A Phase 2 interventional study of dapansutrile and placebo in Parkinson Disease, sponsored by Cambridge University Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Cambridge University Hospitals NHS Foundation Trust · Phase 2, Interventional, and Treatment
In Parkinson's disease (PD), there is inflammation in the brain, the gut and the blood, which is thought to contribute to the development and progression of the disease. The Nod-like receptor (NLR) family pyrin domain containing 3 (NLRP3) inflammasome is a complex of proteins which plays a critical role in mediating inflammation, and there is growing evidence from laboratory research that the inflammasome plays a role in Parkinson's disease.
Dapansutrile is a new drug which has a highly specific effect on the NLRP3 inflammasome. In animal models, dapansutrile can protect against inflammation in the brain and prevent loss of dopamine cells. Initial 'in human' studies have indicated that this drug can effectively reduce inflammation without causing significant side effects.
The goal of this clinical trial is to test whether dapansutrile might be a useful treatment for Parkinson's disease. The main questions it aims to answer are:
Researchers will compare dapansutrile to a placebo (a look-alike substance that contains no drug) to see whether it is safe and what effects it has on inflammation and on clinical symptoms.
Participants will be asked to take dapansutrile or a placebo every day for 6 months. Following this, all participants will be given the option to take dapansutrile every day for an additional 6 months. Participants will visit the study centre regularly throughout the trial for check-ups and blood tests. They will have a brain scan before starting treatment and again after 5-6 months. They will also be asked to have a lumbar puncture at the beginning of the trial, after 6 months of treatment and after 12 months of treatment.
DAPA-PD is a randomised double-blind, placebo-controlled phase II trial investigating the safety and tolerability of dapansutrile (OLT1177), an NLRP3 inhibitor, in people with early PD (Hoehn and Yahr stage ≤2, disease duration ≤5 years) who have evidence of peripheral inflammation (high sensitivity C-reactive protein [hsCRP] ≥1) as an adjunct to dopaminergic therapies. 36 participants will be recruited at a single site and treated with either dapansutrile (1000mg twice daily) or placebo in a 2:1 ratio for a duration of 6 months. This randomised placebo-controlled phase of the trial will be followed by an optional 6-month open label phase, where all participants will receive the active drug. The primary endpoint will be the safety and tolerability of dapansutrile over the 6-month placebo-controlled phase.
Safety data will be collected throughout both phases of the trial, through venous blood sampling, electrocardiograms and clinical assessments. The trial will assess treatment efficacy on peripheral and central inflammation, using biomarkers in blood and CSF, and translocator protein (TSPO) positron emission tomography (PET) brain imaging. Pharmacokinetics of the drug will also be evaluated. Additionally, clinical outcomes, including motor and cognitive progression, will be assessed throughout.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 36 is close to the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 171 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 3, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be included in the trial, the potential participant must:
Exclusion Criteria:
The presence of any of the following will preclude inclusion:
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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).
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.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Drug: dapansutrile
Drug: placebo
Dapansutrile tablets administered for 26 weeks, starting at 1,000 mg daily (500 mg twice daily) for 4 weeks, escalated to 2,000 mg daily (1,000 mg twice daily) thereafter.
Matched placebo tablets administered for 26 weeks, admistered as per the active treatment.
Number of adverse events (AEs) recorded during the 6-month double-blind period
Adverse events are recorded from the point of participant informed consent and at every trial visit
Time frame: Assessed at screening, baseline, day 1, and weeks 2, 4, 6, 12, 18, 23 and 26.
Change in [¹⁸F]-DPA-714 PET non-displaceable binding potential in the whole brain, and subcortical and cortical regions of interest
Measured using PET- magnetic resonance (MR) brain imaging with \[¹⁸F\]-DPA-714, a TSPO ligand.
Time frame: Between baseline and week 23
Change in concentration of C-reactive protein (CRP) in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of interleukin (IL)-1β in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of interferon (IFN)-γ in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of IL-18 in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of IL-6 in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of tumour necrosis factor (TNF)-α in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of apoptosis-associated speck-like protein containing a CARD (ASC) specks in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18 and 26.
Change in concentration of neurodegenerative marker neurofilament light chain (NfL) in blood
Time frame: Over 6 months of treatment, measured at day 1, and weeks 6, 18, and 26
Change in concentration of CRP in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of IL-1β in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of IFN-γ in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of IL-18 in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of IL-6 in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of TNF-α in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of ASC specks in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26.
Change in concentration of neurodegenerative marker neurofilament light chain (NfL) in CSF
Time frame: Over 6 months of treatment, measured at baseline and week 26
Pharmacokinetics as measured by changes in plasma and CSF dapansutrile concentrations
Time frame: Over 6 months of treatment; measured in the blood at day 1, and weeks 6, 18 and 26; and measured in CSF at baseline and week 26.
Number of AEs recorded
Time frame: During the 6-month open-label period
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I
Part I of the MDS-UPDRS assesses Non-Motor Aspects of Experiences of Daily Living (nM-EDL). Scoring ranges from 0 to 52, with higher scores indicating more severe symptoms.
Time frame: Between baseline and 6 months, and over 12 months (if performed)
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part II
Part II of the MDS-UPDRS assesses Motor Aspects of Experiences of Daily Living (M-EDL). Scoring ranges from 0 to 52, with higher scores indicating more severe symptoms.
Time frame: Between baseline and 6 months, and over 12 months (if performed).
Change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
MDS-UPDRS part III will be used to measure the change in motor examination. Scoring ranges from 0 to 132, with a higher score indicating more severe motor impairment.
