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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04524949




Registration number
NCT04524949
Ethics application status
Date submitted
11/08/2020
Date registered
24/08/2020

Titles & IDs
Public title
IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT Study)
Scientific title
A Phase IIa, Randomized, Double-blind, Dose Comparison, Placebo-controlled, Multi-centre Clinical Trial to Evaluate the Immune Signature of the Treatment With the Imotope IMCY-0098 and Its Effect on the Preservation of Beta-cell Function in Adult Patients With a Recent Onset Type 1 Diabetes
Secondary ID [1] 0 0
2020-001317-20
Secondary ID [2] 0 0
IMCY-T1D-003
Universal Trial Number (UTN)
Trial acronym
IMPACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 1 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IMCY-0098 450 µg
Treatment: Drugs - IMCY-0098 1350 µg
Treatment: Drugs - Placebo

Experimental: IMCY-0098, low dose - 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).

Experimental: IMCY-0098, high dose - 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).

Placebo comparator: Placebo - Participants randomized to placebo will receive subcutaneous administrations of identical volumes of placebo solution to maintain study blind.


Treatment: Drugs: IMCY-0098 450 µg
Small synthetic peptide for SC admin. Solvent: alum hydroxide

Treatment: Drugs: IMCY-0098 1350 µg
Small synthetic peptide for SC admin. Solvent: alum hydroxide

Treatment: Drugs: Placebo
Solvent: alum hydroxide
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From baseline to 48 weeks
Secondary outcome [1] 0 0
Changes in stimulated C-peptide response during the first two hours of a MMTT for the two doses of IMCY-0098 versus placebo
Timepoint [1] 0 0
From baseline to 24 months
Secondary outcome [2] 0 0
Difference in Dried Blood Spots (DBS) fasted C-peptide between treatment and placebo groups
Timepoint [2] 0 0
From baseline to 48 weeks
Secondary outcome [3] 0 0
Changes in DBS C-peptide measurements at each visit comparing each dose with placebo
Timepoint [3] 0 0
From baseline to 24 months
Secondary outcome [4] 0 0
Effects of each dose of IMCY-0098 on HbA1c
Timepoint [4] 0 0
From baseline to 24 months
Secondary outcome [5] 0 0
Effects of each dose of IMCY-0098 on hypoglycaemic events
Timepoint [5] 0 0
From baseline to 24 months
Secondary outcome [6] 0 0
Effects of each dose of IMCY-0098 on diabetic ketoacidosis (DKA) episodes
Timepoint [6] 0 0
From baseline to 24 months
Secondary outcome [7] 0 0
Effects of each dose of IMCY-0098 on daily total insulin dose
Timepoint [7] 0 0
From baseline to 24 months
Secondary outcome [8] 0 0
Effects of each dose of IMCY-0098 on Continuous Glucose Monitoring (CGM) measures
Timepoint [8] 0 0
From baseline to 24 months
Secondary outcome [9] 0 0
Impact of IMCY-0098 at each dose on autoantibodies against GAD65, IA 2, ZnT8 and insulin over time
Timepoint [9] 0 0
From baseline to 24 months
Secondary outcome [10] 0 0
To evaluate the safety features of IMCY-0098 during treatment period
Timepoint [10] 0 0
Up to 7 days after the last dose
Secondary outcome [11] 0 0
To evaluate the safety features of IMCY-0098 during the whole study duration
Timepoint [11] 0 0
Up to 48 weeks
Secondary outcome [12] 0 0
To evaluate the safety features of IMCY-0098 on lymphocytes ratio
Timepoint [12] 0 0
Up to 48 weeks

Eligibility
Key inclusion criteria
1. Have given written informed consent.
2. Participants aged = 18 years and < 45 years at the time of consent
3. Have a diagnosis of T1D within maximum 9 weeks at screening (date of the first insulin injection)
4. Must have at least one or more diabetes-related autoantibodies present at screening (GAD65, IA-2, or ZnT8)
5. Must have random C-peptide levels = 200 pmol/L measured at screening
6. Must be Human Leukocyte Antigen (HLA) DR4 positive to participate in the main study OR HLA DR4 negative but HLA DR3 positive to participate in the substudy
7. Be willing to comply with intensive diabetes management
8. Be treated with insulin therapy in accordance with the local standard of care
9. Males with reproductive potential must agree to use adequate contraception up to 90 days after the completion of the last treatment. This includes:

* Barrier contraception (condom and spermicide) or
* True abstinence (where this is in accordance with the participants preferred and usual lifestyle)
10. All females must have a negative serum pregnancy test at screening. Women sexually active and of childbearing potential must agree to use a highly effective contraception method from screening up to 90 days after last treatment with the investigational product
11. (US ONLY) Have HbA1c levels = 9.5% prior to randomization
Minimum age
18 Years
Maximum age
44 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinically significant abnormal full blood count (FBC), renal function or liver function at screening including

