ABBV-CLS-7262 for Vanishing White Matter Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Utah Hospital, Salt Lake City, UTVanishing White Matter DiseaseABBV-CLS-7262 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Vanishing White Matter Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Baseline up to Approximately Week 96

Week 96
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Day 28
Plasma Concentration

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

ABBV-CLS-7262
1 of 1

Experimental Treatment

8 Total Participants · 1 Treatment Group

Primary Treatment: ABBV-CLS-7262 · No Placebo Group · Phase 1

ABBV-CLS-7262
Drug
Experimental Group · 1 Intervention: ABBV-CLS-7262 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to approximately week 96

Who is running the clinical trial?

Calico Life Sciences LLCLead Sponsor
5 Previous Clinical Trials
794 Total Patients Enrolled
AbbVieIndustry Sponsor
852 Previous Clinical Trials
473,643 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years old, regardless of gender.
You must have an approved guardian who is able to complete the required caregiver-related evaluations.
You or your legal representative have signed and dated a consent form.
Male subjects must be sexually active, not surgically sterilized, agree to use contraception and refrain from donating sperm for 30 days after the last dose of study drug.
All female participants who are sexually active and capable of becoming pregnant must agree to use an extremely reliable form of contraception
You have a clinical diagnosis of VWM disease, confirmed with molecular testing and an MRI presentation indicative of the condition.

Frequently Asked Questions

Are individuals able to enroll in this experimental procedure at present?

"According to records on clinicaltrials.gov, the enrollment period for this study is still ongoing. The trial was initially posted on March 1st 2023 and recently modified six days ago." - Anonymous Online Contributor

Unverified Answer

What is the extent of participation in this experiment?

"Affirmative. On clinicaltrials.gov, there is evidence that this medical trial is actively seeking to include participants in its research. The trail was opened on March 1st 2023 and recently updated on the 6th of the same month. A total of 8 volunteers are needed between a single site for enrolment into the study." - Anonymous Online Contributor

Unverified Answer

Has ABBV-CLS-7262 been endorsed by the FDA?

"There is scarce clinical data available that indicates ABBV-CLS-7262's safety and efficacy, thus receiving a score of 1." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.