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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03755167
Recruitment Status : Suspended (Study was suspended due to IPL344 shortage and may resume once drug supply is available. Survival follow-up is still ongoing following participants' consent)
First Posted : November 27, 2018
Last Update Posted : December 8, 2023
Sponsor:
Information provided by (Responsible Party):
Immunity Pharma Ltd.

Tracking Information
First Submitted Date  ICMJE November 21, 2018
First Posted Date  ICMJE November 27, 2018
Last Update Posted Date December 8, 2023
Actual Study Start Date  ICMJE December 9, 2018
Estimated Primary Completion Date January 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 25, 2018)
  • Changes from baseline in Pulmonary Function [ Time Frame: upto 36 months ]
    Measured by Vital Capacity (VC)
  • Changes from baseline in Muscle strength [ Time Frame: upto 36 months ]
    Assessed by using a quantitative strength testing tool, Hand Held Dynamometry (HHD)
  • Changes from baseline in Muscle strength [ Time Frame: upto 36 months ]
    Assessed by using a quantitative strength testing tool - hand grip
  • 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"
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV
Official Title  ICMJE An Open-Label, Multi-Center, Follow up Study to Protocol 101/2 - Continued Treatment by Intravenously Administered IPL344 to Amyotrophic Lateral Sclerosis (ALS) Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis (ALS)
Intervention  ICMJE 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).
Study Arms  ICMJE Experimental: IPL344
IV IPL344 administered once a day
Intervention: Drug: IPL344
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: November 25, 2018)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2026
Estimated Primary Completion Date January 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03755167
Other Study ID Numbers  ICMJE 101/3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Immunity Pharma Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Immunity Pharma Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Immunity Pharma Ltd.
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP