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New treatment option for Axial Spondyloarthritis (AxSpA)
Official title EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1)
ClinicalTrials.gov ID: NCT07047703
What this study is testing
What is Part A - Single Ascending Dose (SAD) in Healthy Human Volunteers?
Part A - Single Ascending Dose (SAD) in Healthy Human Volunteers is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for axial spondyloarthritis (axspa).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Healthy Volunteers
- Healthy male and female people 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...
- Male participants (and their female partners) / female participants must be willing to adhere to contraception requirements as detailed in the...
You likely can't join if
- Healthy Volunteers
- History or presence of any clinically significant findings in medical history, physical examination, vital signs and/or laboratory tests that, in the...
- Participation in a New Chemical Entity clinical study within the previous 124 days or a marketed drug clinical study within the previous 93 days
- Known infection or lifestyle risk factors for human immunodeficiency virus (HIV) and/or hepatitis B or C infection, as determined at the Screening...
- Participants who have received \>1/(Australia only) \>2 biologic or JAK inhibitor DMARD or are receiving any other disease-modifying antirheumatic...
- Inadequate Haematologic function, defined as:
See the full eligibility criteria
- Healthy Volunteers
- Healthy male and female people 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:
- HLA-B27 +ve (local testing)
- 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...
- Symptom duration of ≥3 months
- Age at onset of active disease of \<40 years
- A score of ≥ 2.1 on the Ankylosing Spondylitis Disease Activity Score (ASDAS) on current treatment.
- At least one of the following:
- Current treatment with a NSAID, at a sufficient dose and following an appropriate dosing duration per local clinical guidelines, with inadequate clinical response OR
- Intolerance to ≥1 NSAID or contraindication(s) to NSAIDs
- Participants may have received 1 prior/(Australia only) 2 prior b/ts DMARD and discontinued due to intolerance or inadequate how well it works.
- Participants who have received 1/(Australia only) 2 prior treatments are required to undergo a washout at minimum:
- Biologic DMARDs 4 weeks or 5 half-lives prior to Day 1, whichever is longer.
- JAK inhibitor DMARDs 2 weeks prior to Day 1
- Healthy Volunteers
- History or presence of any clinically significant findings in medical history, physical examination, vital signs and/or laboratory tests that, in the opinion of the Investigator, would preclude inclusion in the study
- Participation in a New Chemical Entity clinical study within the previous 124 days or a marketed drug clinical study within the previous 93 days
- Known infection or lifestyle risk factors for human immunodeficiency virus (HIV) and/or hepatitis B or C infection, as determined at the Screening visit AxSpA Participants
- Participants who have received \>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)...
- Inadequate Haematologic function, defined as:
- Haemoglobin \<10 g/dL.
- Absolute white blood cell count \<3.0 x 109 /L (\<3000 mm3)
- Absolute neutrophil count \<1.2 x 109 /L (\<1200 mm3)
- Absolute lymphocyte count \<1.0 x 109 /L (\<1000 mm3)
- Platelet count \<100 x 109 /L (\<100.000 mm3)
- Inadequate liver function, defined as; total bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than 1.5 times the upper limit of normal at screening visit. For people with Gilberts...
- History of any other autoimmune rheumatic disease (e.g., psoriatic arthropathy, systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymositis) or known diagnosis of fibromyalgia
- Participants with a previous history of or currently stable psoriasis are eligible
- Active or symptomatic inflammatory bowel disease (IBD). Participants with a history of IBD are allowed to participate
- Presence of active anterior uveitis Please note the following Country-Specific Inclusion Criteria, for study participants in Australia: \- Participants with a score of ≥ 2.1 (High Disease Activity) on the Ankylosing...
- Objective evidence of inflammation may not be required for some participants with low to moderate disease activity.
- Participants with an ASDAS score between ≥1.3 and \< 2.1 (Low to Moderate Disease Activity) will require Sponsor approval prior to screening for the study, as they may not require an MRI to provide objective evidence of...
The study team makes the final eligibility decision.
Where it's taking place
- Birtinya, Australia
- Morayfield, Australia
- Perth, Australia
- Sydney, Australia
- Ghent, Belgium
- Leuven, Belgium
- Bochum, Germany
- Erlangen, Germany
- Amsterdam, Netherlands
- Leiden, Netherlands
- Krakow, Małopolska, Poland
- Lublin, Poland
- Poznan, Poland
- Madrid, Fuencarral-El Pardo, Spain
- Córdoba, Poniente Sur, Spain
- Sabadell, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birtinya, Australia; Morayfield, Australia; Perth, Australia; Sydney, Australia; Ghent, Belgium; Leuven, Belgium and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.