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

Sanofi

Status and phase: Enrolling; Phase 2

Conditions: Dermatitis Atopic

Treatments: Drug: Amlitelimab; Biological: Tdap vaccine; Drug: Placebo; Biological: PPS vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06015308

U1111-1280-8357 (Registry Identifier)

SFY17915

Details and patient eligibility

About

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]).

Full description

The study duration will be up to 36 weeks

Enrollment: 166 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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166 participants in 2 patient groups, including a placebo group

Amlitelimab

Experimental group

Description:

Participants will receive amlitelimab and vaccines as per protocol.

Treatment:

Biological: PPS vaccine

Biological: Tdap vaccine

Drug: Amlitelimab

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matching amlitelimab and vaccines as per protocol.

Treatment:

Biological: PPS vaccine

Drug: Placebo

Biological: Tdap vaccine