A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids (SHORE)

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Sanofi

Status and phase

Enrolling
Phase 3

Conditions

Dermatitis Atopic

Treatments

Drug: Amlitelimab
Drug: Topical corticosteroids
Drug: Placebo
Drug: Topical calcineurin inhibitors

Study type

Interventional

Funder types

Industry

Identifiers

NCT06224348
U1111-1275-9760 (Registry Identifier)
2023-506558-20 (Registry Identifier)
EFC17561

Details and patient eligibility

About

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI). The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate to severe AD aged 12 years and older on background TCS and/or TCI. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY). For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period. The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).

Enrollment

496 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants must be 12 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 inadequate response to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
  • v-IGA-AD of 3 or 4 at baseline visit
  • EASI score of 16 or higher at baseline
  • AD involvement of 10% or more of BSA at baseline
  • Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
  • Able and willing to comply with requested study visits and procedures
  • Body weight ≥25 kg

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

  • Skin co-morbidity that would adversely affect the ability to undertake AD assessments
  • Known history of or suspected significant current immunosuppression
  • Any malignancies or history of malignancies prior to baseline (with the exception of 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 4 weeks prior to baseline
  • Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
  • Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
  • Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
  • In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
  • History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)

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

Quadruple Blind

496 participants in 3 patient groups, including a placebo group

Amlitelimab dose 1
Experimental group
Description:
Subcutaneous injection as per protocol
Treatment:
Drug: Topical calcineurin inhibitors
Drug: Topical corticosteroids
Drug: Amlitelimab
Amlitelimab dose 2
Experimental group
Description:
Subcutaneous injection as per protocol
Treatment:
Drug: Topical calcineurin inhibitors
Drug: Topical corticosteroids
Drug: Amlitelimab
Placebo
Placebo Comparator group
Description:
Subcutaneous injection as per protocol
Treatment:
Drug: Topical calcineurin inhibitors
Drug: Placebo
Drug: Topical corticosteroids

Trial contacts and locations

70

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Central trial contact

Trial Transparency email recommended (Toll free for US & Canada)

Data sourced from clinicaltrials.gov

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