Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials
Public ClinicalTrials.gov record NCT05492578. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05492578
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 1,856 participants
Conditions and interventions
Conditions
Interventions
- Amlitelimab Drug
- Topical corticosteroids Drug
- Topical calcineurin inhibitors Drug
- Oral corticosteroids Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 22, 2022 (Actual)
- Primary completion
- Jan 22, 2029 (Estimated)
- Completion
- Jan 22, 2029 (Estimated)
- Last update posted
- Oct 13, 2026
2022 – 2029
United States locations
- U.S. sites
- 101
- U.S. states
- 30
- U.S. cities
- 80
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Allervie Clinical Research - Birmingham- Site Number : 8401101 | Birmingham | Alabama | 35209 | — |
| Cahaba Dermatology & Skin Health Center- Site Number : 8401066 | Birmingham | Alabama | 35244 | — |
| Center for Dermatology and Plastic Surgery- Site Number : 8401119 | Scottsdale | Arizona | 85260 | — |
| Scottsdale Clinical Trials- Site Number : 8401149 | Scottsdale | Arizona | 85260 | — |
| Eclipse Clinical Research- Site Number : 8401158 | Tucson | Arizona | 85745 | — |
| Arkansas Research Trials- Site Number : 8401244 | North Little Rock | Arkansas | 72217 | — |
| Orange County Clinical Trials- Site Number : 8401271 | Anaheim | California | 92801 | — |
| Encino Research Center- Site Number : 8401042 | Encino | California | 91436 | — |
| First OC Dermatology- Site Number : 8401025 | Fountain Valley | California | 92708 | — |
| Center for Dermatology Clinical Research- Site Number : 8401018 | Fremont | California | 94538 | — |
| Marvel Clinical Research- Site Number : 8401102 | Huntington Beach | California | 92647 | — |
| Sunwise Clinical Research - Lafayette- Site Number : 8401022 | Lafayette | California | 94549 | — |
| Antelope Valley Clinical Trials- Site Number : 8401099 | Lancaster | California | 93534 | — |
| Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027 | Lomita | California | 90717 | — |
| Long Beach Clinical Trials- Site Number : 8401188 | Long Beach | California | 90806 | — |
| Dermatology Research Associates- Site Number : 8401092 | Los Angeles | California | 90045 | — |
| LA Universal Research Center- Site Number : 8401064 | Los Angeles | California | 90057 | — |
| University Dermatology Trials- Site Number : 8401339 | Newport Beach | California | 92660 | — |
| Cura Clinical Research - Oxnard- Site Number : 8401142 | Oxnard | California | 93030 | — |
| Southern California Dermatology- Site Number : 8401043 | Santa Ana | California | 92701 | — |
| Clinical Science Institute- Site Number : 8401028 | Santa Monica | California | 90404 | — |
| Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245 | Wheat Ridge | Colorado | 80033 | — |
| UConn Health - Farmington- Site Number : 8401115 | Farmington | Connecticut | 06030 | — |
| Encore Medical Research of Boynton Beach- Site Number : 8401030 | Boynton Beach | Florida | 33436 | — |
| Pediatric Skin Research- Site Number : 8401198 | Coral Gables | Florida | 33146 | — |
| St. Jude Clinical Research- Site Number : 8401287 | Doral | Florida | 33172 | — |
| Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111 | Fort Myers | Florida | 33912 | — |
| Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286 | Fort Myers | Florida | 33919 | — |
| Direct Helpers Research Center- Site Number : 8401056 | Hialeah | Florida | 33012 | — |
| Doral Medical Research - Hialeah- Site Number : 8401094 | Hialeah | Florida | 33016 | — |
| Apex Clinical Research - Jacksonville- Site Number : 8401332 | Jacksonville | Florida | 32256 | — |
| Clever Medical Research- Site Number : 8401160 | Miami | Florida | 33126 | — |
| Miami Dermatology and Laser Research- Site Number : 8401086 | Miami | Florida | 33133 | — |
| Medical Research Center of Miami II- Site Number : 8401019 | Miami | Florida | 33134 | — |
| Acevedo Clinical Research Associates- Site Number : 8401088 | Miami | Florida | 33142 | — |
| Future Care Solution - Miami- Site Number : 8401144 | Miami | Florida | 33142 | — |
| Sanchez Clinical Research- Site Number : 8401095 | Miami | Florida | 33157 | — |
| Florida International Research Center- Site Number : 8401091 | Miami | Florida | 33173 | — |
| Savin Medical Group - Miami Lakes- Site Number : 8401085 | Miami Lakes | Florida | 33014 | — |
| Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8401109 | Miami Lakes | Florida | 33016 | — |
| K2 South Orlando - South Orange Avenue- Site Number : 8401268 | Orlando | Florida | 32806 | — |
| Nuline Clinical Trial Center- Site Number : 8401161 | Pompano Beach | Florida | 33060 | — |
| Global Clinical Professionals (GCP)- Site Number : 8401045 | St. Petersburg | Florida | 33714 | — |
| Clinical Research Trials of Florida- Site Number : 8401023 | Tampa | Florida | 33607 | — |
| Alliance Clinical Research of Tampa- Site Number : 8401013 | Tampa | Florida | 33615 | — |
| Cleaver Medical Group- Site Number : 8401138 | Dawsonville | Georgia | 30534 | — |
| First Georgia Physician Group- Site Number : 8401190 | Fayetteville | Georgia | 30214 | — |
| Dermatologic Surgery Specialists- Site Number : 8401034 | Macon | Georgia | 31217 | — |
| Aeroallergy Research Laboratory- Site Number : 8401004 | Savannah | Georgia | 31406 | — |
| Javara Research - Thomasville- Site Number : 8401189 | Thomasville | Georgia | 31792 | — |
| Rophe Adult & Pediatric Medicine- Site Number : 8401289 | Union City | Georgia | 30291 | — |
| Northwestern University Feinberg School of Medicine- Site Number : 8401285 | Chicago | Illinois | 60611 | — |
| Northwestern University- Site Number : 8401038 | Chicago | Illinois | 60611 | — |
| Dawes Fretzin Clinical Research- Site Number : 8401015 | Indianapolis | Indiana | 46256 | — |
| Equity Medical - Bowling Green- Site Number : 8401296 | Bowling Green | Kentucky | 42104 | — |
| Skin Sciences- Site Number : 8401039 | Louisville | Kentucky | 40217 | — |
| Velocity Clinical Research at The Dermatology Clinic - Baton Rouge- Site Number : 8401072 | Baton Rouge | Louisiana | 70809 | — |
| MedPharmics - Covington- Site Number : 8401137 | Covington | Louisiana | 70433 | — |
| BRCR Global Gretna- Site Number : 8401243 | Gretna | Louisiana | 70053 | — |
| Velocity Clinical Research - Lafayette- Site Number : 8401152 | Lafayette | Louisiana | 70508 | — |
| MetroBoston Clinical Partners - Brighton- Site Number : 8401128 | Brighton | Massachusetts | 02135 | — |
| Henry Ford Hospital- Site Number : 8401044 | Detroit | Michigan | 48202 | — |
| Revival Research Institute - Troy- Site Number : 8401012 | Troy | Michigan | 48084 | — |
| Oakland Medical Center- Site Number : 8401116 | Troy | Michigan | 48085 | — |
| Allergy Immunology Assoc Ann Arbor- Site Number : 8401078 | Ypsilanti | Michigan | 48197 | — |
| SKY Integrative Medical Center/SKYCRNG- Site Number : 8401058 | Ridgeland | Mississippi | 39157 | — |
| Skin Specialists- Site Number : 8401068 | Omaha | Nebraska | 68144 | — |
| Pulmonology Group - Henderson- Site Number : 8401169 | Henderson | Nevada | 89052 | — |
| Jubilee Clinical Research- Site Number : 8401054 | Las Vegas | Nevada | 89106 | — |
| Schweiger Dermatology Group - East Windsor- Site Number : 8401338 | East Windsor | New Jersey | 08520 | — |
| Care Access - Hoboken- Site Number : 8401132 | Hoboken | New Jersey | 07030 | — |
| The University of New Mexico- Site Number : 8401263 | Albuquerque | New Mexico | 87106 | — |
| Sadick Research Group - New York - Park Avenue- Site Number : 8401050 | New York | New York | 10075 | — |
| OptiSkin- Site Number : 8401163 | New York | New York | 10128 | — |
| Skin Search Rochester- Site Number : 8401216 | Rochester | New York | 14623 | — |
| Equity Medical (LLC)- Site Number : 8401239 | The Bronx | New York | 10455 | — |
| AXIS Clinicals - Fargo- Site Number : 8401196 | Fargo | North Dakota | 58103 | — |
| Cincinnati Children's Hospital Medical Center- Site Number : 8401279 | Cincinnati | Ohio | 45229 | — |
| Apex Clinical Research Center- Site Number : 8401237 | Mayfield Heights | Ohio | 44124 | — |
| Oregon Health & Science University (OHSU)- Site Number : 8401247 | Portland | Oregon | 97239 | — |
| Best Skin Research - Camp Hill- Site Number : 8401031 | Camp Hill | Pennsylvania | 17011 | — |
| Paddington Testing Company- Site Number : 8401041 | Philadelphia | Pennsylvania | 19103 | — |
| Clinical Research of Philadelphia- Site Number : 8401193 | Philadelphia | Pennsylvania | 19114 | — |
| Dermatology Associates of Plymouth Meeting- Site Number : 8401147 | Plymouth Meeting | Pennsylvania | 19462 | — |
| Velocity Clinical Research - Columbia- Site Number : 8401176 | Columbia | South Carolina | 29204 | — |
| Columbia Dermatology & Aesthetics- Site Number : 8401166 | Columbia | South Carolina | 29212 | — |
| Health Concepts- Site Number : 8401059 | Rapid City | South Dakota | 57702 | — |
| Arlington Research Center- Site Number : 8401248 | Arlington | Texas | 76011 | — |
| Dermatology Treatment and Research Center- Site Number : 8401164 | Dallas | Texas | 75230 | — |
| Modern Research Associates- Site Number : 8401093 | Dallas | Texas | 75231 | — |
| Derm Texas- Site Number : 8401217 | Dallas | Texas | 75235 | — |
| Reveal Research Institute - Dallas- Site Number : 8401219 | Dallas | Texas | 75235 | — |
| Prolato Clinical Research Center- Site Number : 8401209 | Houston | Texas | 77054 | — |
| SMS Clinical Research- Site Number : 8401182 | Mesquite | Texas | 75149 | — |
| Synapse Clinical Research - Missouri City- Site Number : 8401148 | Missouri City | Texas | 77459 | — |
| Stryde Research - Epiphany Dermatology- Site Number : 8401185 | Southlake | Texas | 76092 | — |
| Complete Dermatology - Site Number : 8401061 | Sugar Land | Texas | 77479 | — |
| Tanner Clinic - Layton Antelope A- Site Number : 8401151 | Layton | Utah | 84041 | — |
| Care Access Research - Arlington- Site Number : 8401134 | Arlington | Virginia | 22206 | — |
| Virginia Dermatology & Skin Cancer Center- Site Number : 8401047 | Norfolk | Virginia | 23502 | — |
| Wyoming Research Foundation- Site Number : 8401234 | Cheyenne | Wyoming | 82001 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 291 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05492578, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 13, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05492578 live on ClinicalTrials.gov.