A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03755167
• Other study ID #: 101/3
• Status: Suspended
• Phase: Phase 2
• Start date: December 9, 2018
• Est. completion date: February 2026

Study information

• Verified date: December 2023
• Source: Immunity Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 15
• Est. completion date: February 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or female participants ages = 18 to 75 years.

2. Participants that have completed study protocol #101/2

3. A written informed consent signed prior to any study procedure being performed

4. Medically capable to undergo study procedures at the time of study entry

Exclusion Criteria:

1. Participants that did not participate or did not complete 28 treatment days of study protocol #101/2.

2. Concurrent therapy, that in the PI's opinion, would interfere with the evaluation of the safety or efficacy of the study medication

3. Presence of any other condition or circumstance that, in the judgment of the Investigator, might contraindicate or increase the risk to the participant.

4. Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative serum pregnancy test from protocol 101/2)

5. 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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• IPL344
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).

Locations

Country	Name	City	State
Israel	Hadassah Medical Center -Motor Neuron Disease Clinic	Jerusalem
Israel	Hadassah Medical Center/Neuromuscular / EMG service and ALS / Motor Neuron Disease Clinic	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Immunity Pharma Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes from baseline in Pulmonary Function	Measured by Vital Capacity (VC)	upto 36 months
Other	Changes from baseline in Muscle strength	Assessed by using a quantitative strength testing tool, Hand Held Dynamometry (HHD)	upto 36 months
Other	Changes from baseline in Muscle strength	Assessed by using a quantitative strength testing tool - hand grip	upto 36 months
Other	Changes from baseline in Anti-Depression effect	Evaluated by ALS Depression Inventory (ADI-12). Scales: For each question, the following is selected: "I fully agree", "I agree", "I don't agree", "I do not agree at all"	upto 36 months
Other	Changes from baseline in Anti-Depression effect	Evaluated by the Hospital Anxiety and Depression Scale (HADS). The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains	upto 36 months
Primary	Adverse Events (AEs) and Serious Adverse Events (SAEs) Reporting	All AEs will be recorded, whether considered minor or serious, drug-related or not	upto 36 month
Secondary	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	upto 36 months