A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo
Public ClinicalTrials.gov record NCT06015308. 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 Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Amlitelimab on Vaccine Antibody Responses in Adult Participants With Moderate to Severe Atopic Dermatitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 2, multicenter, randomized, double-blind placebo controlled, 2-arm study to evaluate the effect of amlitelimab on vaccine antibody responses, and the safety of amlitelimab concurrently administered with non-live vaccines in adult participants with moderate-to-severe atopic dermatitis (AD). The purpose of this study is to compare the immune responses to concomitantly administered Boostrix (tetanus, diphtheria, and acellular pertussis \[Tdap\]) and Pneumovax 23 (PPSV) vaccines in adult participants with moderate-to-severe AD treated with amlitelimab versus placebo. The study will evaluate the percentage of participants achieving a positive anti-tetanus response at Week 16 (primary endpoint) and a positive anti-pneumococcal response at Week 16 (key secondary endpoint). Study details include: The study duration will be up to 36 weeks (for participants not entering the LTS17367 \[RIVER-AD\]). The screening period will be 9 days to 4 weeks. The treatment duration will be up to 16 weeks. The post-treatment safety follow-up period will be16 weeks. The number of visits will be up to 7 (or 6 for those entering LTS17367 \[RIVER-AD\]).
Study identification
- NCT ID
- NCT06015308
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 224 participants
Conditions and interventions
Conditions
Interventions
- Amlitelimab Drug
- Placebo Drug
- Tdap vaccine Biological
- PPS vaccine Biological
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 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
- Oct 5, 2023
- Primary completion
- Sep 30, 2025
- Completion
- Jan 15, 2026
- Last update posted
- Aug 9, 2026
2023 – 2026
United States locations
- U.S. sites
- 47
- U.S. states
- 19
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Center of Alabama - Homewood- Site Number : 8401101 | Birmingham | Alabama | 35209 | — |
| Center for Dermatology and Plastic Surgery- Site Number : 8401119 | Scottsdale | Arizona | 85260 | — |
| Orange County Clinical Trials- Site Number : 8401271 | Anaheim | California | 92801 | — |
| First OC Dermatology- Site Number : 8401025 | Fountain Valley | California | 92708 | — |
| Center for Dermatology Clinical Research- Site Number : 8401018 | Fremont | California | 94538 | — |
| Valley Research- Site Number : 8401097 | Fresno | California | 93720 | — |
| Paradigm Clinical Research Centers- Site Number : 8401273 | La Mesa | California | 91942 | — |
| Sunwise Clinical Research- Site Number : 8401022 | Lafayette | California | 94549 | — |
| Antelope Valley Clinical Trials- Site Number : 8401099 | Lancaster | California | 93534 | — |
| Torrance Clinical Research- Site Number : 8401027 | Lomita | California | 90717 | — |
| Clinical Science Institute- Site Number : 8401028 | Santa Monica | California | 90404 | — |
| Velocity Clinical Research - Denver Site Number : 8401168 | Denver | Colorado | 80209 | — |
| Daxia Trials- Site Number : 8401145 | Boca Raton | Florida | 33431 | — |
| Encore Medical Research of Boynton Beach- Site Number : 8401030 | Boynton Beach | Florida | 33436 | — |
| Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111 | Fort Myers | Florida | 33912 | — |
| Doral Medical Research- Site Number : 8401094 | Hialeah | Florida | 33016 | — |
| C&R Research Services - Kendall- Site Number : 8401029 | Kendall | Florida | 33183 | — |
| 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 | — |
| Wellness Clinical Research - Miami Lakes- Site Number : 8401109 | Miami Lakes | Florida | 33016 | — |
| K2 South Orlando - South Orange Avenue- Site Number : 8401268 | Orlando | Florida | 32806 | — |
| SEC Clinical Research- Site Number : 8401270 | Pensacola | Florida | 32501 | — |
| Global Clinical Professionals (GCP)- Site Number : 8401045 | St. Petersburg | Florida | 33705 | — |
| Clinical Research Trials of Florida- Site Number : 8401023 | Tampa | Florida | 33607 | — |
| Paradigm Clinical Research - Boise- Site Number : 8401272 | Boise | Idaho | 83709 | — |
| Skin Sciences- Site Number : 8401039 | Louisville | Kentucky | 40217 | — |
| Velocity Clinical Research at The Dermatology Clinic- Site Number : 8401072 | Baton Rouge | Louisiana | 70809 | — |
| BRCR Global Gretna- Site Number : 8401243 | Gretna | Louisiana | 70053 | — |
| Boeson Research - Missoula- Site Number : 8401269 | Missoula | Montana | 59804 | — |
| Henderson Clinical Trials- Site Number : 8401169 | Henderson | Nevada | 89052 | — |
| Skin Search Rochester- Site Number : 8401216 | Rochester | New York | 14623 | — |
| Velocity Clinical Research - Durham- Site Number : 8401175 | Durham | North Carolina | 27701 | — |
| Velocity Clinical Research - Springdale- Site Number : 8401153 | Cincinnati | Ohio | 45246 | — |
| Velocity Clinical Research - Medford- Site Number : 8401170 | Medford | Oregon | 97504 | — |
| Vial Health - DermDox Dermatology- Site Number : 8401031 | Camp Hill | Pennsylvania | 17011 | — |
| Velocity Clinical Research - Providence- Site Number : 8401179 | East Greenwich | Rhode Island | 02818 | — |
| Velocity Clinical Research - Charleston - Ashley Town Center Drive- Site Number : 8401174 | Charleston | South Carolina | 29414 | — |
| Velocity Clinical Research - Columbia- Site Number : 8401176 | Columbia | South Carolina | 29204 | — |
| Velocity Clinical Research - Austin- Site Number : 8401173 | Cedar Park | Texas | 78613 | — |
| Modern Research Associates- Site Number : 8401093 | Dallas | Texas | 75231 | — |
| Heights Dermatology & Aesthetic Center- Site Number : 8401143 | Houston | Texas | 77008 | — |
| Dermatology Clinical Research Center of San Antonio- Site Number : 8401100 | San Antonio | Texas | 78229 | — |
| Discovery Clinical Trials - San Antonio - Stone Oak Parkway- Site Number : 8401026 | San Antonio | Texas | 78258 | — |
| Stryde Research - Epiphany Dermatology- Site Number : 8401185 | Southlake | Texas | 76092 | — |
| Ogden Clinic Mountain View (Avacare) Site Number : 8401167 | Pleasant View | Utah | 84404 | — |
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 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06015308, 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 Aug 9, 2026 · Synced Sep 26, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06015308 live on ClinicalTrials.gov.