Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT04309604
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent prior to initiation of any program-specific procedures.
2. Familial or sporadic ALS defined as clinically possible, probable, or definite by Awaji-Shima Consensus Recommendations or other standard guidance.
3. Adequate hematologic, renal, and liver function as defined by the patient's physician.
4. Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:
1. Sexual abstinence (inactivity) for 1 month prior to screening through study completion; or
2. Intrauterine device (IUD) in place for at least 3 months prior to study through study completion; or
3. Stable hormonal contraception for at least 3 months prior to study through study completion; or
4. Surgical sterilization (vasectomy) of male partner at least 6 months prior to study.
5. 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.
6. Males with female partners of childbearing potential must use contraception through study completion.
Exclusion Criteria:
1. 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;
2. 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.
3. 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.
4. History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.
5. Pregnancy or breastfeeding.
6. 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.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04309604
Study Brief:
Protocol Section:
NCT04309604