Amyotrophic Lateral SclerosisPhase 1/2ALSNCT03652805
A Study of IPL344 in the Treatment of ALS Patients
A Phase 1/2 study testing IPL344 in people with Amyotrophic Lateral Sclerosis, run by Immunity Pharma Ltd. at 1 site in Israel.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- IPL344
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2018to Feb 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants ages ≥18 to 80 years
- Consenting participants fulfilling the El Escorial criteria for probable and definite ALS (sporadic and familial)
- Participant has ALSFRS-R score >20, the latest ALSFRS-R test should be no more than 6 weeks before screening visit, AND:
- 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
- a decline of at least 3 points in ALSFRS-R score within the last 4 months prior to the latest ALSFRS-R test
- Previous data of Force Vital Capacity (FVC) of ≥60% at least 3 months before screening and not more than 12 months.
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- Written informed consent consistent with ICH-GCP and local laws, signed prior to any study procedures being performed.
- BMI 18.5 to 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.
- 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.
- Medically able to undergo the study procedures, and to adhere to the visit schedule at the time of study entry.
- Medically is able and willing to undergo placement and maintain a central venous catheter as determined by the investigator.
- Participant has a competent caregiver or qualified individual who can and will be responsible for the administration of study drug and reporting home activities.
- Geographic accessibility to the study site
- 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].
- Women of child-bearing potential or males whose partners are women of child-bearing potential use an effective method of contraception throughout the trial.
Who cannot join
- Concurrent therapy that, in the PI's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
- Co-existing psychiatric disorder excluding a depression disorder occurred after ALS diagnosis.
- Participant is a respiratory dependent.
- Subjects with a significant pulmonary disorder not attributed to ALS.
- Slow Vital Capacity (SVC) <60.
- 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.
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- History of HIV, positive HBV or HCV serology.
- Participants suffering from significant cardiac, or any other disease that may endanger the participant or interfere with the ability to interpret the results.
- A participant with active infections.
- Documented active cancer.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1/2a, Multi-center, Open-Label, Dose-escalating Study to Assess Safety, Tolerability, and Pharmacokinetics of Intravenously Administered IPL344 for The Treatment of Amyotrophic Lateral Sclerosis (ALS)
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- IPL344
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPL344Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| IPL344 | Experimental | IPL344 will be administered Intravenously on a daily basis. The dose range of IPL344 is 1.7-3.2 mg/kg Receives: Drug: IPL344 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs) and serious adverse events (SAEs) Reporting
All AEs will be recorded, whether considered minor or serious, drug-related or not
Measured: (up-to Day 56)
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).
Measured: Study treatment duration (Day 1 -28 days)
Secondary outcomes (4)
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
Measured: Pre-Dose and 5, 10, 20, 30, 45, 60 and 120 minutes after dosing
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
Measured: Pre-Dose and 5, 10, 20, 30, 45, 60 and 120 minutes after dosing
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
Measured: Pre-Dose and 5, 10, 20, 30, 45, 60 and 120 minutes after dosing
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
Measured: Pre-Dose and 5, 10, 20, 30, 45, 60 and 120 minutes after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Aug 2018
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Why it stopped: Study was suspended due to IPL344 shortage and may resume once drug supply is available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunity Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652805
- Sponsor's protocol ID
- 101/ 2
- Acronym
- ALS
- Status last verified
- Jan 2025
- First submitted
- 13 Aug 2018
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2a, Multi-center, Open-Label, Dose-escalating Study to Assess Safety, Tolerability, and Pharmacokinetics of Intravenously Administered IPL344 for The Treatment of Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT03652805
- Acronym / sponsor ID
- ALS / 101/ 2
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study was suspended due to IPL344 shortage and may resume once drug supply is available.
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Immunity Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPL344 | Experimental | Drug: IPL344IPL344 will be administered Intravenously on a daily basis. The dose range of IPL344 is 1.7-3.2 mg/kg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female participants ages ≥18 to 80 years
- Consenting participants fulfilling the El Escorial criteria for probable and definite ALS (sporadic and familial)
- Participant has ALSFRS-R score >20, the latest ALSFRS-R test should be no more than 6 weeks before screening visit, AND:
- Previous data of Force Vital Capacity (FVC) of ≥60% at least 3 months before screening and not more than 12 months.
- Written informed consent consistent with ICH-GCP and local laws, signed prior to any study procedures being performed.
Key exclusion criteria (11 listed)
- Concurrent therapy that, in the PI's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
- Co-existing psychiatric disorder excluding a depression disorder occurred after ALS diagnosis.
- Participant is a respiratory dependent.
- Subjects with a significant pulmonary disorder not attributed to ALS.
- Slow Vital Capacity (SVC) <60.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPL344The 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. | Drug | IPL344 |
Primary outcome
Adverse Events (AEs) and serious adverse events (SAEs) Reporting
Time frame: (up-to Day 56)
All AEs will be recorded, whether considered minor or serious, drug-related or not
Maximum Tolerated Dose (MTD)
Time frame: Study treatment duration (Day 1 -28 days)
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).
4 secondary outcomes
Pharmacokinetic (PK) profile - Maximum Plasma Concentration (Cmax)
Time frame: Pre-Dose and 5, 10, 20, 30, 45, 60 and 120 minutes after dosing
Pharmacokinetic (PK) profile - Area Under the Curve (AUC)
Time frame: Pre-Dose and 5, 10, 20, 30, 45, 60 and 120 minutes after dosing
Pharmacokinetic (PK) profile - time to reach maximum plasma concentration (Tmax)
Time frame: Pre-Dose and 5, 10, 20, 30, 45, 60 and 120 minutes after dosing
Pharmacokinetic (PK) profile - apparent terminal exponential half-life (T1/2)
Time frame: Pre-Dose and 5, 10, 20, 30, 45, 60 and 120 minutes after dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IPL344 in people with Amyotrophic Lateral Sclerosis, run by Immunity Pharma Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) and serious adverse events (SAEs) Reporting (time frame: (up-to Day 56)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.