Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

Summary

ABBV-CLS-7262 is an investigational drug being researched for the treatment of Amyotrophic Lateral Sclerosis. This is a 48-week, 2-part study. Part 1 will be a 4-week, randomized, double-blind, placebo-controlled study; Part 2 will be a 44-week active treatment extension (ATE) during which all subjects will receive ABBV-CLS-7262. Subjects will attend regular visits during the course of the study and complete medical assessments, blood tests, checking for side effects, and completing questionnaires.

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of ABBV-CLS-7262 in Subjects With Amyotrophic Lateral Sclerosis Followed by an Active Treatment Extension

Keywords

ALS Amyotrophic Lateral Sclerosis Motor Neuron Disease Sclerosis ABBV-CLS-7262

Eligibility

You can join if…

Open to people ages 18-80

  • 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

You CAN'T join if...

  • History of dementia/severe cognitive problems at screening
  • Use of riluzole (Rilutek®) at a dose which has NOT been stable for >1 months prior to Baseline.
  • Use of edaravone (Radicava®) within 1 month prior to screening or intention of initiating edaravone within 3 months after receiving the first dose of ABBV-CLS-7262.
  • 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

Locations

  • UC Irvine Health ALS and Neuromuscular Center accepting new patients
    Irvine California 92868 United States
  • University of Calgary - Heritage Medical Research Clinic accepting new patients
    Calgary Alberta T2V1P9 Canada

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Calico Life Sciences LLC
ID
NCT04948645
Phase
Phase 1 Amyotropic Lateral Sclerosis (ALS) Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated