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

• ClinicalTrials.gov Identifier: NCT03755167
• Recruitment Status: Suspended
• First Posted: November 27, 2018
• Last Update Posted: December 8, 2023
• Sponsor: Immunity Pharma Ltd.
• Information provided by (Responsible Party): Immunity Pharma Ltd.

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Amyotrophic Lateral Sclerosis (ALS)	Drug: IPL344	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 9, 2018
• Estimated Primary Completion Date: January 2026
• Estimated Study Completion Date: February 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: IPL344; IV IPL344 administered once a day	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).

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Changes from baseline in ALS disease progression [ Time Frame: upto 36 months ]
   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

Other Outcome Measures:

1. Changes from baseline in Pulmonary Function [ Time Frame: upto 36 months ]
   Measured by Vital Capacity (VC)
2. Changes from baseline in Muscle strength [ Time Frame: upto 36 months ]
   Assessed by using a quantitative strength testing tool, Hand Held Dynamometry (HHD)
3. Changes from baseline in Muscle strength [ Time Frame: upto 36 months ]
   Assessed by using a quantitative strength testing tool - hand grip
4. Changes from baseline in Anti-Depression effect [ Time Frame: upto 36 months ]
   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"
5. Changes from baseline in Anti-Depression effect [ Time Frame: upto 36 months ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Israel

Hadassah Medical Center/Neuromuscular / EMG service and ALS / Motor Neuron Disease Clinic

Jerusalem, Israel, 91120

Hadassah Medical Center -Motor Neuron Disease Clinic

Jerusalem, Israel

Sponsors and Collaborators

Immunity Pharma Ltd.

More Information

• Responsible Party: Immunity Pharma Ltd.
• ClinicalTrials.gov Identifier: NCT03755167
• Other Study ID Numbers: 101/3
• First Posted: November 27, 2018
• Last Update Posted: December 8, 2023
• Last Verified: December 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis; Pathologic Processes; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases