Phase 1b Study to Investigate ABBV-CLS-7262's Safety, Tolerability & Pharmacokinetics in Vanishing White Matter Patients
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05757141|
Recruitment Status : Recruiting
First Posted : March 7, 2023
Last Update Posted : March 20, 2023
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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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||March 2023|
|Estimated Primary Completion Date :||March 2025|
|Estimated Study Completion Date :||March 2025|
ABBV-CLS-7262 is an eIF2B activator
- 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
- Plasma Concentration [ Time Frame: Baseline up to approximately Day 28 ]Maximum Plasma Concentration [Cmax]
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Males and females ≥18 y of age at the time of Screening.
Have VWM disease defined as:
- A clinical diagnosis by a physician; and
- A molecular diagnosis of VWM disease confirmed through mutation(s) in eIF2B, and
- A magnetic resonance imaging (MRI) presentation consistent with VWM disease.
- Have a designated caregiver who is able to complete the respective caregiver-centered assessments.
- Signed and dated informed consent provided by the subject, or from a legally authorized representative (LAR) if subject is incapable to consent themselves.
- 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.
- 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.
- Changes in medication use for the management of VWM disease symptoms within the 4 weeks preceding Screening.
- Seizure disorder not considered adequately controlled by the investigator within the 6 months preceding Screening.
- Subject who, in the opinion of the investigator, is incapable of completing study-required visits and procedures.
- Pregnant or breastfeeding.
- Treatment with any other investigational treatment within 30 days or 5 half-lives (whichever is longer) prior to Baseline.
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
|Contact: Calico Call Center-Englishemail@example.com|
|Contact: Centro de Llamada de Calico-Españolfirstname.lastname@example.org|
|United States, Utah|
|University of Utah Hospital||Recruiting|
|Salt Lake City, Utah, United States, 46214|
|Contact: Joshua Bonkowsky 801-213-3599 Joshua.email@example.com|
|Responsible Party:||Calico Life Sciences LLC|
|Other Study ID Numbers:||
|First Posted:||March 7, 2023 Key Record Dates|
|Last Update Posted:||March 20, 2023|
|Last Verified:||March 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Nervous System Diseases
Central Nervous System Brain Diseases
Hereditary Central Nervous System
Leukoencephalopathy with Vanishing White Matter
Central Nervous System Diseases
Nervous System Diseases