Alzheimer DiseasePhase 1NCT03943264
A Biomarker-directed Study of XPro1595 in Patients With Alzheimer's
A Phase 1 study testing XPro1595 in people with Alzheimer Disease, run by Inmune Bio, Inc. at 5 sites in Australia.
Trial summary
The purpose of this study is to evaluate safety and target engagement of XPro1595 in Alzheimer's patients with biomarkers of inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- XPro1595
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesAustralia
- Study dates
- 20 Nov 2019to 1 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years and above at screening;
- Diagnosed with probable AD defined by the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria;
- Has hsCRP levels ≥1.5mg/L,OR HbA1c ≥ 6DCCT %, OR Erythrocyte Sedimentation Rate (ESR) ≥10 mm/h, OR APOE4 positive (at least one APOE4 allele);
- Female of childbearing potential (FCBP) must have confirmed negative urine pregnancy test at Screening;
- All female of childbearing potential (FCBP) and male patients who are sexually active with a female of childbearing potential must agree to use a highly effective contraception during the treatment period and until 90 days after the last dose of treatment for sexually active males whose partners are FCBP or until 30 days after the last dose of treatment for FCBP.
- Consents to having lumbar punctures;
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- Consents to apolipoprotein E (APOE) genotyping(if status unknown);
- Provide written informed consent prior to any study procedures being performed;
- Has a caregiver who either lives in the same household or interacts withthe patient at least 4 hours per day and at least 4 days per week, who is knowledgeable about the participant's daytime and night-time behaviours and who canbe available to attend all clinic visits in personat which caregiver assessments are performed.Patients with caregivers that do not meet this criterionbut are determined by the investigator as able to provide an adequate assessment of the patient may also participate with prior approval from the sponsor.
Who cannot join
- Patients taking cholinesterase inhibitors, memantine, or antidepressant medication for less than 45 days from Day 1 (i.e. must be on stable dose for at least 45 days prior to Day 1);
- Have taken within the last 45 days from Day 1; corticosteroids or other immunosuppressive drugs, thalidomide or other TNF active drugs, minocycline.
- Enrolled in another clinical trial where patients receive treatment with investigational drug or device or have received treatment on another AD clinical trial within the last 60 days from Day 1;
- Unable to tolerate lumbar puncture or taking medicine where lumber punctures are contraindicated (anti-coagulants besides daily 100mg of aspirin);
- A prior organ or stem cell transplant;
- A major adverse cardiac event within 6 months before screening;
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- Lymphoma, leukaemia, or any malignancy within the past 5 years with the exception of malignancies with negligible risk of metastasis or death, such as basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ that have been resected with no evidence of metastatic disease for 3 years;
- Jaundice, active hepatitis, or known hepatobiliary disease (except asymptomatic cholelithiasis);
- Positive screening assessment for viral hepatitis B surface antigen or hepatitis C virus (HCV) antibody and positive HCV ribonucleic acid or human immunodeficiency virus, or a history of illicit drug injecting;
- Seated blood pressure of ≥ 165/105 mmHg at screening;
- Unable to comply with the study procedures and assessments;12.Known hypersensitivity to investigational product or its excipients;
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Mater Medical Research Institute
Brisbane, Queensland, 4101
KaRa MINDS
Macquarie Park, New South Wales, 2113
Alfred Heath
Melbourne, Victoria, 3004
Eastern Clinical Research Unit
Melbourne, Victoria, 3128
Central Adelaide Local Health Network
Woodville, South Australia, 5011
About this study
Official title: Phase 1b Open-Label, Dose-Identification Study of XPro1595 in Patients With Alzheimer's Disease and Biomarkers of Inflammation.
The purpose of this study is to evaluate safety and target engagement of XPro1595 in Alzheimer's patients with biomarkers of inflammation.
Read the detailed description
The study is designed as a multicentre, phase 1b open-label study. The objectives of this study are to determine the safety, tolerability, and efficacy of XPro1595 in patients with Alzheimer's disease and at least one of the following inflammatory biomarkers: high sensitivity c-reactive protein (hs-CRP), hemoglobin A1c, erythrocyte sedimentation rate (ESR), or one Apolipoprotein E4 allele.
