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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07047703
Registration number
NCT07047703
Ethics application status
Date submitted
24/06/2025
Date registered
2/07/2025
Date last updated
2/07/2025
Titles & IDs
Public title
EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1)
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Scientific title
A Multi-part, Phase I/II Study to Evaluate the Safety and Tolerability of GRWD0715 in Healthy Human Volunteers and Participants With Axial Spondyloarthritis
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Secondary ID [1]
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GRWD0715-AS-01
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Universal Trial Number (UTN)
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Trial acronym
EAST-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Axial Spondyloarthritis (AxSpA)
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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Rheumatoid arthritis
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Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Part A - Single Ascending Dose (SAD) in Healthy Human Volunteers
Treatment: Drugs - Part B - Multiple Ascending Dose (MAD) in participants with axSpA
Treatment: Drugs - Part C - Safety expansion cohort in participants with axSpA
Treatment: Drugs - Part D - Randomised, placebo-controlled, expansion cohort in participants with axSpA
Experimental: Part A - Single Ascending Dose (SAD) in Healthy Human Volunteers -
Experimental: Part B - Multiple Ascending Dose (MAD) in participants with axSpA -
Experimental: Part C - Safety expansion cohort in participants with axSpA -
Experimental: Part D - Randomised, placebo-controlled, expansion cohort in participants with axSpA -
Treatment: Drugs: Part A - Single Ascending Dose (SAD) in Healthy Human Volunteers
Participants in Part A will receive a single dose of GRWD0715 on Day 1 only.
Treatment: Drugs: Part B - Multiple Ascending Dose (MAD) in participants with axSpA
Participants in Part B will receive GRWD0715 for 28 days
Treatment: Drugs: Part C - Safety expansion cohort in participants with axSpA
Participants in Part C will receive GRWD0715 for 12 weeks
Treatment: Drugs: Part D - Randomised, placebo-controlled, expansion cohort in participants with axSpA
Participants in Part D will receive GRWD0715 or placebo-to-match for 12 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence and nature of dose limiting event(s) (DLE)s (Parts A and B only)
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Assessment method [1]
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To determine safety and tolerability of GRWD0715 in healthy volunteers (Part A) and participants with axSpA (Part B)
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Timepoint [1]
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From first dose to 15 days post last dose of study drug
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Primary outcome [2]
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Incidence, Type and Severity of treatment related adverse events (TRAEs)
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Assessment method [2]
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To determine safety and tolerability of GRWD0715 in healthy volunteers (Part A) and participants with axSpA (Parts B and C)
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Timepoint [2]
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From first dose to 15 days post last dose of study drug
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Primary outcome [3]
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Incidence, type and severity of treatment emergent adverse events (TEAEs)
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Assessment method [3]
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To determine safety and tolerability of GRWD0715 in healthy volunteers (Part A) and participants with axSpA (Parts B and C)
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Timepoint [3]
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From first dose to 15 days post last dose of study drug
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Primary outcome [4]
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Analysis of clinical response per ASAS core outcome Set
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Assessment method [4]
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To determine the efficacy of GRWD0715 compared to placebo in participants with axSpA (Part D) ASAS = Assessment of SpondyloArthritis international Society
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Timepoint [4]
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From baseline/Day 1 to Week 12
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Primary outcome [5]
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Analysis of SPARCC MRI activity of the SIJs (sacroiliac joints) and spine
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Assessment method [5]
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To determine the efficacy of GRWD0715 compared to placebo in participants with axSpA (Part D)
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Timepoint [5]
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From baseline/Day 1 to Week 12
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Secondary outcome [1]
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PK Parameter Trough Concentrations
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Assessment method [1]
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To characterise the plasma PK of GRWD0715 following single dose administration (Part A) and multiple dose administration (Parts B, C and D)
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Timepoint [1]
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From Day 1 to Day 4 (Part A) / Day 35 (Part B) / Week 12 (Parts C and D)
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Secondary outcome [2]
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PK Parameter Cmax (Maximum observed concentration)
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Assessment method [2]
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To characterise the plasma PK of GRWD0715 following single dose administration (Part A) and multiple dose administration (Part B)
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Timepoint [2]
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From Day 1 to Day 4 (Part A) / Day 35 (Part B)
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Secondary outcome [3]
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PK Parameter Tmax (Time to maximum observed concentration)
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Assessment method [3]
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To characterise the plasma PK of GRWD0715 following single dose administration (Part A) and multiple dose administration (Part B).
