A Long-term Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants of Previous Amlitelimab Clinical Trials in Moderate to Severe Atopic Dermatitis.

Status: Recruiting
Location: See all (240) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

This is an open-label, Phase 2/Phase 3, long-term extension study for treatment of participants of previous amlitelimab clinical trials in moderate to severe atopic dermatitis. The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated participants with moderate to severe atopic dermatitis (AD) who have previously been enrolled in an amlitelimab clinical trial. All participants will have visits during the treatment period every 4 weeks. Responder participants rolling over from EFC17599 and EFC17600, and responder participants enrolling through screening from DRI17366 will be initiated into drug withdrawal (with no drug administration) at LTS17367 baseline visit to monitor durability of treatment response. If these responder participants relapse during LTS17367, they will have treatment restored. Non-responder participants rolling over from EFC17599 or EFC17600, and non-responder participants enrolling through screening from DRI17366 will have treatment administration from LTS17367 baseline. Participants rolling over from DRI17366, SFY17915 and INT18404 will also have treatment administration from LTS17367 baseline. Remote visits with home dosing are allowed for the purpose of study drug administration, when applicable. In the case of remote visit with home dosing, the participant or a caregiver may administer study drug after appropriate training. Alternatively, if needed, and based on the investigator's judgement, home visits with healthcare professional assistance or on-site study drug administration visits can be performed. Where participants discontinue amlitelimab permanently during LTS17367, safety follow up will be performed for a minimum of 140 days from the last amlitelimab administration.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Participant must be at least 12 years of age inclusive 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 feeder study SFY17915, INT18404, EFC17599, or EFC17600

⁃ 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 feeder study, due to loss of clinical response in the part 2 of the feeder study. Timepoints for entering LTS17367 are Weeks 28, 32, 36, 40, 44, 48 or 52.

∙ 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.

⁃ Participated in DRI17366 completing the previous study safety follow up (Week 68) and wish to re-initiate treatment with amlitelimab up to one year after the last visit

• Complied with the previous clinical trial protocol to the satisfaction of the investigator

• Body weight must be ≥25 kg

Locations
United States
Alabama
Allervie Clinical Research - Birmingham- Site Number : 8401101
RECRUITING
Birmingham
Cahaba Dermatology & Skin Health Center- Site Number : 8401066
RECRUITING
Birmingham
Arkansas
Arkansas Research Trials- Site Number : 8401244
RECRUITING
North Little Rock
Arizona
Center for Dermatology and Plastic Surgery- Site Number : 8401119
RECRUITING
Scottsdale
Scottsdale Clinical Trials- Site Number : 8401149
RECRUITING
Scottsdale
California
Orange County Clinical Trials- Site Number : 8401271
RECRUITING
Anaheim
Encino Research Center- Site Number : 8401042
RECRUITING
Encino
First OC Dermatology- Site Number : 8401025
RECRUITING
Fountain Valley
Center for Dermatology Clinical Research- Site Number : 8401018
RECRUITING
Fremont
Sunwise Clinical Research- Site Number : 8401022
RECRUITING
Lafayette
Antelope Valley Clinical Trials- Site Number : 8401099
RECRUITING
Lancaster
Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027
RECRUITING
Lomita
Long Beach Clinical Trials- Site Number : 8401188
RECRUITING
Long Beach
Dermatology Research Associates - Los Angeles- Site Number : 8401092
RECRUITING
Los Angeles
LA Universal Research Center- Site Number : 8401064
RECRUITING
Los Angeles
Cura Clinical Research - Oxnard- Site Number : 8401142
RECRUITING
Oxnard
Clinical Science Institute- Site Number : 8401028
RECRUITING
Santa Monica
Colorado
Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245
RECRUITING
Wheat Ridge
Florida
Encore Medical Research of Boynton Beach- Site Number : 8401030
RECRUITING
Boynton Beach
St. Jude Clinical Research- Site Number : 8401287
RECRUITING
Doral
Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111
RECRUITING
Fort Myers
Direct Helpers Research Center- Site Number : 8401056
RECRUITING
Hialeah
Doral Medical Research - Hialeah- Site Number : 8401094
RECRUITING
Hialeah
Acevedo Clinical Research Associates- Site Number : 8401088
RECRUITING
Miami
Clever Medical Research- Site Number : 8401160
RECRUITING
Miami
Florida International Research Center- Site Number : 8401091
RECRUITING
Miami
Future Care Solution - Miami- Site Number : 8401144
RECRUITING
Miami
Medical Research Center of Miami II- Site Number : 8401019
COMPLETED
Miami
Sanchez Clinical Research- Site Number : 8401095
RECRUITING
Miami
Savin Medical Group - Miami Lakes- Site Number : 8401085
RECRUITING
Miami Lakes
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8401109
RECRUITING
Miami Lakes
K2 South Orlando - South Orange Avenue- Site Number : 8401268
RECRUITING
Orlando
Global Clinical Professionals (GCP)- Site Number : 8401045
RECRUITING
St. Petersburg
Alliance Clinical Research of Tampa- Site Number : 8401013
RECRUITING
Tampa
Clinical Research Trials of Florida- Site Number : 8401023
RECRUITING
Tampa
Georgia
First Georgia Physician Group- Site Number : 8401190
RECRUITING
Fayetteville
Aeroallergy Research Laboratory- Site Number : 8401004
RECRUITING
Savannah
Illinois
Northwestern University- Site Number : 8401038
RECRUITING
Chicago
Kentucky
Equity Medical - Bowling Green- Site Number : 8401296
RECRUITING
Bowling Green
Skin Sciences- Site Number : 8401039
RECRUITING
Louisville
Louisiana
Velocity Clinical Research at The Dermatology Clinic - Baton Rouge- Site Number : 8401072
RECRUITING
Baton Rouge
MedPharmics - Covington- Site Number : 8401137
RECRUITING
Covington
BRCR Global Gretna- Site Number : 8401243
RECRUITING
Gretna
Michigan
Oakland Medical Center- Site Number : 8401116
RECRUITING
Troy
Revival Research Corporation - Michigan- Site Number : 8401012
RECRUITING
Troy
Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078
RECRUITING
Ypsilanti
Mississippi
SKY Integrative Medical Center/SKYCRNG - Ridgeland- Site Number : 8401058
RECRUITING
Ridgeland
North Dakota
Axis Clinical Trials- Site Number : 8401196
RECRUITING
Fargo
Nebraska
Skin Specialists- Site Number : 8401068
RECRUITING
Omaha
New Mexico
The University of New Mexico- Site Number : 8401263
RECRUITING
Albuquerque
Nevada
Pulmonology Group - Henderson- Site Number : 8401169
RECRUITING
Henderson
New York
Equity Medical- Site Number : 8401239
RECRUITING
New York
Skin Search Rochester- Site Number : 8401216
RECRUITING
Rochester
Pennsylvania
Best Skin Research - Camp Hill- Site Number : 8401031
RECRUITING
Camp Hill
Clinical Research of Philadelphia- Site Number : 8401193
RECRUITING
Philadelphia
Paddington Testing Company- Site Number : 8401041
RECRUITING
Philadelphia
Dermatology Associates of Plymouth Meeting- Site Number : 8401147
RECRUITING
Plymouth Meeting
South Carolina
Velocity Clinical Research - Columbia- Site Number : 8401176
RECRUITING
Columbia
South Dakota
Health Concepts - Site Number : 8401059
RECRUITING
Rapid City
Texas
Arlington Research Center- Site Number : 8401248
RECRUITING
Arlington
Modern Research Associates- Site Number : 8401093
RECRUITING
Dallas
Reveal Research Institute - Dallas- Site Number : 8401219
