Actively Recruiting
EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1)
Led by Grey Wolf Therapeutics · Updated on 2026-05-14
141
Participants Needed
15
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males and females aged 18-55 years at screening for Part A
- Willing and able to comply with study requirements, including dietary restrictions
- Willing to follow contraception requirements
- Non-smokers or ex-smokers who have not smoked in the past 6 months
- Body Mass Index between 19 and 30
- Males and females aged 18-65 years with axial spondyloarthritis
- Diagnosis of axial spondyloarthritis meeting ASAS classification criteria
- Positive HLA-B27 test
- Evidence of active sacroiliac joint inflammation on MRI or elevated C-reactive protein (CRP 9.0 mg/L)
- Symptoms lasting at least 3 months
- Disease onset before age 40
- Ankylosing Spondylitis Disease Activity Score (ASDAS) 9 2.1 on current treatment
- Currently treated with NSAIDs but with inadequate response or intolerance
- May have received up to 1 biologic or targeted synthetic DMARD (2 in Australia) and discontinued due to intolerance or inadequate efficacy
- Required washout period from prior biologic or JAK inhibitor treatments before Day 1
You will not qualify if you...
- Any clinically significant medical conditions or findings that would prevent study participation
- Participation in other clinical drug studies recently (within 124 days for new chemical entities or 93 days for marketed drugs)
- Known infection or risk factors for HIV, hepatitis B, or hepatitis C
- Use of more than 1 biologic or JAK inhibitor DMARD (more than 2 in Australia) or other prohibited medications
- Low blood counts (hemoglobin <10 g/dL, low white blood cells, neutrophils, lymphocytes, or platelets)
- Liver function tests higher than 1.5 times upper normal limits
- History of other autoimmune rheumatic diseases or fibromyalgia
- Active anterior uveitis
- Active or symptomatic inflammatory bowel disease
- Presence of psoriasis is allowed if stable or previous history only
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
University of the Sunshine Coast (UniSC)
Birtinya, Australia
Actively Recruiting
2
University of the Sunshine Coast (UniSC)
Morayfield, Australia
Completed
3
The Colin Bayliss Research and Teaching Unit
Perth, Australia
Not Yet Recruiting
4
Pioneer Clinical Research
Sydney, Australia
Actively Recruiting
5
University Ghent
Ghent, Belgium
Actively Recruiting
6
UZ Leuven
Leuven, Belgium
Actively Recruiting
7
Rheumazentrum Ruhrgebiet, Ruhr-University Bochum
Bochum, Germany
Actively Recruiting
8
Universitätsklinikum Erlangen - Medizinische Klinik 3
Erlangen, Germany
Not Yet Recruiting
9
Amsterdam University Medical Center
Amsterdam, Netherlands
Actively Recruiting
10
Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)
Leiden, Netherlands
Not Yet Recruiting
11
ETG Lublin
Lublin, Poland
Not Yet Recruiting
12
Reumedika
Poznan, Poland
Not Yet Recruiting
13
La Paz University Hospital
Madrid, Fuencarral-El Pardo, Spain, 28046
Not Yet Recruiting
14
Reina Sofia University Hospital
Córdoba, Poniente Sur, Spain, 14004
Not Yet Recruiting
15
University hospital Parc Tauli de Sabadell
Sabadell, Spain
Not Yet Recruiting
Research Team
G
Grey Wolf Therapeutics Patient enquiries
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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