Lunsekimig for Eczema

Not currently recruiting at 16 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Disqualifiers: Psoriasis, Tinea corporis, Lupus, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called lunsekimig for individuals with moderate-to-severe eczema, a condition causing itchy and inflamed patches. The trial aims to evaluate the effectiveness and safety of lunsekimig compared to a placebo, which is a non-active treatment. Participants will receive one of three different doses of lunsekimig or a placebo through injections. The trial seeks adults who have had eczema for at least a year and have struggled with or cannot use topical treatments. Participants will be involved for about 36 weeks, including treatment and follow-up. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of a potentially effective new therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants must have had an inadequate response to topical treatments or cannot use them, suggesting that some current treatments might be continued. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that lunsekimig has been tested for safety in earlier studies. These studies found that adults with moderate-to-severe atopic dermatitis (a type of eczema) generally tolerated it well. Most side effects were mild, such as redness or swelling at the injection site, while serious side effects were rare. Since this trial is in Phase 2, previous tests have already addressed major safety issues. However, as with any new treatment, researchers will continue to monitor for any unexpected reactions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Lunsekimig for eczema because it offers a novel approach to treating this skin condition. Unlike standard treatments like topical corticosteroids and calcineurin inhibitors, Lunsekimig is designed to be administered via subcutaneous injection, potentially providing a more systemic solution. This treatment targets specific pathways involved in inflammation, which could mean more precise and effective management of eczema symptoms. By addressing the root causes of the inflammation directly, Lunsekimig may reduce flare-ups and improve skin health more effectively than current topical options.

What evidence suggests that this trial's treatments could be effective for atopic dermatitis?

Research has shown that lunsekimig may help treat moderate-to-severe atopic dermatitis, commonly known as eczema. Early results suggest that lunsekimig works by targeting specific parts of the immune system responsible for skin inflammation. Patients using lunsekimig have experienced skin improvements, particularly when other topical treatments have failed. This trial will test different dosing regimens of lunsekimig. Studies have found that these doses can enhance skin health and reduce symptoms in adults with difficult-to-treat eczema. Although more research is needed to confirm these findings, the initial evidence offers promise for those seeking new ways to manage their eczema. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-80 with moderate-to-severe atopic dermatitis (AD) can join this trial. They must have an EASI score of 16 or higher, a vIGA-AD score of 3 or 4, AD covering at least 10% of their body, and a weekly average itchiness score of ≥4. Participants should have used moisturizers daily for most days before the trial and not responded well to topical treatments in the past six months.

Inclusion Criteria

My eczema severity score is 16 or higher.

My skin condition is rated as moderate or severe.

I have been diagnosed with Atopic Dermatitis for at least 1 year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Treatment

Participants receive one of three subcutaneous dose regimens of lunsekimig or placebo

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lunsekimig

Trial Overview The study is testing Lunsekimig's effectiveness and safety against a placebo in adults with AD who haven't seen results from topical treatments. It involves three different doses of Lunsekimig given by injection under the skin compared to fake injections without active medication over a period that includes screening, treatment for half a year, and follow-up.

How Is the Trial Designed?

Group I: Lunsekimig arm E Experimental Treatment 1 Intervention

Participants will receive subcutaneous injection of lunsekimig dosing regimen E.

Group II: Lunsekimig arm C Experimental Treatment 1 Intervention

Participants will receive subcutaneous injection of lunsekimig dosing regimen C.

Group III: Lunsekimig arm A Experimental Treatment 1 Intervention

Participants will receive subcutaneous injection of lunsekimig dosing regimen A.

Group IV: Placebo arm D Placebo Group 1 Intervention

Participants will receive subcutaneous injection of matching placebo.

Group V: Placebo arm F Placebo Group 1 Intervention

Participants will receive subcutaneous injection of matching placebo.

Group VI: Placebo arm B Placebo Group 1 Intervention

Participants will receive subcutaneous injection of matching placebo.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

Pimecrolimus cream is effective in treating both acute and chronic stages of atopic eczema in children, helping to reduce the occurrence of flares that require stronger topical corticosteroids.

The cream has a favorable safety profile, with mild side effects and no increase in infections or systemic immune suppression, making it a safe option for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pimecrolimus cream in the management of patients with atopic eczema. Spergel, JM.[2021]

In a study of 30 children aged 5 to 13 with atopic dermatitis, treatment with Dr Michaels® (Eczitinex® and Itchinex®) products led to significant improvement in skin rashes and itching within the first week, with most symptoms resolved by 10 to 12 weeks.

