years after discontinuation of AT-1501

  • Exploratory- Glycemic variability (using CGMS)

    Day 75, 365, and 1, 2 and 3 years after discontinuation of AT-1501

  • +9 more other outcomes

Study Arms (1)

AT-1501 Single Arm

EXPERIMENTAL
Drug: AT-1501

Interventions

AT-1501DRUG

AT-1501 IV infusion

AT-1501 Single Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women 18-65 years of age
  • A diagnosis of T1D ≥5 years with onset of disease at \<40 years of age
  • Involvement in intensive diabetes management as directed by an endocrinologist or diabetologist with at least 3 clinical evaluations within the 12 months prior to Screening; using an insulin pump or multiple daily injection (MDI) insulin therapy; and, unable to achieve acceptable metabolic control because of the occurrence of severe hypoglycemia
  • At least 2 unexplained SHEs not secondary to a missed meal or dosing error, etc., in the 12 months prior to Screening
  • Glycosylated hemoglobin (HbA1c) level greater than 7% (53 mmol/mol) and less than 9.5% (80 mmol/mol) inclusive
  • Absence of stimulated C peptide (\< 0.3 ng/mL) in response to a mixed meal tolerance test (MMTT) measured at 60 and 90 minutes after the start of consumption
  • Reduced awareness of hypoglycemia as defined by a Clarke Score \[Clarke 1995\] of 4 or more at the time of Screening, during the Screening period and within the last 6 months prior to the transplant

You may not qualify if:

  • Any previous transplant
  • HbA1c level less than 7% (53 mmol/mol)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Endocrine System DiseasesMetabolic DiseasesImmune System DiseasesAutoimmune DiseasesHypoglycemiaHyperglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersNutritional and Metabolic Diseases

Study Officials

  • Jeff Bornstein, MD

    Eledon Pharmaceuticals

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2021

First Posted

January 15, 2021

Study Start

February 19, 2021

Primary Completion

June 1, 2024

Study Completion (Estimated)

June 1, 2026

Last Updated

August 10, 2022

Record last verified: 2022-08

Locations

CA(1)