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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1299-1958 | Registry Identifier | ICTRP | |
| 2024-511549-20 | Registry Identifier | CTIS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lunsekimig arm A | Experimental | Participants will receive subcutaneous injection of lunsekimig dosing regimen A. |
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| Placebo arm B | Placebo Comparator | Participants will receive subcutaneous injection of matching placebo. |
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| Lunsekimig arm C | Experimental | Participants will receive subcutaneous injection of lunsekimig dosing regimen C. |
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| Placebo arm D | Placebo Comparator | Participants will receive subcutaneous injection of matching placebo. |
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| Lunsekimig arm E | Experimental | Participants will receive subcutaneous injection of lunsekimig dosing regimen E. |
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| Placebo arm F | Placebo Comparator | Participants will receive subcutaneous injection of matching placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lunsekimig | Drug | Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline throughout the study, up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving EASI-75 at Week 24 | EASI 75 is defined by reduction of EASI score by ≥75% from baseline | From Baseline throughout the study, up to Week 24 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| T. Joseph Raoof MD Inc-Site Number: 8400004 | Encino | California | 91436 | United States | ||
| Integrative Skin Science and Research-Site Number: 8400002 |
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| Label | URL |
|---|---|
| DRI18252 Plain Language Results Summary | View source |
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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
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| Placebo | Drug | Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection |
|
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). |
| From Baseline throughout the study, up to Week 24 |
| 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". | From Baseline throughout the study, up to Week 24 |
| 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. | From Baseline throughout the study, up to Week 24 |
| 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. | From Baseline throughout the study, up to Week 24 |
| 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). | From Baseline throughout the study, up to Week 24 |
| 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). | From Baseline throughout the study, up to Week 24 |
| 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". | From Baseline throughout tje study, up to Week 24 |
| 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. | From Baseline throughout the study, up to Week 24 |
| 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. | From Baseline throughout the study, up to Week 24 |
| 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. | From Baseline throughout the study, up to Week 24 |
| Proportion of participants achieving EASI-50 at Week 24 | EASI-50 is defined by reduction of EASI score by ≥50% from baseline. | From Baseline throughout the study, up to Week 24 |
| Proportion of participants achieving EASI-90 at Week 24 | EASI-90 is defined by reduction of EASI score by ≥90% from baseline. | From Baseline throughout the study, up to Week 24 |
| 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". | From Baseline throughout the study, up to Week 24 |
| 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. | From Baseline throughout the study, up to Week 24 |
| 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. | From Baseline throughout the study, up to Week 24 |
| 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). | From Baseline throughout the study, up to Week 24 |
| 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. | From Baseline throughout the study, up to Week 24 |
| 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. | From Baseline throughout the study, up to Week 24 |
| 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. | From Baseline throughout the study, up to Week 24, |
| 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. | From Baseline throughout the study, up to to Week 24 |
| Incidence of Antidrug antibody (ADA) against lunsekimig up to end of study | From Baseline throughout the study, up to Week 32 |
