WithdrawnPhase 2

IC14 for Treatment of Amyotrophic Lateral Sclerosis

Stopped: No participants enrolled in study

Australia0Started 2021-08-15

Plain-language summary

Fifty patients with amyotrophic lateral sclerosis that is progressing rapidly will be randomized to receive either the monoclonal antibody IC14 or placebo to be given intravenously over two hours twice weekly for 12 weeks. Blood and urine tests will be done to measure biomarkers in order to evaluate clinical response and to monitor for safety. Other evaluations include patient questionnaires about function, quality of life and mental function; pulmonary function test; and sniff nasal pressure.

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

✓. Signed informed consent prior to initiation of any study-specific procedures.
✓. Familial or sporadic MND defined as clinically possible, probable, or definite by Awaji-Shima Consensus Recommendations.
✓. Rapidly progressive MND as defined by a decline of 3 or more points in the ALSFRS-R score during the prior 3 months.
✓. First symptoms of MND within 3 years of informed consent.
✓. Age between 18 and 75 years at time of informed consent.
✓. Seated Forced Vital Capacity (FVC) ≥ 65% of predicted value.
✓. Not taking riluzole or edaravone or on a stable dose of riluzole or edaravone for at least 3 months prior to screening visit.
✓. Adequate bone marrow reserve, renal and liver function:

Exclusion criteria

✕. Dependence on mechanical ventilation, defined as being unable to lay supine without it, unable to sleep without it, or continuous daytime use; presence of tracheostomy at screening; or presence of diaphragm pacing system at screening.
✕. Treatment with a drug or device within the last 30 days that has not received regulatory approval.
✕. Treatment within 12 months with immunomodulator or immunosuppressant agent (including but not limited to cyclophosphamide, cyclosporine, interferon-α, interferon-β-1a, rituximab, alemtuzumab, azathioprine, etanercept, infliximab, adalimumab, certolizumab, golimumab, anakinra, rilonacept, secukinumab, tocilizumab, mycophenolate mofetil, methotrexate, haematopoietic stem cell transplantation, anti-sense drugs, gene therapy, cell-depleting agents, total lymphoid irradiation). Treatment with intravenous immunoglobulin within 2 months or dimethyl fumarate within 3 months. Non-steroidal anti-inflammatory drugs are acceptable.

What they're measuring

Neurofilament (biomarker)

Timeframe: 12 weeks

Urinary p75 neurotrophin receptor (biomarker)

Timeframe: 12 weeks

Monocyte CD14 receptor occupancy

Timeframe: 12 weeks

Trial details

NCT IDNCT03508453

SponsorImplicit Bioscience

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-15

View on ClinicalTrials.gov More Amyotrophic Lateral Sclerosis trials

Plain-language summary

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

✓. Signed informed consent prior to initiation of any study-specific procedures.
✓. Familial or sporadic MND defined as clinically possible, probable, or definite by Awaji-Shima Consensus Recommendations.
✓. Rapidly progressive MND as defined by a decline of 3 or more points in the ALSFRS-R score during the prior 3 months.
✓. First symptoms of MND within 3 years of informed consent.
✓. Age between 18 and 75 years at time of informed consent.
✓. Seated Forced Vital Capacity (FVC) ≥ 65% of predicted value.
✓. Not taking riluzole or edaravone or on a stable dose of riluzole or edaravone for at least 3 months prior to screening visit.
✓. Adequate bone marrow reserve, renal and liver function:

Exclusion criteria

✕. Dependence on mechanical ventilation, defined as being unable to lay supine without it, unable to sleep without it, or continuous daytime use; presence of tracheostomy at screening; or presence of diaphragm pacing system at screening.
✕. Treatment with a drug or device within the last 30 days that has not received regulatory approval.
✕. Treatment within 12 months with immunomodulator or immunosuppressant agent (including but not limited to cyclophosphamide, cyclosporine, interferon-α, interferon-β-1a, rituximab, alemtuzumab, azathioprine, etanercept, infliximab, adalimumab, certolizumab, golimumab, anakinra, rilonacept, secukinumab, tocilizumab, mycophenolate mofetil, methotrexate, haematopoietic stem cell transplantation, anti-sense drugs, gene therapy, cell-depleting agents, total lymphoid irradiation). Treatment with intravenous immunoglobulin within 2 months or dimethyl fumarate within 3 months. Non-steroidal anti-inflammatory drugs are acceptable.