An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant

Phase 3

Recruiting

• Conditions: Type 1 Diabetes; Kidney Transplant
• Interventions: Biological: Biological/Vaccine

• Registration Number: NCT06832410
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-13
• Study First Posted: 2025-02-18
• Status Verified: 2025-03
• Study Start: 2025-03-31
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-05-30
• Primary Completion: 2026-09-17
• Study Completion: 2027-09-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Clinical history of T1D with greater than or equal to (≥)5 years of insulin dependence
• Taking a stable immunosuppression regimen of tacrolimus and mycophenolate mofetil, mycophenolate sodium, or sirolimus for at least 4 weeks
• Consistent use of continuous glucose monitor (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study

Key

Exclusion Criteria

• Prior islet cell transplant, organ transplant (other than kidney transplant) or cell therapy
• Participants had greater than (>)1 kidney transplant procedure

Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VX-880	Biological/Vaccine	-

Primary Outcome Measures

Name	Time	Method
Proportion of Participants who are Insulin Independent	At 1 year After VX-880 infusion

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who achieve insulin independence and are insulin independent 12 months later	1 year after achieving insulin independence
Change from Baseline in glycosylated hemoglobin (HbA1c)	Baseline, At 1 year After VX-880 infusion
Proportion of Participants who Maintain Insulin Independence for at least 1 year	From VX-880 infusion to End of Study (up to 2 years)
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	From Signing of informed consent to End of Study (up to 2 years)

Trial Locations

Locations (4)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center Montefiore; 🇺🇸 Pittsburgh, Pennsylvania, United States

Toronto General Hospital (TGH); 🇨🇦 Toronto, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, Canada