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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05492578
Other study ID # LTS17367
Secondary ID U1111-1269-64902
Status Recruiting
Phase Phase 2
First received
Last updated
Start date August 22, 2022
Est. completion date April 18, 2028

Study information

Verified date May 2024
Source Sanofi
Contact Trial Transparency email recommended (Toll free number for US &
Phone 800-633-1610
Email contact-us@sanofi.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single group, Phase 2, long-term extension study for treatment. The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated adult participants with moderate to severe AD who have previously been enrolled in an amlitelimab clinical trial. Visits during the on-treatment period will be at Week 0, 1, 2, 4 and every 4 weeks (Q4W) thereafter. If remote visits are considered appropriate for participants instead of clinic visits at the timepoints indicated in the schedule of activities (SoA) participants/caregivers/legally authorized representatives (LAR) are allowed to perform participant-injections at home according to the schedule of dosing. This decision is at the discretion of the investigator.


Recruitment information / eligibility

Status Recruiting
Enrollment 450
Est. completion date April 18, 2028
Est. primary completion date October 29, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participant must be 18 years of age, inclusive, or older at the time of signing the informed consent. - Participated in an amlitelimab clinical trial for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period. - Have reached the rollover timepoint to LTS17367 at the last visit of the treatment period of their parent study SFY17915 - Participants in DRI17366 must only be enrolled from 1 of the following 3 groups: - The first group: participants at Week 24 in the DRI17336 study who have not achieved an = Eczema Area and Skin Severity Index (EASI)-75 and are Investigator Global Assessment (IGA) = 2. - The second group: participants entering LTS17367 between Week 28 and Week 52 of the parent study, due to loss of clinical response in the part 2 of the parent study. Timepoints for entering LTS17367 are Weeks 28, 32, 36, 40, 44, 48 or 52. For DRI17366 loss of clinical response is defined as the first instance of < EASI 50 during the second study period and where rescue therapy is no longer permitted. - The third group: participants at Week 24 in DRI17366 who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up or thereafter - Provide signed informed consent and able to comply with the requirements of the protocol Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: - Developed a medical condition that would preclude participation as described in the permanent discontinuation - Known history of or suspected significant current immunosuppression, including history of invasive opportunistic infections or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration - History of solid organ or stem cell transplant - Any malignancies or history of malignancies prior to Baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to Baseline) - Participants positive for human immunodeficiency virus; participants with any of the following results at Screening (Visit 1) or at any point during the parent study: presence of HBsAg with or without HBV DNA PCR test, or presence of anti-HBc Ab or presence of anti-HBs Ab with positive HBV DNA PCR test; positive HCVAb confirmed by positive HCV RNA - History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator - Participants with active TB, latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to screening - Participants with an intermediate or a positive IGRA test are excluded from the study unless all of the following conditions are met: 1. Have a history of prior documented completed chemoprophylaxis for latent TB infection (with a treatment regimen as per local guidelines), OR treated for active TB infection 2. Have been in written form approved for participation in the present trial by a TB specialist who ruled out latent or active TB infection or other mycobacterial infection in the participant 3. For whom review and approval from Sponsor have been granted are eligible - Severe concomitant illness that would in the Investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease - Skin co-morbidity that would adversely affect the ability to undertake AD assessments - Any medical or psychiatric condition which, in the opinion of the Investigator may present an unreasonable risk to the study patient as a result of his/her participation in this clinical study, may make patient's participation unreliable, or may interfere with study assessments - In the Investigator's opinion, medical conditions related to prior AD medications that have not healed/fully recovered for more than 2 weeks before screening visit, including, but not limited to, conjunctivitis, keratitis, eosinophilic conditions, arthralgia, herpes zoster, thrombosis

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Amlitelimab
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Other:
Topical corticosteroids
Pharmaceutical form: Topical Route of administration: Topical
Topical calcineurin inhibitors
Pharmaceutical form: Topical Route of administration: Topical
Oral corticosteroids
Pharmaceutical form: Oral Route of administration: Oral

