Amlitelimab for Atopic Dermatitis (SHORE)
(SHORE Trial)

Recruiting in Palo Alto (17 mi)

+150 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Sanofi

Must be taking: Topical corticosteroids, Topical calcineurin

Disqualifiers: Immunosuppression, Malignancies, Active infections, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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).

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should have a history of inadequate response to topical treatments. It seems you may need to continue using topical corticosteroids or calcineurin inhibitors during the trial.

Eligibility Criteria

You are eligible if you have been diagnosed with moderate-to-severe AD for a year or longer and used topical corticosteroids or topical calcineurin inhibitors without adequate benefit from topical medications within the last 6 months or used systemic therapies for AD without adequate benefit within the last 12 months.

Inclusion Criteria

Have you had atopic dermatitis for at least 1 year?

In the last six months, have you had a poor response to any topical medications?

Does your atopic dermatitis cover a significant portion of your body?

Exclusion Criteria

Have you been diagnosed with any of the following: psoriasis, tinea corporis, or lupus erythematosus?

Have you experienced suicidal ideation or thoughts of self-harm in the past 6 months?

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive amlitelimab or placebo via subcutaneous injection for 24 weeks

24 weeks

Up to 10 visits (or 9 visits for those entering the extension study)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Blinded Extension (optional)

Participants may opt into a separate blinded extension study EFC17600 (ESTUARY)

Up to 28 weeks including screening and treatment

Participant Groups

Atopic dermatitis is an immune system condition. The investigational drug, amlitelimab, is an immunotherapy that targets the inflammation cascade. It is aimed to calm the immune system to prevent inflammation. Amlitelimab has been shown to be well tolerated by patients in previous clinical studies but is not yet approved for treating atopic dermatitis.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Amlitelimab dose 2Experimental Treatment3 Interventions

Subcutaneous injection as per protocol

Group II: Amlitelimab dose 1Experimental Treatment3 Interventions

Subcutaneous injection as per protocol

Group III: PlaceboPlacebo Group3 Interventions

Subcutaneous injection as per protocol