A Phase 1/2 interventional study of Part A - Single Ascending Dose (SAD) in Healthy Human Volunteers and Part B - Multiple Ascending Dose (MAD) in participants with axSpA in Axial Spondyloarthritis (AxSpA), sponsored by Grey Wolf Therapeutics. Recruiting at 16 sites in 6 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Grey Wolf Therapeutics · Phase 1/2, Interventional, and Treatment
…and 3 more changes, on the record history on ClinicalTrials.gov ↗
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.
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.
ERAP1 is involved in trimming antigens from foreign bodies (e.g. bacteria, viruses) which are presented on the surface of a cell to trigger an immune response. In axSpA, it is thought an antigen from the person's own body, called a 'self-peptide' is presented by the ERAP1 processing pathway and incorrectly recognised by the immune system. The hypothesis is that stimulation of the immune system by the presentation of this self-peptide causes the inflammatory symptoms experienced by people living with axSpA.
As an inhibitor of ERAP1, GRWD0715 aims to prevent the generation of the antigenic self-peptide, and thus remove the stimulus of the immune system. If the immune system is not activated, the immune attack on the sacroiliac joint (SIJ) and spine would stop, halting the axSpA disease progress.
The study will consist of 4 parts: Part A conducted in healthy human volunteers, and Part B, Part C and/or D in participants with axSpA. The primary goal of Parts A, B and C is to assess whether GRWD0715 is safe and well tolerated in healthy human volunteers and participants with axSpA. The primary goal of Part D is to review whether GRWD0715 is efficacious when compared to placebo.
186 studies on the registry are indexed under Axial Spondyloarthritis; 56 are open to participants now.
This study's planned enrollment of 140 is above the median of 108 across 122 interventional studies indexed under Axial Spondyloarthritis.
Browse Axial Spondyloarthritis studies →Grey Wolf Therapeutics is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 12, 2026. See what changed
Key Inclusion Criteria:
Healthy Volunteers
AxSpA Participants
Participants diagnosed with Axial Spondyloarthritis, also fulfilling 2009 ASAS classification criteria including:
At least one of the following:
Participants may have received one or two prior b/tsDMARDs and discontinued due to intolerance or inadequate efficacy, provided that:
- Part B: Participants who have received two prior b/ts DMARDs require Sponsor confirmation prior to screening.
Part D: Participants with prior b/tsDMARD treatment will be capped
Participants who have received prior b/tsDMARDs treatment(s) are required to undergo a at minimum:
Key Exclusion Criteria:
Healthy Volunteers
AxSpA Participants
Inadequate Haematologic function, defined as:
count \<100 x 109 /L (\<100.000 mm3)
Participants who require prohibited concomitant medications.
Part C Immediate Rollover:
For Immediate Rollover participants, all eligibility requirements are accounted for within the Part C Inclusion Criteria, and participants that have ongoing safety issues that, in the opinion of the investigator would preclude continued treatment, are excluded.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Part A - Single Ascending Dose (SAD) of GRWD0715 Participants in Part A will receive a single dose of GRWD0715 on Day 1 only.
Drug: Part A - Single Ascending Dose (SAD) in Healthy Human Volunteers
Drug: Part B - Multiple Ascending Dose (MAD) of GRWD0715 Participants in Part B will receive GRWD0715 for 28 days
Drug: Part B - Multiple Ascending Dose (MAD) in participants with axSpA
Participants from Part B or Part D of the study will be permitted to participate in Part C will receive GRWD0715 for 8 or 12 weeks, respectively. Immediate rollovers from Part B: If Part C is open while a Part B cohort is enrolling, participants may roll over directly into Part C without a washout period and continue treatment at their current assigned dose level of GRWD0715 from Part B, once daily, for an additional 8 weeks. Returning rollovers from Part B: Participants from previously completed Part B cohorts may return to enrol in Part C and receive open-label GRWD0715 for up to 56 days (8 weeks) at the most recent dose level evaluated and assessed as tolerable by the Safety Review Committee (SRC) during Part B. No further GRWD0715 washout period is required. Placebo Rollovers from Part D: Upon database lock and unblinding of Part D, participants previously randomised to the placebo arm in Part D will receive 12 weeks of open-label, daily dosing with GRWD0715 in Part C
Drug: Part C - Safety expansion cohort in participants with axSpA
Part D - Randomised expansion cohort of GRWD0715 vs. placebo Depending on the data from Part B, and the availability of one or more biologically active doses that are safe and well tolerated, participants will be randomised to receive either one or two dose levels of GRWD0715, or placebo to match (PTM). If one dose level is selected, participants will be randomised in a 4:1 ratio (GRWD0715:PTM). If two dose levels are selected, participants will be randomised in a 2:2:1 ratio (two GRWD0715 dose arms and PTM). Treatment will be administered once daily for up to 12 weeks.
