Media Update: EADV: Sanofi builds on legacy in immunology with new data highlighting advances in treatment of chronic inflammatory skin diseases

EADV: Sanofi builds on legacy in immunology with new data highlighting advances in treatment of chronic inflammatory skin diseases

• New positive analyses for Dupixent across atopic dermatitis, prurigo nodularis and chronic spontaneous urticaria
• New phase 2a results for brivekimig evaluating efficacy and safety in moderate-to-severe hidradenitis suppurativa

Sanofi will present data from 45 abstracts, including 4 oral presentations, across approved and investigational medicines at the European Academy of Dermatology and Venereology (EADV) Congress in Paris, France from September 17 to 20, 2025. Presentations in partnership with Regeneron include studies assessing the impact of Dupixent across various inflammatory skin diseases, including atopic dermatitis (AD), prurigo nodularis (PN) and chronic spontaneous urticaria (CSU). From Sanofi’s extensive immunology pipeline, new analyses will be shared, including an oral presentation featuring for the first time, results from the HS-OBTAIN phase 2a study evaluating brivekimig, a dual-target nanobody VHH inhibiting tumor necrosis factor (TNF) and OX40 ligand (OX40L), in adult patients with moderate-to-severe hidradenitis suppurativa (HS).

“Our wide range of data being presented at EADV is a testament to our relentless focus on advancing transformative therapies to treat patients living with a variety of chronic inflammatory skin diseases, many of whom are in urgent need of novel therapeutic options,” said Alyssa Johnsen, MD, PhD, Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi. “Our Dupixent data builds on the growing body of evidence in atopic dermatitis, including clinical and real-world data evaluating longer-term outcomes in children as well as adult patients with skin of color. In addition, the first results for brivekimig in hidradenitis suppurativa support that targeting the OX40L pathway and TNF blockade together may be a promising strategy to reduce inflammation and improve HS.”

Notable presentations across approved and pipeline medicines include:

Dupixent
Presentations highlighting data from the Dupixent clinical program will be featured, including studies across AD, PN, and CSU. Key posters include:

Atopic dermatitis

• LIBERTY PEDS AD study (clinical study identifier: NCT03345914): an analysis examining the impact of Dupixent on growth in children with AD.  
• DISCOVER study (clinical study identifier: NCT05590585): an analysis evaluating the impact of Dupixent on skin structure in individuals with skin of color, including lesions and epidermal thickness, as measured by a 3D-imaging technique in adults.
• Three abstracts from open-label extension and real-world studies examining the effect of Dupixent on long-term outcomes up to four years in children with skin of color.
  

Prurigo nodularis

• PRIME and PRIME2 studies (clinical study identifiers: NCT04183335 and NCT04202679): analyses evaluating the impact of Dupixent on the multi-dimensional burden of the disease, including the physical lesions and feelings of itch, skin pain, and stinging as well as the emotional burden of embarrassment and self-consciousness.
  

Chronic spontaneous urticaria

• CUPID study A and study C (clinical study identifier: NCT04180488): assessing early and sustained effects of Dupixent on itch and hives.
  

The safety results of these studies were generally consistent with the known safety profile of Dupixent in its approved dermatological indications.

Immunology pipeline
New data from Sanofi’s immunology pipeline will be featured, with studies evaluating brivekimig in moderate-to-severe HS, amlitelimab in moderate-to-severe AD and a proof of mechanism study for SAR445399, a novel IL1R3 monoclonal antibody (mAb) in reducing skin inflammation. Key oral presentations include:

• HS-OBTAIN phase 2a study (clinical study identifier: NCT05849922): 16-week results assessing the efficacy and safety of brivekimig in adults with moderate-to-severe HS.
• STREAM-AD phase 2b study (clinical study identifier: NCT05131477): 52-week results evaluating the maintenance of treatment response with amlitelimab in moderate-to-severe AD.
• RILECSU phase 2 study (clinical study identifier: NCT05107115): 12-week results evaluating the effects of rilzabrutinib on angioedema in participants with moderate-to-severe CSU.
• Proof-of-mechanism study evaluating SAR445399, a novel IL1R3 mAb in reducing skin inflammation via the IL1 and IL36 pathways.

Brivekimig, amlitelimab and rilzabrutinib are investigational and no conclusions regarding efficacy and safety should be drawn.

About Dupixent
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin 4 (IL4) and interleukin 13 (IL13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type-2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of the type-2 inflammation that plays a major role in multiple related and often co-morbid diseases.

Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, chronic obstructive pulmonary disease, and bullous pemphigoid in different age populations. More than one million patients are being treated with Dupixent globally.

Dupilumab development program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by type-2 inflammation.

In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type-2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.

About brivekimig
Brivekimig is a dual-target nanobody inhibiting TNF and OX40L, key immune regulators. It is being investigated for potential uses across a range of immune-mediated diseases and inflammatory disorders, including atopic dermatitis, inflammatory bowel disease, type 1 diabetes mellitus, primary focal segmental glomerulosclerosis and minimal change disease.

About amlitelimab  
Amlitelimab is a fully human, non-T cell depleting monoclonal antibody that blocks OX40L, a key immune regulator. With its novel mechanism of action, amlitelimab aims to normalize the overactive immune system and restore immune balance, without depleting T cells, with the goal of enabling a quarterly dosing interval for patients. It has the potential to be a first- or best-in-class treatment for a range of immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis, moderate-to-severe asthma, systemic sclerosis, celiac disease, and alopecia.

About rilzabrutinib  
Rilzabrutinib is an oral, reversible, covalent BTK inhibitor that has the potential to be a first- or best-in-class treatment of a number of immune-mediated diseases. BTK, expressed in B cells and mast cells, plays a critical role in multiple immune-mediated disease processes. With the application of Sanofi’s TAILORED COVALENCY^® technology, rilzabrutinib can selectively inhibit the BTK target while potentially reducing the risk of off-target side effects.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.