Time frame: Between baseline and 6 months, and over 12 months (if performed)
Change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV
Part IV of the MDS-UPDRS assesses Motor Complications. Scoring ranges from 0 to 24, with higher scores indicating more severe symptoms.
Time frame: Between baseline and 6 months, and over 12 months (if applicable).
Change in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) gait/axial score
This score is a sum of the points from the following sections of MDS-UPDRS part III: speech, facial expression, rising from a chair, gait, postural stability, posture, and body bradykinesia. Scoring ranges from 0 to 28. A higher score is more severe.
Time frame: Between baseline and 6 months, and over 12 months (if performed).
Change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) parts I + II sum score
Sum of Parts I + II of the MDS-UPDRS.
Time frame: Between baseline and 6 months, and over 12 months (if applicable).
Change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score
Scoring ranges from 0 to 260, with higher scores indicating greater severity.
Time frame: Between baseline and 6 months, and over 12 months (if performed).
Change in Addenbrooke's Cognitive Examination-III (ACE-III)
ACE-III is a global cognitive assessment tool. Scores range from 0 to 100, with higher scores indicating better cognitive functioning.
Time frame: Between baseline and 6 months, and over 12 months (if performed)
Change in Movement Disorder Society-Non-Motor Rating Scale (MDS-NMS)
MDS-NMS measures the burden of non-motor symptoms, including non-motor fluctuations in Parkinson's disease. Scores range from 0 to 180 with higher scores indicating a greater symptom burden.
Time frame: Between baseline and 6 months, and over 12 months (if performed)
Change in Gastrointestinal Dysfunction Scale for Parkinson's Disease (GIDS-PD)
GIDS-PD is a patient-reported outcome measure of gastrointestinal symptoms in Parkinson's disease. Scores range from 1 to 108, with a higher score representing a greater number and/or severity of gastrointestinal symptoms.
Time frame: Between baseline and 6 months, and over 12 months (if performed)
Geriatric Depression Scale-30 (GDS-30)
GDS-30 is a patient-reported outcome measure of depression. Scores range from 0 to 30, with a higher score indicating greater severity of depression.
Time frame: Between baseline and 6 months, and over 12 months (if performed)
Parkinson's Disease Questionnaire-39 (PDQ-39)
PDQ-39 is a patient-reported outcome measure of quality of life in Parkinson's disease. Scores range from 0 to 100 with a higher score indicating greater functional impairment and lower quality of life .
Time frame: Between baseline and 6 months, and over 12 months (if performed).
Changes in other inflammatory markers related to inflammasome activation in the blood and CSF, which are deemed relevant by the investigators
Time frame: Between baseline and 6 months, and over 12 months (if performed)
Change in concentration of C-reactive protein (CRP) in blood
Time frame: Over 12 months (if performed), measured at day 1, and weeks 6, 18, 26, 32, 44 and 52
Change in concentration of interleukin (IL)-1β in blood
Time frame: Over 12 months (if performed), measured at day 1, and weeks 6, 18, 26, 32, 44 and 52
Change in concentration of interferon (IFN)-γ in blood
Time frame: Over 12 months (if performed), measured at day 1, and weeks 6, 18, 26, 32, 44 and 52
Change in concentration of IL-18 in blood
Time frame: Over 12 months (if performed), measured at day 1, and weeks 6, 18, 26, 32, 44 and 52
Change in concentration of apoptosis-associated speck-like protein containing a CARD (ASC) specks in blood
Time frame: Over 12 months (if performed), measured at day 1, and weeks 6, 18, 26, 32, 44 and 52
Change in concentration of IL-6 in blood
Time frame: Over 12 months (if performed), measured at day 1, and weeks 6, 18, 26, 32, 44 and 52
Change in concentration of tumour necrosis factor (TNF)-α in blood
Time frame: Over 12 months (if performed), measured at day 1, and weeks 6, 18, 26, 32, 44 and 52
Change in concentration of neurodegenerative marker neurofilament light chain (NfL) in blood
Time frame: Over 12 months (if performed), measured at day 1, and weeks 6, 18, 26, 32, 44 and 52
Change in concentration of neurodegenerative marker neurofilament light chain (NfL) in CSF
Time frame: Over 12 months (if performed), measured at baseline, week 26 and week 52
Change in concentration of ASC specks in CSF
Time frame: Over 12 months (if performed), measured at baseline, week 26 and week 52
Change in concentration of TNF-α in CSF
Time frame: Over 12 months (if performed), measured at baseline, week 26 and week 52
Change in concentration of IL-6 in CSF
Time frame: Over 12 months (if performed), measured at baseline, week 26 and week 52
Change in concentration of IL-18 in CSF
Time frame: Over 12 months (if performed), measured at baseline, week 26 and week 52
Change in concentration of IL-1β in CSF
Time frame: Over 12 months (if performed), measured at baseline, week 26 and week 52
Change in concentration of CRP in CSF
Time frame: Over 12 months (if performed), measured at baseline, week 26 and week 52
Change in concentration of interferon (IFN)-γ in CSF
Time frame: Over 12 months (if performed), measured at baseline, week 26 and week 52
Pharmacokinetics as measured by changes in plasma and CSF dapansutrile concentrations
Time frame: Over 12 months of treatment; measured in the blood at day 1, and weeks 6, 18, 26, 32, 44, 52 and 56; and measured in CSF at baseline, week 26 and week 52.
Plan to share: Undecided
No publications or documents are linked to this record.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dapansutrile
Cambridge University Hospitals NHS Foundation Trust →