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NCT07047703
EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1)
Conditions: Axial Spondyloarthritis (AxSpA)
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 141
Sponsor: Grey Wolf Therapeutics
Location: University of the Sunshine Coast (UniSC) Birtinya
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 Criteria
Inclusion Criteria:
Healthy Volunteers
* Healthy male and female subjects aged 18-55 years inclusive, at the Screening visit
* Participant must provide written informed consent to participate in the study
* Participant must be able and willing to comply with the requirements of the protocol (including dietary restrictions and exclusion of grapefruit juice)
* Male participants (and their female partners) / female participants must be willing to adhere to contraception requirements as detailed in the protocol
* Non-smokers or ex-smokers who have not smoked within the previous 6 months, as determined at the Screening visit
* Participant with a Body Mass Index (BMI) of 19-30. Body Mass Index = Body weight (kg) / \[Height (m)\]2
AxSpA Participants
* Male or female, 18-65 years of age
* Participants diagnosed with Axial Spondyloarthritis, also fulfilling ASAS classification criteria including:
1. HLA-B27 +ve (local testing)
2. Objective evidence of inflammation at screening, specifically active sacroiliac joint inflammation on MRI fulfilling the ASAS MRI criteria (MRI+), assessed by the Principal Investigator or appropriately trained delegate, and/or elevated C-reactive protein (CRP+) ≥5.0mg/L.
* Symptom duration of ≥3 months
* Age at onset of active disease of \1/(Australia only) \>2 biologic or JAK inhibitor DMARD or are receiving any other disease-modifying antirheumatic drugs (other than those allowed), thalidomide (including previous use) and other prohibited concomitant medications.
* Inadequate Haematologic function, defined as:
1. Haemoglobin \
Source: ClinicalTrials.gov (NCT07047703). StuddyBuddy aggregates publicly available trial information.