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Kamlanoflast In Amyotrophic Lateral Sclerosis

ConditionsALS (Amyotrophic Lateral Sclerosis)ALSNeuro-Degenerative DiseaseNeuro-Degenerative DiseasesMotor Neuron Disease (MND)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInflammasome Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Kamlanoflast

    Drug

    Low dose Kamlanoflast by oral administration

  • Kamlanoflast

    Drug

    High dose Kamlanoflast by oral administration

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Dose Cohort AExperimental treatment 1 intervention
Group B: Dose Cohort BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events [Safety]

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.

Time frame
From drug initiation through study completion, an average of 28 weeks
2

Incidence of Completing Study Treatment [Tolerability]

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.

Time frame
From drug initiation through study completion, an average of 24 weeks
3

Biological Efficacy

Biological Efficacy: Changes from baseline over 24 weeks (longitudinal assessments) in blood neuroinflammatory marker levels following oral study drug treatment.

Time frame
From enrollment through the end of study treatment at the Week 24 visit (longitudinal assessments)
4

ALS Functional Rating Scale Revised (ALSFRS-R) total and sub-domain scores

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.

Time frame
From enrollment to the end of study treatment at the Week 24 Visit (longitudinal assessments)

Secondary outcomes

1

Systemic Exposure

Systemic Exposure: Defined as blood study drug level measurement over 24 weeks of treatment (longitudinal assessments).

Time frame
From enrollment to end of study treatment at the Week 24 Visit (longitudinal assessments)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inflammasome Therapeutics

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: