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 range18 Years – 75 Years

SexALL

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.
✕. Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to investigator's judgment (e.g., cardiovascular instability, systemic infection), or clinically significant laboratory abnormality.

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 range18 Years – 75 Years

SexALL

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.
✕. Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to investigator's judgment (e.g., cardiovascular instability, systemic infection), or clinically significant laboratory abnormality.

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)