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Clinical Trials/NCT03755167
NCT03755167SuspendedPhase 2

An Open-Label, Multi-Center, Follow up Study to Protocol 101/2 - Continued Treatment by Intravenously Administered IPL344 to Amyotrophic Lateral Sclerosis (ALS) Patients

Immunity Pharma Ltd.2 sites in 1 country15 target enrollmentStarted: December 9, 2018Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Suspended
Enrollment
15
Locations
2
Primary Endpoint
Adverse Events (AEs) and Serious Adverse Events (SAEs) Reporting
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

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

Arms & Interventions

IPL344

Experimental

IV IPL344 administered once a day

Intervention: IPL344 (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • Changes from baseline in ALS disease progression(upto 36 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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