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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)
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
Secondary ID [1] 0 0
GRWD0715-AS-01
Universal Trial Number (UTN)
Trial acronym
EAST-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Axial Spondyloarthritis (AxSpA) 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and nature of dose limiting event(s) (DLE)s (Parts A and B only)
Timepoint [1] 0 0
From first dose to 15 days post last dose of study drug
Primary outcome [2] 0 0
Incidence, Type and Severity of treatment related adverse events (TRAEs)
Timepoint [2] 0 0
From first dose to 15 days post last dose of study drug
Primary outcome [3] 0 0
Incidence, type and severity of treatment emergent adverse events (TEAEs)
Timepoint [3] 0 0
From first dose to 15 days post last dose of study drug
Primary outcome [4] 0 0
Analysis of clinical response per ASAS core outcome Set
Timepoint [4] 0 0
From baseline/Day 1 to Week 12
Primary outcome [5] 0 0
Analysis of SPARCC MRI activity of the SIJs (sacroiliac joints) and spine
Timepoint [5] 0 0
From baseline/Day 1 to Week 12
Secondary outcome [1] 0 0
PK Parameter Trough Concentrations
Timepoint [1] 0 0
From Day 1 to Day 4 (Part A) / Day 35 (Part B) / Week 12 (Parts C and D)
Secondary outcome [2] 0 0
PK Parameter Cmax (Maximum observed concentration)
Timepoint [2] 0 0
From Day 1 to Day 4 (Part A) / Day 35 (Part B)
Secondary outcome [3] 0 0
PK Parameter Tmax (Time to maximum observed concentration)
Timepoint [3] 0 0
From Day 1 to Day 4 (Part A) / Day 35 (Part B)
Secondary outcome [4] 0 0
PK Parameter AUC0-t (Area under the concentration-time curve)
Timepoint [4] 0 0
From Day 1 to Day 4 (Part A) / Day 35 (Part B)
Secondary outcome [5] 0 0
PK Parameter T1/2 (Half life)
Timepoint [5] 0 0
From Day 1 to Day 4 (Part A) / Day 35 (Part B)
Secondary outcome [6] 0 0
Analysis of clinical response per ASAS core outcome set
Timepoint [6] 0 0
From baseline/Day 1 to Week 12
Secondary outcome [7] 0 0
Analysis of SPARCC MRI activity of the SIJs (sacroiliac joints) and spine
Timepoint [7] 0 0
From baseline/Day 1 to Week 12
Secondary outcome [8] 0 0
Incidence, Type and Severity of treatment related adverse events (TRAEs)
Timepoint [8] 0 0
From first dose to 15 days post last dose of study drug
Secondary outcome [9] 0 0
Incidence, type and severity of treatment emergent adverse events (TEAEs)
Timepoint [9] 0 0
From first dose to 15 days post last dose of study drug

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of the Sunshine Coast (UniSC) - Birtinya
Recruitment hospital [2] 0 0
University of the Sunshine Coast (UniSC) - Morayfield
Recruitment hospital [3] 0 0
Pioneer Clinical Research - Sydney
Recruitment postcode(s) [1] 0 0
- Birtinya
Recruitment postcode(s) [2] 0 0
- Morayfield
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Ghent
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Germany
State/province [3] 0 0
Berlin
Country [4] 0 0
Germany
State/province [4] 0 0
Bochum
Country [5] 0 0
Netherlands
State/province [5] 0 0
Amsterdam

Funding & Sponsors
Primary sponsor type
Other
Name
Grey Wolf Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Grey Wolf Therapeutics Patient enquiries
Address 0 0
Country 0 0
Phone 0 0
+44 1235644970
Fax 0 0
Email 0 0
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.