HYDRO: A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo
Study Details
Study Description
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 (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]).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The study duration will be up to 36 weeks
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Amlitelimab Participants will receive amlitelimab and vaccines as per protocol. |
Drug: Amlitelimab
Subcutaneous injection in abdomen, outer thigh, or upper arm
Biological: Tdap vaccine
Intramuscular (IM) injection into the deltoid muscle of the upper arm
Biological: PPS vaccine
Intramuscular or subcutaneous injection into the deltoid muscle of the upper arm
|
| Placebo Comparator: Placebo Participants will receive placebo matching amlitelimab and vaccines as per protocol. |
Drug: Placebo
Subcutaneous injection in abdomen, outer thigh, or upper arm
Biological: Tdap vaccine
Intramuscular (IM) injection into the deltoid muscle of the upper arm
Biological: PPS vaccine
Intramuscular or subcutaneous injection into the deltoid muscle of the upper arm
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
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AD involvement of 10% or more of body surface area (BSA) at baseline
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Able and willing to comply with requested study visits and procedures
-
Body weight ≥40 kg and ≤150 kg
Exclusion Criteria:
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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
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Prior receipt of two or more doses of Pneumovax 23 at any time
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Receipt of any tetanus-, diphtheria-, or pertussis-containing vaccine within approximate timeframe of 5 years prior to screening
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Participants for whom administration of the pneumococcal vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine
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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
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Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
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Known history of or suspected significant current immunosuppression
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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)
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History of solid organ or stem cell transplant
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Any active or chronic infection including helminthic infection requiring systemic treatment within 2 weeks prior baseline
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Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Clinical Sciences & Operations, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SFY17915
- U1111-1280-8357