Drug: Part D - Randomised, placebo-controlled, expansion cohort in participants with axSpA
Participants in Part A will receive a single dose of GRWD0715 on Day 1 only.
Participants in Part B will receive GRWD0715 for 28 days
Participants in Part C will receive GRWD0715 for 12 weeks
Participants in Part D will receive GRWD0715 or placebo-to-match for 12 weeks
Parts A, B and C: Incidence of treatment emergent (TEAE) and treatment related adverse events (TRAEs)
Any adverse event AE reported or observed after the start of dosing with any study treatment until completion of the last study related procedure (includes follow-up for safety assessments) will be recorded as a treatment-emergent AE (TEAE). If the TEAE is considered related to the study drug as per the definitions of relatedness listed in ('possibly', 'probably' or 'definitely' related) it will be considered a treatment-related AE (TRAE).
Time frame: Immediately after the first dose of GRWD0715 through to study completion after 4-12 weeks.
Parts A and B: Incidence and nature of dose limiting events (DLEs).
DLEs are on Grade 2 (moderate) events that are classified as related to study drug and are not resolved within 7 days. Any Grade 2 events lasting longer than 7 days, events of a higher grade, events that require study drug discontinuation or which meet the criteria for Seriousness and are related to study drug are counted as DLEs.
Time frame: Part A: the DLE period will be 15 Days from the start of dosing Part B: the DLE period will be 35 days from the start of dosing
Analysis of clinical response per Assessment of SpondyloArthritis International Society (ASAS) core outcome set compared to placebo. Higher scores mean worse outcome: Continuous Calculated Scores
The ASAS core outcome set (COS) will be conducted in participants and includes the following questionnaires which use Continuous Calculated Scores: Ankylosing Spondylitis Disease Activity Score (ASDAS)- A specific mathematically weighted index that combines patient-reported outcomes and blood inflammatory markers. Bath Ankylosing Spondylitis Function Index (BASFI) - A mean score derived from 10 individual visual/numeric questions regarding physical function. Assessment of SpondyloArthritis (ASAS) Health Index - A composite health and functioning score calculated from a specific 17-item questionnaire.
Time frame: This will be conducted at Screening, Week 1, Week 4, Week 8, Week 12 and the 15 Day End of Study visit
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
The ASAS core outcome set (COS) will be conducted in participants and includes the following questionnaires which use numeric rating scales (0-10): NRS Patient Global Assessment of Disease Activity (PGA-DA): A single 0-10 scale rating overall disease impact. NRS total back pain (BASDAI Q2): A single 0-10 scale rating spinal pain. NRS fatigue (BASDAI Q1): A single 0-10 scale rating tiredness levels. NRS average duration and severity of morning stiffness (BASDAI \[Q5+Q6\]/2): An average calculation derived from two separate 0-10 numeric rating scales.
Time frame: This will be conducted at Screening, Week 1, Week 4, Week 8, Week 12 and the 15 Day End of Study visit
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
The ASAS core outcome set (COS) will be conducted in participants and includes the following assessments which use direct anatomical counts: 44 swollen joint count (Part D): A literal tally of how many joints out of 44 are actively swollen. Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) (Part D only): A tally of painful areas out of 13 specific enthesitic insertion sites. Dactylitis count: A literal tally of the number of digits (fingers and toes) exhibiting uniform swelling (Part D only) ASAS20 and ASAS 40 scores will be calculated from constituent questions within the ASAS COS clinical outcome measures and patient reported outcome measures.
Time frame: This will be conducted at Screening, Week 1, Week 4, Week 8, Week 12 and the 15 Day End of Study visit
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
The SPARCC Scoring System measures active inflammation and structural joint damage in the sacroiliac joints using MRI, through the following: Inflammation Scoring (Bone Marrow Edema): Slice selection: Evaluates six consecutive, specialized coronal MRI slices through the joint. Joint quadrants: Divides each sacroiliac joint into four distinct quadrants (upper and lower iliac, upper and lower sacral). Basic scoring: Gives 1 point for the presence of bone marrow edema in each quadrant. Intensity and depth bonuses: Adds extra points for lesions that show very high signal intensity or great depth (\>1 cm). Maximum score: Reaches a total high score of 72 points for inflammation Structural Damage Scoring: Erosions: Measures loss of bone at the joint surface. Fat lesions: Tracks areas where bone marrow is replaced by fat. Backfill and ankylosis: Detects tissue repair and joint fusion
Time frame: This will be conducted at Screening, Week 1, Week 4, Week 8, Week 12 and the 15 Day End of Study visit
Parts A, B and C: PK - trough concentrations (Cmin)
PK samples will be collected during the study to measure the to measure how the study drug moves into, through, and out of the body over time, and how its concentration in the body changes over time. Whole blood will be collected for the determination of GRWD0715 levels in plasma. The trough is the lowest concentration of a drug reached in the body, it is collected from a blood sample drawn immediately before administering the next scheduled dose.
Time frame: Part A: From first dose to Day 4 Part B: From first dose to Day 28 Part C: Immediate Rollover: Week 4, 8 and 10 Returning Rollover: Week 1, 4 and 8
Parts A, B and C: PK - maximum observed concentration (Cmax)
The Cmax is the highest measured drug concentration in the blood or plasma after a dose and is measured or identified directly as the highest peak data point on the experimental concentration-time graph.
Time frame: Part A: From first dose to Day 4 Part B: From first dose to Day 28 Part C: Immediate Rollover: Week 4, 8 and 10 Returning Rollover: Week 1, 4 and 8
Parts A, B and C: PK - time to Cmax (Tmax)
This is the exact time elapsed from drug administration until the peak concentration (Cmax) is reached and is found by looking at the time value on the x-axis that corresponds directly to the peak concentration of the drug in the blood.
Time frame: Part A: From first dose to Day 4 Part B: From first dose to Day 28 Part C: Immediate Rollover: Week 4, 8 and 10 Returning Rollover: Week 1, 4 and 8
Parts A, B and C: PK - area under the concentration-time curve (AUC0-t)
A measure of the total drug exposure in the body from time zero up to the timepoints specified below for each study Part.
Time frame: Part A: From first dose to Day 4 Part B: From first dose to Day 28 Part C: Immediate Rollover: Week 4, 8 and 10 Returning Rollover: Week 1, 4 and 8
Parts A, B and C: PK - half-life (t1/2)
The time required for the GRWD0715's plasma concentration to decrease by exactly 50% during the final elimination phase.
Time frame: Part A: From first dose to Day 4 Part B: From first dose to Day 28 Part C: Immediate Rollover: Week 4, 8 and 10 Returning Rollover: Week 1, 4 and 8
Part B: A Biologically Active Dose (BAD) will be identified
A BAD is defined as a dose level with evidence supporting a biological effect of GRWD0715. A BAD will be identified based on meeting at least one of the following pre-specified criteria: Steady state pharmacokinetics: Dose levels achieving mean steady-state Cavg concentration at or above a predefined threshold of 1166 ng/ml will be considered to provide sufficient target engagement to meet the definition of a BAD. This threshold corresponds to the predicted IC50 as a relative Cavg concentration and is supported by human PK-PD modelling of a related oral ERAP1 inhibitor (GRWD5769) in oncology, which demonstrated that significant immunopeptidome shifts occur at levels that achieve PK exposures ≥ predicted IC50 as a relative Cavg concentration. Preliminary signals of clinical activity, including clinically important improvements in validated disease activity measures (e.g., ASDAS). Other supporting evidence may be considered including evidence of pharmacodynamic activity.
Time frame: The Biologically Active Dose will be assessed every 3 months in Part B on the completion of each of the 6 dose cohorts for up to a total of 14 months.
Parts A, B and C: Maximum tolerated dose (MTD): the MTD will be determined by the incidence of DLEs according to the MTD evaluation process.
Multiple ascending doses will be evaluated in this study. The MTD will be decided using a BOIN design escalation/de-escalation/elimination criteria model. If the true DLE rate is greater than 0.22 for a dose level, no future participants can be dosed at that level or higher.
Time frame: MTD will be assessed on the completion of each dose level cohort.
Not enrolling at this site.
Plan to share: No — IPD may not be shared for this Phase 1 study, or the IPD plan may be updated at a later point
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Apr 2028, 33 months after the start.
How these figures are worked out, and which studies are left out of them.
…and 3 more changes, on the record history on ClinicalTrials.gov ↗
…and 3 more changes, on the record history on ClinicalTrials.gov ↗
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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