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Biological/Vaccine

Phase 3

Type 1 Diabetes | Monoclonal antibody | Metabolic |Vertex Pharmaceuticals Incorporated|Last Updated: Mar 23, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

Biological/Vaccine · 1 trial · 2 indications

Phase 3 1
NCT06832410An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney TransplantType 1 Diabetes
RECRUITING10 Analytics
PHASE3RECRUITING
An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant
Type 1 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VX-880EXPERIMENTAL -

Interventions

NameTypeDescription
Biological/VaccineBIOLOGICALInfused into the hepatic portal vein.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites7

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 monito...

Countries:United StatesCanadaSaudi Arabia
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Frequently asked questions about Biological/Vaccine

What is VX-880 used for?

VX-880 is an investigational therapy being studied for the treatment of type 1 diabetes in patients who have also received a kidney transplant. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

Who is developing VX-880?

VX-880 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. The company is conducting a Phase 3 clinical trial to evaluate the therapy in patients with type 1 diabetes and a kidney transplant.

What phase is VX-880 in?

VX-880 is in Phase 3 clinical development. It is an investigational therapy and has not yet been approved for commercial use. The ongoing Phase 3 trial is currently recruiting participants.

What clinical trials is VX-880 in?

VX-880 is being studied in a Phase 3 clinical trial with the identifier NCT06832410. This trial is evaluating the efficacy, safety, and tolerability of VX-880 in participants with type 1 diabetes who have a kidney transplant. The study is currently recruiting and aims to enroll 10 participants.

Is VX-880 the same as a biological or vaccine?

VX-880 is described as a biological therapy, specifically a monoclonal antibody. It is being investigated as a treatment for type 1 diabetes in patients with a kidney transplant. It is not a vaccine; it is a therapeutic biologic in clinical development.