A study to investigate the efficacy and safety of subcutaneous lunsekimig (SAR443765) compared with placebo in adult participants with moderate to severe atopic dermatitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

22 Apr 2025 → 10 Apr 2026

Decision date (initial)

2025-04-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Developpement

External identifiers

EU CT number

2024-511549-20-00

WHO UTN

U1111-1299-1958

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic, Pharmacodynamic

To evaluate the efficacy of different dosing regimens of lunsekimig on skin lesions using Eczema Area and Severity Index (EASI) score in adult participants with moderate-to-severe atopic dermatitis (AD)

Secondary objectives 4

1. To evaluate the efficacy of lunsekimig compared to placebo in adult participants with moderate to severe AD
2. To evaluate the immunogenicity to lunsekimig in adult participants with moderate to severe AD
3. Assessment of the pharmacokinetic (PK) behavior of lunsekimig in adult participants with moderate-to-severe AD
4. To evaluate the safety of lunsekimig in adult participants with moderate-to-severe AD

Conditions and MedDRA coding

Dermatitis atopic

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Participants must be 18 to 80 years of age, inclusive, at the time of signing the informed consent.
2. Diagnosis of Atopic Dermatitis (AD) as defined by the American Academy of Dermatology (AAD) clinical guidelines (2023) for 1 year or longer at baseline (Day 1)
3. Documented history within 6 months prior to Screening Visit, of either inadequate response or inadvisability of topical treatments
4. Eczema Area and Severity Index (EASI) score of 16 or higher (range, 0 to 72) at baseline (Day 1)
5. Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 3 or 4 at baseline (Day 1) (on the 0 to 4 vIGA-AD scale, a vIGA-AD score of 3 and 4 represents moderate and severe, respectively).
6. AD involvement of 10% or more of Body Surface Area (BSA) at baseline (Day 1)
7. Weekly average of daily Peak Pruritis-Numerical Rating (PP-NRS) score of ≥4 at baseline (Day 1)
8. Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives [eg, urea]) at least once daily for a minimum of 5 out of 7 consecutive days before baseline (Day 1).

Exclusion criteria 2

1. Skin comorbidity that would adversely affect the ability to undertake AD assessments (eg, psoriasis, tinea corporis, and lupus erythematosus) according to the Investigator’s judgment
2. Known history of, or suspected, significant current immunosuppression

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 24

Secondary endpoints 25

1. Proportion of participants achieving EASI 75 at Week 24
2. Proportion of participants with a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA AD) score of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 24
3. Proportion of participants with reduction (improvement) of ≥4 in the weekly average of daily Peak Pruritis-Numerical Rating Scale (PP-NRS) score from baseline to Week 24
4. Absolute change from baseline in EASI score at Week 24
5. Percent change from baseline in EASI score throughout the study
6. Proportion of participants with a vIGA-AD score of 0 (clear) or 1 (almost clear) at Week 24
7. Proportion of participants with a response of vIGA AD 0 or 1 and a reduction from baseline of ≥2 points throughout the study
8. Percent change in the weekly average of daily PP NRS scores from baseline to Week 24
9. Percent change in the weekly average of daily sleep disturbance NRS score from baseline to Week 24
10. Percent change in the weekly average of daily skin pain NRS score from baseline to Week 24
11. Change in percent Body Surface Area (BSA) affected by Atopic Dermatitis from baseline to Week 24
12. Proportion of participants achieving EASI 50 at Week 24
13. Proportion of participants achieving EASI 90 at Week 24
14. Proportion of participants with improvement (reduction) of ≥4 points in the weekly average of daily PP NRS scores from baseline throughout the study
15. Proportion of participants with improvement (reduction) of ≥4 points in the weekly average of daily Sleep Disturbance NRS scores from baseline to Week 24, in participants with a baseline weekly average of daily Sleep Disturbance NRS scores of ≥4 points
16. Proportion of participants with improvement (reduction) of ≥4 points in the weekly average of daily Skin Pain NRS scores from baseline to Week 24, in participants with a baseline weekly average of daily Skin Pain NRS scores of ≥4 points
17. Percent change in Scoring of Atopic Dermatitis (SCORAD) Index from baseline to Week 24
18. Proportion of participants with an improvement of ≥4 points in Dermatology Life Quality Index (DLQI) score from baseline to Week 24 and throughout the study
19. Percent change in Dermatology Life Quality Index (DLQI) score from baseline to Week 24 and throughout the study
20. Percent change in Patient Oriented Eczema Measure (POEM) score from baseline to Week 24
21. Percent change in Hospital Anxiety and Depression Scale (HADS) from baseline to Week 24
22. Incidence of Antidrug antibody (ADA) against lunsekimig up to end of study
23. Serum concentrations of lunsekimig throughout the study
24. Serum concentrations of lunsekimig in the pharmacokinetic/pharmacodynamics (PK/PD) subgroup throughout the study
25. Number of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interest (AESIs), and serious adverse events (SAEs)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 16

Locations

2 EU/EEA countries · 21 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 30 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications