NCT04677179

A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)

An Adaptive Phase 2, Randomized, Double Blind, Placebo Controlled Study of LY3471851 (NKTR 358) in Patients With Moderately to Severely Active Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The reason for this study is to determine if the study drug LY3471851 is safe and effective in adult participants with active ulcerative colitis (UC). The study treatment will last about 52 weeks.

Detailed description

In stage 1, two doses (high and low) of LY3471851 will be compared to placebo. In stage 2, up to two additional doses (to be confirmed) of LY3471851 will be compared to placebo. LY3471851 (NKTR-358) is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	LY3471851	administered SC
DRUG	Placebo	administered SC

Timeline

• Start date: 2021-03-22
• Primary completion: 2022-08-09
• Completion: 2022-08-09
• First posted: 2020-12-21
• Last updated: 2023-09-05
• Results posted: 2023-09-05

Locations

116 sites across 22 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Georgia, Hungary, India, Israel, Japan, Latvia, Poland, Romania, Russia, Slovakia, South Korea, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study