EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1)
Sponsor: Grey Wolf Therapeutics • ClinicalTrials.gov ID: NCT07047703
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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.
Interventions
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Part A - Single Ascending Dose (SAD) in Healthy Human Volunteers
(Drug)
Participants in Part A will receive a single dose of GRWD0715 on Day 1 only.
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Part B - Multiple Ascending Dose (MAD) in participants with axSpA
(Drug)
Participants in Part B will receive GRWD0715 for 28 days
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Part C - Safety expansion cohort in participants with axSpA
(Drug)
Participants in Part C will receive GRWD0715 for 12 weeks
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Part D - Randomised, placebo-controlled, expansion cohort in participants with axSpA
(Drug)
Participants in Part D will receive GRWD0715 or placebo-to-match for 12 weeks
Eligibility criteria
Conditions
Locations
- 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
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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