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

Vertex Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Type 1 Diabetes; Kidney Transplant

Treatments: Biological: Biological/Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06832410

VX23-880-102

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

VX-880

Experimental group

Treatment:

Biological: Biological/Vaccine