An Efficacy, Safety, and Tolerability Study of VX-880 in... | NCT06832410

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 31, 2025Actual

Primary Completion Date

Sep 17, 2026Estimated

Completion Date

Sep 17, 2027Estimated

First Submitted Date

Feb 13, 2025

First Submission Date that Met QC Criteria

Feb 13, 2025

First Posted Date

Feb 18, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2026

Last Update Posted Date

Mar 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VX-880	Experimental		Biological: Biological/Vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological/Vaccine	Biological	Infused into the hepatic portal vein.	VX-880

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Participants who are Insulin Independent		At 1 year After VX-880 infusion

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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, except prior pancreatic graft that failed within the first 4 weeks
Participants had >1 kidney transplant procedure

Other protocol defined Inclusion/Exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Medical Information	Contact	617-341-6777		medicalinfo@vrtx.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Perelman Center for Advanced Medicine - Endocrinology	Recruiting	Philadelphia	Pennsylvania	19104	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D001688	Biological Products
D014612	Vaccines