A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo
- Conditions
- Dermatitis Atopic
- Interventions
- Registration Number
- NCT06015308
- Lead Sponsor
- Sanofi
- Brief Summary
This is a Phase 2, multicenter, randomized, double-blind placebo controlled, 2-arm study to evaluate the effect of amlitelimab on vaccine antibody responses, and the safety of amlitelimab concurrently administered with non-live vaccines in adult participants with moderate-to-severe atopic dermatitis (AD).
The purpose of this study is to compare the immune responses to concomitantly administered Boostrix (tetanus, diphtheria, and acellular pertussis \[Tdap\]) and Pneumovax 23 (PPSV) vaccines in adult participants with moderate-to-severe AD treated with amlitelimab versus placebo. The study will evaluate the percentage of participants achieving a positive anti-tetanus response at Week 16 (primary endpoint) and a positive anti-pneumococcal response at Week 16 (key secondary endpoint).
Study details include:
The study duration will be up to 36 weeks (for participants not entering the LTS17367 \[RIVER-AD\]).
The screening period will be 9 days to 4 weeks. The treatment duration will be up to 16 weeks. The post-treatment safety follow-up period will be16 weeks. The number of visits will be up to 7 (or 6 for those entering LTS17367 \[RIVER-AD\]).
- Detailed Description
The study duration will be up to 36 weeks
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 215
- Participants must be 18 years of age (when signing informed consent form)
- Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
- Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments
- Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit
- Eczema area and severity index (EASI) score of 12 or higher at baseline
- AD involvement of 10% or more of body surface area (BSA) at baseline
- Able and willing to comply with requested study visits and procedures
- Body weight ≥40 kg and ≤150 kg
- Skin co-morbidity that would adversely affect the ability to undertake AD assessments
- Receipt of any vaccine (expect influenza and COVID-19 vaccines) within 3 months prior to screening
- Receipt of any pneumococcal vaccine within approximate timeframe of 5 years prior to screening
- Prior receipt of two or more doses of Pneumovax 23 at any time
- Receipt of any tetanus-, diphtheria-, or pertussis-containing vaccine within approximate timeframe of 5 years prior to screening
- Participants for whom administration of the pneumococcal vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine
- Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine
- Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
- Known history of or suspected significant current immunosuppression
- Any malignancies or history of malignancies prior to baseline (excluding non-melanoma skin cancer excised and cured >5 years prior to baseline)
- History of solid organ or stem cell transplant
- Any active or chronic infection including helminthic infection requiring systemic treatment within 2 weeks prior baseline
- Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
- Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amlitelimab Amlitelimab Participants will receive amlitelimab and vaccines as per protocol. Amlitelimab Tdap vaccine Participants will receive amlitelimab and vaccines as per protocol. Amlitelimab PPS vaccine Participants will receive amlitelimab and vaccines as per protocol. Placebo Placebo Participants will receive placebo matching amlitelimab and vaccines as per protocol. Placebo Tdap vaccine Participants will receive placebo matching amlitelimab and vaccines as per protocol. Placebo PPS vaccine Participants will receive placebo matching amlitelimab and vaccines as per protocol.
- Primary Outcome Measures
Name Time Method Percentage of participants with a positive tetanus response at Week 16 Week 16 Positive tetanus response is defined as a ≥4-fold increase from pre-vaccination at baseline in anti-tetanus immunoglobulin G \[IgG\] titer for participants with a pre-vaccination tetanus antibody titers ≥0.1 IU/mL or a titer of ≥0.2 IU/mL for participants with pre-vaccination titers of \<0.1 IU/mL.
- Secondary Outcome Measures
Name Time Method Percentage of participants with a positive pneumococcal vaccine response at Week 16 Week 16 Positive pneumococcal vaccine response is defined as a ≥2-fold increase from baseline in anti-pneumococcal antibodies (APAb) against \>50% of the 23 serotypes.
Percentage of participants who experienced treatment-emergent adverse events (TEAE), including serious adverse events (SAE) and adverse events of special interest (AESI) Week 0 up to Week 32 Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments Week 0 up to Week 32 Percentage of participants discontinued from study treatment due to TEAEs Week 0 up to Week 32 Proportion of participants with validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction of ≥2 points from baseline at Week 16 Week 16 The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
Proportion of participants with a ≥75% reduction in EASI score (EASI-75) from baseline at Week 16 Week 16 The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD using a 4-point scale; 0 (absent) to 3 (severe).
Serum amlitelimab concentrations Week 0 up to Week 16 Incidence of antidrug antibodies (ADAs) of amlitelimab Week 0 up to Week 16
Trial Locations
- Locations (57)
Clinical Research Center of Alabama - Homewood- Site Number : 8401101
🇺🇸Birmingham, Alabama, United States
Center for Dermatology and Plastic Surgery- Site Number : 8401119
🇺🇸Scottsdale, Arizona, United States
Orange County Clinical Trials- Site Number : 8401271
🇺🇸Anaheim, California, United States
First OC Dermatology- Site Number : 8401025
🇺🇸Fountain Valley, California, United States
Center for Dermatology Clinical Research- Site Number : 8401018
🇺🇸Fremont, California, United States
Valley Research- Site Number : 8401097
🇺🇸Fresno, California, United States
Paradigm Clinical Research Centers- Site Number : 8401273
🇺🇸La Mesa, California, United States
Sunwise Clinical Research- Site Number : 8401022
🇺🇸Lafayette, California, United States
Antelope Valley Clinical Trials- Site Number : 8401099
🇺🇸Lancaster, California, United States
Torrance Clinical Research- Site Number : 8401027
🇺🇸Lomita, California, United States
Clinical Science Institute- Site Number : 8401028
🇺🇸Santa Monica, California, United States
Velocity Clinical Research - Denver Site Number : 8401168
🇺🇸Denver, Colorado, United States
Daxia Trials- Site Number : 8401145
🇺🇸Boca Raton, Florida, United States
Encore Medical Research of Boynton Beach- Site Number : 8401030
🇺🇸Boynton Beach, Florida, United States
Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111
🇺🇸Fort Myers, Florida, United States
Doral Medical Research- Site Number : 8401094
🇺🇸Hialeah, Florida, United States
C&R Research Services - Kendall- Site Number : 8401029
🇺🇸Kendall, Florida, United States
Wellness Clinical Research - Miami Lakes- Site Number : 8401109
🇺🇸Miami Lakes, Florida, United States
Acevedo Clinical Research Associates- Site Number : 8401088
🇺🇸Miami, Florida, United States
Future Care Solution - Miami- Site Number : 8401144
🇺🇸Miami, Florida, United States
Sanchez Clinical Research- Site Number : 8401095
🇺🇸Miami, Florida, United States
Florida International Research Center- Site Number : 8401091
🇺🇸Miami, Florida, United States
K2 South Orlando - South Orange Avenue- Site Number : 8401268
🇺🇸Orlando, Florida, United States
SEC Clinical Research- Site Number : 8401270
🇺🇸Pensacola, Florida, United States
Global Clinical Professionals (GCP)- Site Number : 8401045
🇺🇸Saint Petersburg, Florida, United States
Clinical Research Trials of Florida- Site Number : 8401023
🇺🇸Tampa, Florida, United States
Paradigm Clinical Research - Boise- Site Number : 8401272
🇺🇸Boise, Idaho, United States
Skin Sciences- Site Number : 8401039
🇺🇸Louisville, Kentucky, United States
Velocity Clinical Research at The Dermatology Clinic- Site Number : 8401072
🇺🇸Baton Rouge, Louisiana, United States
BRCR Global Gretna- Site Number : 8401243
🇺🇸Gretna, Louisiana, United States
Boeson Research - Missoula- Site Number : 8401269
🇺🇸Missoula, Montana, United States
Henderson Clinical Trials- Site Number : 8401169
🇺🇸Henderson, Nevada, United States
Skin Search Rochester- Site Number : 8401216
🇺🇸Rochester, New York, United States
Velocity Clinical Research - Durham- Site Number : 8401175
🇺🇸Durham, North Carolina, United States
Velocity Clinical Research - Springdale- Site Number : 8401153
🇺🇸Cincinnati, Ohio, United States
Velocity Clinical Research - Medford- Site Number : 8401170
🇺🇸Medford, Oregon, United States
Vial Health - DermDox Dermatology- Site Number : 8401031
🇺🇸Camp Hill, Pennsylvania, United States
Velocity Clinical Research - Providence- Site Number : 8401179
🇺🇸East Greenwich, Rhode Island, United States
Velocity Clinical Research - Charleston- Site Number : 8401174
🇺🇸Charleston, South Carolina, United States
VitaLink Research - Columbia- Site Number : 8401176
🇺🇸Columbia, South Carolina, United States
Velocity Clinical Research - Austin- Site Number : 8401173
🇺🇸Cedar Park, Texas, United States
Modern Research Associates- Site Number : 8401093
🇺🇸Dallas, Texas, United States
Heights Dermatology & Aesthetic Center- Site Number : 8401143
🇺🇸Houston, Texas, United States
Dermatology Clinical Research Center of San Antonio- Site Number : 8401100
🇺🇸San Antonio, Texas, United States
Discovery Clinical Trials - San Antonio - Stone Oak Parkway- Site Number : 8401026
🇺🇸San Antonio, Texas, United States
Stryde Research - Epiphany Dermatology- Site Number : 8401185
🇺🇸Southlake, Texas, United States
Ogden Clinic Mountain View (Avacare) Site Number : 8401167
🇺🇸Pleasant View, Utah, United States
Investigational Site Number : 1240019
🇨🇦Calgary, Alberta, Canada
Investigational Site Number : 1240023
🇨🇦Calgary, Alberta, Canada
Investigational Site Number : 1240016
🇨🇦Edmonton, Alberta, Canada
Investigational Site Number : 1240014
🇨🇦Barrie, Ontario, Canada
Investigational Site Number : 1240020
🇨🇦Hamilton, Ontario, Canada
Investigational Site Number : 1240017
🇨🇦London, Ontario, Canada
Investigational Site Number : 1240018
🇨🇦Newmarket, Ontario, Canada
Investigational Site Number : 1240024
🇨🇦Richmond Hill, Ontario, Canada
Investigational Site Number : 1240021
🇨🇦Toronto, Ontario, Canada
Investigational Site Number : 1240026
🇨🇦Toronto, Ontario, Canada