Clinical trial NCT06783309: CNP-103 in Adolescent and Adult Subjects Ages 12-35 with Recently Diagnosed (within 6 Months) Stage 3 Type 1 Diabetes (T1D)
Official title: A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Subjects Ages 12-35 with Recent Onset Stage 3 Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes Mellitus
T1D
T1DM
T1DM - Type 1 Diabetes Mellitus
Type 1 Diabetes in Adolescence
Type 1 Diabetes in Children
Type 1 Diabetes (Juvenile Onset)
Type 1 Diabetes
Type 1 Diabetes Patients
Type 1 Diabetes Mellitis
Keywords: Diabetes
T1D
Stage 3
Adolescents
Adults
T1DM
Newly Diagnosed
Recently Diagnosed
Lead sponsor: COUR Pharmaceutical Development Company, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-20
Enrollment: 72
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is planned to enroll up to three cohorts in two descending age groups \[(adults, 18-35, and adolescents, 12-17), six subjects per cohort, approximately 18 subjects total per age range, for a total of 36 subjects)\] at multiple ascending dose levels in the Escalation Phase. Each adolescent dose level will be staggered after the corresponding cohort of adults (18-35) has completed the Day 15 office visit and DMC review. Subjects will be randomized in a 2:1 ratio to receive either CNP-103 or placebo (0.9% Sodium Chloride Injection USP) as a 200 mL intravenous infusion on Day 1, Day 8, and Day 90.

The Escalation Phase will be followed by an Expansion Phase expected to enroll approximately 36 subjects with a safe and tolerated dose(s) identified in the Escalation Phase.

Expansion Phase subjects will be randomized in a 3:1 ratio to receive either CNP-103 or placebo (0.9% S
Primary purpose: TREATMENT

Brief summary: This study is a Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103. The approximately 208-day study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (90 days).


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.

Primary outcomes:
measure: Safety
timeFrame: Day 1 Through Day 180
measure: Immune Safety
timeFrame: Day 1 Through Day 180
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: COUR Pharma
name: Paul Peloso, MD
role: STUDY_DIRECTOR
References: