NCT07047703

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

A Multi-part, Phase I/II Study to Evaluate the Safety and Tolerability of GRWD0715 in Healthy Human Volunteers and Participants With Axial Spondyloarthritis

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 141 (estimated)
• Sponsor: Grey Wolf Therapeutics · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

GRWD0715 is an orally administered, selective inhibitor of the Endoplasmic Reticulum Aminopeptidase 1 \[ERAP1\] enzyme being explored as a potential new treatment for axial spondyloarthritis (axSpA), a long term condition caused by inflammation predominantly affecting the sacroiliac joints (SIJs) and spine.

Detailed description

GRWD0715 is an orally administered, selective inhibitor of the Endoplasmic Reticulum Aminopeptidase 1 \[ERAP1\] enzyme being explored as a potential new treatment for axial spondyloarthritis (axSpA), a long term condition caused by inflammation predominantly affecting the sacroiliac joints (SIJs) and spine. ERAP1 is involved in trimming antigens from foreign bodies (e.g. bacteria, viruses) which are presented on the surface of a cell to trigger an immune response. In axSpA, it is thought an antigen from the person's own body, called a 'self-peptide' is presented by the ERAP1 processing pathway and incorrectly recognised by the immune system. The hypothesis is that stimulation of the immune system by the presentation of this self-peptide causes the inflammatory symptoms experienced by people living with axSpA. As an inhibitor of ERAP1, GRWD0715 aims to prevent the generation of the antigenic self-peptide, and thus remove the stimulus of the immune system. If the immune system is not activated, the immune attack on the sacroiliac joint (SIJ) and spine would stop, halting the axSpA disease progress. The study will consist of 4 parts: Part A conducted in healthy human volunteers, and Part B, Part C and/or D in participants with axSpA. The primary goal of Parts A, B and C is to assess whether GRWD0715 is safe and well tolerated in healthy human volunteers and participants with axSpA. The primary goal of Part D is to review whether GRWD0715 is efficacious when compared to placebo.

Conditions

• Axial Spondyloarthritis (AxSpA)

Interventions

Type	Name	Description
DRUG	Part A - Single Ascending Dose (SAD) in Healthy Human Volunteers	Participants in Part A will receive a single dose of GRWD0715 on Day 1 only.
DRUG	Part B - Multiple Ascending Dose (MAD) in participants with axSpA	Participants in Part B will receive GRWD0715 for 28 days
DRUG	Part C - Safety expansion cohort in participants with axSpA	Participants in Part C will receive GRWD0715 for 12 weeks
DRUG	Part D - Randomised, placebo-controlled, expansion cohort in participants with axSpA	Participants in Part D will receive GRWD0715 or placebo-to-match for 12 weeks

Timeline

• Start date: 2025-07-28
• Primary completion: 2028-04-30
• Completion: 2028-09-30
• First posted: 2025-07-02
• Last updated: 2026-04-15

Locations

14 sites across 6 countries: Australia, Belgium, Germany, Netherlands, Poland, Spain