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Phase 1b Study to Investigate ABBV-CLS-7262's Safety, Tolerability & Pharmacokinetics in Vanishing White Matter Patients

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ClinicalTrials.gov Identifier: NCT05757141
Recruitment Status : Recruiting
First Posted : March 7, 2023
Last Update Posted : May 26, 2023
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Calico Life Sciences LLC

Study Description
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Brief Summary:

ABBV-CLS-7262 is an investigational drug being researched for the treatment of Vanishing White Matter disease. This is a 96-week, open-label, single arm study.

Subjects will attend regular visits during the course of the study and complete medical assessments, blood tests, checking for side effects, and completing questionnaires.


Condition or disease Intervention/treatment Phase
Vanishing White Matter Disease Drug: ABBV-CLS-7262 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following ABBV-CLS-7262 Administration in Adult Subjects With Vanishing White Matter Disease
Actual Study Start Date : March 13, 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ABBV-CLS-7262 Drug: ABBV-CLS-7262
ABBV-CLS-7262 is an eIF2B activator


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Baseline up to Approximately Day 49 ]
    Number of patients with treatment-related adverse events as assessed by CTCAE v4.03

  2. Plasma Concentration [ Time Frame: Baseline up to approximately Day 28 ]
    Maximum Plasma Concentration [Cmax]


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Baseline up to Approximately Week 96 ]
    Number of patients with treatment-related adverse events as assessed by CTCAE v4.03


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females ≥18 y of age at the time of Screening.

  2. Have VWM disease defined as:

    1. A clinical diagnosis by a physician; and
    2. A molecular diagnosis of VWM disease confirmed through mutation(s) in eIF2B, and
    3. A magnetic resonance imaging (MRI) presentation consistent with VWM disease.
  3. Have a designated caregiver who is able to complete the respective caregiver-centered assessments.
  4. Signed and dated informed consent provided by the subject, or from a legally authorized representative (LAR) if subject is incapable to consent themselves.
  5. All male subjects who are sexually active and not surgically sterilized must agree to use an acceptable contraceptive method. Additionally, male subjects must agree to not donate sperm during the study until 30 days after the final dose of study drug.
  6. All female subjects who are sexually active and of childbearing potential must agree to use a highly effective contraceptive method. Additionally, female subjects must agree to not donate eggs during the study and for 30 days after the final dose of study drug.

Exclusion Criteria:

  1. Changes in medication use for the management of VWM disease symptoms within the 4 weeks preceding Screening.
  2. Seizure disorder not considered adequately controlled by the investigator within the 6 months preceding Screening.
  3. Subject who, in the opinion of the investigator, is incapable of completing study-required visits and procedures.
  4. Pregnant or breastfeeding.
  5. Treatment with any other investigational treatment within 30 days or 5 half-lives (whichever is longer) prior to Baseline.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05757141


Contacts
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Contact: Calico Call Center-English 1-833-250-9660 vwminfo@mylocalstudy.com

Locations
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United States, Utah
University of Utah Hospital Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Joshua Bonkowsky    801-213-3599    Joshua.bonkowsky@hsc.utah.edu   
Sponsors and Collaborators
Calico Life Sciences LLC
AbbVie
More Information
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Responsible Party: Calico Life Sciences LLC
ClinicalTrials.gov Identifier: NCT05757141    
Other Study ID Numbers: M23-523
First Posted: March 7, 2023    Key Record Dates
Last Update Posted: May 26, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Calico Life Sciences LLC:
Neurodegenerative Diseases
Nervous System Diseases
Central Nervous System Brain Diseases
Hereditary Central Nervous System
Leukoencephalopathy with Vanishing White Matter
Additional relevant MeSH terms:
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Leukoencephalopathies
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases