Rezpegaldesleukin for New Onset Type 1 Diabetes

Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus

Recruiting Phase 2 Interventional Study
Type 1 Diabetes Mellitus
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
8 – 45
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
66 (estimated)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
Who this trial is looking for

This trial is looking for people recently diagnosed with type 1 diabetes. Participants will take either the study drug or a placebo every two weeks for 26 weeks, followed by a 6-month check-up.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am diagnosed with type 1 diabetes within the last 100 days.
  • I am between 8 and 45 years old.
  • I weigh between 35 kg and 130 kg if I am at least 18 years old.
  • I provide informed consent if I am at least 8 years old.
  • I have a positive test for islet cell autoantibodies.
  • I am willing to manage my diabetes intensively.

You may not be able to join if

  • I have had active infections that require treatment in the last 4 weeks.
  • I have a history of serious heart disease.
  • I am currently pregnant or breastfeeding.
  • I have any autoimmune disease other than type 1 diabetes.
  • I had a major surgery in the last 12 weeks.
  • I have had a major organ transplant.
  • I have a history of cancer in the last 5 years.
  • I have active signs of an infection at the time of randomization.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial

This Phase 2 study is a 2-arm, multi-center, double-masked (masking of the participant, care provider and investigator), placebo-controlled, 2:1 randomized trial design in new onset T1D participants (within 100 days of diagnosis). Participants will be administered rezpegaldesleukin/placebo once every 14 days over 26 weeks with an additional 6-month follow-up period.

Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: * Provide informed consent or assent as appropriate and if \< 18 years of age have a parent or legal guardian provide informed consent. * Age ≥ 8 and ≤ 45 years at the time of signing informed consent and (as applicable) assent A. * Diagnosis of T1D within 100 days of randomizat…
Contacts

Jessica Conaty

813-396-9234

Jessica.Conaty@epi.usf.edu

CONTACT