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Immunomodulator

IMCY-0098 for Type 1 Diabetes (IMPACT Trial)

Phase 2
Waitlist Available
Research Sponsored by Imcyse SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be treated with insulin therapy in accordance with the local standard of care
Participants aged ≥ 18 years and < 45 years at the time of consent
Must not have
Have signs or symptoms of serious active infection requiring IV antibiotics and/or hospitalization at study entry
Be diagnosed with Latent Autoimmune Diabetes in Adults (LADA)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 24 months
Awards & highlights

Summary

This trial is studying a new experimental drug to see if it can stop the body's immune system from attacking and destroying the insulin-producing cells in people with type 1 diabetes.

Who is the study for?
Adults aged 18-45 with recent Type 1 Diabetes diagnosis, on insulin therapy, and certain autoantibodies. They must have specific C-peptide levels, not be pregnant or breastfeeding, agree to contraception use if applicable, and meet other health criteria including HLA types.Check my eligibility
What is being tested?
The IMPACT study is testing IMCY-0098 at two different doses versus a placebo in people with Type 1 Diabetes. The drug aims to protect insulin-producing cells by targeting the immune system's harmful cells.See study design
What are the potential side effects?
While the trial description doesn't list specific side effects for IMCY-0098, similar drugs may cause immune reactions, injection site discomfort, fatigue or flu-like symptoms. Safety will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am being treated with insulin as per my local healthcare guidelines.
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I am between 18 and 45 years old.
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I have diabetes-related autoantibodies like GAD65, IA-2, or ZnT8.
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I am HLA DR4 positive for the main study or HLA DR3 positive for the substudy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently experiencing a serious infection that requires IV antibiotics or hospitalization.
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I have been diagnosed with LADA.
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My blood tests show I have low white blood cells, neutrophils, lymphocytes, or platelets.
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My kidney function is impaired, shown by high creatinine or low eGFR.
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I have symptoms of COVID or tested positive for COVID recently.
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I have not received any live vaccines in the last 3 months.
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I have a history of cancer, except for basal cell skin cancer that was removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in stimulated C-peptide response during the first two hours of a mixed meal tolerance test (MMTT) from baseline to 48 weeks between IMCY-0098 and placebo groups
Secondary outcome measures
Changes in DBS C-peptide measurements at each visit comparing each dose with placebo
Changes in stimulated C-peptide response during the first two hours of a MMTT for the two doses of IMCY-0098 versus placebo
Difference in Dried Blood Spots (DBS) fasted C-peptide between treatment and placebo groups
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: IMCY-0098, low doseExperimental Treatment1 Intervention
The dose A (Cohort 1) will consist of subcutaneous administrations of 450 µg of the peptide in two separate injections of 225 µg each (500 µL each).
Group II: IMCY-0098, high doseExperimental Treatment1 Intervention
The dose B (Cohort 2) will consist of subcutaneous administrations of 1350 µg of the peptide in two separate injections of 675 µg each (500 µL each).
Group III: PlaceboPlacebo Group1 Intervention
Participants randomized to placebo will receive subcutaneous administrations of identical volumes of placebo solution to maintain study blind.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The IMCY-0098 trial focuses on a novel approach to treating Type 1 Diabetes by inducing new immune cells to specifically target and destroy the harmful immune cells that attack insulin-producing beta cells in the pancreas. This mechanism aims to preserve and potentially restore the body's ability to produce insulin, addressing the root cause of the disease. Traditional treatments, such as insulin therapy, manage blood glucose levels but do not address the autoimmune attack on beta cells. Immunomodulatory treatments, like anti-CD3 or anti-CD20 antibodies, aim to modulate the immune response to prevent further beta cell destruction. These mechanisms are crucial for Type 1 Diabetes patients as they offer potential for long-term disease modification and improved quality of life by targeting the underlying autoimmune process.
Type 1 diabetes induced by immune checkpoint inhibitors.Learning From Past Failures of Oral Insulin Trials.

Find a Location

Who is running the clinical trial?

Imcyse SALead Sponsor
6 Previous Clinical Trials
7,238 Total Patients Enrolled
Jean Van RampelberghStudy DirectorImcyse SA

Media Library

IMCY-0098 (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT04524949 — Phase 2
IMCY-0098 (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04524949 — Phase 2
~24 spots leftby Jul 2025
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