CNP-103 in Adolescent and Adult Subjects Ages 12-35 with Recently Diagnosed (within 6 Months) Stage 3 Type 1 Diabetes (T1D)

Launched by COUR PHARMACEUTICAL DEVELOPMENT COMPANY, INC. · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CNP-103 for young people and adults aged 12 to 35 who have been recently diagnosed with stage 3 Type 1 Diabetes (T1D) within the last six months. The aim is to determine how safe the treatment is, how well it works, and how the body responds to it. The study will last about 208 days and includes a screening phase, a treatment phase, and follow-up evaluations to check on participants' health after receiving the treatment.

To be eligible for this trial, participants must be willing to provide consent and be between the ages of 12 and 35. They should have been diagnosed with T1D according to specific guidelines and have some remaining insulin-producing capability, as indicated by a blood test. Participants will need to stay on stable doses of any current medications for diabetes. During the study, participants will receive CNP-103 in increasing doses and will be monitored closely by medical professionals. It’s important to know that some individuals, such as those who have experienced certain complications or have taken specific medications in the past, may not qualify for this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.
• • 2. Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive. 3. Documented diagnosis of T1D within 180 days prior to study enrollment according to American Diabetes Association \[ADA\] criteria.
• • 4. Subjects with a peak stimulated C-peptide of \>0.2 nmol/L measured from a mixed meal tolerance test (MMTT). Note: this test result may be obtained from an MMTT conducted within 1 month of planned first dose.
• • 5. For subjects on any medication used to treat the symptoms of T1D (e.g., corticosteroids), subjects must be on a stable dose for a minimum of 1 month prior to enrollment and must agree not to increase their dose from Screening Visit through End of Study Visit unless reviewed and approved by the medical monitor and the site investigator
• Exclusion Criteria:
• * Subjects who have used the following medications:
• • a. Within 5 half-lives or 90 days prior to first dose, whichever is shorter: i. Oral immunomodulators: (i.e., cyclosporin, azathioprine, methotrexate) ii. B cell depleting immunotherapy (e.g., Rituximab) iii. Other anti-diabetic agents besides insulin (e.g., Verapamil). Insulin is allowed if on a stable dose for 30 days prior to the Day 1 dose). b. Within 6 months prior to first dose: i. T cell modifying immunotherapy (e.g., Abatacept, Etanercept, Ustekinumab) within 6 months prior to the first dose c. Within 12 months prior to first dose: i. T cell depleting immunotherapy (e.g., Teplizumab) within 12 months prior to the first dose d. Exclusion of additional immunomodulation will be at the discretion of the medical monitor and study site Investigator.
• • 2. Subjects who present with diabetic ketoacidosis (DKA) at the time of diagnosis. Note: any MMTT must be performed no sooner than 2 weeks and up to 4 weeks after DKA diagnosis.