Study of GRWD0715 Safety and Effectiveness in Healthy Volunteers and Adults With Axial Spondyloarthritis

What this Trial Is About

Researchers are studying GRWD0715, an oral drug that selectively inhibits the Endoplasmic Reticulum Aminopeptidase 1 ERAP1 enzyme, as a potential treatment for axial spondyloarthritis axSpA. AxSpA is a long-term inflammatory condition mainly affecting the sacroiliac joints and spine. The study explores whether blocking ERAP1 can reduce the immune systems attack on these joints by preventing the creation of inflammatory self-peptides. The trial has four parts involving both healthy volunteers and people with axSpA. Part A tests single doses of GRWD0715 in healthy volunteers, while Parts B and C involve participants with axSpA receiving multiple doses over 4 weeks and 12 weeks respectively. Part D compares GRWD0715 with a placebo over 12 weeks to assess efficacy. Some participants may roll over between parts without washout periods, continuing treatment based on their previous dose. Participants will undergo various assessments including monitoring for dose-limiting events, treatment-related and emergent adverse events, and MRI scans of the sacroiliac joints and spine to measure inflammation. Blood samples will be taken to study drug levels. The study evaluates safety, tolerability, and preliminary effectiveness over several weeks, with follow-up visits extending up to 12 weeks depending on the study part. Overall participation may last several months depending on enrollment in different parts of the trial.

EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1)