| Serum concentrations of lunsekimig throughout the study | From Baseline throughout the study, up to Week 32 |
| Serum concentrations of lunsekimig in the pharmacokinetic/pharmacodynamics (PK/PD) subgroup throughout the study | From Baseline throughout the study, up to Week 32 |
| Number of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interest (AESIs), and serious adverse events (SAEs) | From Baseline throughout the study, up to Week 32 |
| Sacramento |
| California |
| 95815 |
| United States |
| Clinical Trials Research Institute-Site Number: 8400003 | Thousand Oaks | California | 91320 | United States |
| Skin Care Research-Site Number: 8400013 | Boca Raton | Florida | 33486 | United States |
| Driven Research LLC-Site Number: 8400020 | Coral Gables | Florida | 33134 | United States |
| Revival Research Institute, LLC-Site Number: 8400021 | Evans | Georgia | 30809 | United States |
| Treasure Valley Medical Research-Site Number: 8400026 | Boise | Idaho | 83706 | United States |
| Southern Indiana Clinical Trials-Site Number: 8400024 | New Albany | Indiana | 47150 | United States |
| Indiana Clinical Trials Center, P.C.-Site Number: 8400018 | Plainfield | Indiana | 46168 | United States |
| Optima Research-Site Number: 8400019 | Plainfield | Indiana | 46168 | United States |
| Options Research Group-Site Number: 8400012 | West Lafayette | Indiana | 47906 | United States |
| DS Research - Kentucky-Site Number: 8400005 | Louisville | Kentucky | 40241 | United States |
| Clinical Trials Management LLC-Site Number: 8400010 | Covington | Louisiana | 70433 | United States |
| Beacon Clinical Research-Site Number: 8400006 | Quincy | Massachusetts | 02169 | United States |
| Somerset Skin Centre-Site Number: 8400009 | Troy | Michigan | 48084 | United States |
| Medisearch LLC-Site Number: 8400017 | Saint Joseph | Missouri | 64506 | United States |
| Skin Cancer and Dermatology Institute-Site Number: 8400011 | Reno | Nevada | 89509 | United States |
| Icahn School of Medicine at Mount Sinai-Site Number: 8400023 | New York | New York | 10029 | United States |
| Red River Research Partners-Site Number: 8400008 | Fargo | North Dakota | 58103 | United States |
| Health Concepts-Site Number: 8400025 | Rapid City | South Dakota | 57702 | United States |
| DermResearch-Site Number: 8400014 | Austin | Texas | 78759 | United States |
| Progressive Clinical Research-Site Number: 8400001 | San Antonio | Texas | 78213 | United States |
| Burien US-WA 98168 Dermatology of Seattle and Bellevue-Site Number: 8400015 | Burien | Washington | 98168 | United States |
| Investigational Site Number: 0203003 | Prague | 101 00 | Czechia |
| Investigational Site Number: 0203001 | Prague | 128 00 | Czechia |
| Investigational Site Number: 0203004 | Prague | 128 00 | Czechia |
| Investigational Site Number: 0203002 | Prague | 160 00 | Czechia |
| Investigational Site Number: 3920005 | Asahikawa-shi | 070-8610 | Japan |
| Investigational Site Number: 3920003 | Fukuoka | 812-8582 | Japan |
| Investigational Site Number: 3920004 | Kofu | 400-8506 | Japan |
| Investigational Site Number: 3920002 | Mibu | 321-0293 | Japan |
| Investigational Site Number: 3920006 | Nerima-ku | 177-0041 | Japan |
| Investigational Site Number: 3920001 | Ōta-ku | 160-0023 | Japan |
| Investigational Site Number: 3920008 | Tachikawa-shi | 190-0023 | Japan |
| Investigational Site Number: 3920007 | Yokohama | 221-0825 | Japan |
| Investigational Site Number: 6160014 | Bochnia | 32-700 | Poland |
| Investigational Site Number: 6160006 | Bydgoszcz | 85-231 | Poland |
| Investigational Site Number: 6160010 | Jelenia Góra | 58-506 | Poland |
| Investigational Site Number: 6160007 | Katowice | 40-611 | Poland |
| Investigational Site Number: 6160003 | Katowice | 40-748 | Poland |
| Investigational Site Number: 6160013 | Lublin | 20-011 | Poland |
| Investigational Site Number: 6160001 | Mikołów | 43-190 | Poland |
| Investigational Site Number: 6160011 | Nowa Sól | 67-100 | Poland |
| Investigational Site Number: 6160015 | Ostrowiec Swietokrzyskie | 27-400 | Poland |
| Investigational Site Number: 6160009 | Poznan | 60-192 | Poland |
| Investigational Site Number: 6160012 | Sosnowiec | 41-200 | Poland |
| Investigational Site Number: 6160004 | Szczecin | 70-332 | Poland |
| Investigational Site Number: 6160017 | Warsaw | 01-142 | Poland |
| Investigational Site Number: 6160018 | Warsaw | 02-172 | Poland |
| Investigational Site Number: 6160002 | Warsaw | 02-953 | Poland |
| Investigational Site Number: 6160005 | Wroclaw | 50-224 | Poland |
| Investigational Site Number: 6160016 | Łodź | 91-495 | Poland |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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