A Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis

Overview

About this study

The purpose of this study is to assess safety, tolerability, and pharmacokinetics (PK) following multiple doses of ABBV-CLS-7262 in subjects with amyotrophic lateral sclerosis (ALS).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Must have an identified, reliable caregiver

- Confirmed diagnosis of Familial ALS or Sporadic ALS

- First ALS symptoms occurred ≤36 months before screening

- Able to swallow solids

- No known active COVID-19 infection at screening

- Vital capacity ≥50% predicted value (for sex, age, ethnic origin, and height) at
screening

- Subjects must be a) nai?ve to, or b) off riluzole (Rilutek), or c) on a stable dose
>30 days prior to Baseline visit to enter study

- Subjects must be a) nai?ve to, or b) off edaravone (Radicava), or c) have completed 2
treatment cycles prior to the Baseline visit.

Exclusion Criteria:

- History of dementia/severe cognitive problems at screening

- Use of riluzole (Rilutek®) if dose has NOT been stable for > 30 days prior to Baseline
visit

- History of clinically significant medical conditions (other than ALS) or any other
reason, including any physical, psychological, or psychiatric condition that, in the
opinion of the Investigator, would compromise the safety or interfere with the
subject's participation in the study, or would make the subject an unsuitable
candidate to receive study drug, or would put the subject at risk by participating in
the study.

- History of abnormal screening laboratory or imaging results that, in the opinion of
the Investigator, are indicative of any significant cardiac, endocrinologic,
hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary,
gastrointestinal, dermatologic, psychiatric, renal, neurologic, and/or other major
disease that would preclude administration of ABBV-CLS-7262.

- If female, is known to be pregnant, breastfeeding, considering becoming pregnant, or
donating/banking eggs during the study or within 30 days or >5 half-lives (whichever
is longer) after the last dose of study drug

- If male, plans to donate sperm or father a child during the study or within 30 days
after the last dose of study drug.

- Known to have received any investigational product within 30 days or 5 half-lives of
the drug (whichever is longer) prior to the first dose of study drug or is currently
enrolled in another clinical study.

- History of ABBV-CLS-7262 use prior to participation in this study

- Recent (within 6 months prior to Screening) history of drug or alcohol abuse

- Previous participation in a stem cell clinical study

- Current or anticipated use of diaphragmatic pacing during the study period

- Tracheostomy or use of non-invasive ventilatory support ≥22 hours a day

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 11/23/22. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nathan Staff, M.D., Ph.D.

Open for enrollment

Contact information:

Megan Means

(507) 293-0545

Means.Megan@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Bjorn Oskarsson, M.D.

Open for enrollment

Contact information:

Megan Donahue

Donahue.Megan@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20525270

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