Actively Recruiting
A Multi-part, Phase I/II Study to Evaluate the Safety and Tolerability of GRWD0715 in Healthy Volunteers and Participants With Axial Spondyloarthritis
Led by Grey Wolf Therapeutics · Updated on 2026-05-26
141
Participants Needed
15
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying GRWD0715, an oral medication that selectively inhibits the Endoplasmic Reticulum Aminopeptidase 1 (ERAP1) enzyme, as a potential treatment for axial spondyloarthritis (axSpA). AxSpA is a long-term inflammatory condition primarily affecting the sacroiliac joints and spine. The study explores whether blocking ERAP1 can prevent the immune system from attacking the body's own tissues, which may help stop disease progression. The trial has four parts: Part A involves healthy volunteers receiving a single dose of GRWD0715, while Parts B, C, and D involve participants with axSpA. Part B participants receive the drug daily for 28 days, Part C participants take it for 12 weeks, and Part D participants are randomly assigned to receive GRWD0715 or a placebo for 12 weeks. Some participants may roll over between parts to continue treatment without interruption. Participants will undergo safety and effectiveness evaluations, including monitoring for adverse events and MRI scans of the sacroiliac joints and spine. The study measures how well the drug is tolerated and its effects on inflammation and disease activity over up to 12 weeks. Blood samples will assess drug levels, and participants will be closely monitored from first dose through follow-up periods lasting up to 15 days post-treatment.
CONDITIONS
Brief 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 to 55 years for Part A
- Axial spondyloarthritis participants aged 18 to 65 years
- Diagnosis of axial spondyloarthritis fulfilling ASAS classification criteria
- Positive HLA-B27 test and objective evidence of sacroiliac joint inflammation by MRI or elevated C-reactive protein (CRP ≥ 5.0 mg/L)
- Symptom duration of at least 3 months
- Disease onset before age 40
- Ankylosing Spondylitis Disease Activity Score (ASDAS) of 2.1 or higher on current treatment
- Current treatment with NSAIDs showing inadequate response or intolerance to at least one NSAID
- Allowed prior use of 1 or 2 biologic or targeted synthetic DMARDs with appropriate washout periods
- Ability and willingness to comply with study requirements including contraception and dietary restrictions
You will not qualify if you...
- Significant medical history or findings that would prevent study participation
- Recent participation in other clinical drug studies
- Known infections or risk factors for HIV, hepatitis B or C
- Use of more than one biologic or JAK inhibitor DMARD or prohibited medications
- Blood disorders including low hemoglobin, white blood cells, neutrophils, lymphocytes, or platelets
- Liver function abnormalities beyond defined limits
- Other autoimmune rheumatic diseases or fibromyalgia
- Active inflammatory bowel disease or active anterior uveitis
- For healthy volunteers: smoking within past 6 months or BMI outside 19-30 range
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day with follow-up to 15 days post dose
Participants receive a single oral dose of GRWD0715 on Day 1 to assess safety and tolerability.
1 dosing visit and follow-up visits up to 15 days
Duration - 28 days with follow-up to 15 days post last dose
Participants receive daily oral doses of GRWD0715 for 28 days to evaluate safety and tolerability.
Daily dosing with planned follow-up visits after treatment
Duration - 12 weeks
Participants receive GRWD0715 daily for 12 weeks to further assess safety and preliminary efficacy.
Regular visits during 12 weeks of dosing
Duration - 12 weeks
Participants receive daily GRWD0715 or placebo for 12 weeks to evaluate efficacy and safety compared to placebo.
Regular visits during 12 weeks of dosing
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
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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