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

Phase 2

Suspended

• Conditions: Amyotrophic Lateral Sclerosis (ALS)
• Interventions: Drug: IPL344

• Registration Number: NCT03755167
• Lead Sponsor: Immunity Pharma Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-25
• Study First Posted: 2018-11-27
• Study Start: 2018-12-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2027-01
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IPL344	IPL344	IV IPL344 administered once a day

Primary Outcome Measures

Name	Time	Method
Adverse Events (AEs) and Serious Adverse Events (SAEs) Reporting	upto 36 month	All AEs will be recorded, whether considered minor or serious, drug-related or not

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in ALS disease progression	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

Trial Locations

Locations (2)

Hadassah Medical Center -Motor Neuron Disease Clinic; 🇮🇱 Jerusalem, Israel

Hadassah Medical Center/Neuromuscular / EMG service and ALS / Motor Neuron Disease Clinic; 🇮🇱 Jerusalem, Israel