XPro1595 is a second-generation inhibitor of tumor necrosis factor (TNF) that selectively neutralizes soluble TNF, an inflammatory factor implicated in Alzheimer's pathology.
A key element of this study is to identify Alzheimer's patients that are most likely to benefit from XPro1595 treatment. Enrollment is limited to patients with evidence of inflammation. For instance, hs-CRP is an inflammatory biomarker elevated in the blood of some Alzheimer's patients and elevated CRP has been shown to predict response to TNF inhibitors in multiple other diseases.
Alzheimer's patients with elevated inflammatory biomarkers will be enrolled in a 12-week study to determine the safety and the ability of XPro1595 to reduce neuroinflammation using a combination of invasive and non-invasive biomarkers of inflammation. The study will identify the dose of XPro1595 to be used in a larger Phase II disease modification study.
- Conditions
- Alzheimer Disease
- Being tested
- XPro1595
- Keywords
- inflammation, Biomarker, TNF
- Medical subject headings
- Alzheimer Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XPro1595Drug
Also called INB03, DN-TNF, XENP345
XPro1595 will be delivered by subcutaneous injection once a week
| Study group | Role | What they receive |
|---|---|---|
| 0.3 mg/kg XPro1595 | Experimental | 0.3 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 12 weeks. Receives: Drug: XPro1595 |
| 0.6 mg/kg XPro1595 | Experimental | 0.6 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 12 weeks. Receives: Drug: XPro1595 |
| 1.0 mg/kg XPro1595 | Experimental | 1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 12 weeks. Receives: Drug: XPro1595 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with a treatment-emergent adverse event throughout 12 weeks of treatment with XPro1595
Adverse events will be assessed by clinical and laboratory measures
Measured: 12 weeks
The percentage of patients with a treatment-emergent adverse event throughout 12 weeks of treatment with XPro1595
Adverse events will be assessed by clinical and laboratory measures
Measured: 12 weeks
Secondary outcomes (12)
Changes from baseline in high sensitivity C-reactive protein in the blood and cerebral spinal fluid following 12 weeks of treatment with XPro1595
To compare changes in high sensitivity C-reactive protein
Measured: 12 weeks
Changes from baseline in inflammatory cytokines in the blood and cerebral following 12 weeks of treatment with XPro1595 spinal fluid
To compare changes in Inflammatory cytokines; including but not limited to tumor necrosis factor, interleukin-1, and interleukin-6
Measured: 12 weeks
Changes from baseline in blood and cerebral spinal fluid levels of amyloid beta following 12 weeks of treatment with XPro1595
To compare changes in amyloid in cerebral spinal fluid
Measured: 12 weeks
Changes from baseline in cerebral spinal fluid levels of tau following 12 weeks of treatment with XPro1595
To compare changes in tau in cerebral spinal fluid
Measured: 12 weeks
Change from baseline in FreeWater content (edema) using magnetic resonance imaging following 12 weeks of treatment with XPro1595
To compare changes in FreeWater content as a proxy of neuroinflammation following 12 weeks of treatment with XPro1595
Measured: 12 weeks
Change from baseline in the Mini-Mental State Examination (MMSE) following 12 weeks of treatment with XPro1595
The Mini-Mental State Examination (MMSE) provides a comprehensive measure of cognitive function. The maximum possible score is 30 and patients scoring below 23 are classified as having cognitive impairment as follows, mild (19 to 23), moderate (10 to 18), severe (below 9).
Measured: 12 weeks
Change from baseline in the Digit Symbol Substitution Test (DSST) following 12 weeks of treatment with XPro1595
The Digit Symbol Substitution Test (DSST) is a cognitive test that consists of digit-symbol pairs. The patient records the corresponding symbol to each presented digit in 90 seconds. The total number of correct symbols is counted to provide a score between 0 and 133. Higher scores indicate better cognitive functioning.
Measured: 12 weeks
Change from baseline in the Verbal Fluency Test following 12 weeks of treatment with XPro1595
In the Verbal Fluency Test, patients are given a letter and asked to name as many words as they can that begin with that letter in 60 seconds. The number of correct responses is counted. A higher number of responses indicates better cognitive functioning.
