Health TrialsbyHealthPanel

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

ConditionAxial Spondyloarthritis (AxSpA)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGrey Wolf Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

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) and other prohibited concomitant medications.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Part A - Single Ascending Dose (SAD) in Healthy Human Volunteers

    Drug

    Participants in Part A will receive a single dose of GRWD0715 on Day 1 only.

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

    Drug

    Participants in Part B will receive GRWD0715 for 28 days

  • Part C - Safety expansion cohort in participants with axSpA

    Drug

    Participants in Part C will receive GRWD0715 for 12 weeks

  • Part D - Randomised, placebo-controlled, expansion cohort in participants with axSpA

    Drug

    Participants in Part D will receive GRWD0715 or placebo-to-match for 12 weeks

Treatment groups

141 Participants
are divided into 4 treatment groups
Group A: Part A - Single Ascending Dose (SAD) in Healthy Human VolunteersExperimental treatment 1 intervention
Group B: Part B - Multiple Ascending Dose (MAD) in participants with axSpAExperimental treatment 1 intervention
Group C: Part C - Safety expansion cohort in participants with axSpAExperimental treatment 1 intervention
Group D: Part D - Randomised, placebo-controlled, expansion cohort in participants with axSpAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and nature of dose limiting event(s) (DLE)s (Parts A and B only)

To determine safety and tolerability of GRWD0715 in healthy volunteers (Part A) and participants with axSpA (Part B)

Time frame
From first dose to 15 days post last dose of study drug
2

Incidence, Type and Severity of treatment related adverse events (TRAEs)

To determine safety and tolerability of GRWD0715 in healthy volunteers (Part A) and participants with axSpA (Parts B and C)

Time frame
From first dose to 15 days post last dose of study drug
3

Incidence, type and severity of treatment emergent adverse events (TEAEs)

To determine safety and tolerability of GRWD0715 in healthy volunteers (Part A) and participants with axSpA (Parts B and C)

Time frame
From first dose to 15 days post last dose of study drug
4

To determine the efficacy of GRWD0715 compared to placebo in participants with axSpA (Part D)

Analysis of the Assessment of Spondyloarthritis International Society (ASAS) Core Outcome Set (COS). ASAS20 (improvement of 20% or more and 1 unit or more; improvement in at least 3 of 4 domains; no worsening on fourth dimension) and ASAS40 (improvement of 40% and 2 units or more; improvement in at least 3 of 4 domains; no worsening on fourth dimension) will be calculated from constituent questions with the ASAS COS clinical measures and patient reported outcomes

Time frame
From baseline/Day 1 to Week 12

Secondary outcomes

1

PK Parameter Trough Concentrations

To characterise the plasma PK of GRWD0715 following single dose administration (Part A) and multiple dose administration (Parts B, C and D)

Time frame
From Day 1 to Day 4 (Part A) / Day 35 (Part B) / Week 12 (Parts C and D)
2

PK Parameter Cmax (Maximum observed concentration)

To characterise the plasma PK of GRWD0715 following single dose administration (Part A) and multiple dose administration (Part B)

Time frame
From Day 1 to Day 4 (Part A) / Day 35 (Part B)
3

PK Parameter Tmax (Time to maximum observed concentration)

To characterise the plasma PK of GRWD0715 following single dose administration (Part A) and multiple dose administration (Part B).

Time frame
From Day 1 to Day 4 (Part A) / Day 35 (Part B)
4

PK Parameter AUC0-t (Area under the concentration-time curve)

To characterise the plasma PK of GRWD0715 following single dose administration (Part A) and multiple dose administration (Parts B)

Time frame
From Day 1 to Day 4 (Part A) / Day 35 (Part B)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Grey Wolf Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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