Lunsekimig for Eczema

Recruiting at 15 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

144 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a parallel, Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of lunsekimig monotherapy in adult participants (aged 18 to 80 years, inclusive) with moderate-to-severe atopic dermatitis (AD). This study explores the efficacy and safety of 3 subcutaneous (SC) dose regimens of lunsekimig in adult participants with moderate-to-severe AD who have a documented history, within 6 months prior to baseline, of an inadequate response to topical treatments or for whom topical therapies are not advised. The study consists of 6 arms: 3 parallel dosing regimens and matching placebo arms. Additionally, participants have the option of engaging in a dense pharmacokinetic/pharmodynamic (PK/PD) sampling subgroup. The study duration will be up to approximately 36 weeks, including up to 4 weeks of screening, 24 weeks of treatment period and an 8-week safety follow-up period.

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.

What safety data exists for Lunsekimig for eczema?

There is no specific safety data available for Lunsekimig for eczema in the provided research articles. ^{1 2 3 4 5}

How does the drug Lunsekimig differ from other eczema treatments?

The research provided does not contain specific information about Lunsekimig, so I cannot determine how it differs from other eczema treatments. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

An update on the safety and tolerability of pimecrolimus cream 1%: evidence from clinical trials and post-marketing surveillance. [2014]

2. Switzerland pubmed.ncbi.nlm.nih.gov

New Cosmetic Formulation for the Treatment of Mild to Moderate Infantile Atopic Dermatitis. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Safety of topical corticosteroids in atopic eczema: an umbrella review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Cancer risk with topical calcineurin inhibitors, pimecrolimus and tacrolimus, for atopic dermatitis: a systematic review and meta-analysis. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

The US FDA 'black box' warning for topical calcineurin inhibitors: an ongoing controversy. [2021]

6. Italy 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. [2018]

7. Italy pubmed.ncbi.nlm.nih.gov

Successful treatment of a chronic eczema in a 48-year-old female with Dr Michaels® (Eczitinex® and Itchinex®) product family. A case report. [2018]

8. India pubmed.ncbi.nlm.nih.gov

Pimecrolimus: a review of pre-clinical and clinical data. [2014]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The role of pimecrolimus cream 1% (Elidel)) in managing adult atopic eczema. [2014]

10. New Zealand pubmed.ncbi.nlm.nih.gov

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