The treatment was well-tolerated, with only two patients showing a slow response, indicating that Dr Michaels® products are a safe and effective option for managing atopic dermatitis in children who have not responded to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of the efficacy and tolerability of Dr Michaels® (also branded as Eczitinex® and Itchinex Eczitinex®) topical products in the treatment of atopic dermatitis in children. França, K., Hercogovấ, J., Fioranelli, M., et al.[2018]

Dermacare, a new cosmetic formulation for atopic dermatitis, was found to be safe and well-tolerated in a multicenter study with no reported adverse events, demonstrating its potential for daily use.

After 28 days of treatment, Dermacare significantly reduced skin barrier disruption, as shown by a 70.4% decrease in the Eczema Area and Severity Index and a 36.7% decrease in transepidermal water loss, indicating improved skin condition and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Cosmetic Formulation for the Treatment of Mild to Moderate Infantile Atopic Dermatitis. de Lucas, R., García-Millán, C., Pérez-Davó, A., et al.[2020]

Pimecrolimus cream 1% is effective in treating atopic eczema, providing rapid relief from itching and reducing redness and swelling in up to 70% of patients within the first three weeks of treatment.

It is well tolerated, even on sensitive skin areas like the face and neck, with low blood concentrations and no significant systemic side effects observed in both short- and long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pimecrolimus: a review of pre-clinical and clinical data. Graham-Brown, RA., Grassberger, M.[2014]

Pimecrolimus cream 1% is minimally absorbed through the skin and has a favorable safety profile, with the most common side effects being transient local reactions like skin burning.

While there is an increased risk of herpes simplex virus infections in children using pimecrolimus compared to a placebo, it does not increase the risk of skin infections compared to topical corticosteroids and does not cause corticosteroid-related side effects like skin atrophy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on the safety and tolerability of pimecrolimus cream 1%: evidence from clinical trials and post-marketing surveillance. Langley, RG., Luger, TA., Cork, MJ., et al.[2014]

Topical corticosteroids (TCS) used for atopic eczema showed no significant increased risk of skin thinning in short-term studies, indicating they are generally safe for use in both adults and children.

While TCS may have a higher relative risk of skin thinning compared to topical calcineurin inhibitors, the overall long-term safety data is limited, suggesting that intermittent use of TCS is safe but requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of topical corticosteroids in atopic eczema: an umbrella review. Axon, E., Chalmers, JR., Santer, M., et al.[2023]

A systematic review of 110 studies involving 3.4 million patients found no significant increase in cancer risk associated with the use of topical calcineurin inhibitors (pimecrolimus and tacrolimus) in individuals with atopic dermatitis, with an absolute risk of 4.70 per 1000 for those using the medications compared to 4.56 per 1000 for those not using them.

The evidence suggests that both pimecrolimus and tacrolimus have little to no association with cancer risk across all age groups, supporting their safe use in managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer risk with topical calcineurin inhibitors, pimecrolimus and tacrolimus, for atopic dermatitis: a systematic review and meta-analysis. Devasenapathy, N., Chu, A., Wong, M., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06790121

NCT06790121 | A Study to Investigate the Efficacy and ... This study explores the efficacy and safety of 3 subcutaneous (SC) dose regimens of lunsekimig in adult participants with moderate-to-severe AD.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11196376/

A first‐in‐human, single and multiple dose study of ... Tralokinumab for moderate‐to‐severe atopic dermatitis: results from two 52‐week, randomized, double‐blind, multicentre, placebo‐controlled ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-lunsekimig-sar443765-for-adults-with-moderate-to-severe-atopic-dermatitis/

Study on the Effectiveness and Safety of Lunsekimig ... The purpose of the study is to evaluate how effective different doses of lunsekimig are in improving skin conditions in adults with moderate to severe atopic ...

4. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/abs/10.1111/cts.13864

A first‐in‐human, single and multiple dose study of lunsekimig ... Overall, 48 participants were randomized 3:1 in the SAD part and 4:1 in the MAD part for lunsekimig or placebo. The primary endpoint was safety ...

5. withpower.com withpower.com/trial/phase-2-dermatitis-atopic-1-2025-81c5e

Lunsekimig for Eczema · Info for Participants Trial Overview The study is testing Lunsekimig's effectiveness and safety against a placebo in adults with AD who haven't seen results from topical treatments.

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-investigate-the-efficacy-and-safety-of-subcutaneous-lunsekimig-sar443765-compared-with

A Study to Investigate the Efficacy and Safety of Subcutaneous ... This study explores the efficacy and safety of 3 subcutaneous (SC) dose regimens of lunsekimig in adult participants with moderate-to-severe AD.

7. go.drugbank.com go.drugbank.com/indications/DBCOND0087400/clinical_trials/DB19009?phase=2&status=recruiting

Atopic Dermatitis Eczema Recruiting Phase 2 Trials for ... NCT06790121. A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to- ...