[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596610":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":11,"centralContacts":41,"locations":47,"responsibleParty":197,"collaborators":11,"id":199,"slug":200,"hasResults":201,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":201,"sex":207,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":11,"studyType":213,"phases":214,"briefSummary":217,"conditions":218,"keywords":220,"overallStatus":50,"whyStopped":11,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},{"fullName":5,"class":6},"Grey Wolf Therapeutics","OTHER",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A - Single Ascending Dose (SAD) in Healthy Human Volunteers","EXPERIMENTAL",null,[13],"Drug: Part A - Single Ascending Dose (SAD) in Healthy Human Volunteers",{"label":15,"type":10,"description":11,"interventionNames":16},"Part B - Multiple Ascending Dose (MAD) in participants with axSpA",[17],"Drug: Part B - Multiple Ascending Dose (MAD) in participants with axSpA",{"label":19,"type":10,"description":20,"interventionNames":21},"Part C - Safety expansion cohort in participants with axSpA","Immediate Rollovers:\n\nIf Part C is open while a Part B cohort is enrolling, participants may rollover directly into Part C without a washout period and continue treatment at their current assigned dose level from Part B. Immediate Rollovers must commence Part C Day 1 dosing on what would have been Day 29 of Part B and may receive up to an additional 56 days (8 weeks) of dosing.\n\nParticipants who do not immediately roll over to Part C must complete the standard Part B follow-up period.\n\nReturning Rollovers:\n\nParticipants from previously completed Part B cohorts may return to enrol in Part C and receive up to an additional 56 days (8 weeks) of dosing at the most recent dose level assessed as tolerable by the SRC during Part B. No further GRWD0715 washout period is required.\n\nPart D Placebo Rollover:\n\nParticipants assigned placebo during participation in Part D may enrol in Part C and receive up to 84 days or 12 weeks of dosing of GRWD0175.",[22],"Drug: Part C - Safety expansion cohort in participants with axSpA",{"label":24,"type":10,"description":11,"interventionNames":25},"Part D - Randomised, placebo-controlled, expansion cohort in participants with axSpA",[26],"Drug: Part D - Randomised, placebo-controlled, expansion cohort in participants with axSpA",[28,32,35,38],{"type":29,"name":9,"description":30,"armGroupLabels":31,"otherNames":11},"DRUG","Participants in Part A will receive a single dose of GRWD0715 on Day 1 only.",[9],{"type":29,"name":15,"description":33,"armGroupLabels":34,"otherNames":11},"Participants in Part B will receive GRWD0715 for 28 days",[15],{"type":29,"name":19,"description":36,"armGroupLabels":37,"otherNames":11},"Participants in Part C will receive GRWD0715 for 12 weeks",[19],{"type":29,"name":24,"description":39,"armGroupLabels":40,"otherNames":11},"Participants in Part D will receive GRWD0715 or placebo-to-match for 12 weeks",[24],[42],{"name":43,"role":44,"phone":45,"phoneExt":11,"email":46},"Grey Wolf Therapeutics Patient enquiries","CONTACT","+44 1235644970","enquiries@gwt.bio",[48,60,68,76,84,94,102,112,121,131,139,151,159,167,179,189],{"facility":49,"status":50,"city":51,"state":11,"zip":11,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":11},"University of the Sunshine Coast (UniSC)","RECRUITING","Birtinya","Australia","AU",{"type":55,"coordinates":56},"Point",[57,58],153.11913,-26.74322,{"lat":58,"lon":57},{"facility":49,"status":61,"city":62,"state":11,"zip":11,"country":52,"countryCode":53,"cosmosGeoPoint":63,"geoPoint":67,"contacts":11},"COMPLETED","Morayfield",{"type":55,"coordinates":64},[65,66],152.94907,-27.10876,{"lat":66,"lon":65},{"facility":69,"status":50,"city":70,"state":11,"zip":11,"country":52,"countryCode":53,"cosmosGeoPoint":71,"geoPoint":75,"contacts":11},"The Colin Bayliss Research and Teaching Unit","Perth",{"type":55,"coordinates":72},[73,74],115.8614,-31.95224,{"lat":74,"lon":73},{"facility":77,"status":50,"city":78,"state":11,"zip":11,"country":52,"countryCode":53,"cosmosGeoPoint":79,"geoPoint":83,"contacts":11},"Pioneer Clinical Research","Sydney",{"type":55,"coordinates":80},[81,82],151.20732,-33.86785,{"lat":82,"lon":81},{"facility":85,"status":50,"city":86,"state":11,"zip":11,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":93,"contacts":11},"University Ghent","Ghent","Belgium","BE",{"type":55,"coordinates":90},[91,92],3.71667,51.05,{"lat":92,"lon":91},{"facility":95,"status":50,"city":96,"state":11,"zip":11,"country":87,"countryCode":88,"cosmosGeoPoint":97,"geoPoint":101,"contacts":11},"UZ Leuven","Leuven",{"type":55,"coordinates":98},[99,100],4.70093,50.87959,{"lat":100,"lon":99},{"facility":103,"status":50,"city":104,"state":11,"zip":11,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":111,"contacts":11},"Rheumazentrum Ruhrgebiet, Ruhr-University Bochum","Bochum","Germany","DE",{"type":55,"coordinates":108},[109,110],7.21648,51.48165,{"lat":110,"lon":109},{"facility":113,"status":114,"city":115,"state":11,"zip":11,"country":105,"countryCode":106,"cosmosGeoPoint":116,"geoPoint":120,"contacts":11},"Universitätsklinikum Erlangen - Medizinische Klinik 3","NOT_YET_RECRUITING","Erlangen",{"type":55,"coordinates":117},[118,119],11.00783,49.59099,{"lat":119,"lon":118},{"facility":122,"status":50,"city":123,"state":11,"zip":11,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":11},"Amsterdam University Medical Center","Amsterdam","Netherlands","NL",{"type":55,"coordinates":127},[128,129],4.88969,52.37403,{"lat":129,"lon":128},{"facility":132,"status":114,"city":133,"state":11,"zip":11,"country":124,"countryCode":125,"cosmosGeoPoint":134,"geoPoint":138,"contacts":11},"Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)","Leiden",{"type":55,"coordinates":135},[136,137],4.49306,52.15833,{"lat":137,"lon":136},{"facility":140,"status":114,"city":141,"state":142,"zip":143,"country":144,"countryCode":145,"cosmosGeoPoint":146,"geoPoint":150,"contacts":11},"Malopolskie Badania Kliniczne (MBK Clinic)","Krakow","Małopolska","30-002","Poland","PL",{"type":55,"coordinates":147},[148,149],19.93658,50.06143,{"lat":149,"lon":148},{"facility":152,"status":114,"city":153,"state":11,"zip":11,"country":144,"countryCode":145,"cosmosGeoPoint":154,"geoPoint":158,"contacts":11},"ETG Lublin","Lublin",{"type":55,"coordinates":155},[156,157],22.57009,51.25058,{"lat":157,"lon":156},{"facility":160,"status":114,"city":161,"state":11,"zip":11,"country":144,"countryCode":145,"cosmosGeoPoint":162,"geoPoint":166,"contacts":11},"Reumedika","Poznan",{"type":55,"coordinates":163},[164,165],16.92993,52.40692,{"lat":165,"lon":164},{"facility":168,"status":114,"city":169,"state":170,"zip":171,"country":172,"countryCode":173,"cosmosGeoPoint":174,"geoPoint":178,"contacts":11},"La Paz University Hospital","Madrid","Fuencarral-El Pardo","28046","Spain","ES",{"type":55,"coordinates":175},[176,177],-3.70256,40.4165,{"lat":177,"lon":176},{"facility":180,"status":114,"city":181,"state":182,"zip":183,"country":172,"countryCode":173,"cosmosGeoPoint":184,"geoPoint":188,"contacts":11},"Reina Sofia University Hospital","Córdoba","Poniente Sur","14004",{"type":55,"coordinates":185},[186,187],-4.77275,37.89155,{"lat":187,"lon":186},{"facility":190,"status":114,"city":191,"state":11,"zip":11,"country":172,"countryCode":173,"cosmosGeoPoint":192,"geoPoint":196,"contacts":11},"University hospital Parc Tauli de Sabadell","Sabadell",{"type":55,"coordinates":193},[194,195],2.10942,41.54329,{"lat":195,"lon":194},{"type":198,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100596610","phase-1-east-1-erap-inhibition-in-axial-spondyloarthritis-trial---1-100596610",false,"NCT07047703","EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1)","A Multi-part, Phase I\u002FII Study to Evaluate the Safety and Tolerability of GRWD0715 in Healthy Human Volunteers and Participants With Axial Spondyloarthritis","EAST-1","Inclusion Criteria:\n\nHealthy Volunteers\n\n* Healthy male and female subjects aged 18-55 years inclusive, at the Screening visit\n* Participant must provide written informed consent to participate in the study\n* Participant must be able and willing to comply with the requirements of the protocol (including dietary restrictions and exclusion of grapefruit juice)\n* Male participants (and their female partners) \u002F female participants must be willing to adhere to contraception requirements as detailed in the protocol\n* Non-smokers or ex-smokers who have not smoked within the previous 6 months, as determined at the Screening visit\n* Participant with a Body Mass Index (BMI) of 19-30. Body Mass Index = Body weight (kg) \u002F \\[Height (m)\\]2\n\nAxSpA Participants\n\n* Male or female, 18-65 years of age\n* Participants diagnosed with Axial Spondyloarthritis, also fulfilling ASAS classification criteria including:\n\n  1. HLA-B27 +ve (local testing)\n  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\u002For elevated C-reactive protein (CRP+) ≥5.0mg\u002FL.