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

NCT07047703 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2026-05-26

No results posted yet for this study

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.

Conditions

  • Axial Spondyloarthritis (AxSpA)

Interventions

DRUG

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.

DRUG

Part B - Multiple Ascending Dose (MAD) in participants with axSpA

Participants in Part B will receive GRWD0715 for 28 days

DRUG

Part C - Safety expansion cohort in participants with axSpA

Participants in Part C will receive GRWD0715 for 12 weeks

DRUG

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

Sponsors & Collaborators

  • Grey Wolf Therapeutics

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-28
Primary Completion
2028-04-30
Completion
2028-09-30

Countries

  • Australia
  • Belgium
  • Germany
  • Netherlands
  • Poland
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07047703 on ClinicalTrials.gov