Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 4 for:    calico

A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04948645
Recruitment Status : Recruiting
First Posted : July 2, 2021
Last Update Posted : October 13, 2021
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Calico Life Sciences LLC

Brief 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.


Condition or disease Intervention/treatment Phase
ALS Amyotrophic Lateral Sclerosis Drug: ABBV-CLS-7262 Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 22, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2023


Arm Intervention/treatment
Active Comparator: ABBV-CLS-7262 LOW DOSE Drug: ABBV-CLS-7262
Oral

Active Comparator: ABBV-CLS-7262 MEDIUM DOSE Drug: ABBV-CLS-7262
Oral

Active Comparator: ABBV-CLS-7262 HIGH DOSE Drug: ABBV-CLS-7262
Oral

Placebo Comparator: PLACEBO Drug: Placebo
Oral




Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: Baseline Up to Approximately Day 28 ]
    Number of patients with treatment-related adverse events as assessed by CTCAE v4.03

  2. Pharmacokinetics [ Time Frame: Baseline Up to Approximately Day 28 ]
    Maximum Plasma Concentration [Cmax]

  3. Pharmacokinetics [ Time Frame: Baseline Up to Approximately Day 28 ]
    Area Under the Curve [AUC]


Secondary Outcome Measures :
  1. CSF Pharmacokinetics [ Time Frame: Baseline Up to Approximately Day 28 ]
    Concentration at steady state in CSF

  2. Safety and Tolerability [ Time Frame: Baseline Up to Approximately Week 48 ]
    Number of patients with treatment-related adverse events as assessed by CTCAE v4.03



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04948645


Contacts
Layout table for location contacts
Contact: Calico Call Center 1-844-463-2423 CalicoALS@patientrm.com

Locations
Layout table for location information
Canada, New Brunswick
Horizon Health Network Recruiting
Fredericton, New Brunswick, Canada, E3B 4R3
Canada, Quebec
Montreal Neurological Institute and Hospital Recruiting
Montreal, Quebec, Canada, H3A 2B4
Sponsors and Collaborators
Calico Life Sciences LLC
AbbVie
Layout table for additonal information
Responsible Party: Calico Life Sciences LLC
ClinicalTrials.gov Identifier: NCT04948645    
Other Study ID Numbers: M20-405
First Posted: July 2, 2021    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases