Not Yet RecruitingPhase 1/2

Kamlanoflast In Amyotrophic Lateral Sclerosis

40 participantsStarted 2026-02

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:

Exclusion criteria

. 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).
. Taking any medications containing nucleotide reverse transcriptase inhibitors (NRTIs), including but not limited to Abacavir, Emtricitabine, Lamivudine, or Zidovudine; trade names Atripla, Biktarvy, Cimduo, Combivir, Complera, Delstrigo, Descovy, Dovato, Emtriva, Epivir, Epzicom, Genvoya, Odefsey, Retrovir, Stribild, Symfi, Symtuza, Triumeq, Trizivir, Truvada, Ziagen.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Treatment-Emergent Adverse Events [Safety]

Timeframe: From drug initiation through study completion, an average of 28 weeks

Incidence of Completing Study Treatment [Tolerability]

Timeframe: From drug initiation through study completion, an average of 24 weeks

Biological Efficacy

Timeframe: From enrollment through the end of study treatment at the Week 24 visit (longitudinal assessments)

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

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

Slow vital capacity (SVC)

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

Trial details

NCT IDNCT07396818

SponsorInflammasome Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

View on ClinicalTrials.gov More ALS (Amyotrophic Lateral Sclerosis) trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:

Exclusion criteria

. 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).
. Taking any medications containing nucleotide reverse transcriptase inhibitors (NRTIs), including but not limited to Abacavir, Emtricitabine, Lamivudine, or Zidovudine; trade names Atripla, Biktarvy, Cimduo, Combivir, Complera, Delstrigo, Descovy, Dovato, Emtriva, Epivir, Epzicom, Genvoya, Odefsey, Retrovir, Stribild, Symfi, Symtuza, Triumeq, Trizivir, Truvada, Ziagen.

What they're measuring

Incidence of Treatment-Emergent Adverse Events [Safety]

Timeframe: From drug initiation through study completion, an average of 28 weeks

Incidence of Completing Study Treatment [Tolerability]

Timeframe: From drug initiation through study completion, an average of 24 weeks

Biological Efficacy

Timeframe: From enrollment through the end of study treatment at the Week 24 visit (longitudinal assessments)

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

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

Slow vital capacity (SVC)

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