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

  • STATUS
    Recruiting
  • End date
    May 27, 2023
  • participants needed
    30
  • sponsor
    Calico Life Sciences LLC
Updated on 22 September 2021
blood tests
experimental drug
primary lateral sclerosis

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.

Details
Condition Myelopathy, Amyotrophic Lateral Sclerosis, Antilymphocyte Serum, lou gehrig's disease
Treatment Placebo, ABBV-CLS-7262
Clinical Study IdentifierNCT04948645
SponsorCalico Life Sciences LLC
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note