RECRUITING
Dallas
SMS Clinical Research- Site Number : 8401182
RECRUITING
Mesquite
Synapse Clinical Research - Missouri City- Site Number : 8401148
RECRUITING
Missouri City
Stryde Research - Epiphany Dermatology- Site Number : 8401185
RECRUITING
Southlake
Complete Dermatology - Sugar Land- Site Number : 8401061
RECRUITING
Sugar Land
Virginia
Virginia Dermatology & Skin Cancer Center- Site Number : 8401047
RECRUITING
Norfolk
Wyoming
Wyoming Research Foundation- Site Number : 8401234
RECRUITING
Cheyenne
Other Locations
Argentina
Investigational Site Number : 0320002
RECRUITING
Buenos Aires
Investigational Site Number : 0320004
RECRUITING
Buenos Aires
Investigational Site Number : 0320005
RECRUITING
Buenos Aires
Investigational Site Number : 0320008
RECRUITING
Buenos Aires
Investigational Site Number : 0320011
RECRUITING
Buenos Aires
Investigational Site Number : 0320019
RECRUITING
Buenos Aires
Investigational Site Number : 0320014
RECRUITING
Córdoba
Investigational Site Number : 0320013
RECRUITING
Mendoza
Investigational Site Number : 0320007
RECRUITING
Rosario
Australia
Investigational Site Number : 0363002
RECRUITING
Carlton
Investigational Site Number : 0360006
RECRUITING
Melbourne
Investigational Site Number : 0363003
RECRUITING
Melbourne
Investigational Site Number : 0363001
RECRUITING
Parkville
Investigational Site Number : 0361006
RECRUITING
Traralgon
Investigational Site Number : 0360010
RECRUITING
Westmead
Investigational Site Number : 0360007
RECRUITING
Woolloongabba
Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
RECRUITING
Porto Alegre
Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
RECRUITING
Salvador
Faculdade de Medicina do ABC- Site Number : 0760001
RECRUITING
Santo André
Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014
RECRUITING
São Paulo
Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010
RECRUITING
São Paulo
Clinica de Alergia Martti Antila- Site Number : 0760006
RECRUITING
Sorocaba
Bulgaria
Investigational Site Number : 1002004
RECRUITING
Pleven
Investigational Site Number : 1002002
RECRUITING
Sofia
Investigational Site Number : 1002003
RECRUITING
Sofia
Investigational Site Number : 1002005
RECRUITING
Sofia
Investigational Site Number : 1002006
RECRUITING
Sofia
Canada
Investigational Site Number : 1240033
RECRUITING
Ajax
Investigational Site Number : 1240014
RECRUITING
Barrie
Investigational Site Number : 1240019
RECRUITING
Calgary
Investigational Site Number : 1240023
RECRUITING
Calgary
Investigational Site Number : 1240016
RECRUITING
Edmonton
Investigational Site Number : 1240031
RECRUITING
Edmonton
Investigational Site Number : 1240020
RECRUITING
Hamilton
Investigational Site Number : 1240017
RECRUITING
London
Investigational Site Number : 1240053
RECRUITING
London
Investigational Site Number : 1241106
ACTIVE_NOT_RECRUITING
Markham
Investigational Site Number : 1240018
RECRUITING
Newmarket
Investigational Site Number : 1241108
RECRUITING
Niagara Falls
Investigational Site Number : 1240034
RECRUITING
Ottawa
Investigational Site Number : 1240006
RECRUITING
Québec
Investigational Site Number: 1240028
RECRUITING
Regina
Investigational Site Number : 1240024
RECRUITING
Richmond Hill
Investigational Site Number : 1240036
RECRUITING
Saskatoon
Investigational Site Number : 1240040
RECRUITING
Surrey
Investigational Site Number : 1240012
RECRUITING
Toronto
Investigational Site Number : 1240021
RECRUITING
Toronto
Investigational Site Number : 1240026
RECRUITING
Toronto
Investigational Site Number: 1240035
RECRUITING
Toronto
Investigational Site Number : 1241107
RECRUITING
Waterloo
Investigational Site Number : 1241101
RECRUITING
Windsor
Investigational Site Number : 1240041
RECRUITING
Winnipeg
Chile
Investigational Site Number : 1520001
RECRUITING
Santiago
Investigational Site Number : 1520002
RECRUITING
Santiago
Investigational Site Number : 1520003
RECRUITING
Santiago
Investigational Site Number : 1520005
RECRUITING
Santiago
China
Investigational Site Number : 1560022
RECRUITING
Chengdu
Investigational Site Number : 1560021
RECRUITING
Guangzhou
Investigational Site Number : 1560025
RECRUITING
Guangzhou
Investigational Site Number : 1560036
RECRUITING
Guangzhou
Investigational Site Number : 1560002
RECRUITING
Hangzhou
Investigational Site Number : 1560006
RECRUITING
Hangzhou
Investigational Site Number : 1560029
RECRUITING
Hangzhou
Investigational Site Number : 1560044
RECRUITING
Hangzhou
Investigational Site Number : 1560035
RECRUITING
Ningbo
Investigational Site Number : 1560001
RECRUITING
Shanghai
Investigational Site Number : 1560026
RECRUITING
Shenyang
Investigational Site Number : 1560041
RECRUITING
Shenyang
Investigational Site Number : 1560023
RECRUITING
Wenzhou
Investigational Site Number : 1560038
RECRUITING
Wuhan
Investigational Site Number : 1560003
RECRUITING
Wuxi
Investigational Site Number : 1560028
RECRUITING
Zhenjiang
France
Investigational Site Number : 2500008
RECRUITING
Antony
Investigational Site Number : 2500011
RECRUITING
Bordeaux
Investigational Site Number : 2500014
RECRUITING
Clermont-ferrand
Investigational Site Number : 2500001
RECRUITING
Lille
Investigational Site Number : 2500012
RECRUITING
Rouen
Germany
Investigational Site Number : 2762203
RECRUITING
Berlin
Investigational Site Number : 2762202
RECRUITING
Blankenfelde-mahlow
Investigational Site Number : 2762207
RECRUITING
Gera
Investigational Site Number : 2760017
RECRUITING
Hamburg
Investigational Site Number : 2762208
RECRUITING
Kiel
Investigational Site Number : 2761002
RECRUITING
Lübeck
Investigational Site Number : 2762201
RECRUITING
Münster
Greece
Investigational Site Number : 3000001
RECRUITING
Athens
Hungary
Investigational Site Number : 3482303
ACTIVE_NOT_RECRUITING
Debrecen
Investigational Site Number : 3482306
ACTIVE_NOT_RECRUITING
Szolnok
Israel
Investigational Site Number : 3760005
RECRUITING
Beersheba
Investigational Site Number : 3760003
RECRUITING
Jerusalem
Investigational Site Number : 3760007
RECRUITING
Tel Aviv
Investigational Site Number : 3760008
RECRUITING
Tel Litwinsky
Italy
Investigational Site Number : 3800016
RECRUITING
Chieti
Investigational Site Number : 3800021
RECRUITING
Modena
Investigational Site Number : 3800015
RECRUITING
Perugia
Investigational Site Number : 3800020
RECRUITING
Torino
Japan
Investigational Site Number : 3923112
RECRUITING
Adachi-ku
Investigational Site Number : 3923115
RECRUITING
Chuo-ku
Investigational Site Number : 3923104
RECRUITING
Edogawa-ku
Investigational Site Number : 3923109
RECRUITING
Habikino-shi
Investigational Site Number : 3920007
RECRUITING
Hiroshima
Investigational Site Number : 3923108
RECRUITING
Kagoshima
Investigational Site Number : 3920003
RECRUITING
Kyoto
Investigational Site Number : 3923102
RECRUITING
Kyoto
Investigational Site Number : 3923107
RECRUITING
Minato-ku
Investigational Site Number : 3923114
RECRUITING
Obihiro-shi
Investigational Site Number : 3923110
RECRUITING
Sakai-shi
Investigational Site Number : 3923101
RECRUITING
Sapporo
Investigational Site Number : 3923105
RECRUITING
Setagaya-ku
Investigational Site Number : 3923106
RECRUITING
Shimotsuga-gun
Investigational Site Number : 3920001
RECRUITING
Tachikawa-shi
Investigational Site Number : 3923113
RECRUITING
Yokohama
Investigational Site Number : 3923113
RECRUITING
Yokohama
Poland
Investigational Site Number : 6162419
RECRUITING
Bialystok
Investigational Site Number : 6160006
RECRUITING
Gdansk
Investigational Site Number : 6162402
ACTIVE_NOT_RECRUITING
Gdansk
Investigational Site Number : 6162403
ACTIVE_NOT_RECRUITING
Gdansk
Investigational Site Number : 6162404
ACTIVE_NOT_RECRUITING
Gdynia
