Clinical trial NCT06015308: A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Amlitelimab on Vaccine Antibody Responses in Adult Participants With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dermatitis Atopic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-08-29
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of participants with a positive tetanus response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of participants with a positive pneumococcal vaccine response at Week 16
timeFrame: Week 16
measure: Percentage of participants who experienced treatment-emergent adverse events (TEAE), including serious adverse events (SAE) and adverse events of special interest (AESI)
timeFrame: Week 0 up to Week 32
measure: Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments
timeFrame: Week 0 up to Week 32
measure: Percentage of participants discontinued from study treatment due to TEAEs
timeFrame: Week 0 up to Week 32
measure: 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
timeFrame: Week 16
measure: Proportion of participants with a ≥75% reduction in EASI score (EASI-75) from baseline at Week 16
timeFrame: Week 16
measure: Serum amlitelimab concentrations
timeFrame: Week 0 up to Week 16
measure: Incidence of antidrug antibodies (ADAs) of amlitelimab
timeFrame: Week 0 up to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama - Homewood- Site Number : 8401101
state: Alabama
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery- Site Number : 8401119
state: Arizona
city: Anaheim
country: United States
facility: Orange County Clinical Trials- Site Number : 8401271
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology- Site Number : 8401025
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research- Site Number : 8401018
state: California
city: Fresno
country: United States
facility: Valley Research- Site Number : 8401097
state: California
city: La Mesa
country: United States
facility: Paradigm Clinical Research Centers- Site Number : 8401273
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research- Site Number : 8401022
state: California
city: Lancaster
country: United States
facility: Antelope Valley Clinical Trials- Site Number : 8401099
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research- Site Number : 8401027
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute- Site Number : 8401028
state: California
city: Denver
country: United States
facility: Velocity Clinical Research - Denver Site Number : 8401168
state: Colorado
city: Boca Raton
country: United States
facility: Daxia Trials- Site Number : 8401145
state: Florida
city: Boynton Beach
country: United States
facility: Encore Medical Research of Boynton Beach- Site Number : 8401030
state: Florida
city: Fort Myers
country: United States
facility: Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111
state: Florida
city: Hialeah
country: United States
facility: Doral Medical Research- Site Number : 8401094
state: Florida
city: Kendall
country: United States
facility: C&R Research Services - Kendall- Site Number : 8401029
state: Florida
city: Miami Lakes
country: United States
facility: Wellness Clinical Research - Miami Lakes- Site Number : 8401109
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates- Site Number : 8401088
state: Florida
city: Miami
country: United States
facility: Future Care Solution - Miami- Site Number : 8401144
state: Florida
city: Miami
country: United States
facility: Sanchez Clinical Research- Site Number : 8401095
state: Florida
city: Miami
country: United States
facility: Florida International Research Center- Site Number : 8401091
state: Florida
city: Orlando
country: United States
facility: K2 South Orlando - South Orange Avenue- Site Number : 8401268
state: Florida
city: Pensacola
country: United States
facility: SEC Clinical Research- Site Number : 8401270
state: Florida
city: Saint Petersburg
country: United States
facility: Global Clinical Professionals (GCP)- Site Number : 8401045
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida- Site Number : 8401023
state: Florida
city: Boise
country: United States
facility: Paradigm Clinical Research - Boise- Site Number : 8401272
state: Idaho
city: Louisville
country: United States
facility: Skin Sciences- Site Number : 8401039
state: Kentucky
city: Baton Rouge
country: United States
facility: Velocity Clinical Research at The Dermatology Clinic- Site Number : 8401072
state: Louisiana
city: Gretna
country: United States
facility: BRCR Global Gretna- Site Number : 8401243
state: Louisiana
city: Missoula
country: United States
facility: Boeson Research - Missoula- Site Number : 8401269
state: Montana
city: Henderson
country: United States
facility: Henderson Clinical Trials- Site Number : 8401169
state: Nevada
city: Rochester
country: United States
facility: Skin Search Rochester- Site Number : 8401216
state: New York
city: Durham
country: United States
facility: Velocity Clinical Research - Durham- Site Number : 8401175
state: North Carolina
city: Cincinnati
country: United States
facility: Velocity Clinical Research - Springdale- Site Number : 8401153
state: Ohio
city: Medford
country: United States
facility: Velocity Clinical Research - Medford- Site Number : 8401170
state: Oregon
city: Camp Hill
country: United States
facility: Vial Health - DermDox Dermatology- Site Number : 8401031
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research - Providence- Site Number : 8401179
state: Rhode Island
city: Charleston
country: United States
facility: Velocity Clinical Research - Charleston- Site Number : 8401174
state: South Carolina
city: Columbia
country: United States
facility: VitaLink Research - Columbia- Site Number : 8401176
state: South Carolina
city: Cedar Park
country: United States
facility: Velocity Clinical Research - Austin- Site Number : 8401173
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates- Site Number : 8401093
state: Texas
city: Houston
country: United States
facility: Heights Dermatology & Aesthetic Center- Site Number : 8401143
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio- Site Number : 8401100
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials - San Antonio - Stone Oak Parkway- Site Number : 8401026
state: Texas
city: Southlake
country: United States
facility: Stryde Research - Epiphany Dermatology- Site Number : 8401185
state: Texas
city: Pleasant View
country: United States
facility: Ogden Clinic Mountain View (Avacare) Site Number : 8401167
state: Utah
city: Calgary
country: Canada
facility: Investigational Site Number : 1240019
state: Alberta
city: Calgary
country: Canada
facility: Investigational Site Number : 1240023
state: Alberta
city: Edmonton
country: Canada
facility: Investigational Site Number : 1240016
state: Alberta
city: Barrie
country: Canada
facility: Investigational Site Number : 1240014
state: Ontario
city: Hamilton
country: Canada
facility: Investigational Site Number : 1240020
state: Ontario
city: London
country: Canada
facility: Investigational Site Number : 1240017
state: Ontario
city: Newmarket
country: Canada
facility: Investigational Site Number : 1240018
state: Ontario
city: Richmond Hill
country: Canada
facility: Investigational Site Number : 1240024
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240021
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240026
state: Ontario
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: