IC14 for ALS Patients Expanded Access

NCT04309604 | Unknown

• 1 other identifier: ALS-03
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Motor Neurone Disease; Compassionate use

Interventions

IC14 BIOLOGICAL

monoclonal antibody directed against CD14

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Implicit Bioscience: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 36533976 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 16, 2020
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

US (1)