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 \[RIVER-AD\]).
The study duration will be up to 36 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
224
Subcutaneous injection in abdomen, outer thigh, or upper arm
Subcutaneous injection in abdomen, outer thigh, or upper arm
Intramuscular (IM) injection into the deltoid muscle of the upper arm
Intramuscular or subcutaneous injection into the deltoid muscle of the upper arm
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
Percentage of participants with a positive tetanus response at Week 16
Positive tetanus response is defined as ≥2.5 IU/mL in anti-tetanus immunoglobulin G \[IgG\] titer for participants with a pre-vaccination baseline \[Week 12\] tetanus antibody titer of \>1 IU/mL or a titer ≥ 3-fold increase for participants with a pre-vaccination titer of ≤1 IU/mL).
Time frame: Week 16
Percentage of participants with a positive pneumococcal vaccine response at 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.
Time frame: Week 16
Percentage of participants who experienced treatment-emergent adverse events (TEAE), including serious adverse events (SAE) and adverse events of special interest (AESI)
Time frame: Week 0 up to Week 32
Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments
Time frame: Week 0 up to Week 32
Percentage of participants discontinued from study treatment due to TEAEs
Time frame: 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
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).
Time frame: Week 16
Proportion of participants with a ≥75% reduction in EASI score (EASI-75) from baseline at 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).
Time frame: Week 16
Serum amlitelimab concentrations
Time frame: Week 0 up to Week 16
Incidence of antidrug antibodies (ADAs) of amlitelimab
Time frame: Week 0 up to Week 16
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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
...and 47 more locations