Amyotrophic Lateral Sclerosis (ALS)Phase 2NCT03755167
A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV
A Phase 2 study testing IPL344 in people with Amyotrophic Lateral Sclerosis (ALS), run by Immunity Pharma Ltd. at 2 sites in Israel.
Trial summary
This is a prospective, open-label, follow up study to protocol 101/2 - continued treatment by IPL344 IV administered once a day in up to 15 participants with ALS. The study is designed to determine the safety, tolerability and initial efficacy of IPL344, administered once a day, by IV infusion for up to 36 months Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- 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
- 2 sitesIsrael
- Study dates
- 9 Dec 2018to Feb 2027
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants ages ≥ 18 to 75 years.
- Participants that have completed study protocol #101/2
- A written informed consent signed prior to any study procedure being performed
- Medically capable to undergo study procedures at the time of study entry
Who cannot join
- Participants that did not participate or did not complete 28 treatment days of study protocol #101/2.
- Concurrent therapy, that in the PI's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
- Presence of any other condition or circumstance that, in the judgment of the Investigator, might contraindicate or increase the risk to the participant.
- Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative serum pregnancy test from protocol 101/2)
- Women of child-bearing potential or males whose partners are women of child-bearing potential, unwilling or unable to use an effective method of contraception throughout the trial
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah Medical Center/Neuromuscular / EMG service and ALS / Motor Neuron Disease Clinic
Jerusalem, 91120
Hadassah Medical Center -Motor Neuron Disease Clinic
Jerusalem
About this study
Official title: An Open-Label, Multi-Center, Follow up Study to Protocol 101/2 - Continued Treatment by Intravenously Administered IPL344 to Amyotrophic Lateral Sclerosis (ALS) Patients
This is a prospective, open-label, follow up study to protocol 101/2 - continued treatment by IPL344 IV administered once a day in up to 15 participants with ALS.
The study is designed to determine the safety, tolerability and initial efficacy of IPL344, administered once a day, by IV infusion for up to 36 months
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- 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
IPL344 will be administered by intravenously (IV) infusion once a day (every 24±6 hours), using a Peripherally Inserted Central Catheter (PICC) line or a permanent port. IPL344 will be administered using an electronic pump at a flow rate that will be determined in protocol 101/2. The dose will be fixed as MTD as established in protocol 101/2 (up to 3.2 mg/kg).
| Study group | Role | What they receive |
|---|---|---|
| IPL344 | Experimental | IV IPL344 administered once a day 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: upto 36 month
Secondary outcomes (1)
Changes from baseline in ALS disease progression
Evaluated by the Amyotrophic Lateral Sclerosis Functional Rating Scale(ALSFRS-R). The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing
Measured: upto 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start9 Dec 2018
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Why it stopped: Study was suspended due to IPL344 shortage and may resume once drug supply is available. Survival follow-up is still ongoing following participants' consent
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies 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 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
- NCT03755167
- Sponsor's protocol ID
- 101/3
- Status last verified
- Jan 2025
- First submitted
- 21 Nov 2018
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- An Open-Label, Multi-Center, Follow up Study to Protocol 101/2 - Continued Treatment by Intravenously Administered IPL344 to Amyotrophic Lateral Sclerosis (ALS) Patients
- ClinicalTrials.gov ID
- NCT03755167
- Acronym / sponsor ID
- 101/3
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study was suspended due to IPL344 shortage and may resume once drug supply is available. Survival follow-up is still ongoing following participants' consent
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Immunity Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2018 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Nov 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, follow up study to protocol 101/2 - continued treatment by IPL344 IV administered once a day in up to 15 participants with ALS.
The study is designed to determine the safety, tolerability and initial efficacy of IPL344, administered once a day, by IV infusion for up to 36 months
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: IPL344IV IPL344 administered once a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female participants ages ≥ 18 to 75 years.
- Participants that have completed study protocol #101/2
- A written informed consent signed prior to any study procedure being performed
- Medically capable to undergo study procedures at the time of study entry
Key exclusion criteria (5 listed)
- Participants that did not participate or did not complete 28 treatment days of study protocol #101/2.
- Concurrent therapy, that in the PI's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
- Presence of any other condition or circumstance that, in the judgment of the Investigator, might contraindicate or increase the risk to the participant.
- Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative serum pregnancy test from protocol 101/2)
- Women of child-bearing potential or males whose partners are women of child-bearing potential, unwilling or unable to use an effective method of contraception throughout the trial
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 |
|---|---|---|
| IPL344IPL344 will be administered by intravenously (IV) infusion once a day (every 24±6 hours), using a Peripherally Inserted Central Catheter (PICC) line or a permanent port. IPL344 will be administered using an electronic pump at a flow rate that will be determined in protocol 101/2. The dose will be fixed as MTD as established in protocol 101/2 (up to 3.2 mg/kg). | Drug | IPL344 |
Primary outcome
Adverse Events (AEs) and Serious Adverse Events (SAEs) Reporting
Time frame: upto 36 month
All AEs will be recorded, whether considered minor or serious, drug-related or not
1 secondary outcome
Changes from baseline in ALS disease progression
Time frame: upto 36 months
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: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPL344 in people with Amyotrophic Lateral Sclerosis (ALS), run by Immunity Pharma Ltd. at 2 sites 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 4 inclusion and 5 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 2 sites 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 phase mean?
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: upto 36 month). 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.