A Multi-part, Phase I/II Study to Evaluate the Safety and Tolerability of GRWD0715 in Healthy Human Volunteers and Participants With Axial Spondyloarthritis

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

∙ 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:

‣ HLA-B27 +ve (local testing)

⁃ 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:

‣ Current treatment with a NSAID, at a sufficient dose and following an appropriate dosing duration per local clinical guidelines, with inadequate clinical response OR

⁃ Intolerance to ≥1 NSAID or contraindication(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 treatments are required to undergo a washout at minimum:

‣ Biologic DMARDs 4 weeks or 5 half-lives prior to Day 1, whichever is longer.

⁃ JAK inhibitor DMARDs 2 weeks prior to Day 1

Locations
Other Locations
Australia
University of the Sunshine Coast (UniSC)
RECRUITING
Birtinya
University of the Sunshine Coast (UniSC)
RECRUITING
Morayfield
Pioneer Clinical Research
RECRUITING
Sydney
Belgium
University Ghent
RECRUITING
Ghent
UZ Leuven
RECRUITING
Leuven
Germany
Charité - Universitätsmedizin Berlin
NOT_YET_RECRUITING
Berlin
Rheumazentrum Ruhrgebiet, Ruhr-University Bochum
RECRUITING
Bochum
Netherlands
Amsterdam University Medical Center
NOT_YET_RECRUITING
Amsterdam
Contact Information
Primary
Grey Wolf Therapeutics Patient enquiries
enquiries@gwt.bio
+44 1235644970
Time Frame
Start Date: 2025-07-28
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 141
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Grey Wolf Therapeutics

This content was sourced from clinicaltrials.gov