Type 1 Diabetes MellitusPhase 2NCT04711226
Safety, Tolerability and Efficacy of Immunomodulation With AT-1501 in Islet Cell Transplantation
A Phase 2 study testing AT-1501 in people with Type 1 Diabetes Mellitus, run by Anelixis Therapeutics, LLC at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- AT-1501
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 19 Feb 2021to Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any previous transplant
- HbA1c level less than 7% (53 mmol/mol)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Immunomodulation With AT-1501 in Adults With Type 1 Diabetes Undergoing Islet Cell Transplant
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.
Read the detailed description
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. This study will also provide valuable data with respect to its potential additional uses in autoimmunity and solid organ transplant. This is a single arm open-label study and up to 6 participants will be recruited at a single center in Canada.
The objectives include:
- To assess the safety and tolerability of immunomodulation with AT-1501, in combination (AT+) with rabbit anti-thymoglobulin (ATG), etanercept and mycophenolate mofetil (MMF/EC-MPS) in adults with T1D undergoing islet cell transplant.
- To assess the efficacy of immunomodulation with AT-1501 in adults with T1D undergoing islet cell transplant.
The duration of treatment may vary from participant to participant and could be up to 20 months. Participants may receive up to 2 islet cell transplants.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- AT-1501
- Keywords
- Type 1 Diabetes, T1D, Islet Cell Transplant, AT-1501, humanized blocking antibody to CD40L, CD40L inhibitor, monoclonal antibody, Glucose Metabolism Diseases, Diabetes Mellitus, Type 1, Endocrine System Diseases, Graft, Metabolic Diseases, Immune System Diseases, Autoimmune Diseases, Hypoglycemia, Hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Endocrine System Diseases, Metabolic Diseases, Immune System Diseases, Autoimmune Diseases, Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-1501Drug
AT-1501 IV infusion
| Study group | Role | What they receive |
|---|---|---|
| AT-1501 Single Arm | Experimental | Not described Receives: Drug: AT-1501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety- Adverse Events (AE) and Adverse Events of Special Interest (AEoSI)
Incidence of adverse events
Measured: 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
Measured: Days 75 , Day 365 post-first transplant, and final transplant and 1 year after discontinuation of AT-1501
Secondary outcomes (3)
Efficacy- Graft failure
Proportion of participants with graft failure
Measured: Day 365
Efficacy- Durability of insulin independence- long term
Change in the proportion of participants that become insulin independent at year 2 and year 3
Measured: 2 and 3 years after discontinuation of AT- 1501
Efficacy- HbA1c
- Proportion of participants with HbA1c <7.0% (53 mmol/mol) and free of serious hypoglycemic events (SHEs)
- Proportion of participants with HbA1c ≤6.5% (48 mmol/mol) and free from SHEs
Measured: Day 365 and free of serious hypoglycemic events from Day 28 to 365 post-first transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start19 Feb 2021
- Primary completionJun 2024 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anelixis Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Bornstein, MD, Study chair, Eledon Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711226
- Sponsor's protocol ID
- AT-1501-I203
- Other IDs
- AT-1501-I203
- Status last verified
- Aug 2022
- First submitted
- 10 Jan 2021
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Immunomodulation With AT-1501 in Adults With Type 1 Diabetes Undergoing Islet Cell Transplant
- ClinicalTrials.gov ID
- NCT04711226
- Acronym / sponsor ID
- AT-1501-I203
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes, T1D, Islet Cell Transplant, AT-1501, humanized blocking antibody to CD40L, CD40L inhibitor, monoclonal antibody, Glucose Metabolism Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anelixis Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. This study will also provide valuable data with respect to its potential additional uses in autoimmunity and solid organ transplant. This is a single arm open-label study and up to 6 participants will be recruited at a single center in Canada.
The objectives include:
- To assess the safety and tolerability of immunomodulation with AT-1501, in combination (AT+) with rabbit anti-thymoglobulin (ATG), etanercept and mycophenolate mofetil (MMF/EC-MPS) in adults with T1D undergoing islet cell transplant.
- To assess the efficacy of immunomodulation with AT-1501 in adults with T1D undergoing islet cell transplant.
The duration of treatment may vary from participant to participant and could be up to 20 months. Participants may receive up to 2 islet cell transplants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AT-1501 Single Arm | Experimental | Drug: AT-1501 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Any previous transplant
- HbA1c level less than 7% (53 mmol/mol)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AT-1501AT-1501 IV infusion | Drug | AT-1501 Single Arm |
Primary outcome
Safety- Adverse Events (AE) and Adverse Events of Special Interest (AEoSI)
Time frame: Accessed from date of transplant through 1 year post transplant for approximately 2 years
Incidence of adverse events
Efficacy- Insulin independence
Time frame: Days 75 , Day 365 post-first transplant, and final transplant and 1 year after discontinuation of AT-1501
Change in the proportion of participants that become insulin independent at Days 75 and 365 post-first, and final transplant
3 secondary outcomes
Efficacy- Graft failure
Time frame: Day 365
Efficacy- Durability of insulin independence- long term
Time frame: 2 and 3 years after discontinuation of AT- 1501
Efficacy- HbA1c
Time frame: Day 365 and free of serious hypoglycemic events from Day 28 to 365 post-first transplant
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Bornstein, MD study chair
Eledon Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AT-1501 in people with Type 1 Diabetes Mellitus, run by Anelixis Therapeutics, LLC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety- Adverse Events (AE) and Adverse Events of Special Interest (AEoSI) (time frame: Accessed from date of transplant through 1 year post transplant for approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.