Investigational Site Number : 6162405
RECRUITING
Katowice
Investigational Site Number : 6162406
RECRUITING
Krakow
Investigational Site Number : 6162407
RECRUITING
Krakow
Investigational Site Number : 6162408
RECRUITING
Krakow
Investigational Site Number : 6162409
RECRUITING
Krakow
Investigational Site Number : 6162415
RECRUITING
Lodz
Investigational Site Number : 6162416
RECRUITING
Lódz
Investigational Site Number : 6162401
RECRUITING
Rzeszów
Investigational Site Number : 6162410
RECRUITING
Szczecin
Investigational Site Number: 6160010
RECRUITING
Tarnów
Investigational Site Number : 6162411
RECRUITING
Warsaw
Investigational Site Number : 6162412
RECRUITING
Warsaw
Investigational Site Number : 6162413
RECRUITING
Warsaw
Investigational Site Number : 6162414
ACTIVE_NOT_RECRUITING
Wroclaw
Investigational Site Number : 6162417
RECRUITING
Wroclaw
Investigational Site Number : 6162418
RECRUITING
Wroclaw
Republic of Korea
Investigational Site Number : 4100002
RECRUITING
Ansan-si
Investigational Site Number : 4100008
RECRUITING
Daegu
Investigational Site Number : 4100012
RECRUITING
Gwangju
Investigational Site Number : 4100015
RECRUITING
Incheon
Investigational Site Number : 4100006
RECRUITING
Seoul
Investigational Site Number : 4100007
RECRUITING
Seoul
Investigational Site Number : 4100010
RECRUITING
Seoul
Investigational Site Number : 4100013
RECRUITING
Seoul
Investigational Site Number : 4100009
RECRUITING
Suwon
Investigational Site Number : 4100003
RECRUITING
Yangsan
Saudi Arabia
Investigational Site Number : 6820001
RECRUITING
Riyadh
South Africa
Investigational Site Number : 7100010
RECRUITING
Cape Town
Investigational Site Number: 7100009
RECRUITING
Claremont
Investigational Site Number : 7100001
RECRUITING
Durban
Investigational Site Number : 7100012
RECRUITING
Durban
Spain
Investigational Site Number : 7242505
RECRUITING
Alicante
Investigational Site Number : 7240002
RECRUITING
Badalona
Investigational Site Number : 7240023
RECRUITING
Burjassot - Valencia
Investigational Site Number : 7242501
COMPLETED
Córdoba
Investigational Site Number : 7240018
RECRUITING
Granada
Investigational Site Number : 7240012
RECRUITING
Las Palmas De Gran Canaria
Investigational Site Number : 7242503
RECRUITING
Madrid
Investigational Site Number : 7242504
ACTIVE_NOT_RECRUITING
Pontevedra
Taiwan
Investigational Site Number : 1583201
RECRUITING
Kaohsiung City
Investigational Site Number : 1583202
RECRUITING
Taichung
Investigational Site Number : 1580001
RECRUITING
Taipei
Investigational Site Number : 1583203
RECRUITING
Taoyuan
Turkey
Investigational Site Number : 7920005
RECRUITING
Istanbul
Investigational Site Number : 7920004
RECRUITING
Kayseri
Investigational Site Number : 7920008
RECRUITING
Şahinbey
United Arab Emirates
Investigational Site Number : 7840001
RECRUITING
Abu Dhabi
United Kingdom
Investigational Site Number : 8260013
RECRUITING
Bristol
Investigational Site Number : 8260006
RECRUITING
Glasgow
Investigational Site Number : 8260004
RECRUITING
Leicester
Investigational Site Number : 8260008
RECRUITING
Liverpool
Investigational Site Number : 8262601
COMPLETED
London
Investigational Site Number : 8262603
RECRUITING
London
Investigational Site Number : 8260003
RECRUITING
Portsmouth
Investigational Site Number : 8260010
RECRUITING
Sutton In Ashfield
Contact Information
Primary
Trial Transparency email recommended (Toll free number for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2022-08-22
Estimated Completion Date: 2029-01-22
Participants
Target number of participants: 1663
Treatments
Experimental: Amlitelimab dose level 1
Subcutaneous injection as per protocol
Experimental: Amlitelimab dose level 2
Subcutaneous injection as per protocol
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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