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Immunomodulator

Single Arm AT-1501 for Diabetes

Phase 1 & 2
Waitlist Available
Research Sponsored by Eledon Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up accessed from date of transplant through day 364 post final transplant for approximately 2 years
Awards & highlights

Study 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.

Eligible Conditions
  • Brittle Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~accessed from date of transplant through day 364 post final transplant for approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and accessed from date of transplant through day 364 post final transplant for approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy - Insulin independence
Safety - Adverse Events (AE) and Adverse Events of Special Interest (AEoSI)
Secondary outcome measures
Efficacy - Durability of insulin independence
Efficacy - Durability of insulin independence - long term
Efficacy - Graft failure
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm AT-1501Experimental Treatment2 Interventions
Single-arm, open-label trial

Find a Location

Who is running the clinical trial?

Eledon PharmaceuticalsLead Sponsor
4 Previous Clinical Trials
300 Total Patients Enrolled
Jeff Bornstein, MDStudy DirectorEledon Pharmaceuticals
4 Previous Clinical Trials
226 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are minors welcome in this clinical trial?

"Eligibility for this study is restricted to individuals aged 18-65. However, there are 225 other trials seeking participants who are below the age of majority and 964 studies recruiting patients that are elderly."

Answered by AI

Why was this clinical trial designed in this way?

"The primary outcome of this trial, which will be monitored over the course of 2 years, is insulin independence. Additionally, this study will also seek to understand secondary outcomes such as the durability of insulin independence and graft failure."

Answered by AI

Can new patients still sign up for this experiment?

"The information available on clinicaltrials.gov suggests that this study is still open to participants. This particular trial was posted on September 30th, 2022 and updated as recently as October 25th, 2022. 6 individuals are needed from 1 site total."

Answered by AI

How many people with the condition are being given the chance to participate in this research?

"According to the clinicaltrials.gov website, this research is still recruiting individuals. The listing was first put up on September 30th, 2020 and updated as recently as October 25th, 2020. Currently, there is room for 6 more people at a single location."

Answered by AI

How can I sign up for this research opportunity?

"This study is only looking for 6 participants that have brittle type 1 diabetes mellitus and are between 18-65 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, and Efficacy of Immunomodulation With AT-1501 in Combination With Transplanted Islet Cells in Adults With Brittle T1D
2022. "Safety, Tolerability, and Efficacy of Immunomodulation With AT-1501 in Combination With Transplanted Islet Cells in Adults With Brittle T1D". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05480657.
~0 spots leftby Aug 2024
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