\n* Symptom duration of ≥3 months\n* Age at onset of active disease of \\\u003C40 years\n* A score of ≥ 2.1 on the Ankylosing Spondylitis Disease Activity Score (ASDAS) on current treatment.\n* At least one of the following:\n\n  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\n  2. Intolerance to ≥1 NSAID or contraindication(s) to NSAIDs\n* Participants may have received 1 prior\u002F(Australia only) 2 prior b\u002Fts DMARD and discontinued due to intolerance or inadequate efficacy.\n* Participants who have received 1\u002F(Australia only) 2 prior treatments are required to undergo a washout at minimum:\n\n  1. Biologic DMARDs 4 weeks or 5 half-lives prior to Day 1, whichever is longer.\n  2. JAK inhibitor DMARDs 2 weeks prior to Day 1\n\nExclusion Criteria:\n\nHealthy Volunteers\n\n* History or presence of any clinically significant findings in medical history, physical examination, vital signs and\u002For laboratory tests that, in the opinion of the Investigator, would preclude inclusion in the study\n* Participation in a New Chemical Entity clinical study within the previous 124 days or a marketed drug clinical study within the previous 93 days\n* Known infection or lifestyle risk factors for human immunodeficiency virus (HIV) and\u002For hepatitis B or C infection, as determined at the Screening visit\n\nAxSpA Participants\n\n* Participants who have received \\>1\u002F(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.\n* Inadequate Haematologic function, defined as:\n\n  1. Haemoglobin \\\u003C10 g\u002FdL.\n  2. Absolute white blood cell count \\\u003C3.0 x 109 \u002FL (\\\u003C3000 mm3)\n  3. Absolute neutrophil count \\\u003C1.2 x 109 \u002FL (\\\u003C1200 mm3)\n  4. Absolute lymphocyte count \\\u003C1.0 x 109 \u002FL (\\\u003C1000 mm3)\n  5. Platelet count \\\u003C100 x 109 \u002FL (\\\u003C100.000 mm3)\n* 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\u002Fdl\n* 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\n* Participants with a previous history of or currently stable psoriasis are eligible\n* Active or symptomatic inflammatory bowel disease (IBD). Participants with a history of IBD are allowed to participate\n* Presence of active anterior uveitis\n\nPlease note the following Country-Specific Inclusion Criteria, for study participants in Australia:\n\n\\- Participants with a score of ≥ 2.1 (High Disease Activity) on the Ankylosing Spondylitis Disease Activity Score (ASDAS) on current treatment.\n\nFor study participants in Part B only:\n\n* Objective evidence of inflammation may not be required for some participants with low to moderate disease activity.\n* Participants with an ASDAS score between ≥1.3 and \\\u003C 2.1 (Low to Moderate Disease Activity) will require Sponsor approval prior to screening for the study, as they may not require an MRI to provide objective evidence of inflammation if on current treatment. For participants with low to moderate disease activity, MRI should only be performed if required to confirm ASAS classification.\n\nFor axSpA participants in Part B, MRI assessment of the SI joints is only required for participant eligibility criteria evaluation to assess objective inflammation in case CRP measurement at baseline is negative and the objective evidence of inflammation is required.","ALL","18 Years","65 Years",{"count":211,"type":212},141,"ESTIMATED","INTERVENTIONAL",[215,216],"PHASE1","PHASE2","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.",[219],"Axial Spondyloarthritis (AxSpA)",[221,222],"Axial Spondyloarthritis","AxSpA","2026-06-25",{"date":225,"type":226},"2026-06-26","ACTUAL",{"date":228,"type":226},"2025-07-28",{"date":230,"type":212},"2028-09-30",{"name":5,"class":6},16]