NCT07396818

A Trial of Kamlanoflast In Patients With Amyotrophic Lateral Sclerosis

Not yet recruiting Phase 1/Phase 2 Last updated 2 February 2026

What this trial tests

Phase 1/Phase 2 trial testing Kamlanoflast in ALS (Amyotrophic Lateral Sclerosis) in 40 participants. Not yet recruiting.

Timeline

1 February 2026

Primary endpoint
1 January 2027

1 January 2027

Quick facts

Lead sponsor	Inflammasome Therapeutics
Phase	Phase 1/Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 February 2026
Primary completion	1 January 2027
Estimated completion	1 January 2027

Drugs / interventions tested

• Kamlanoflast — full drug profile →
• Kamlanoflast — full drug profile →

Conditions studied

• ALS (Amyotrophic Lateral Sclerosis) — all drugs for ALS (Amyotrophic Lateral Sclerosis) →
• ALS — all drugs for ALS →
• Neuro-Degenerative Disease — all drugs for Neuro-Degenerative Disease →
• Neuro-Degenerative Diseases — all drugs for Neuro-Degenerative Diseases →

Sponsor

Inflammasome Therapeutics — full company profile →

Who can join

Adults 18 to 75, any sex, with ALS (Amyotrophic Lateral Sclerosis) or ALS. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of Treatment-Emergent Adverse Events [Safety]
  Time frame: From drug initiation through study completion, an average of 28 weeks
  Safety: Defined as the occurrence of serious and non-serious treatment-emergent adverse events (TEAEs) and clinically significant treatment-emergent abnormalities in clinical and laboratory values, in ALS subjects treated with study treatment.
• Incidence of Completing Study Treatment [Tolerability]
  Time frame: From drug initiation through study completion, an average of 24 weeks
  Tolerability: Defined as percentage of ALS subjects who complete the 24 weeks of study treatment (survival), without study drug-attributed intolerable AEs that lead to early permanent drug discontinuation.
• Biological Efficacy
  Time frame: From enrollment through the end of study treatment at the Week 24 visit (longitudinal assessments)
  Biological Efficacy: Changes from baseline over 24 weeks (longitudinal assessments) in blood neuroinflammatory marker levels following oral study drug treatment.
• ALS Functional Rating Scale Revised (ALSFRS-R) total and sub-domain scores
  Time frame: From enrollment to the end of study treatment at the Week 24 Visit (longitudinal assessments)
  Changes from baseline over 6 month period (longitudinal monthly assessments) in ALS Functional Rating Scale Revised (ALSFRS-R) total and sub-domain scores. The 12 domains included in the ALSFRS-R are rated on a 5-point scale, 0 to 4, with a maximum score of 48 indicating the highest level of functioning.
• Slow vital capacity (SVC)
  Time frame: From enrollment to the end of study treatment at the Week 24 Visit (longitudinal assessments)
  Changes from baseline over 24 weeks in SVC (longitudinal assessments).

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.