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Dermatitis AtopicPhase 2NCT06790121

A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis

A Phase 2 study testing Lunsekimig in people with Dermatitis Atopic, run by Sanofi at 52 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Dermatitis Atopic
What is being tested?
Lunsekimig
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
52 sitesin 4 countries
Study dates
30 Jan 2025to 9 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be 18 to 80 years of age, inclusive, at the time of signing the informed consent.
  • 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)
  • Documented history within 6 months prior to Screening Visit, of either inadequate response or inadvisability of topical treatments
  • Eczema Area and Severity Index (EASI) score of 16 or higher (range, 0 to 72) at baseline (Day 1)
  • Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 3 or 4 at baseline visit (Day 1) (on the 0 to 4 vIGA-AD scale, a vIGA-AD score of 3 and 4 represents moderate and severe, respectively).
  • AD involvement of 10% or more of Body Surface Are (BSA) at baseline (Day 1)
  • Weekly average of daily Peak Pruritis-Numerical Rating (PP-NRS) score of ≥4 at baseline (Day 1)
  • 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).

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • 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.
  • Known history of, or suspected, significant current immunosuppression
  • NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Trial locations and contacts

52 sites in 4 countries.

52 sites in 4 countries

United States23 sites

  • DermResearch-Site Number: 8400014

    Austin, Texas, 78759

  • Skin Care Research-Site Number: 8400013

    Boca Raton, Florida, 33486

  • Treasure Valley Medical Research-Site Number: 8400026

    Boise, Idaho, 83706

  • Burien US-WA 98168 Dermatology of Seattle and Bellevue-Site Number: 8400015

    Burien, Washington, 98168

  • Driven Research LLC-Site Number: 8400020

    Coral Gables, Florida, 33134

  • Clinical Trials Management LLC-Site Number: 8400010

    Covington, Louisiana, 70433

  • T. Joseph Raoof MD Inc-Site Number: 8400004

    Encino, California, 91436

  • Revival Research Institute, LLC-Site Number: 8400021

    Evans, Georgia, 30809

  • Red River Research Partners-Site Number: 8400008

    Fargo, North Dakota, 58103

  • DS Research - Kentucky-Site Number: 8400005

    Louisville, Kentucky, 40241

  • Southern Indiana Clinical Trials-Site Number: 8400024

    New Albany, Indiana, 47150

  • Icahn School of Medicine at Mount Sinai-Site Number: 8400023

    New York, New York, 10029

  • Indiana Clinical Trials Center, P.C.-Site Number: 8400018

    Plainfield, Indiana, 46168

  • Optima Research-Site Number: 8400019

    Plainfield, Indiana, 46168

  • Beacon Clinical Research-Site Number: 8400006

    Quincy, Massachusetts, 02169

  • Health Concepts-Site Number: 8400025

    Rapid City, South Dakota, 57702

  • Skin Cancer and Dermatology Institute-Site Number: 8400011

    Reno, Nevada, 89509

  • Integrative Skin Science and Research-Site Number: 8400002

    Sacramento, California, 95815

  • Medisearch LLC-Site Number: 8400017

    Saint Joseph, Missouri, 64506

  • Progressive Clinical Research-Site Number: 8400001

    San Antonio, Texas, 78213

  • Clinical Trials Research Institute-Site Number: 8400003

    Thousand Oaks, California, 91320

  • Somerset Skin Centre-Site Number: 8400009

    Troy, Michigan, 48084

  • Options Research Group-Site Number: 8400012

    West Lafayette, Indiana, 47906

Other trials in United States

Poland17 sites

  • Investigational Site Number: 6160014

    Bochnia, 32-700

  • Investigational Site Number: 6160006

    Bydgoszcz, 85-231

  • Investigational Site Number: 6160010

    Jelenia Góra, 58-506

  • Investigational Site Number: 6160007

    Katowice, 40-611

  • Investigational Site Number: 6160003

    Katowice, 40-748

  • Investigational Site Number: 6160016

    Łodź, 91-495

  • Investigational Site Number: 6160013

    Lublin, 20-011

  • Investigational Site Number: 6160001

    Mikołów, 43-190

  • Investigational Site Number: 6160011

    Nowa Sól, 67-100

  • Investigational Site Number: 6160015

    Ostrowiec Swietokrzyskie, 27-400

  • Investigational Site Number: 6160009

    Poznan, 60-192

  • Investigational Site Number: 6160012

    Sosnowiec, 41-200

  • Investigational Site Number: 6160004

    Szczecin, 70-332

  • Investigational Site Number: 6160017

    Warsaw, 01-142

  • Investigational Site Number: 6160018

    Warsaw, 02-172

  • Investigational Site Number: 6160002

    Warsaw, 02-953

  • Investigational Site Number: 6160005

    Wroclaw, 50-224

Other trials in Poland

Japan8 sites

  • Investigational Site Number: 3920005

    Asahikawa-shi, 070-8610

  • Investigational Site Number: 3920003

    Fukuoka, 812-8582

  • Investigational Site Number: 3920004

    Kofu, 400-8506

  • Investigational Site Number: 3920002

    Mibu, 321-0293

  • Investigational Site Number: 3920006

    Nerima-ku, 177-0041

  • Investigational Site Number: 3920001

    Ōta-ku, 160-0023

  • Investigational Site Number: 3920008

    Tachikawa-shi, 190-0023

  • Investigational Site Number: 3920007

    Yokohama, 221-0825

Other trials in Japan

Czechia4 sites

  • Investigational Site Number: 0203003

    Prague, 101 00

  • Investigational Site Number: 0203001

    Prague, 128 00

  • Investigational Site Number: 0203004

    Prague, 128 00

  • Investigational Site Number: 0203002

    Prague, 160 00

Other trials in Czechia

About this study

Official title: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of 3 Subcutaneous Dose Regimens of Lunsekimig (SAR443765) in Adult Participants With Moderate-to-severe Atopic Dermatitis

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.

Being tested
Lunsekimig, Placebo
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LunsekimigDrug

    Also called SAR443765

    Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection

  • PlaceboDrug

    Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection

Study groups in NCT06790121
Study groupRoleWhat they receive
Lunsekimig arm AExperimentalParticipants will receive subcutaneous injection of lunsekimig dosing regimen A.
Receives: Drug: Lunsekimig
Placebo arm BPlacebo comparatorParticipants will receive subcutaneous injection of matching placebo.
Receives: Drug: Placebo
Lunsekimig arm CExperimentalParticipants will receive subcutaneous injection of lunsekimig dosing regimen C.
Receives: Drug: Lunsekimig
Placebo arm DPlacebo comparatorParticipants will receive subcutaneous injection of matching placebo.
Receives: Drug: Placebo
Lunsekimig arm EExperimentalParticipants will receive subcutaneous injection of lunsekimig dosing regimen E.
Receives: Drug: Lunsekimig
Placebo arm FPlacebo comparatorParticipants will receive subcutaneous injection of matching placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Eczema Area and Severity index is an Investigator-assessed validated tool used to measure the extent (area) and severity of atopic dermatitis (AD). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

    Measured: From Baseline throughout the study, up to Week 24

Secondary outcomes (25)

  1. Proportion of participants achieving EASI-75 at Week 24

    EASI 75 is defined by reduction of EASI score by ≥75% from baseline

    Measured: From Baseline throughout the study, up to 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

    The Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score is a 5-point scale used to determine severity of AD and clinical response to treatment, ranging from 0 (clear) to 4 (severe).

    Measured: From Baseline throughout the study, up to 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

    The Peak Pruritis-Numerical Rating Scale (PP-NRS) is a validated single-item patient-reported outcome (PRO) to assess worst itch intensity on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

    Measured: From Baseline throughout the study, up to Week 24

  4. Absolute change from Baseline in EASI score at Week 24

    Eczema Area and Severity index is an Investigator-assessed validated tool used to measure the extent (area) and severity of atopic dermatitis (AD). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

    Measured: From Baseline throughout the study, up to Week 24

  5. Percent change from Baseline in EASI score throughout the study

    Eczema Area and Severity index is an Investigator-assessed validated tool used to measure the extent (area) and severity of atopic dermatitis (AD). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

    Measured: From Baseline throughout the study, up to Week 24

  6. Proportion of participants with a vIGA-AD score of 0 (clear) or 1 (almost clear) at Week 24

    The Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score is a 5-point scale used to determine severity of AD and clinical response to treatment, ranging from 0 (clear) to 4 (severe).

    Measured: From Baseline throughout the study, up to 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

    The Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score is a 5-point scale used to determine severity of AD and clinical response to treatment, ranging from 0 (clear) to 4 (severe).

    Measured: From Baseline throughout the study, up to Week 24

  8. Percent change in the weekly average of daily PPNRS scores from Baseline to Week 24

    The Peak Pruritis-Numerical Rating Scale (PP-NRS) is a validated single-item patient-reported outcome (PRO) to assess worst itch intensity on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

    Measured: From Baseline throughout tje study, up to Week 24

  9. Percent change in the weekly average of daily sleep disturbance NRS score from Baseline to Week 24

    The Sleep Disturbance-Numerical Rating Scale (SD-NRS) is a validated single item 0-10 numerical rating scale assessing sleep disturbance associated with AD, with 0 being 'no sleep loss related to the symptoms of AD' and 10 being 'I did not sleep at all' due to the symptoms of AD.

    Measured: From Baseline throughout the study, up to Week 24

  10. Percent change in the weekly average of daily skin pain NRS score from Baseline to Week 24

    The Skin Pain-NRS is a whole number scale ranging from 0 to 10 with a 24-hour recall period, with 0 = no pain and 10 = worst possible pain imaginable. The threshold for determining clinically meaningful change is ≥ 4-point change in the weekly average SP-NRS.

    Measured: From Baseline throughout the study, up to Week 24

  11. Change in percent Body Surface Area (BSA) affected by Atopic Dermatitis from Baseline to Week 24.

    The BSA affected by AD will be assessed in 4 body regions: head/neck, trunk (including the genitals), upper extremities, and lower extremities (including the buttocks). Each body region should be evaluated from 0 to 100%. The percentage of the affected area will be multiplied by the proportion of that body region to the whole body.

    Measured: From Baseline throughout the study, up to Week 24

  12. Proportion of participants achieving EASI-50 at Week 24

    EASI-50 is defined by reduction of EASI score by ≥50% from baseline.

    Measured: From Baseline throughout the study, up to Week 24

  13. Proportion of participants achieving EASI-90 at Week 24

    EASI-90 is defined by reduction of EASI score by ≥90% from baseline.

    Measured: From Baseline throughout the study, up to 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

    The Peak Pruritis-Numerical Rating Scale (PP-NRS) is a validated single-item patient-reported outcome (PRO) to assess worst itch intensity on a scale of 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable".

    Measured: From Baseline throughout the study, up to Week 24

  15. Proportion of participants with improvement (reduction) of ≥4 points in the weekly average of daily SD-NRS scores from Baseline to Week 24, in participants with a baseline weekly average of daily SD-NRS scores of ≥4 points

    The Sleep Disturbance-Numerical Rating Scale (SD-NRS) is a validated single item 0-10 numerical rating scale assessing sleep disturbance associated with AD, with 0 being 'no sleep loss related to the symptoms of AD' and 10 being 'I did not sleep at all' due to the symptoms of AD.

    Measured: From Baseline throughout the study, up to Week 24

  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

    The Skin Pain--Numerical Rating Scale (SP-NRS) is a whole number scale ranging from 0 to 10 with a 24-hour recall period, with 0 = no pain and 10 = worst possible pain imaginable. The threshold for determining clinically meaningful change is ≥ 4-point change in the weekly average SP-NRS.

    Measured: From Baseline throughout the study, up to Week 24

  17. Percent change in Scoring of Atopic Dermatitis (SCORAD) Index from Baseline to Week 24

    The Scoring of Atopic Dermatitis (SCORAD) Index is a validated clinical tool that was developed to standardize the evaluation of the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).

    Measured: From Baseline throughout the study, up 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

    The Dermatology Life Quality Index (DLQI) is a 10-item dermatology specific health-related quality of life (HRQoL) questionnaire. The total score is correlated to the detrimental effect of AD on QoL and ranges from 0 to 30, with a higher score indicating a poorer QoL.

    Measured: From Baseline throughout the study, up to Week 24

  19. Percent change in Dermatology Life Quality Index (DLQI) score from Baseline to Week 24 and throughout the study

    The Dermatology Life Quality Index (DLQI) is a 10-item dermatology specific health-related quality of life (HRQoL) questionnaire. The total score is correlated to the detrimental effect of AD on QoL and ranges from 0 to 30, with a higher score indicating a poorer QoL.

    Measured: From Baseline throughout the study, up to Week 24

  20. Percent change in Patient Oriented Eczema Measure (POEM) score from Baseline to Week 24

    The Scoring of Atopic Dermatitis (SCORAD) Index is a validated clinical tool that was developed to standardise the evaluation of the extent and severity of AD.

    Measured: From Baseline throughout the study, up to Week 24,

  21. Percent change in Hospital Anxiety and Depression Scale (HADS) from Baseline to Week 24

    The Hospital Anxiety and Depression Scale (HADS) is a 14-item patient-reported outcome (PRO) questionnaire used to assess states of anxiety and depression over the past week with two subscales. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.

    Measured: From Baseline throughout the study, up to to Week 24

  22. Incidence of Antidrug antibody (ADA) against lunsekimig up to end of study

    Measured: From Baseline throughout the study, up to Week 32

  23. Serum concentrations of lunsekimig throughout the study

    Measured: From Baseline throughout the study, up to Week 32

  24. Serum concentrations of lunsekimig in the pharmacokinetic/pharmacodynamics (PK/PD) subgroup throughout the study

    Measured: From Baseline throughout the study, up to Week 32

  25. Number of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interest (AESIs), and serious adverse events (SAEs)

    Measured: From Baseline throughout the study, up to Week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2025
  2. Study start30 Jan 2025
  3. Primary completion12 Feb 2026
  4. Study completion9 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06790121
Sponsor's protocol ID
DRI18252
Other IDs
U1111-1299-1958, 2024-511549-20
Status last verified
Apr 2026
First submitted
17 Jan 2025
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lunsekimig in people with Dermatitis Atopic, run by Sanofi at 52 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Poland, Japan, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 24 (time frame: From Baseline throughout the study, up to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06790121.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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