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Timepoint [3]
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From Day 1 to Day 4 (Part A) / Day 35 (Part B)
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Secondary outcome [4]
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PK Parameter AUC0-t (Area under the concentration-time curve)
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Assessment method [4]
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To characterise the plasma PK of GRWD0715 following single dose administration (Part A) and multiple dose administration (Parts B)
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Timepoint [4]
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From Day 1 to Day 4 (Part A) / Day 35 (Part B)
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Secondary outcome [5]
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PK Parameter T1/2 (Half life)
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Assessment method [5]
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To characterise the plasma PK of GRWD0715 following single dose administration (Part A) and multiple dose administration (Part B).
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Timepoint [5]
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From Day 1 to Day 4 (Part A) / Day 35 (Part B)
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Secondary outcome [6]
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Analysis of clinical response per ASAS core outcome set
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Assessment method [6]
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To assess the preliminary efficacy of GRWD0715 (Part C). ASAS = Assessment of SpondyloArthritis international Society
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Timepoint [6]
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From baseline/Day 1 to Week 12
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Secondary outcome [7]
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Analysis of SPARCC MRI activity of the SIJs (sacroiliac joints) and spine
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Assessment method [7]
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To assess the preliminary efficacy of GRWD0715 (Part C)
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Timepoint [7]
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From baseline/Day 1 to Week 12
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Secondary outcome [8]
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Incidence, Type and Severity of treatment related adverse events (TRAEs)
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Assessment method [8]
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To determine safety and tolerability of GRWD0715 in participants with axSpA (Part D).
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Timepoint [8]
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From first dose to 15 days post last dose of study drug
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Secondary outcome [9]
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Incidence, type and severity of treatment emergent adverse events (TEAEs)
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Assessment method [9]
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To determine safety and tolerability of GRWD0715 in participants with axSpA (Part D)
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Timepoint [9]
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From first dose to 15 days post last dose of study drug
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Eligibility
Key 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 <40 years
* A score of = 2.1 on the Ankylosing Spondylitis Disease Activity Score (ASDAS) on current treatment.
* At least one of the following:
1. Current treatment with a NSAID, at a sufficient dose and following an appropriate dosing duration per local clinical guidelines, with inadequate clinical response OR
2. Intolerance to =1 NSAID or contraindication(s) to NSAIDs Participants may have received 1 prior b/ts DMARD and discontinued due to intolerance or inadequate efficacy.
* Participants who have received 1 prior treatment are required to undergo a washout at minimum:
1. Biologic DMARDs 4 weeks or 5 half-lives prior to Day 1, whichever is longer.
2. JAK inhibitor DMARDs 2 weeks prior to Day 1
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Minimum age
18
Years
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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 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 <10 g/dL.
2. Absolute white blood cell count <3.0 x 109 /L (<3000 mm3)
3. Absolute neutrophil count <1.2 x 109 /L (<1200 mm3)
4. Absolute lymphocyte count <1.0 x 109 /L (<1000 mm3)
5. 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 subjects with Gilberts syndrome, upper limit of normal for total bilirubin will be 2.9mg/dl
* 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
31/08/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2028
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Actual
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Sample size
Target
141
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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University of the Sunshine Coast (UniSC) - Birtinya
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Recruitment hospital [2]
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University of the Sunshine Coast (UniSC) - Morayfield
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Recruitment hospital [3]
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Pioneer Clinical Research - Sydney
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Recruitment postcode(s) [1]
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- Birtinya
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Recruitment postcode(s) [2]
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- Morayfield
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Recruitment postcode(s) [3]
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- Sydney
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Ghent
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Country [2]
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Belgium
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State/province [2]
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Leuven
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Country [3]
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Germany
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State/province [3]
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Berlin
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Country [4]
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Germany
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State/province [4]
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Bochum
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Country [5]
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Netherlands
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State/province [5]
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Amsterdam
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Funding & Sponsors
Primary sponsor type
Other
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Name
Grey Wolf Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT07047703
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Grey Wolf Therapeutics Patient enquiries
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Address
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Country
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Phone
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+44 1235644970
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07047703
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