Locations

Country Name City State
Australia Investigational Site Number : 0363002 Carlton Victoria
Australia Investigational Site Number : 0363003 East Melbourne Victoria
Australia Investigational Site Number : 0363001 Parkville Victoria
Bulgaria Investigational Site Number : 1002004 Pleven
Bulgaria Investigational Site Number : 1002002 Sofia
Bulgaria Investigational Site Number : 1002003 Sofia
Bulgaria Investigational Site Number : 1002005 Sofia
Bulgaria Investigational Site Number : 1002006 Sofia
Canada Investigational Site Number : 1240014 Barrie Ontario
Canada Investigational Site Number : 1240020 Hamilton Ontario
Canada Investigational Site Number : 1241106 Markham Ontario
Canada Investigational Site Number : 1240018 Newmarket Ontario
Canada Investigational Site Number : 1241108 Niagara Falls Ontario
Canada Investigational Site Number : 1240026 Toronto Ontario
Canada Investigational Site Number : 1241107 Waterloo Ontario
Canada Investigational Site Number : 1241101 Windsor Ontario
Czechia Investigational Site Number : 2032108 Brno
Czechia Investigational Site Number : 2032106 Kutna Hora
Czechia Investigational Site Number : 2032104 Ostrava
Czechia Investigational Site Number : 2032102 Praha 10
Czechia Investigational Site Number : 2032101 Praha 2
Czechia Investigational Site Number : 2032103 Praha 3
Germany Investigational Site Number : 2762203 Berlin
Germany Investigational Site Number : 2762202 Blankenfelde-Mahlow
Germany Investigational Site Number : 2762207 Gera
Germany Investigational Site Number : 2762208 Kiel
Germany Investigational Site Number : 2762201 Münster
Hungary Investigational Site Number : 3482303 Debrecen
Hungary Investigational Site Number : 3482305 Gyula
Hungary Investigational Site Number : 3482306 Szolnok
Japan Investigational Site Number : 3923112 Adachi-Ku Tokyo
Japan Investigational Site Number : 3923115 Chuo-Ku Tokyo
Japan Investigational Site Number : 3923104 Edogawa-Ku Tokyo
Japan Investigational Site Number : 3923109 Habikino-Shi
Japan Investigational Site Number : 3923108 Kagoshima-Shi Kagoshima
Japan Investigational Site Number : 3923102 Kyoto-Shi Kyoto
Japan Investigational Site Number : 3923107 Minato-Ku Tokyo
Japan Investigational Site Number : 3923114 Obihiro-Shi Hokkaido
Japan Investigational Site Number : 3923110 Sakai-shi Osaka
Japan Investigational Site Number : 3923101 Sapporo Hokkaido
Japan Investigational Site Number : 3923105 Setagaya-Ku Tokyo
Japan Investigational Site Number : 3923106 Shimotsuga-gun Tochigi
Japan Investigational Site Number : 3923113 Yokohama-Shi Kanagawa
Poland Investigational Site Number : 6162419 Bialystok Podlaskie
Poland Investigational Site Number : 6162402 Gdansk Pomorskie
Poland Investigational Site Number : 6162403 Gdansk Pomorskie
Poland Investigational Site Number : 6162404 Gdynia Pomorskie
Poland Investigational Site Number : 6162405 Katowice Slaskie
Poland Investigational Site Number : 6162406 Krakow Malopolskie
Poland Investigational Site Number : 6162408 Krakow
Poland Investigational Site Number : 6162409 Krakow
Poland Investigational Site Number : 6162407 Kraków Malopolskie
Poland Investigational Site Number : 6162415 Lódz Lódzkie
Poland Investigational Site Number : 6162416 Lódz Lódzkie
Poland Investigational Site Number : 6162401 Rzeszow Podkarpackie
Poland Investigational Site Number : 6162410 Szczecin Zachodniopomorskie
Poland Investigational Site Number : 6162411 Warszawa Mazowieckie
Poland Investigational Site Number : 6162412 Warszawa Mazowieckie
Poland Investigational Site Number : 6162413 Warszawa Mazowieckie
Poland Investigational Site Number : 6162414 Wroclaw Dolnoslaskie
Poland Investigational Site Number : 6162417 Wroclaw Dolnoslaskie
Poland Investigational Site Number : 6162418 Wroclaw Dolnoslaskie
Spain Investigational Site Number : 7242505 Alicante
Spain Investigational Site Number : 7242501 Córdoba
Spain Investigational Site Number : 7242503 Madrid Madrid, Comunidad De
Spain Investigational Site Number : 7242504 Pontevedra Galicia [Galicia]
Taiwan Investigational Site Number : 1583201 Kaohsiung Hsien,
Taiwan Investigational Site Number : 1583202 Taichung
Taiwan Investigational Site Number : 1583203 Tao Yuan County
United Kingdom Investigational Site Number : 8262601 London London, City Of
United Kingdom Investigational Site Number : 8262603 London London, City Of
United States CONTINENTAL CLINICAL RESEARCH Site Number : 8401011 Baltimore Maryland
United States Revival Research Corporation - Michigan - ClinEdge - PPDS Site Number : 8401012 Doral Florida
United States Florida International Research Center Site Number : 8401091 Miami Florida
United States Medical Research Center of Miami II, Inc Site Number : 8401019 Miami Florida
United States Sanchez Clinical Research, Inc Site Number : 8401095 Miami Florida
United States International Clinical Research-Tennessee LLC Site Number : 8401008 Murfreesboro Tennessee
United States Aeroallergy Research Laboratories Of Savannah Inc Site Number : 8401004 Savannah Georgia
United States Alliance Clinical Research - Tampa Site Number : 8401013 Tampa Florida
United States Vital Prospects Clinical Research Institute, P.C. Site Number : 8401005 Tulsa Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Czechia,  Germany,  Hungary,  Japan,  Poland,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of participants who experienced treatment-emergent adverse event (TEAE) Percentage of participants who experienced TEAE Baseline to Week 120
Secondary Percentage of participants who experienced treatment-emergent SAEs Percentage of participants who experienced treatment-emergent SAEs Baseline to Week 120
