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

NCT03755167 | Suspended Phase 2

• 1 other identifier: 101/3
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Outcome Measures

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

  upto 36 month

Secondary Outcomes (1)

• Changes from baseline in ALS disease progression

  upto 36 months

Other Outcomes (5)

• Changes from baseline in Pulmonary Function

  upto 36 months

• Changes from baseline in Muscle strength

  upto 36 months

• Changes from baseline in Muscle strength

  upto 36 months

Study Arms (1)

IPL344

EXPERIMENTAL

IV IPL344 administered once a day

Drug: IPL344

Interventions

IPL344 DRUG

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).

IPL344

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Immunity Pharma Ltd.: lead

Study Sites (2)

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

Jerusalem, 91120, Israel

Location

Hadassah Medical Center -Motor Neuron Disease Clinic

Jerusalem, Israel

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 27, 2018
• Study Start: December 9, 2018
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

IL (2)