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Recruiting 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 \

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Source: ClinicalTrials.gov (NCT07047703). StuddyBuddy aggregates publicly available trial information.