Secondary Percentage of participants who experienced treatment-emergent adverse events of special interest (AESI) Percentage of participants who experienced treatment-emergent AESI Baseline to Week 120
Secondary Absolute change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24 EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. DRI17366 Baseline to Week 104
Secondary Percent change from DRI17366 baseline in EASI score at each LTS17367 visit in participants entering the study from DRI17366 Week 24 EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. DRI17366 Baseline to Week 104
Secondary Proportion of participants with EASI75/EASI90/EASI100 from DRI17366 baseline at each LTS17367 visit in participants entering the study from DRI17366 Week 24 EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline; EASI100: >= 100% reduction in score from baseline.
DRI17366 Baseline to Week 104
Secondary Proportion of participants with a response of validated investigator global assessment (vIGA-AD) 0 or 1 at each LTS17367 visit in participants entering the study from DRI17366 Week 24 The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. Baseline to Week 104
Secondary Absolute change from parent study baseline in EASI score at pre-specified timepoints in all participants entering the study EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. Baseline to Week 104
Secondary Percent change from parent study baseline in EASI score at pre-specified timepoints in all participants entering the study EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. Baseline to Week 104
Secondary Proportion of participants with EASI50/ EASI75/ EASI90/ EASI100 at pre-specified timepoints in all participants entering the studyPercent change from parent study baseline in EASI score at pre-specified timepoints in all participants entering the study EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
EASI50: >= 50% reduction in score from baseline; EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline; EASI100: >= 100% reduction in score from baseline.
Baseline to Week 104
Secondary Time to first EASI75/EASI90/EASI100 in those participants who had not achieved it by the time of LTS17367 entry in all participants entering the study EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.
EASI75: >= 75% reduction in score from baseline; EASI90: >= 90% reduction in score from baseline; EASI100: >= 100% reduction in score from baseline.
Baseline to Week 104
Secondary Time to first remission after LTS17367 enrolment (achieving vIGA-AD 0/1) in those participants who had not achieved vIGA-AD 0/1 by the time of LTS17367 entry in all participants entering the study The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. Baseline to Week 104
Secondary Proportion of participants with vIGA-AD score 0/1 at each visit in all participants entering the study The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. Baseline to Week 104
Secondary Proportion of participants with low disease activity state (e.g., vIGA-AD =2) at each visit in all participants entering the study The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. Baseline to Week 104
Secondary Proportion of participants requiring rescue treatment at each visit: all treatments in all participants entering the study Proportion of participants requiring rescue treatment at each visit: all treatments in all participants entering the study. Baseline to Week 120
Secondary Proportion of participants requiring rescue treatment at each visit: topical treatments in all participants entering the study Proportion of participants requiring rescue treatment at each visit: topical treatments in all participants entering the study. Baseline to Week 120
Secondary Proportion of participants requiring rescue treatment at each visit: systematic treatments in all participants entering the study Proportion of participants requiring rescue treatment at each visit: systematic treatments in all participants entering the study. Baseline to Week 120
Secondary Number of days on topical medication (per patient-year) in all participants entering the study Number of days on topical medication (per patient-year) in all participants entering the study. Baseline to Week 120
Secondary Change from parent study baseline to prespecified time points through the end of the study: atopic dermatitis control tool (ADCT) in all participants entering the study ADCT is a six-item patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control. The score ranges from 0-24 with higher scores indicate worsening disease control. Baseline to Week 104
Secondary Change from parent study baseline to prespecified time points through the end of the study: dermatology life quality index (DLQI) in all participants entering the study The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL. Baseline to Week 104
Secondary Change from parent study baseline to prespecified time points through the end of the study: patient oriented eczema measure (POEM) in all participants entering the study The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life. Baseline to Week 104
Secondary Serum amlitelimab concentration assessed at prespecified time points through the end of the study Serum amlitelimab concentration assessed at prespecified time points through the end of the study. Baseline to Week 104
Secondary Anti-amlitelimab antibody titre in participants with positive response Anti-amlitelimab antibody titre in participants with positive response. Baseline to Week 120
Secondary Number of participants with positive anti-drug antibody response Number of participants with positive anti-drug antibody response. Baseline to Week 120
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