NCT07047703 - EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1) | Biotech Hunter

Enrollment

141

Participants

Timeline

Start Date

July 28, 2025

Primary Completion Date

April 30, 2028

Study Completion Date

September 30, 2028

Conditions

Axial Spondyloarthritis (AxSpA)

Interventions

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

Trial Locations (8)

NOT_YET_RECRUITING

University of the Sunshine Coast (UniSC), Birtinya

RECRUITING

University of the Sunshine Coast (UniSC), Morayfield

NOT_YET_RECRUITING

Pioneer Clinical Research, Sydney

NOT_YET_RECRUITING

University Ghent, Ghent

NOT_YET_RECRUITING

UZ Leuven, Leuven

NOT_YET_RECRUITING

Charité - Universitätsmedizin Berlin, Berlin

NOT_YET_RECRUITING

Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Bochum

NOT_YET_RECRUITING

Amsterdam University Medical Center, Amsterdam