Measured: 12 weeks
Change from baseline in the Neuropsychiatric Inventory (NPI) following 12 weeks of treatment with XPro1595
Neuropsychiatric Inventory (NPI) is a measure of frequency and severity of common psychiatric symptoms related to dementia using a 12-question measure. For each question, a score is given for frequency, severity and caregiver distress. Total scores range from 0 to 144. A higher score means greater neuropsychiatric disturbance.
Measured: 12 weeks
Change from baseline in the Bristol Activities of Daily Living Scale (BALDS) following 12 weeks of treatment with XPro1595
Bristol Activities of Daily Living Scale (BADLS) is a questionnaire that measures the impact of Alzheimer's disease on daily activities using a 20-item questionnaire. Total scores range from 0 to 60. A higher score indicates a greater disturbance in daily living.
Measured: 12 weeks
Change from baseline in the Memory-Enhanced Retrospective Evaluation of Treatment Observer Reported Global Impression of Improvement (MERET OBSRO-C) following 12 weeks of treatment with XPro1595
Memory-Enhanced Retrospective Evaluation of Treatment Observer Reported Global Impression of Improvement (MERET OBSRO-C) evaluates caregivers' self-reports of treatment efficacy with self-prompted memory aids regarding their clinical experiences obtained prior to treatment initiation.
Measured: 12 weeks
Evaluate changes in the Memory-Enhanced Retrospective Evaluation of Change from baseline Global Impression of Improvement (MERET PGI-C) following 12 weeks of treatment with XPro1595
Memory-Enhanced Retrospective Evaluation of Treatment Patient Global Impression of Improvement (MERET PGI-C) evaluates patients self-reports of treatment efficacy with self-prompted memory aids regarding their clinical experience obtained prior to treatment initiation. Patient's global impression of (PGI-I) ratings will be obtained using a web-based interface prior to and following playback of impromptu patient recordings obtained prior to the start of treatment (MERET).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start20 Nov 2019
- Primary completion30 Jun 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmune Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alzheimer's Association
- Responsible party
- Sponsor
- Investigators
- Terrence O'Brien, MD, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943264
- Sponsor's protocol ID
- XPRO1595-AD
- Other IDs
- 18PTC-R-592167
- Status last verified
- Jun 2023
- First submitted
- 26 Apr 2019
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McAlpine FE, Lee JK, Harms AS, Ruhn KA, Blurton-Jones M, Hong J, Das P, Golde TE, LaFerla FM, Oddo S, Blesch A, Tansey MG. Inhibition of soluble TNF signaling in a mouse model of Alzheimer's disease prevents pre-plaque amyloid-associated neuropathology. Neurobiol Dis. 2009 Apr;34(1):163-77. doi: 10.1016/j.nbd.2009.01.006.
PubMed 19320056Cavanagh C, Tse YC, Nguyen HB, Krantic S, Breitner JC, Quirion R, Wong TP. Inhibiting tumor necrosis factor-alpha before amyloidosis prevents synaptic deficits in an Alzheimer's disease model. Neurobiol Aging. 2016 Nov;47:41-49. doi: 10.1016/j.neurobiolaging.2016.07.009. Epub 2016 Jul 25.
PubMed 27552480Sama DM, Mohmmad Abdul H, Furman JL, Artiushin IA, Szymkowski DE, Scheff SW, Norris CM. Inhibition of soluble tumor necrosis factor ameliorates synaptic alterations and Ca2+ dysregulation in aged rats. PLoS One. 2012;7(5):e38170. doi: 10.1371/journal.pone.0038170. Epub 2012 May 29.
PubMed 22666474MacPherson KP, Sompol P, Kannarkat GT, Chang J, Sniffen L, Wildner ME, Norris CM, Tansey MG. Peripheral administration of the soluble TNF inhibitor XPro1595 modifies brain immune cell profiles, decreases beta-amyloid plaque load, and rescues impaired long-term potentiation in 5xFAD mice. Neurobiol Dis. 2017 Jun;102:81-95. doi: 10.1016/j.nbd.2017.02.010. Epub 2017 Feb 24.
PubMed 28237313
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Open-Label, Dose-Identification Study of XPro1595 in Patients With Alzheimer's Disease and Biomarkers of Inflammation.
- ClinicalTrials.gov ID
- NCT03943264
- Acronym / sponsor ID
- XPRO1595-AD
- Conditions
- Alzheimer Disease
- Keywords
- inflammation, Biomarker, TNF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Inmune Bio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Alzheimer's Association
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety and target engagement of XPro1595 in Alzheimer's patients with biomarkers of inflammation.
Detailed description
The study is designed as a multicentre, phase 1b open-label study. The objectives of this study are to determine the safety, tolerability, and efficacy of XPro1595 in patients with Alzheimer's disease and at least one of the following inflammatory biomarkers: high sensitivity c-reactive protein (hs-CRP), hemoglobin A1c, erythrocyte sedimentation rate (ESR), or one Apolipoprotein E4 allele.
XPro1595 is a second-generation inhibitor of tumor necrosis factor (TNF) that selectively neutralizes soluble TNF, an inflammatory factor implicated in Alzheimer's pathology.
A key element of this study is to identify Alzheimer's patients that are most likely to benefit from XPro1595 treatment. Enrollment is limited to patients with evidence of inflammation. For instance, hs-CRP is an inflammatory biomarker elevated in the blood of some Alzheimer's patients and elevated CRP has been shown to predict response to TNF inhibitors in multiple other diseases.
Alzheimer's patients with elevated inflammatory biomarkers will be enrolled in a 12-week study to determine the safety and the ability of XPro1595 to reduce neuroinflammation using a combination of invasive and non-invasive biomarkers of inflammation. The study will identify the dose of XPro1595 to be used in a larger Phase II disease modification study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.3 mg/kg XPro1595 | Experimental | Drug: XPro15950.3 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 12 weeks. |
| 0.6 mg/kg XPro1595 | Experimental | Drug: XPro15950.6 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 12 weeks. |
| 1.0 mg/kg XPro1595 | Experimental | Drug: XPro15951.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 years and above at screening;
- Diagnosed with probable AD defined by the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria;
- Has hsCRP levels ≥1.5mg/L,OR HbA1c ≥ 6DCCT %, OR Erythrocyte Sedimentation Rate (ESR) ≥10 mm/h, OR APOE4 positive (at least one APOE4 allele);
- Female of childbearing potential (FCBP) must have confirmed negative urine pregnancy test at Screening;
- All female of childbearing potential (FCBP) and male patients who are sexually active with a female of childbearing potential must agree to use a highly effective contraception during the treatment period and until 90 days after the last dose of treatment for sexually active males whose partners are FCBP or until 30 days after the last dose of treatment for FCBP.
Key exclusion criteria (11 listed)
- Patients taking cholinesterase inhibitors, memantine, or antidepressant medication for less than 45 days from Day 1 (i.e. must be on stable dose for at least 45 days prior to Day 1);
- Have taken within the last 45 days from Day 1; corticosteroids or other immunosuppressive drugs, thalidomide or other TNF active drugs, minocycline.
