A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo

Dermatitis Atopic Clinical Trial

— HYDRO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015308
• Other study ID #: SFY17915
• Secondary ID: U1111-1280-8357
• Status: Recruiting
• Phase: Phase 2
• Start date: October 6, 2023
• Est. completion date: August 18, 2025

Study information

• Verified date: June 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Can
• Phone: 800-633-1610
• Email: contact-us[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (primary 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 2 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]).

Description:

The study duration will be up to 36 weeks

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: August 18, 2025
• Est. primary completion date: April 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 in situ excised and cured cervical carcinoma, non-melanoma skin cancer excised and cured >3 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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis Atopic
• Dermatitis, Atopic

Intervention

Drug:
• Amlitelimab
Subcutaneous injection in abdomen, outer thigh, or upper arm
• Placebo
Subcutaneous injection in abdomen, outer thigh, or upper arm

Biological:
• Tdap vaccine
Intramuscular (IM) injection into the deltoid muscle of the upper arm
• PPS vaccine
Intramuscular or subcutaneous injection into the deltoid muscle of the upper arm

Locations

Country	Name	City	State
Canada	Investigational Site Number : 1240014	Barrie	Ontario
Canada	Investigational Site Number : 1240019	Calgary	Alberta
Canada	Investigational Site Number : 1240023	Calgary	Alberta
Canada	Investigational Site Number : 1240016	Edmonton	Alberta
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 : 1240042	Niagara Falls	Ontario
Canada	Investigational Site Number : 1240024	Richmond Hill	Ontario
Canada	Investigational Site Number : 1240021	Toronto	Ontario
Canada	Investigational Site Number : 1240026	Toronto	Ontario
United States	Velocity Clinical Reseach - Austin Site Number : 8401173	Austin	Texas
United States	Velocity Clinical Research at The Dermatology Clinic Site Number : 8401072	Baton Rouge	Louisiana
United States	Allervie Clinical Research Site Number : 8401101	Birmingham	Alabama
United States	Daxia Trials Site Number : 8401145	Boca Raton	Florida
United States	Encore Medical Research of Boynton Beach LLC. Site Number : 8401030	Boynton Beach	Florida
United States	DermDox Dermatology Centers Site Number : 8401031	Camp Hill	Pennsylvania
United States	Velocity Clinical Research, Charleston Site Number : 8401174	Charleston	South Carolina
United States	Velocity Clinical Research, Springdale Site Number : 8401153	Cincinnati	Ohio
United States	Velocity Clinical Research, Columbia Site Number : 8401176	Columbia	South Carolina
United States	Modern Research Associates, PLLC Site Number : 8401093	Dallas	Texas
United States	Velocity Clinical Research - Denver Site Number : 8401168	Denver	Colorado
United States	Doral Medical Research LLC Site Number : 8401094	Doral	Florida
United States	Velocity Clinical Research - Providence Site Number : 8401179	East Greenwich	Rhode Island
United States	AMR Fort Myers Site Number : 8401111	Fort Myers	Florida
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	Henderson Clinical Trials Site Number : 8401169	Henderson	Nevada
United States	Heights Dermatology and Aesthetic Center Site Number : 8401143	Houston	Texas
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 Institute, Inc. Site Number : 8401027	Lomita	California
United States	Skin Sciences, PLLC Site Number : 8401039	Louisville	Kentucky
United States	Velocity Clinical Research, Medford Site Number : 8401170	Medford	Oregon
United States	Acevedo Clinical Research Associates Site Number : 8401088	Miami	Florida
United States	C&R Research Services USA, Inc Site Number : 8401029	Miami	Florida
United States	Florida International Research Center Site Number : 8401091	Miami	Florida
United States	Future Care Solutions, LLC Site Number : 8401144	Miami	Florida
United States	Sanchez Clinical Research, Inc Site Number : 8401095	Miami	Florida
United States	Wellness Clinical Research (WCR) Site Number : 8401109	Miami Lakes	Florida
United States	Skin Search of Rochester, Inc Site Number : 8401216	Rochester	New York
United States	Dermatology 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	Clinical Science Institute Site Number : 8401028	Santa Monica	California
United States	Center for Dermatology and Plastic Surgery Site Number : 8401119	Scottsdale	Arizona
United States	Clinical Research Trials of Florida, Inc Site Number : 8401023	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with a positive tetanus response at 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.	Week 16
Primary	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.	Week 16
Secondary	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
Secondary	Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments		Week 0 up to Week 32
Secondary	Percentage of participants discontinued from study treatment due to TEAEs		Week 0 up to Week 32
Secondary	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).	Week 16
Secondary	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).	Week 16
Secondary	Serum amlitelimab concentrations		Week 0 up to Week 16
Secondary	Incidence of antidrug antibodies (ADAs) of amlitelimab		Week 0 up to Week 16