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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 24 months
Awards & highlights
IMPACT Trial 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.
IMPACT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
IMPACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 24 months
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 moreIMPACT 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.
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Who is running the clinical trial?
Imcyse SALead Sponsor
6 Previous Clinical Trials
7,253 Total Patients Enrolled
Jean Van RampelberghStudy DirectorImcyse SA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am being treated with insulin as per my local healthcare guidelines.I am currently experiencing a serious infection that requires IV antibiotics or hospitalization.I am between 18 and 45 years old.I have been diagnosed with LADA.You have or had HIV, Hepatitis B, or Hepatitis C infection.I do not have any uncontrolled diseases or abnormal lab results that could affect the study.I was diagnosed with Type 1 Diabetes less than 9 weeks ago.I have not taken diabetes medication other than insulin in the last week.I do not have a blood condition that affects my HbA1c levels.My blood tests show I have low white blood cells, neutrophils, lymphocytes, or platelets.My kidney function is impaired, shown by high creatinine or low eGFR.(For people in the United States only) Your HbA1c levels should be less than or equal to 9.5% before you can join the study.My liver tests are not more than 3 times the normal limit, and I don't have liver disease.Your blood pressure is consistently high, with the top number (systolic) above 129 or the bottom number (diastolic) above 89.Your C-peptide levels must be at least 200 pmol/L when tested.I have symptoms of COVID or tested positive for COVID recently.I have diabetes-related autoantibodies like GAD65, IA-2, or ZnT8.You have had a bad reaction to any part of the drug before.I am HLA DR4 positive for the main study or HLA DR3 positive for the substudy.I am on long-term steroids or other drugs that suppress my immune system.I have not received any live vaccines in the last 3 months.I am a man who can father children and will use contraception or practice abstinence for 90 days after treatment.I have a history of cancer, except for basal cell skin cancer that was removed.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many locales are presently hosting this clinical experiment?
"The four clinical trial sites participating in this research are the University of Chicago, Barbara Davis Center, the Joslin Diabetes Center and a further quartet of medical centres."
Answered by AI
Are there any openings for participants in this current clinical trial?
"Affirmative. As per information found on clinicaltrials.gov, this medical experiment is presently recruiting patients and was initially posted in late December 2020, with the last update occurring in September 2022. There are 108 participants that need to be recruited from 4 different sites."
Answered by AI
What are the eligibility criteria for participation in this investigation?
"To become a part of this medical investigation, individuals must have diabetes and some form of autoimmune disorder while also being between 18-44 years old. The total number of participants will be around 108 people."
Answered by AI
Has the FDA granted authorization for IMCY-0098 450 μg?
"IMCY-0098 450 μg has been given a rating of 2 on our scale, due to the findings from Phase 2 trials that indicate its safety but lack conclusive evidence for efficacy."
Answered by AI
Does this medical trial accept participants younger than twenty years old?
"This research project requires that individuals be aged between 18 to 44 for enrollment. In contrast, there are 217 studies available for minors and 916 trials open to seniors."
Answered by AI
How many individuals are enrolled in the research project?
"Affirmative. According to information hosted on clinicaltrials.gov, this medical trial commenced enrollment as of December 29th 2020 and is currently recruiting participants. As such, 108 patients need to be recruited from 4 distinct sites."
Answered by AI
Who else is applying?
How old are they?
< 18
What site did they apply to?
Royal Devon and Exeter Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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