A Phase 1 interventional study of IC14 in Motor Neuron Disease and Amyotrophic Lateral Sclerosis, sponsored by Implicit Bioscience. Completed at 1 site in Australia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Implicit Bioscience · Phase 1, Interventional, and Treatment
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Among 44 studies in Amyotrophic Lateral Sclerosis with a site in Australia — 8 open to participants now, 13 under way, 2 of them phase 3. Amyotrophic Lateral Sclerosis · Australia.
Among the 44 studies in Amyotrophic Lateral Sclerosis with a site in Australia, this one is the 38th largest by enrollment, is one of 2 that started in 2017, is one of 5 in phase 1, and was the 9th registered.
979 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 278 are open to participants now.
Browse Amyotrophic Lateral Sclerosis studies →8 of the 44 studies in Amyotrophic Lateral Sclerosis with a site in Australia are open now. Recruiting first, the newest first:
Nura Bio · Sites in Australia, Canada, Netherlands and 1 more country
Ages 18–80
Celosia Therapeutics Pty Ltd · Sites in Australia
Ages 18–80
Zydus Therapeutics Inc. · Sites in Australia, United States, Belgium and 9 more countries
Ages 18+
Mario Negri Institute for Pharmacological Research · Sites in Australia, Italy
Ages 18+
Regeneron Pharmaceuticals · Sites in Australia, Belgium, Canada and 6 more countries
Ages 18+
A study can be open while its sites in Australia have not opened yet or have stopped. Only those recruiting at a site in Australia →
Of the 193 Amyotrophic Lateral Sclerosis studies recruiting now, 118 (61%) set no upper age limit and 23 (12%) stop at 75 or younger; 15 take children under 18; 55 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
44 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 22 · Phase 3 15 · Phase 4 1
First in 2011; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 10 is below the median of 38 across 663 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Median enrollment 63 across the 44 interventional studies. Of the 24 that completed or were terminated, 14 (58%) have results posted.
This tab as a report to print or save as PDF → With an account.
33 of 44 have an industry lead sponsor. The 10 most frequent:
Implicit Bioscience is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Implicit Bioscience has 4 studies filed under Amyotrophic Lateral Sclerosis — fewer than ten, so there is no comparison to draw.
3 of the studies in Amyotrophic Lateral Sclerosis with a site in Australia that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06126315Phase 3Mario Negri Institute for Pharmacological ResearchTrial on the Biological and Clinical Effects of Acetyl-L-carnitine in ALS | 2027-04 |
| NCT04856982Phase 3BiogenStudy to Learn If Tofersen (BIIB067) Can Delay ALS Symptoms and About Its Safety in Adults With a SOD1 Gene Mutation Who Have Not Yet Developed ALS Symptoms | 2027-08-07 |
| NCT07369076Nura BioA Clinical Trial to Evaluate NB-4746 in Participants With Amyotrophic Lateral Sclerosis. | 2027-04 |
Add all 3 to your calendar (.ics) → With an account.
Among the 44 studies in Amyotrophic Lateral Sclerosis with a site in Australia, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Ten patients with motor neurone disease (MND, also known as amyotrophic lateral sclerosis or ALS) will be successively enrolled to one of two dose levels of IC14 (human chimeric monoclonal anti-CD14) intravenously for four doses. Patients must be within 3 years of MND diagnosis and have adequate respiratory function. Safety, tolerability, immunogenicity, and PK/PD will be measured. To evaluate feasibility of the endpoints, additional endpoints of ALSFRS-R, respiratory function tests, disease biomarkers and patient-reported outcomes will be measured.
The objectives of this study are to determine:
Ten patients with MND will be sequentially assigned to receive one of two dose regimens of IC14 in an unblinded manner:
Study participation will continue until 28 days after the last dose of study drug.
979 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 278 are open to participants now.
This study's enrollment of 10 is below the median of 38 across 663 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →Implicit Bioscience is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Compared within Amyotrophic Lateral Sclerosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Neuron Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
A patient must fulfill all of the following criteria to be eligible for enrollment:
Adequate bone marrow reserve, renal and liver function:
Females of should be using and committed to continue using one of the following acceptable methods:
Exclusion Criteria:
A patient fulfilling any of the following criteria at screening is to be excluded from enrollment in the study:
Presence of any of the following clinical conditions:
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.
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.
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).
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.
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 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.
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.
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.
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).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
For the initial 3 patients: intravenous IC14 at a dosage of 2 mg/kg on Study Day 1, then 1 mg/kg once daily on Study Days 3-5 for 4 total doses
Biological: IC14
For the subsequent 7 patients: intravenous IC14 at a dosage of 4 mg/kg/day on Day 1, followed by IC14 2 mg/kg/day on Days 2-4
Biological: IC14
chimeric monoclonal antibody against human IC14
Also known as: monoclonal antibody against CD14
Incidence of treatment-emergent adverse events (safety, tolerability)
Number of participants with treatment-emergent adverse events (safety, tolerability) classified by MedDRA
Time frame: one month
Treatment-related change in ALSFRS-R functional scale
Treatment-related change in Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) \[0 (worst) to 48 (best)\]
Time frame: one month
Respiratory function
Treatment-related change in percent normal Forced Vital Capacity \[0% (worst) to 100% (best)\]
Time frame: one month
Muscle function
Treatment-related change in percent normal Sniff Nasal Pressure \[0% (worst) to 100% (best)\]
Time frame: one month
Quality of life measured by ALSSQOL
Treatment-related change in Amyotrophic Lateral Sclerosis Specific Quality of Life - Revised (ALSSQOL-R) \[0 (worst) to 460 (best)\]
Time frame: one month
Patient-reported outcome
Treatment-related change Edinburgh Cognitive and Behavioural Assessment Score (ECAS) \[0 (worst) to 136 (best)\]
Time frame: one month
Maximum Plasma Concentration (Cmax)
Maximum serum IC14 concentration (micrograms per milliliter)
Time frame: one month
Area Under the Curve (AUC)
Area Under the Curve for serum IC14 (microgram x hr/mL)
Time frame: one month
Monocyte CD14 Receptor Occupancy
Treatment-related change in percent monocyte CD14 receptor occupancy as a pharmacodynamic marker
Time frame: one month
Urinary p75 neurotrophin receptor (biomarker)
Treatment-related change in urinary concentration of urinary p75 neurotrophin receptor (NTR) (nanograms per milligram creatinine)
Time frame: one month
Neurofilament (biomarker)
Treatment-related change in concentration of neurofilament (picograms per milliliter)
Time frame: one month
Anti-drug antibodies
Development of human anti-monoclonal antibodies following treatment
Time frame: one month
Plan to share: No
Ran from Oct 2017 to primary completion in Apr 2018, 6 months.
Of 40 industry-sponsored phase 1 interventional studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's 6 months is below that.
Counting every sponsor, half of 70 studies reached it within 21 months; a quarter within 13 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Atibuclimab
Amyotrophic Lateral Sclerosis →
Implicit Bioscience