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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07321860
Eligibility Criteria:
Inclusion Criteria
Participants must meet all of the following criteria:
1. Age:
* 18 to 80 years, inclusive, at the time of informed consent.
2. Diagnosis of ALS:
* Diagnosis of amyotrophic lateral sclerosis according to revised El Escorial criteria or equivalent, confirmed by a qualified neurologist.
3. GREM2-Positive Status:
* Evidence of elevated GREM2 at screening, defined as:
* CSF GREM2 above a pre-specified threshold OR
* Plasma GREM2 above a pre-specified threshold with supportive evidence of astrocytic or TGF-β pathway activation (e.g., elevated GFAP or TGF-β-responsive biomarker).
* Biomarker thresholds will be defined prospectively in the protocol and laboratory manual.
4. Disease Duration:
* Time from first ALS-related symptom onset ≤ 24 months at screening.
5. Functional Status:
* ALS Functional Rating Scale - Revised (ALSFRS-R) total score ≥ a protocol-defined minimum (e.g., ≥ 25) at screening, sufficient to allow detection of functional change.
6. Respiratory Function:
* Slow vital capacity (SVC) or forced vital capacity (FVC) ≥ 50% of predicted at screening.
7. Stable Background ALS Therapy:
* If receiving riluzole and/or edaravone, participants must be on a stable dose for ≥ 30 days prior to screening and willing to maintain the regimen throughout the study.
8. Ability to Consent:
* Ability to understand and provide written informed consent personally or via a legally authorized representative, in accordance with local regulations.
9. Contraception:
* Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during the study and for a defined period after the last dose.
Exclusion Criteria
Participants will be excluded if any of the following apply:
1. Non-ALS Motor Neuron Disease:
* Diagnosis of primary lateral sclerosis (PLS), progressive muscular atrophy (PMA), or other non-ALS motor neuron disorders.
2. Advanced Respiratory Insufficiency:
* Requirement for invasive mechanical ventilation at screening or anticipated need within the immediate study period.
3. Clinically Significant Hepatic Disease:
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 × upper limit of normal (ULN) at screening.
* Known cirrhosis or active chronic liver disease.
4. Clinically Significant Cardiac Disease:
* Uncontrolled arrhythmia, recent myocardial infarction, unstable angina, or clinically significant cardiac dysfunction that may increase risk with study participation.
5. Active or Uncontrolled Infection:
* Active systemic infection requiring treatment at screening or known chronic infection that could interfere with immune or biomarker assessments.
6. Immunocompromised State:
* History of organ transplantation, active malignancy requiring systemic therapy, or chronic immunosuppressive therapy (excluding stable low-dose corticosteroids, if allowed by protocol).
7. Prior Exposure to TGF-β Pathway Inhibitors:
* Previous treatment with galunisertib or other direct TGF-β or ALK5 inhibitors within a protocol-defined washout period.
8. Recent Investigational Therapy:
* Participation in another interventional clinical trial or receipt of an investigational drug within 30-60 days prior to screening (exact window defined in protocol).
9. Concomitant Medications with High Interaction Risk:
* Use of strong CYP modulators or medications known to significantly interfere with galunisertib or nerandomilast metabolism, unless safely discontinued.
10. Pregnancy or Breastfeeding:
* Pregnant or breastfeeding women.
11. Other Medical Conditions:
* Any medical, neurological, or psychiatric condition that, in the investigator's judgment, could:
* Interfere with study participation or compliance,
* Confound interpretation of efficacy or biomarker outcomes,
* Increase risk to the participant.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07321860
Study Brief:
Protocol Section:
NCT07321860