Amyotrophic Lateral SclerosisPhase 2NCT03474263
IC14 for Rapidly Progressive Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study testing Biologic: IC14 (monoclonal antibody against human CD14) in people with Amyotrophic Lateral Sclerosis, run by Implicit Bioscience at 1 site in Australia.
Trial summary
Patients with rapidly progressive ALS will be assigned to IC14 intravenously on Day 1-4. This 4-day course will be repeated on Days 8-11. Patients will all undergo MR-PET scans at two time points: before treatment onset and after the last treatment cycle. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Biologic: IC14 (monoclonal antibody against human CD14)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Sep 2019to 12 Jul 2021
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of providing informed consent and informed consent form signed prior to initiation of any study-specific procedures.
- Familial or sporadic ALS defined as clinically possible, probable, or definite by El Escorial Criteria.
- Rapidly progressive ALS defined by the Revised ALS Functional Rating Scale (ALSFRS-R) slope ≥1 (48 minus ALSFRS-R score at screening / disease duration in months ≥ 1).
- Upper Motor Neuron Burden Score of ≥ 25 (out of 45) at screening
- First symptoms of ALS within 3 years of the screening visit
- Age between 18 and 80 years at the time of the screening visit.
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- Not taking riluzole or edaravone or on a stable dose of riluzole or edaravone for at least 3 months prior to screening visit.
- Adequate bone marrow reserve, renal and liver function:
- absolute neutrophil count ≥ 1500/µL
- lymphocyte count < 6000/µL
- platelet count ≥ 150,000/µL
- hemoglobin ≥ 11 g/dL
- creatinine clearance ≥ 60 mL/min
- alanine transaminase (ALT) and/or aspartate transaminase (AST) ≤ 3x upper limits of normal (ULN)
- total bilirubin ≤ 1.5x ULN
- serum albumin ≥ 2.8 g/dL
- Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:
- Sexual abstinence (inactivity) for 1 month prior to screening through study completion; or
- Intrauterine device (IUD) in place for at least 3 months prior to study through study completion; or
- Stable hormonal contraception for at least 3 months prior to study through study completion; or
- Surgical sterilization (vasectomy) of male partner at least 6 months prior to study.
- To be considered of non-childbearing potential, females should be surgically sterilized (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be post-menopausal and at least 3 years since last menses.
- Males with female partners of childbearing potential must use contraception through study completion.
- Ability to safely lie flat for 90 min for magnetic resonance-positron emission tomography (MR-PET) procedures in the opinion of the Investigator.
- Patients must also have a genotype associated with a high or mixed affinity translocator protein (TSPO) (Ala/Ala or Ala/Thr) and ability to safely undergo MR-PET scans based on the opinion of the Investigator.
Who cannot join
- Dependence on invasive or non-invasive ventilation, defined as being unable to lay supine without it, unable to sleep without it, or continuous daytime use; presence of tracheostomy at screening; or presence of diaphragm pacing system at screening.
- Exposure to any experimental treatment for ALS within the last 30 days or five half-lives, whichever is longer.
- Treatment within 12 months with immunomodulator or immunosuppressant agent (including but not limited to cyclophosphamide, cyclosporine, interferon-α, interferon-β-1a, rituximab, alemtuzumab, azathioprine, etanercept, infliximab, adalimumab, certolizumab, golimumab, anakinra, rilonacept, secukinumab, tocilizumab, mycophenolate mofetil, methotrexate, cell-depleting agents, total lymphoid irradiation, dimethyl fumarate). Treatment with intravenous immunoglobulin (IVIG) within 2 months. Non-steroidal anti-inflammatory drugs (NSAIDs) are acceptable.
- Exposure at any time to any cell or gene therapies under investigation for the treatment of ALS.
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other opportunistic infections; or major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks.
- Live-attenuated vaccines within 30 days before dosing. Subjects must agree to forego live-attenuated vaccines throughout the study, including 60 days after the last dose of study drug.
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- History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.
- History of one or more of the following: cardiac insufficiency (New York Heart Association [NYHA] III/IV), uncontrolled cardiac arrhythmias, unstable ischemic heart disease, or uncontrolled hypertension (systolic blood pressure > 170 mmHg or diastolic blood pressure > 110 mmHg).
- History of myocardial infarction, or cerebrovascular accident.
- Unstable pulmonary, renal, hepatic, endocrine or hematologic disease.
- Autoimmune disease, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis.
- Evidence of active malignant disease, malignancies diagnosed within the previous 5 years, or breast cancer diagnosed within the previous 5 years (except skin cancers other than melanoma).
- History of human immunodeficiency virus infection or other immunodeficiency illness.
- Unstable psychiatric illness defined as psychosis or untreated major depression within 90 days.
- History of drug abuse (not including marijuana use) or alcoholism within the past 12 months.
- Significant neuromuscular disease other than ALS.
- Other ongoing disease that may cause neuropathy, such as toxin exposure, dietary deficiency, uncontrolled diabetes, hyperthyroidism, cancer, systemic lupus erythematosus or other connective diseases, infection with HIV, hepatitis B virus (HBV), or hepatitis C (HCV), Lyme disease, multiple myeloma, Waldenström's macroglobulinemia, amyloid, and hereditary neuropathy.
- Pregnancy or breastfeeding.
- Deprivation of freedom by administrative or court order.
- Any contraindication to undergo magnetic resonance imaging (MRI) studies such as history of a cardiac pacemaker or pacemaker wires; metallic particles in the body; vascular clips in the head; prosthetic heart valves; or severe claustrophobia.
- Unwilling or unable to discontinue benzodiazepine usage [other than lorazepam (Ativan®), clonazepam (Klonopin®), or zolpidem (Ambien®)] for one day prior to and during scanning.
- Research imaging-related radiation exposure exceeds current institutional Radiology Department guidelines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a, Open-Label Biomarker Study of IC14 for the Treatment of Patients With
Patients with rapidly progressive ALS will be assigned to IC14 intravenously on Day 1-4. This 4-day course will be repeated on Days 8-11. Patients will all undergo MR-PET scans at two time points: before treatment onset and after the last treatment cycle. This scan will measure areas of ALS disease activity and assess response to IC14 treatment. MR-PET scans will be compared to historical controls.
Read the detailed description
This is an open-label, biomarkers-driven study.
Patients with rapidly progressive ALS will be assigned to the following dose regimen of IC14:
- 4 mg/kg intravenously on Day 1, followed by 2 mg/kg daily x 3 days on Days 2-4. This 4-day course will be repeated on Days 8-11.
Patients will be followed for 28 days after the last dose of study drug. Patients will all undergo [11C]-PBR28-MR-PET scans at two time points: before treatment onset and after the last treatment cycle.
Patients will be followed for 28 days after the last dose of study drug for safety.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Biologic: IC14 (monoclonal antibody against human CD14)
- Keywords
- Motor Neurone Disease (MND), Amyotrophic Lateral Sclerosis (ALS)
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic: IC14 (monoclonal antibody against human CD14)Biological
Also called Anti-CD14
IC14 intravenous infusion daily for four days on two successive weeks then MR-PET Scan evaluation for impact on glial activation.
| Study group | Role | What they receive |
|---|---|---|
| IC14 (monoclonal anti-CD14 antibody) | Experimental | Biologic: IC14 (monoclonal anti-CD14 antibody) 4 mg/kg intravenously followed by IC14 2 mg/kg intravenously on Days 2-4. This four-day cycle will be repeated on Days 8-11. Receives: Biological: Biologic: IC14 (monoclonal antibody against human CD14) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glial Activation
Glial activation measured in the motor region measured by [11C]-PBR28 positron emission tomography (PET). Studies have shown this marker localizes to areas of glial activation and correlates with disease progression and outcomes.
Measured: one month
Serum neurofilament
Serum neurofilament is a biomarker that has been shown to correlate with ALS severity
Measured: one month
Urinary p75 neurotrophin receptor
Urinary p75 neurotrophin receptor is a biomarker that has been shown to correlate with ALS severity
Measured: one month
Secondary outcomes (4)
Incidence of Treatment-Emergent Adverse Events (Safety, Tolerability)
Adverse event reporting
Measured: six weeks
Immunogenicity
Human anti-monoclonal antibodies
Measured: six weeks
Peak Plasma Concentration of IC14
Peak Plasma Concentration (Cmax) of IC14
Measured: one month
Pharmacodynamics
Monocyte CD14 saturation
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Sep 2019 (estimated)
- Primary completion12 Apr 2021 (estimated)
- Study completion12 Jul 2021 (estimated)
Why it stopped: No enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label Biomarkers-Driven Study Historical controls
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Implicit Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Agosti, MD, Principal investigator, Implicit Bioscience Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474263
- Sponsor's protocol ID
- ALS02
- Status last verified
- Jun 2020
- First submitted
- 9 Mar 2018
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-Label Biomarker Study of IC14 for the Treatment of Patients With
- ClinicalTrials.gov ID
- NCT03474263
- Acronym / sponsor ID
- ALS02
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Motor Neurone Disease (MND), Amyotrophic Lateral Sclerosis (ALS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Implicit BioscienceIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 12 Apr 2021 (estimated)
- Study completion
- 12 Jul 2021 (estimated)
- First posted
- 22 Mar 2018 (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.
Patients with rapidly progressive ALS will be assigned to IC14 intravenously on Day 1-4. This 4-day course will be repeated on Days 8-11. Patients will all undergo MR-PET scans at two time points: before treatment onset and after the last treatment cycle. This scan will measure areas of ALS disease activity and assess response to IC14 treatment. MR-PET scans will be compared to historical controls.
Detailed description
This is an open-label, biomarkers-driven study.
Patients with rapidly progressive ALS will be assigned to the following dose regimen of IC14:
- 4 mg/kg intravenously on Day 1, followed by 2 mg/kg daily x 3 days on Days 2-4. This 4-day course will be repeated on Days 8-11.
Patients will be followed for 28 days after the last dose of study drug. Patients will all undergo [11C]-PBR28-MR-PET scans at two time points: before treatment onset and after the last treatment cycle.
Patients will be followed for 28 days after the last dose of study drug for safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label Biomarkers-Driven Study Historical controls
| Arm | Type | Receives |
|---|---|---|
| IC14 (monoclonal anti-CD14 antibody) | Experimental | Biological: Biologic: IC14 (monoclonal antibody against human CD14)Biologic: IC14 (monoclonal anti-CD14 antibody) 4 mg/kg intravenously followed by IC14 2 mg/kg intravenously on Days 2-4. This four-day cycle will be repeated on Days 8-11. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Capable of providing informed consent and informed consent form signed prior to initiation of any study-specific procedures.
- Familial or sporadic ALS defined as clinically possible, probable, or definite by El Escorial Criteria.
- Rapidly progressive ALS defined by the Revised ALS Functional Rating Scale (ALSFRS-R) slope ≥1 (48 minus ALSFRS-R score at screening / disease duration in months ≥ 1).
- Upper Motor Neuron Burden Score of ≥ 25 (out of 45) at screening
- First symptoms of ALS within 3 years of the screening visit
Key exclusion criteria (22 listed)
- Dependence on invasive or non-invasive ventilation, defined as being unable to lay supine without it, unable to sleep without it, or continuous daytime use; presence of tracheostomy at screening; or presence of diaphragm pacing system at screening.
- Exposure to any experimental treatment for ALS within the last 30 days or five half-lives, whichever is longer.
- Treatment within 12 months with immunomodulator or immunosuppressant agent (including but not limited to cyclophosphamide, cyclosporine, interferon-α, interferon-β-1a, rituximab, alemtuzumab, azathioprine, etanercept, infliximab, adalimumab, certolizumab, golimumab, anakinra, rilonacept, secukinumab, tocilizumab, mycophenolate mofetil, methotrexate, cell-depleting agents, total lymphoid irradiation, dimethyl fumarate). Treatment with intravenous immunoglobulin (IVIG) within 2 months. Non-steroidal anti-inflammatory drugs (NSAIDs) are acceptable.
- Exposure at any time to any cell or gene therapies under investigation for the treatment of ALS.
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other opportunistic infections; or major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks.
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 |
|---|---|---|
| Biologic: IC14 (monoclonal antibody against human CD14)Also: Anti-CD14IC14 intravenous infusion daily for four days on two successive weeks then MR-PET Scan evaluation for impact on glial activation. | Biological | IC14 (monoclonal anti-CD14 antibody) |
Primary outcome
Glial Activation
Time frame: one month
Glial activation measured in the motor region measured by [11C]-PBR28 positron emission tomography (PET). Studies have shown this marker localizes to areas of glial activation and correlates with disease progression and outcomes.
Serum neurofilament
Time frame: one month
Serum neurofilament is a biomarker that has been shown to correlate with ALS severity
Urinary p75 neurotrophin receptor
Time frame: one month
Urinary p75 neurotrophin receptor is a biomarker that has been shown to correlate with ALS severity
4 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (Safety, Tolerability)
Time frame: six weeks
Immunogenicity
Time frame: six weeks
Peak Plasma Concentration of IC14
Time frame: one month
Pharmacodynamics
Time frame: one month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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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.
Jan Agosti, MD principal investigator
Implicit Bioscience Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biologic: IC14 (monoclonal antibody against human CD14) in people with Amyotrophic Lateral Sclerosis, run by Implicit Bioscience at 1 site 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 25 inclusion and 22 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: withdrawn, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Glial Activation (time frame: one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.