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

Immunity Pharma

Status and phase: Suspended; Phase 2

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Treatments: Drug: IPL344

Study type: Interventional

Funder types: Industry

Identifiers

NCT03755167

101/3

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

IPL344

Experimental group

Description:

IV IPL344 administered once a day

Treatment:

Drug: IPL344