Amyotrophic Lateral SclerosisEAPNCT04309604
IC14 for ALS Patients Expanded Access
A study testing IC14 in people with Amyotrophic Lateral Sclerosis, run by Implicit Bioscience at 1 site in United States.
Trial summary
The primary objective is to provide the investigational product, IC14, at the dose of 8 mg/kg intravenously every 2 weeks for 12 weeks to 6 participants with amyotrophic lateral sclerosis (ALS). No clinical hypotheses are being tested. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- IC14
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to initiation of any program-specific procedures.
- Familial or sporadic ALS defined as clinically possible, probable, or definite by Awaji-Shima Consensus Recommendations or other standard guidance.
- Adequate hematologic, renal, and liver function as defined by the patient's physician.
- 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
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- 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.
Who cannot join
- Dependence on invasive mechanical ventilation, defined as being unable to lay supine without it, unable to sleep without it, or continuous daytime use; presence of tracheostomy at screening;
- 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 IV antibiotics within 4 weeks of baseline.
- Immunized with live-attenuated vaccines within 30 days before dosing. Participants must agree to forego live-attenuated vaccines throughout the program, including 12 weeks after the last dose of IC14.
- History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.
- Pregnancy or breastfeeding.
- Presence of any of the following clinical conditions:
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- History of one or more of the following: cardiac insufficiency (New York Heart Association 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 venous thromboembolic disease within 6 months, 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
The primary objective is to provide the investigational product, IC14, at the dose of 8 mg/kg intravenously every 2 weeks for 12 weeks to 6 participants with amyotrophic lateral sclerosis (ALS). No clinical hypotheses are being tested. An extension for 6 additional doses every 2 weeks will be allowed if the drug is safe and well tolerated.A second extension for 14 doses every 2 weeks will be allowed if the drug is safe and well tolerated.
Read the detailed description
Manipulation of immune-driven inflammatory responses may have therapeutic utility in amyotrophic lateral sclerosis (ALS) and recent data suggest that ALS may respond to peripheral intervention by expanding Tregs in mice and humans. The approach with IC14 builds on this hypothesis by targeting CD14 as a master regulator of the immune response of peripheral cell populations, which in turn determines the activation status and phenotype of peripheral T cells that enter the central nervous system (CNS) and drive further microglia activation .Binding and blocking membrane CD14 (mCD14) on peripheral immune cell populations with IC14 may thus be a relevant therapeutic target in ALS.
IC14 has been safe, well tolerated and had no serious adverse events related to study drug.
This is a protocol for 12 weeks of the investigational medication IC14 for 6 participants. An extension for 6 additional doses every 2 weeks will be done if the drug is safe and well tolerated. Up to 20 subjects may be screened in order to identify eligible subjects that meet all inclusion and exclusion criteria.
At the screening visit, the Principal Investigator will review the study procedures and consent form with the participant. After obtaining informed consent, the participant will receive IC14 8 mg/kg intravenously every two weeks (± 7 days) for 6 doses (12 weeks). An extension for 6 additional doses every 2 weeks will be allowed if the drug is safe and well tolerated. A second extension for 14 additional doses every 2 weeks will be allowed if the drug is safe and well tolerated.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- IC14
- Keywords
- Motor Neurone Disease, Compassionate use
- 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.
IC14Biological
monoclonal antibody directed against CD14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Implicit Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309604
- Sponsor's protocol ID
- ALS-03
- Acronym
- EAP
- Status last verified
- Aug 2025
- First submitted
- 12 Mar 2020
- Last updated
- 20 Aug 2025
- Results posted
- No
Publications
Gelevski D, Addy G, Rohrer M, Cohen C, Roderick A, Winter A, Carey J, Scalia J, Yerton M, Weber H, Doyle M, Parikh N, Kane G, Ellrodt A, Burke K, D'Agostino D, Sinani E, Yu H, Sherman A, Agosti J, Redlich G, Charmley P, Crowe D, Appleby M, Ziegelaar B, Hanus K, Li Z, Babu S, Nicholson K, Luppino S, Berry J, Baecher-Allan C, Paganoni S, Cudkowicz M. Safety and activity of anti-CD14 antibody IC14 (atibuclimab) in ALS: Experience with expanded access protocol. Muscle Nerve. 2023 May;67(5):354-362. doi: 10.1002/mus.27775. Epub 2022 Dec 30.
PubMed 36533976
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IC14 for ALS Patients Expanded Access
- ClinicalTrials.gov ID
- NCT04309604
- Acronym / sponsor ID
- EAP / ALS-03
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Motor Neurone Disease, Compassionate use
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Implicit BioscienceIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- First posted
- 16 Mar 2020 (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 primary objective is to provide the investigational product, IC14, at the dose of 8 mg/kg intravenously every 2 weeks for 12 weeks to 6 participants with amyotrophic lateral sclerosis (ALS). No clinical hypotheses are being tested. An extension for 6 additional doses every 2 weeks will be allowed if the drug is safe and well tolerated.A second extension for 14 doses every 2 weeks will be allowed if the drug is safe and well tolerated.
Detailed description
Manipulation of immune-driven inflammatory responses may have therapeutic utility in amyotrophic lateral sclerosis (ALS) and recent data suggest that ALS may respond to peripheral intervention by expanding Tregs in mice and humans. The approach with IC14 builds on this hypothesis by targeting CD14 as a master regulator of the immune response of peripheral cell populations, which in turn determines the activation status and phenotype of peripheral T cells that enter the central nervous system (CNS) and drive further microglia activation .Binding and blocking membrane CD14 (mCD14) on peripheral immune cell populations with IC14 may thus be a relevant therapeutic target in ALS.
IC14 has been safe, well tolerated and had no serious adverse events related to study drug.
This is a protocol for 12 weeks of the investigational medication IC14 for 6 participants. An extension for 6 additional doses every 2 weeks will be done if the drug is safe and well tolerated. Up to 20 subjects may be screened in order to identify eligible subjects that meet all inclusion and exclusion criteria.
At the screening visit, the Principal Investigator will review the study procedures and consent form with the participant. After obtaining informed consent, the participant will receive IC14 8 mg/kg intravenously every two weeks (± 7 days) for 6 doses (12 weeks). An extension for 6 additional doses every 2 weeks will be allowed if the drug is safe and well tolerated. A second extension for 14 additional doses every 2 weeks will be allowed if the drug is safe and well tolerated.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent prior to initiation of any program-specific procedures.
- Familial or sporadic ALS defined as clinically possible, probable, or definite by Awaji-Shima Consensus Recommendations or other standard guidance.
- Adequate hematologic, renal, and liver function as defined by the patient's physician.
- Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:
- 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.
Key exclusion criteria (12 listed)
- Dependence on invasive mechanical ventilation, defined as being unable to lay supine without it, unable to sleep without it, or continuous daytime use; presence of tracheostomy at screening;
- 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 IV antibiotics within 4 weeks of baseline.
- Immunized with live-attenuated vaccines within 30 days before dosing. Participants must agree to forego live-attenuated vaccines throughout the program, including 12 weeks after the last dose of IC14.
- History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| IC14monoclonal antibody directed against CD14 | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Results publication: PubMed 36533976Gelevski D, Addy G, Rohrer M, Cohen C, Roderick A, Winter A, Carey J, Scalia J, Yerton M, Weber H, Doyle M, Parikh N, Kane G, Ellrodt A, Burke K, D'Agostino D, Sinani E, Yu H, Sherman A, Agosti J, Redlich G, Charmley P, Crowe D, Appleby M, Ziegelaar B, Hanus K, Li Z, Babu S, Nicholson K, Luppino S, Berry J, Baecher-Allan C, Paganoni S, Cudkowicz M. Safety and activity of anti-CD14 antibody IC14 (atibuclimab) in ALS: Experience with expanded access protocol. Muscle Nerve. 2023 May;67(5):354-362. doi: 10.1002/mus.27775. Epub 2022 Dec 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IC14 in people with Amyotrophic Lateral Sclerosis, run by Implicit Bioscience at 1 site in United States.
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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 20 Aug 2025. 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 United States. 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.
Are results available for this study?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04309604, which also lists 1 linked publication.
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 20 Aug 2025.