- Enrolled in another clinical trial where patients receive treatment with investigational drug or device or have received treatment on another AD clinical trial within the last 60 days from Day 1;
- Unable to tolerate lumbar puncture or taking medicine where lumber punctures are contraindicated (anti-coagulants besides daily 100mg of aspirin);
- A prior organ or stem cell transplant;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XPro1595Also: INB03, DN-TNF, XENP345XPro1595 will be delivered by subcutaneous injection once a week | Drug | 0.3 mg/kg XPro1595, 0.6 mg/kg XPro1595, 1.0 mg/kg XPro1595 |
Primary outcome
The number of patients with a treatment-emergent adverse event throughout 12 weeks of treatment with XPro1595
Time frame: 12 weeks
Adverse events will be assessed by clinical and laboratory measures
The percentage of patients with a treatment-emergent adverse event throughout 12 weeks of treatment with XPro1595
Time frame: 12 weeks
Adverse events will be assessed by clinical and laboratory measures
12 secondary outcomes
Changes from baseline in high sensitivity C-reactive protein in the blood and cerebral spinal fluid following 12 weeks of treatment with XPro1595
Time frame: 12 weeks
Changes from baseline in inflammatory cytokines in the blood and cerebral following 12 weeks of treatment with XPro1595 spinal fluid
Time frame: 12 weeks
Changes from baseline in blood and cerebral spinal fluid levels of amyloid beta following 12 weeks of treatment with XPro1595
Time frame: 12 weeks
Changes from baseline in cerebral spinal fluid levels of tau following 12 weeks of treatment with XPro1595
Time frame: 12 weeks
Change from baseline in FreeWater content (edema) using magnetic resonance imaging following 12 weeks of treatment with XPro1595
Time frame: 12 weeks
Change from baseline in the Mini-Mental State Examination (MMSE) following 12 weeks of treatment with XPro1595
Time frame: 12 weeks
Change from baseline in the Digit Symbol Substitution Test (DSST) following 12 weeks of treatment with XPro1595
Time frame: 12 weeks
Change from baseline in the Verbal Fluency Test following 12 weeks of treatment with XPro1595
Time frame: 12 weeks
Change from baseline in the Neuropsychiatric Inventory (NPI) following 12 weeks of treatment with XPro1595
Time frame: 12 weeks
Change from baseline in the Bristol Activities of Daily Living Scale (BALDS) following 12 weeks of treatment with XPro1595
Time frame: 12 weeks
Change from baseline in the Memory-Enhanced Retrospective Evaluation of Treatment Observer Reported Global Impression of Improvement (MERET OBSRO-C) following 12 weeks of treatment with XPro1595
Time frame: 12 weeks
Evaluate changes in the Memory-Enhanced Retrospective Evaluation of Change from baseline Global Impression of Improvement (MERET PGI-C) following 12 weeks of treatment with XPro1595
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Results publication: PubMed 19320056McAlpine FE, Lee JK, Harms AS, Ruhn KA, Blurton-Jones M, Hong J, Das P, Golde TE, LaFerla FM, Oddo S, Blesch A, Tansey MG. Inhibition of soluble TNF signaling in a mouse model of Alzheimer's disease prevents pre-plaque amyloid-associated neuropathology. Neurobiol Dis. 2009 Apr;34(1):163-77. doi: 10.1016/j.nbd.2009.01.006.
- Results publication: PubMed 27552480Cavanagh C, Tse YC, Nguyen HB, Krantic S, Breitner JC, Quirion R, Wong TP. Inhibiting tumor necrosis factor-alpha before amyloidosis prevents synaptic deficits in an Alzheimer's disease model. Neurobiol Aging. 2016 Nov;47:41-49. doi: 10.1016/j.neurobiolaging.2016.07.009. Epub 2016 Jul 25.
- Results publication: PubMed 22666474Sama DM, Mohmmad Abdul H, Furman JL, Artiushin IA, Szymkowski DE, Scheff SW, Norris CM. Inhibition of soluble tumor necrosis factor ameliorates synaptic alterations and Ca2+ dysregulation in aged rats. PLoS One. 2012;7(5):e38170. doi: 10.1371/journal.pone.0038170. Epub 2012 May 29.
- Results publication: PubMed 28237313MacPherson KP, Sompol P, Kannarkat GT, Chang J, Sniffen L, Wildner ME, Norris CM, Tansey MG. Peripheral administration of the soluble TNF inhibitor XPro1595 modifies brain immune cell profiles, decreases beta-amyloid plaque load, and rescues impaired long-term potentiation in 5xFAD mice. Neurobiol Dis. 2017 Jun;102:81-95. doi: 10.1016/j.nbd.2017.02.010. Epub 2017 Feb 24.
- Related InfoLink provided by the sponsor.
- Part the cloud grant information - Alzheimer's AssociationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terrence O'Brien, MD principal investigator
The Alfred
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XPro1595 in people with Alzheimer Disease, run by Inmune Bio, Inc. at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with a treatment-emergent adverse event throughout 12 weeks of treatment with XPro1595 (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03943264, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.