RecruitingPhase 1Phase 2NCT07047703

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

Sponsor

Grey Wolf Therapeutics

Enrollment

141 participants

Start Date

Jul 28, 2025

Study Type

INTERVENTIONAL

Conditions

Axial Spondyloarthritis (AxSpA)

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Part A - Single Ascending Dose (SAD) in Healthy Human Volunteers, a drug called Part B - Multiple Ascending Dose (MAD) in participants with axSpA, and others for people with axial spondyloarthritis (axspa). The study is currently recruiting participants at 16 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPart A - Single Ascending Dose (SAD) in Healthy Human Volunteers

Participants in Part A will receive a single dose of GRWD0715 on Day 1 only.

DRUGPart B - Multiple Ascending Dose (MAD) in participants with axSpA

Participants in Part B will receive GRWD0715 for 28 days

DRUGPart C - Safety expansion cohort in participants with axSpA

Participants in Part C will receive GRWD0715 for 12 weeks

DRUGPart D - Randomised, placebo-controlled, expansion cohort in participants with axSpA

Participants in Part D will receive GRWD0715 or placebo-to-match for 12 weeks

Locations(16)

University of the Sunshine Coast (UniSC)

Birtinya, Australia

University of the Sunshine Coast (UniSC)

Morayfield, Australia

The Colin Bayliss Research and Teaching Unit

Perth, Australia

Pioneer Clinical Research

Sydney, Australia

University Ghent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Rheumazentrum Ruhrgebiet, Ruhr-University Bochum

Bochum, Germany

Universitätsklinikum Erlangen - Medizinische Klinik 3

Erlangen, Germany

Amsterdam University Medical Center

Amsterdam, Netherlands

Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)

Leiden, Netherlands

Malopolskie Badania Kliniczne (MBK Clinic)

Krakow, Małopolska, Poland

ETG Lublin

Lublin, Poland

Reumedika

Poznan, Poland

La Paz University Hospital

Madrid, Fuencarral-El Pardo, Spain

Reina Sofia University Hospital

Córdoba, Poniente Sur, Spain

University hospital Parc Tauli de Sabadell

Sabadell, Spain

View Full Details on ClinicalTrials.gov

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NCT07047703

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