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ABBV-CLS-7262 for Vanishing White Matter Disease

Phase 1 & 2
Recruiting
Research Sponsored by Calico Life Sciences LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately week 100
Awards & highlights

Study Summary

This trial is studying a drug to treat a rare brain disorder. Subjects will have regular visits for 96 weeks to monitor safety and effectiveness.

Who is the study for?
Adults diagnosed with Vanishing White Matter disease, confirmed by a physician and MRI, who have a caregiver to assist them. Participants must be able to consent or have someone who can legally do so on their behalf. They should not have changed VWM medications in the last 4 weeks or received other investigational treatments recently. Adequate contraception is required for sexually active participants.Check my eligibility
What is being tested?
The trial tests ABBV-CLS-7262's safety and how the body processes it over a period of 96 weeks in patients with Vanishing White Matter disease. It's an open-label study, meaning everyone knows they're getting the drug, without any comparison group.See study design
What are the potential side effects?
Potential side effects are monitored through regular medical assessments and blood tests but are not specified here as this is an early phase trial investigating safety and tolerability.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately week 100
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately week 100 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma Concentration
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Trial Design

3Treatment groups
Experimental Treatment
Group I: ABBV-CLS-7262 - Cohort 3Experimental Treatment1 Intervention
Cohort 3: VWM children ≥6 y and <12 years
Group II: ABBV-CLS-7262 - Cohort 2Experimental Treatment1 Intervention
Cohort 2: VWM children ≥12 y and <18 years
Group III: ABBV-CLS-7262 - Cohort 1Experimental Treatment1 Intervention
Cohort 1: VWM adults ≥18 years
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABBV-CLS-7262
2023
Completed Phase 1
~30

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Who is running the clinical trial?

AbbVieIndustry Sponsor
971 Previous Clinical Trials
505,114 Total Patients Enrolled
Calico Life Sciences LLCLead Sponsor
9 Previous Clinical Trials
951 Total Patients Enrolled

Media Library

ABBV-CLS-7262 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05757141 — Phase 1 & 2
Vanishing White Matter Disease Research Study Groups: ABBV-CLS-7262 - Cohort 1, ABBV-CLS-7262 - Cohort 2, ABBV-CLS-7262 - Cohort 3
Vanishing White Matter Disease Clinical Trial 2023: ABBV-CLS-7262 Highlights & Side Effects. Trial Name: NCT05757141 — Phase 1 & 2
ABBV-CLS-7262 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05757141 — Phase 1 & 2
~9 spots leftby Oct 2026
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