VX-880 for Type 1 Diabetes
Recruiting at 4 trial locations
MI
Overseen ByMedical Information
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Vertex Pharmaceuticals Incorporated
Must be taking: Immunosuppressants
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
What You Need to Know Before You Apply
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.
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: VX-880Experimental Treatment1 Intervention
Find a Clinic Near You
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
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