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Monoclonal Antibodies

AT-1501 for Type 1 Diabetes

Phase 2
Waitlist Available
Research Sponsored by Anelixis Therapeutics, LLC
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 days 75 , day 365 post-first transplant, and final transplant and 1 year after discontinuation of at-1501
Awards & highlights

Study Summary

This study is evaluating whether a new drug can improve the health of people with type 1 diabetes.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 75 , day 365 post-first transplant, and final transplant and 1 year after discontinuation of at-1501
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 75 , day 365 post-first transplant, and final transplant and 1 year after discontinuation of at-1501 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- long term
Efficacy- Graft failure
Efficacy- HbA1c
Other outcome measures
Exploratory -Pharmacokinetic Parameters-AUC
Exploratory- Albumin excretion ratio (AER)
Exploratory- Glycemic lability (using CGMS)
+9 more

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT04322149
44%
Fatigue
33%
Headache
22%
Depression
22%
Dizziness
22%
Muscle spasms
22%
Musculoskeletal stiffness
11%
Post-traumatic pain
11%
Dermatitis contact
11%
Muscle twitching
11%
Confusional state
11%
Prostatitis
11%
Feeling jittery
11%
Diarrhoea
11%
Affect lability
11%
Hypoaesthesia
11%
Abdominal pain upper
11%
Neuropathy peripheral
11%
Muscular weakness
11%
Neck pain
11%
Actinic keratosis
11%
Dyspnoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
AT-1501 1.0 mg/kg
AT-1501 2.0 mg/kg
AT-1501 4.0 mg/kg
AT-1501 8.0 mg/kg

Trial Design

1Treatment groups
Experimental Treatment
Group I: AT-1501 Single ArmExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AT-1501
2020
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Anelixis Therapeutics, LLCLead Sponsor
1 Previous Clinical Trials
54 Total Patients Enrolled
Jeff Bornstein, MDStudy ChairEledon 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.
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability and Efficacy of Immunomodulation With AT-1501 in Islet Cell Transplantation
2021. "Safety, Tolerability and Efficacy of Immunomodulation With AT-1501 in Islet Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04711226.
~0 spots leftby Jun 2024
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