NCT07396818
Kamlanoflast In Amyotrophic Lateral Sclerosis
Not Yet Recruiting · Phase 1, Phase 2 · Inflammasome Therapeutics · registry updated 2026-02-09
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This is a study of Kamlanoflast in patients with ALS. Kamlanoflast is orally administered over 24 weeks. Its effects on inflammatory and functional parameters will be studied. Information on safety and tolerability will be collected.
Inclusion
- Diagnosis of definite, probable, laboratory-supported probable, or possible ALS by revised El Escorial research criteria.
- Ages 18 to 75 years.
- Onset of weakness within three years of study enrollment.
- ALS with progression, characterized either by:
- i. a reduction of 0.5 points per month or greater on the ALS Functional Rating Scale-Revised (ALSFRS-R), which will be calculated based on (most recent ALSFRS-R at least 12 weeks from screening - ALSFRS-R at screening)/time interval; or ii. a calculated progression rate: (48 - ALSFRS-R at "time of diagnosis") / duration from onset to diagnosis (month) that is 0.5 points per month or greater.
- e) Plasma NfL levels ≥ 2 times the upper limit of the age-specific reference values for normal at the measuring laboratory at screening.
Exclusion
- Inability to follow the study protocol, based on the investigator's assessment.
- Pregnant or nursing women.
- Recently（within 28 days）received other experimental treatments.
- Presence of any active infections or inflammatory diseases at the time of enrollment that may confound the assessment of levels of inflammatory markers.
- Taking any medication or supplements with anti-inflammatory effects, including but not limited to prednisone, colchicine, or curcumin.
- Taking Qalsody (tofersen).