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EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1)

Study acronym: EAST-1
StatusRecruiting
PhasePhase 1/2
Started2025-07-28
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 5 → 6 primary endpoints
See other at-risk trials from Grey Wolf Therapeutics

Amendment history

2026-09-19
Primary endpoint(s) modified5 to 6 entries
WasAnalysis of SPARCC MRI activity of the SIJs (sacroiliac joints) and spine, Incidence and nature of dose limiting event(s) (DLE)s (Parts A and B only), Incidence, Type and Severity of treatment related adverse events (TRAEs), Incidence, type and severity of treatment emergent adverse events (TEAEs), To determine the efficacy of GRWD0715 compared to placebo in participants with axSpA (Part D)
NowAnalysis of clinical response per Assessment of SpondyloArthritis International Society (ASAS) core outcome set compared to placebo. Higher scores mean worse outcome: Continuous Calculated Scores, Analysis of clinical response per Assessment of SpondyloArthritis International Society (ASAS) core outcome set compared to placebo. Higher scores mean worse outcome: Direct Anatomical Counts, Analysis of clinical response per Assessment of SpondyloArthritis International Society (ASAS) core outcome set compared to placebo. Higher scores mean worse outcome: Numeric Rating Scales, Analysis of clinical response per SPARCC MRI (magnetic resonance imaging) Activity of the sacroiliac joints and spine in the core outcome set compared to placebo, Parts A and B: Incidence and nature of dose limiting events (DLEs)., Parts A, B and C: Incidence of treatment emergent (TEAE) and treatment related adverse events (TRAEs)
2026-07-22
Study Status, Contacts/Locations v14
Study sitesdetails revised at 2 of 16 sites
2026-06-25
Study Status, Contacts/Locations v13
Study sites15→16
2026-05-21
Study Status, Arms and Interventions v12
Re-verified, no change to tracked fields
2026-05-13
Study Status, Contacts/Locations v11
Study sites14→15
Show 10 earlier versions
2026-04-14
Study Status, Contacts/Locations v10
Study sites12→14
2026-02-24
Study Status, Contacts/Locations v9
Study sites13→12
2026-02-16
Study Status, Contacts/Locations v8
Study sites10→13
2026-02-05
Study Status, Eligibility v7
Eligibility criteria+1,053 characters
[...] e 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 Spondylitis Disease Activity Score (ASDAS) on current treatment. For study participants in Part B only: Objective eviden [...]
2026-01-26
Study Status, Contacts/Locations v6
Study sites8→10
2026-01-19
Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 8 sites
2025-12-03
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 8 sites
2025-11-21
Study Status, Eligibility, Contacts/Locations v3
Eligibility criteria+65 characters
[...] ntraindication(s) to NSAIDs Participants may have received 1 prior/(Australia only) 2 prior b/ts DMARD and discontinued due to intolerance or inadequate efficacy. Participants who have received 1/(Australia only) 2 prior treatmenttreatments are required to undergo a washout at minimum: Biologic DMAR [...] g visit AxSpA Participants Participants who have received >1/(Australia only) >2 biologic or JAK inhibitor DMARD or are receiving any other [...]
Study sitesdetails revised at 4 of 8 sites
2025-08-05
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-08-31→confirmed 2025-07-28
Study sitesdetails revised at 8 of 8 sites
2025-07-15
Study Status, Outcome Measures v1
Secondary endpoints9 entries, revised
AnalysisTo assess the preliminary efficacy of clinicalGRWD0715 response(Part per ASAS core outcome setC)
Primary endpoints5 entries, revised
AnalysisTo determine the efficacy of clinicalGRWD0715 responsecompared perto ASASplacebo corein outcomeparticipants Setwith axSpA (Part D)
2025-06-24
Original filing
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.
Trial Details
NCT Number NCT07047703
Lead Sponsor Grey Wolf Therapeutics
Conditions Axial Spondyloarthritis (AxSpA)
Enrollment 140 participants
Start Date 2025-07-28
Primary Completion 2028-04-30 (estimated)
Study Completion 2028-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-18