1.1. Be immunodeficient or have any clinically significant chronic lymphopenia: Leukopenia (< 3,000 leukocytes /µL), neutropenia (<1,500 neutrophils/µL), lymphopenia (<800 lymphocytes/µL), or thrombocytopenia (<100,000 platelets/µL)

1.2. Evidence of renal dysfunction with serum creatinine greater than 1.5 times the upper limit of normal OR (US ONLY) estimated Glomerular Filtration Rate (eGFR) calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) <90 mL/min per 1.73 m2 in absence of other signs of CKD or rapidly progressing renal disease

1.3. Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal or (US ONLY) total bilirubin = 2x Upper Limit of Normal (ULN) or Alkaline phosphatase = 2x ULN. For participants presenting with values above ULN but below above threshold for these parameters, the underlying reason should be investigated by the site team to exclude liver disease. Patients for which a liver disease would be diagnosed will be excluded from the study.

Participants with elevated unconjugated bilirubin (Gilbert's syndrome) are eligible if bilirubin is = 3 times the upper limits of normal and hepatic enzymes and function are otherwise normal (AST/ALT/Alkaline phosphatase within ULN), and there is no evidence of hemolysis
2. Have signs or symptoms of serious active infection requiring IV antibiotics and/or hospitalization at study entry
3. Have signs or symptoms of active COVID infection or a positive COVID PCR test during the screening period
4. Have received any live attenuated vaccine within 3 months prior to the first planned administration of the study product (which includes, but is not limited to: oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, live-attenuated zoster vaccine, Bacillus Calmette-Guérin [BCG] vaccine, oral typhoid vaccine)
5. Be currently pregnant or lactating, or anticipate getting pregnant until at least 24 weeks after last study drug administration
6. Require the use of immunosuppressive agents including chronic use of systemic steroids. Topical, inhalational or intranasal corticosteroids are allowed
7. Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
8. Presence of any uncontrolled disease (including uncontrolled autoimmune disease) or abnormal clinical laboratory results that may interfere with study conduct as judged by the investigator
9. History of, or current malignancy (except excised basal cell skin cancer)
10. Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control within 7 days prior to screening visit
11. Active participation in another T1D treatment study or any investigational intervention study in the previous 30 days or (US ONLY) received gene therapy in the past
12. Known hypersensitivity to any component of the drug product
13. CRO or Sponsor employees or employees under the direct supervision of the Investigator and/or involved directly in the study
14. Be diagnosed with Latent Autoimmune Diabetes in Adults (LADA)
15. (US ONLY) History or current evidence of hematologic condition that would make HbA1c uninterpretable including:

15.1. Grade 1 anemia, defined as: Hemoglobin (Hb) < Lower Limit of Normal (LLN) - 10.0 g/dL or < LLN - 6.2 mmol/L or < LLN - 100 g/L

15.2. Hemoglobinopathy, with the exception of sickle cell trait or thalassemia minor; or chronic or recurrent hemolysis

15.3. Donation of blood or blood products to a blood bank, blood transfusion or participation in a clinical study requiring withdrawal of > 400 mL of blood during the 90 days prior to the Screening visit

15.4. Significant iron deficiency anemia

15.5. Heart malformations or Vaso-Occlusive Crisis (VOC) leading to increased turnover of erythrocytes
16. (US ONLY) Current evidence of hypertension defined as the mean (average) of Diastolic Blood Pressure (DBP) > 89 mm Hg or Systolic Blood Pressure (SBP) > 129 mm Hg based on 3 consecutive readings at least 2 minutes apart
17. (US ONLY) History or current evidence of active drug, chemical or alcohol dependency.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/05/2024
Sample size
Target
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [3] 0 0
St. Vincent's Hospital - Melbourne
Recruitment hospital [4] 0 0
Royal North Shore Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
Belgium
State/province [5] 0 0
Brussels
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Italy
State/province [7] 0 0
Milan
Country [8] 0 0
Italy
State/province [8] 0 0
Pisa
Country [9] 0 0
Lithuania
State/province [9] 0 0
Kaunas
Country [10] 0 0
Lithuania
State/province [10] 0 0
Klaipeda
Country [11] 0 0
Lithuania
State/province [11] 0 0
Vilnius
Country [12] 0 0
Slovenia
State/province [12] 0 0
Ljubljana
Country [13] 0 0
Sweden
State/province [13] 0 0
Lund
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Cambridge
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Cardiff
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Edinburgh
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Exeter
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Leeds
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Leicester
Country [20] 0 0
United Kingdom
State/province [20] 0 0
London
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Newcastle
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Imcyse SA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jean Van Rampelbergh
Address 0 0
Imcyse SA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04524949