NCT05769777 (ATLANTIS) is a Phase 2 clinical trial of Amlitelimab in Dermatitis Atopic, sponsored by Sanofi.

Who is sponsoring NCT05769777?

NCT05769777 is sponsored by Sanofi.

What drugs are being tested in NCT05769777?

Interventions in NCT05769777: Amlitelimab.

What condition does NCT05769777 study?

NCT05769777 studies Dermatitis Atopic.

Is NCT05769777 still recruiting?

NCT05769777 is currently recruiting now. Last updated 8 April 2026.

Last reviewed 2026-04-08 · How we verify

NCT05769777: ATLANTIS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

Recruiting now Phase 2 Last updated 8 April 2026

What this trial tests

Phase 2 trial testing Amlitelimab in Dermatitis Atopic in 901 participants. Currently enrolling.

Timeline

3 April 2023

Primary endpoint
11 June 2031

11 June 2031

Quick facts

Lead sponsor	Sanofi
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	901
Start date	3 April 2023
Primary completion	11 June 2031
Estimated completion	11 June 2031
Sites	175 locations across Italy, Japan, Taiwan, Poland, South Korea, Denmark, Netherlands, Mexico

Drugs / interventions tested

Amlitelimab — full drug profile →

Conditions studied

Dermatitis Atopic — all drugs for Dermatitis Atopic →

Sponsor

Sanofi — full company profile →

Who can join

12 and older, any sex, with Dermatitis Atopic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 284 weeks, including: * A screening period of up to 2 to 4 weeks * An open label treatment period of up to 268 weeks (approximately 5 years) * A post-treatment safety follow-up period of at least 20 weeks after the last dose administration (last IMP administration at Week 264) The planned number of visits will be 35 visits.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

OX40 in the Pathogenesis of Atopic Dermatitis-A New Therapeutic Target.
Croft M, Esfandiari E, Chong C, Hsu H, et al · · 2024 · cited 58× · PMID 38236520 · DOI 10.1007/s40257-023-00838-9
Emerging Biologic Therapies for the Treatment of Atopic Dermatitis.
Alvarenga JM, Bieber T, Torres T. · · 2024 · cited 20× · PMID 39365406 · DOI 10.1007/s40265-024-02095-4
Advances in Biologic Therapies for Allergic Diseases: Current Trends, Emerging Agents, and Future Perspectives.
Alska E, Łaszczych D, Napiórkowska-Baran K, Szymczak B, et al · · 2025 · cited 13× · PMID 40004611 · DOI 10.3390/jcm14041079
Role of IL-4 and IL-13 in Cutaneous T Cell Lymphoma.
Mazzetto R, Miceli P, Tartaglia J, Ciolfi C, et al · · 2024 · cited 12× · PMID 38398754 · DOI 10.3390/life14020245
A Narrative Review of the OX40-OX40L Pathway as a Potential Therapeutic Target in Atopic Dermatitis: Focus on Rocatinlimab and Amlitelimab.
Abdelhalim A, Yilmaz O, Elshaikh Berair M, Torres T. · · 2024 · cited 6× · PMID 39565527 · DOI 10.1007/s13555-024-01308-8
Emerging Systemic Treatment Options in Atopic Dermatitis.
Salman A, Giménez-Arnau AM. · · 2024 · cited 3× · PMID 38966900 · DOI 10.4274/balkanmedj.galenos.2024.2024-5-78
The Role of OX40 Pathway Inhibition as a New Therapeutic Strategy for Atopic Dermatitis.
Oliveira Dos Santos D, Mohamed A, Mohamed A, Alvarenga JM, et al · · 2026 · PMID 41535648 · DOI 10.1007/s40259-025-00762-w

Verify or expand the search:

Other trials of Amlitelimab

Trials testing the same drug.

NCT06686628 — An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates · Phase 1 · active not recruiting
NCT06557772 — A Phase 2a/b Study of the Efficacy and Safety of Subcutaneous Amlitelimab in Adults With Nonresponsive Celiac Disease · Phase 2 · active not recruiting
NCT06444451 — A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Adult Parti · Phase 2 · active not recruiting
NCT06407934 — A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Tre · Phase 3 · active not recruiting
NCT06241118 — A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in · Phase 3 · recruiting

Other recruiting trials for Dermatitis Atopic

Currently open trials in the same condition.

NCT06790121 — A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Par · Phase 2 · active not recruiting
NCT06686628 — An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates · Phase 1 · active not recruiting
NCT06407934 — A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Tre · Phase 3 · active not recruiting
NCT06241118 — A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in · Phase 3 · recruiting
NCT05983068 — A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis · Phase 4 · active not recruiting

Other Sanofi trials

Trials by the same sponsor.

NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05769777 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sanofi
Last refreshed: 8 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05769777.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing