RECRUITING

Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with lunsekimig. The study duration will be up to 100 weeks with a treatment duration being up to 96 weeks.

Official Title

An Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of Subcutaneous Lunsekimig in Adult Participants With Asthma Who Participated in Study DRI16762 or ACT18301

Quick Facts

Study Start:2024-09-30
Study Completion:2031-01-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06609239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants who completed the 48-week treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol
  2. 2. Participants with stable background therapy with moderate or high-dose ICS in combination with the following controller medications, as maintained during the respective parent study in which they have participated:
  3. * For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines) with or without oral prednisone
  4. * For Study ACT18301: LABA with or without LTRA
  5. 3. Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures
  6. 4. Contraception for male and female participants
  7. * must agree to use contraception/barrier
  8. * not pregnant or breast feeding
  9. * no eggs donation or cryopreserving eggs
  10. * No sperm donation or cryopreserving sperm
  11. 5. Capable of giving signed informed consent
  1. 1. Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator's medical judgement would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures
  2. 2. Participant who was diagnosed with a new pulmonary disease which may impair lung function
  3. 3. Current smoker or active vaping of any products and/or marijuana smoking
  4. 4. Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
  5. 5. History of hypersensitivity or allergy to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
  6. 6. Participants who are receiving prohibited concomitant medications
  7. 7. Participants who, during their participation in the parent study, developed an AE or an SAE deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant
  8. 8. Concurrent participation in any other clinical study, including non-interventional studies
  9. 9. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
  10. 10. Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
800-633-1610
contact-us@sanofi.com

Study Locations (Sites)

Allianz Research Institute CO- Site Number : 8400026
Aurora, Colorado, 80014
United States
Western States Clinical Research Inc- Site Number : 8400014
Wheat Ridge, Colorado, 80033
United States
Beautiful Minds Clinical Research Center- Site Number : 8400049
Cutler Bay, Florida, 33157
United States
Qway Research LLC- Site Number : 8400015
Hialeah, Florida, 33010
United States
Clintex Research Group - Miami - Coral Way- Site Number : 8400048
Miami, Florida, 33145
United States
High Quality Research- Site Number : 8400039
Miami, Florida, 33184
United States
Innovations Biotech- Site Number : 8400040
Miami, Florida, 33186
United States
New Access Research & Medical Center- Site Number : 8400043
Miami, Florida, 33186
United States
Deluxe Health Center- Site Number : 8400045
Miami Lakes, Florida, 33014
United States
Brigham and Women's Hospital- Site Number : 8400034
Boston, Massachusetts, 02115
United States
University of Michigan- Site Number : 8400004
Ann Arbor, Michigan, 48109
United States
Tryon Medical Research- Site Number : 8400029
Charlotte, North Carolina, 28210
United States
Toledo Institute of Clinical Research- Site Number : 8400017
Toledo, Ohio, 43617
United States
OK Clinical Research, LLC- Site Number : 8400021
Edmond, Oklahoma, 73034
United States
Allergy and Clinical Immunology Associates- Site Number : 8400007
Pittsburgh, Pennsylvania, 15241
United States
Orion Clinical Research- Site Number : 8400001
Austin, Texas, 78759
United States
South Texas Medical Research Institute, Inc., DBA TTS Research- Site Number : 8400010
Boerne, Texas, 78006
United States
Baylor Martha Foster Lung Care Center- Site Number : 8400002
Dallas, Texas, 75246
United States
Western Sky Medical Research- Site Number : 8400023
El Paso, Texas, 79903
United States
Metroplex Pulmonary and Sleep Center- Site Number : 8400022
McKinney, Texas, 75069
United States

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-30
Study Completion Date2031-01-20

Study Record Updates

Study Start Date2024-09-30
Study Completion Date2031-01-20

Terms related to this study

Additional Relevant MeSH Terms

  • Asthma