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SuspendedNCT03652805ALSUpdated Jan 10, 2025

A Study of IPL344 in the Treatment of ALS Patients

A Phase 1/2 interventional study of IPL344 in Amyotrophic Lateral Sclerosis, sponsored by Immunity Pharma Ltd.. Suspended at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-10.

Sponsored by Immunity Pharma Ltd. · Phase 1/2, Interventional, and Treatment

Why this study was suspended
Study was suspended due to IPL344 shortage and may resume once drug supply is available.
Phase
Phase 1/2
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This is a prospective, open-label, phase 1/2a study, dose escalation, to evaluate tolerability, safety, and PK of I.V. administered IPL344 in participants with Amyotrophic Lateral Sclerosis (ALS).

Read the detailed description

The study is designed to determine the tolerability, safety and PK of IPL344 administered I.V. once a day for 28 days and to identify the maximum tolerated dose.

All patients enrolled will have a documented history of ALS disease prior to study enrollment.

Treatment will start with 1.7mg/kg with dose escalation by 0.5 mg/kg every 3-4 days and will increase to the maximum dose of 3.2mg/kg. Day 1 to Day 28 patients will be on active treatment.

After completion of 28 treatment days, participants who will choose to continue treatment (at the investigator's discretion), will be enrolled in a follow-up study. Participants that discontinue treatment after Day 28 will be followed up by a nurse phone call and return to the clinic for a final visit on Day 56 from the first dose.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis
03

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's planned enrollment of 15 is below the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

Immunity Pharma Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female participants ages ≥18 to 80 years
  2. Consenting participants fulfilling the El Escorial criteria for probable and definite ALS (sporadic and familial)

  3. Participant has ALSFRS-R score >20, the latest ALSFRS-R test should be no more than 6 weeks before screening visit, AND:

    1. a disease progression rate greater than 0.55 ALSFRS-R point per month on average, over at least 4 months, prior to the latest ALSFRS-R test OR
    2. a decline of at least 3 points in ALSFRS-R score within the last 4 months prior to the latest ALSFRS-R test
  4. Previous data of Force Vital Capacity (FVC) of ≥60% at least 3 months before screening and not more than 12 months.
  5. Written informed consent consistent with ICH-GCP and local laws, signed prior to any study procedures being performed.
  6. BMI 18.5 to 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.
  7. If taking riluzole or edaravone, the participant must be on a stable dose for ≥30 days prior to Day 1 and expected to remain at that dose until the final study visit.
  8. Medically able to undergo the study procedures, and to adhere to the visit schedule at the time of study entry.
  9. Medically is able and willing to undergo placement and maintain a central venous catheter as determined by the investigator.
  10. Participant has a competent caregiver or qualified individual who can and will be responsible for the administration of study drug and reporting home activities.
  11. Geographic accessibility to the study site
  12. Females must not be lactating or pregnant at Screening, as documented by a negative beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG].
  13. Women of child-bearing potential or males whose partners are women of child-bearing potential use an effective method of contraception throughout the trial.

Exclusion criteria

Exclusion Criteria:

  1. Concurrent therapy that, in the PI's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
  2. Co-existing psychiatric disorder excluding a depression disorder occurred after ALS diagnosis.
  3. Participant is a respiratory dependent.
  4. Subjects with a significant pulmonary disorder not attributed to ALS.
  5. Slow Vital Capacity (SVC) \<60.
  6. Presence of any other condition or circumstance that, in the judgment of the Investigator, might contraindicate or increase the risk to the participant or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
  7. History of HIV, positive HBV or HCV serology.
  8. Participants suffering from significant cardiac, or any other disease that may endanger the participant or interfere with the ability to interpret the results.
  9. A participant with active infections.
  10. Documented active cancer.
  11. Treatment with another investigational drug, biological agent, or device within 2 months of the first dose, or investigational cell therapy within 6 months of the first dose.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    IPL344

    IPL344 will be administered Intravenously on a daily basis. The dose range of IPL344 is 1.7-3.2 mg/kg

    Drug: IPL344

Interventions

  • DrugIPL344

    The study is designed to determine the tolerability, safety and PK of IPL344 administered I.V. once a day for 28 days and to identify the maximum tolerated dose. All patients enrolled will have a documented history of ALS disease prior to study enrollment. Treatment will start with 1.7mg/kg with dose escalation by 0.5 mg/kg every 3-4 days and will increase to the maximum dose of 3.2mg/kg. Day 1 to Day 28 patients will be on active treatment. After completion of 28 treatment days, participants who will choose to continue treatment (at the investigator's discretion), will be enrolled in a follow-up study. Participants that discontinue treatment after Day 28 will be followed up by a nurse phone call and return to the clinic for a final visit on Day 56 from the first dose.

06

What researchers measure

Primary outcomes

  1. Adverse Events (AEs) and serious adverse events (SAEs) Reporting

    All AEs will be recorded, whether considered minor or serious, drug-related or not

    Time frame: (up-to Day 56)

  2. Maximum Tolerated Dose (MTD)

    Dose defined as the highest dose with no Dose Limiting Toxicity (DLT). DLT will be defined as a Grade ≥ 3 toxicity per participant according to Common Terminology Criteria for Adverse Events (CTCAE v5.0).

    Time frame: Study treatment duration (Day 1 -28 days)

Secondary outcomes

  1. Pharmacokinetic (PK) profile - Maximum Plasma Concentration (Cmax)

    Blood will be collected for PK testing on Day 1 prior to and after first dose and on each dose-escalation administration day and on Day 28

    Time frame: Pre-Dose and 5, 10, 20, 30, 45, 60 and 120 minutes after dosing

  2. Pharmacokinetic (PK) profile - Area Under the Curve (AUC)

    Blood will be collected for PK testing on Day 1 prior to and after first dose and on each dose-escalation administration day and on Day 28

    Time frame: Pre-Dose and 5, 10, 20, 30, 45, 60 and 120 minutes after dosing

  3. Pharmacokinetic (PK) profile - time to reach maximum plasma concentration (Tmax)

    Blood will be collected for PK testing on Day 1 prior to and after first dose and on each dose-escalation administration day and on Day 28

    Time frame: Pre-Dose and 5, 10, 20, 30, 45, 60 and 120 minutes after dosing

  4. Pharmacokinetic (PK) profile - apparent terminal exponential half-life (T1/2)

    Blood will be collected for PK testing on Day 1 prior to and after first dose and on each dose-escalation administration day and on Day 28

    Time frame: Pre-Dose and 5, 10, 20, 30, 45, 60 and 120 minutes after dosing

Other outcomes

  1. Exploratory: Biomarker testing

    Blood samples for exploratory Biomarkers (Biobanking)

    Time frame: up-to Day 56

  2. Exploratory: Anti-Drug Antibody (ADA) testing

    Blood samples for Anti-Drug Antibody (Biobanking)

    Time frame: up-to Day 56

  3. Exploratory: identify a marker based on the mechanism of action (MOA)

    Blood samples for future PD (Biobanking)

    Time frame: up-to Day 56

  4. Changes from baseline in ALS disease progression

    ALS functional rating scale-Revised (ALSFRS-R) - Questionnaire

    Time frame: up-to day 56

  5. Changes from baseline in Pulmonary Function

    Measured by Vital Capacity (VC)

    Time frame: up-to day 56

  6. Changes from baseline in Muscle strength

    Assessed by using a quantitative strength testing tool, Hand Held Dynamometry (HHD)

    Time frame: up-to day 56

  7. Changes from baseline in Anti-Depression effect

    Evaluated by ALS Depression Inventory (ADI-12) - questionnaire

    Time frame: up-to day 56

  8. Changes from baseline in Anti-Depression effect

    the Hospital Anxiety and Depression Scale (HADS) - questionnaire

    Time frame: up-to day 56

07

Study locations

1 site
  • Hadassah Medical Center -Motor Neuron Disease Clinic
    Jerusalem, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03652805
Lead sponsor
Immunity Pharma Ltd.
Responsible party
Sponsor
First posted
Aug 29, 2018
Start date
Aug 1, 2018
Primary completion
Jan 2026 (estimated)
Completion
Feb 2026 (estimated)
Last update
Jan 10, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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