VX-880 for Type 1 Diabetes

Recruiting at 4 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vertex Pharmaceuticals Incorporated

Must be taking: Immunosuppressants

Disqualifiers: Prior islet transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for people with Type 1 Diabetes who have had a kidney transplant. Participants must have been insulin-dependent for at least 5 years, be on a stable immunosuppression regimen for at least 4 weeks, and consistently use a continuous glucose monitor (CGM) for the same duration.

Inclusion Criteria

I have been dependent on insulin for 5 years or more due to Type 1 Diabetes.

I've been on a steady dose of specific immunosuppressants for over 4 weeks.

I have been using a CGM for at least 4 weeks and am willing to continue using it.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VX-880 to evaluate efficacy, safety, and tolerability

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• VX-880

Trial Overview The study tests VX-880's effectiveness, safety, and tolerability in individuals with Type 1 Diabetes who also had a kidney transplant. It aims to see how well VX-880 works as a biological/vaccine intervention in this specific patient group.

Participant Groups

Group I: VX-880 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials

267

Recruited

36,100+

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology