RECRUITING

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

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 single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 284 weeks, including: * A screening period of up to 2 to 4 weeks * An open label treatment period of up to 268 weeks (approximately 5 years) * A post-treatment safety follow-up period of at least 20 weeks after the last dose administration (last IMP administration at Week 264) The planned number of visits will be 35 visits.

Official Title

An Open-Label Multinational, Multicenter Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

Quick Facts

Study Start:2023-04-03
Study Completion:2031-06-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05769777

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:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must be at least 12 years of age inclusive, at the time of signing the informed consent.
  2. * Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at baseline.
  3. * Participant must have documented history (within 6 months prior to screening visit), of inadequate response (including inadequate efficacy or medical inadvisability) to topical treatments and/or inadequate response to systemic therapies (within 12 months prior to screening visit).
  4. * Eczema Area Severity Index (EASI) of 16 or higher at baseline visit/Visit 2.
  5. * Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit/Visit 2.
  6. * AD involvement of 10% or more of body surface area (BSA) at baseline visit/Visit 2.
  7. * Weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) of ≥ 4 at baseline visit/Visit 2.
  8. * Able and willing to comply with requested study visits and procedures.
  9. * Body weight must be greater than or equal to 25 kg.
  10. * Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants must not be pregnant or breastfeeding.
  1. * Skin co-morbidity that would adversely affect the ability to undertake AD assessments as per investigator's judgement
  2. * Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
  3. * Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline).
  4. * History of solid organ or stem cell transplant.
  5. * Any pre-planned major elective surgery known about at baseline that in the opinion of the investigator would necessitate that IMP be permanently discontinued or require more than three doses to be missed.
  6. * Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study.
  7. * Any medical or psychiatric condition which, in the opinion of the Investigator may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments.
  8. * Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline (1 week in the event of superficial skin infections); and any infection which as per Investigator's opinion precludes the participant's participation in the study.
  9. * Treatment with live (attenuated) vaccines within 12 weeks prior to baseline; failure to complete non-live immunizations required by local regulation (eg, vaccination for COVID-19) at least 14 days prior to baseline.
  10. * Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.
  11. * Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit.
  12. * Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening.
  13. * In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, hematology, coagulation, or urinalysis tests at the screening visit.
  14. * In the Investigator's opinion, any significant abnormality on 12-lead electrocardiogram (ECG) at the screening visit that could be suggestive of an unstable or underlying cardio-vascular condition that could preclude the participant's participation in the study.
  15. * History of hypersensitivity or allergy to any of the excipients or IMP or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.

Contacts and Locations

Study Contact

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

Principal Investigator

Clinical Sciences & Operations
STUDY_DIRECTOR
Sanofi

Study Locations (Sites)

Allervie Clinical Research- Site Number : 8400050
Birmingham, Alabama, 35209
United States
Research Solutions of Arizona- Site Number : 8400020
Litchfield Park, Arizona, 85340
United States
Medical Dermatology Specialists- Site Number : 8400016
Phoenix, Arizona, 85006
United States
Dermatology Trial Associates- Site Number : 8400027
Bryant, Arkansas, 72022
United States
University Dermatology Trials, INC.- Site Number : 8400052
Newport Beach, California, 92660
United States
Childrens Hospital Colorado- Site Number : 8400041
Aurora, Colorado, 80045-7106
United States
IMMUNOe International Research Centers - Centennial- Site Number : 8400024
Centennial, Colorado, 80112
United States
Renaissance Research and Medical Group- Site Number : 8400006
Cape Coral, Florida, 33991
United States
Life Clinical Trials - Coral Springs- Site Number : 8400040
Coral Springs, Florida, 33071
United States
Florida Pharmaceutical Research and Associates, Inc.- Site Number : 8400018
Miami, Florida, 33143
United States
Bio-Medical Research- Site Number : 8400037
Miami, Florida, 33144
United States
Miami Clinical Research- Site Number : 8400036
Miami, Florida, 33155
United States
Florida Research Center, Inc.- Site Number : 8400011
Miami, Florida, 33174
United States
Clinical Research Trials of Florida- Site Number : 8400054
Tampa, Florida, 33607
United States
Advanced Medical Research PC- Site Number : 8400044
Sandy Springs, Georgia, 30328
United States
Georgia Skin and Cancer Clinic- Site Number : 8400048
Savannah, Georgia, 31419
United States
Sneeze Wheeze And Itch Assoc- Site Number : 8400002
Normal, Illinois, 61761
United States
Velocity Clinical Research, Sioux City- Site Number : 8400046
Sioux City, Iowa, 51106
United States
Kentucky Advanced Medical Research- Site Number : 8400014
Murray, Kentucky, 42071
United States
Oakland Hills Dermatology- Site Number : 8400021
Auburn Hills, Michigan, 48326
United States
The Derm Institute of West Michigan- Site Number : 8400043
Caledonia, Michigan, 49316
United States
Michigan Dermatology Institute- Site Number : 8401010
Livonia, Michigan, 48152
United States
Michigan Dermatology Institute - Waterford- Site Number : 8400010
Waterford, Michigan, 48328
United States
Forest Hills Dermatology Group- Site Number : 8400007
Kew Gardens, New York, 11415
United States
Unity Clinical Research- Site Number : 8400001
Oklahoma City, Oklahoma, 73118
United States
Dermatology Research Center of Oklahoma, PLLC - Site Number : 8400035
Tulsa, Oklahoma, 74132
United States
The Children's Hospital of Philadelphia- Site Number : 8400009
Philadelphia, Pennsylvania, 19104-4319
United States
Texas Dermatology and Laser Specialists- Site Number : 8400053
San Antonio, Texas, 78218
United States
Pioneer Research Solutions- Site Number : 8400026
Sugar Land, Texas, 77479
United States
Private Practice - Dr. Marthe N. Dika- Site Number : 8400022
Burlington, Wisconsin, 53105
United States

Collaborators and Investigators

Sponsor: Sanofi

  • Clinical Sciences & Operations, STUDY_DIRECTOR, 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 Date2023-04-03
Study Completion Date2031-06-11

Study Record Updates

Study Start Date2023-04-03
Study Completion Date2031-06-11

Terms related to this study

Additional Relevant MeSH Terms

  • Dermatitis Atopic