Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma 
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 0 Diseases   10 Trials   10 Trials   128 News 


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  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma
    Journal:  Rapid Resolution of Pediatric Acrodermatitis Continua of Hallopeau With Spesolimab. (Pubmed Central) -  Nov 30, 2025   
    No treatment-related adverse events occurred during therapy or follow-up. Our case report presents the successful application of spesolimab in a 7-year-old child with ACH, thus further supporting the potential of this targeted biologic agent in pediatric ACH treatment.
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma, acitretin / Generic mfg., cyclosporine / Generic mfg.
    Journal:  Highlights of the Brazilian Society of Dermatology's Brazilian Consensus on Psoriasis. (Pubmed Central) -  Nov 26, 2025   
    The updated treatment algorithm used experts' responses through the Delphi method and, among other modifications, removed acitretin from the plaque psoriasis treatment sequence, defined treatment lines for choosing immunobiologicals in both adult and pediatric populations, and included spesolimab and cyclosporine as first-line treatments for generalized pustular psoriasis. Finally, the new Consensus addresses the place of small molecule inhibitors in the algorithm and discusses future treatment options for plaque psoriasis.
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma
    Trial completion:  PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms (clinicaltrials.gov) -  Oct 20, 2025   
    P=N/A,  N=52, Completed, 
    Phase classification: P2a --> P2 Active, not recruiting --> Completed
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma
    Trial completion date, Trial primary completion date:  A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum (clinicaltrials.gov) -  Sep 19, 2025   
    P3,  N=90, Recruiting, 
    Spesolimab is effective in treating pediatric GPP patients, and it is potential to be a clinical treatment strategy for pediatric GPP in the future. Trial completion date: Oct 2027 --> Feb 2028 | Trial primary completion date: Dec 2026 --> Apr 2027
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  Spesolimab in Pyoderma Gangrenosum (clinicaltrials.gov) -  Sep 17, 2025   
    P2,  N=5, Terminated, 
    No abstract available N=20 --> 5 | Trial completion date: Aug 2025 --> Jan 2025 | Recruiting --> Terminated | Trial primary completion date: Aug 2025 --> Jan 2025; The funding sponsor terminated our study and will conduct a multicenter national study in its place.
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma
    Journal, Heterogeneity:  Heterogeneous Response to Spesolimab in Pyoderma Gangrenosum Depends on Underlying Myeloid Disorders. (Pubmed Central) -  Sep 4, 2025   
    N=20 --> 5 | Trial completion date: Aug 2025 --> Jan 2025 | Recruiting --> Terminated | Trial primary completion date: Aug 2025 --> Jan 2025; The funding sponsor terminated our study and will conduct a multicenter national study in its place. No abstract available
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma
    Journal, HEOR, Real-world evidence:  Real-world treatment patterns in patients with generalized pustular psoriasis (GPP). (Pubmed Central) -  Sep 4, 2025   
    No abstract available Corticosteroids were frequently prescribed, despite published reports of GPP flare following withdrawal, and fewer GPP-only than GPP+PsO patients received biologics, consistent with the lack of FDA-approved targeted therapies for GPP during the study.
  • ||||||||||  Remicade (infliximab) / J&J
    Infliximab-Induced Synovitis, Acne, Pustulosis, Hyperostosis, Osteitis (SAPHO) Syndrome (Exhibit Hall) -  Aug 29, 2025 - Abstract #ACG2025ACG_1795;    
    Dermatology evaluation with a biopsy of the lesions favored Infliximab-induced pustular psoriasis, and the patient was transitioned to Upadacitinib...She failed a trial of Risankizumab and cyclosporine but later switched to Spesolimab and methotrexate with rapid improvement in her cutaneous symptoms...Furthermore, our patient responded favorably to Spesolimab, an FDA-approved anti-IL36R used to treat pustular psoriasis. Taken together, this suggests that SAPHO syndrome may be an autoimmune process defined by two distinct pathophysiologies.
  • ||||||||||  Taltz (ixekizumab) / Eli Lilly, Japan Tobacco, Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma, Cosentyx (secukinumab) / Novartis
    Journal:  Spesolimab Treatment in GPP: Impact of IL-36RN Mutations and Concomitant Plaque Psoriasis. (Pubmed Central) -  Aug 18, 2025   
    These findings suggest that spesolimab can effectively treat GPP, regardless of IL-36RN gene mutation status. However, its therapeutic efficacy may be suboptimal in patients with concomitant plaque psoriasis, indicating the need for further investigation to optimize treatment outcomes in this subgroup.
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma
    Trial completion:  A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome (clinicaltrials.gov) -  Aug 7, 2025   
    P2/3,  N=43, Completed, 
    However, its therapeutic efficacy may be suboptimal in patients with concomitant plaque psoriasis, indicating the need for further investigation to optimize treatment outcomes in this subgroup. Active, not recruiting --> Completed
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma
    Comparison of psychological burden of generalized pustular psoriasis and plaque psoriasis from a French claims database (Poster Area) -  Jul 23, 2025 - Abstract #EADV2025EADV_5469;    
    These findings are consistent with those from other real-world studies and may reflect fear of experiencing a flare and the unpredictability of GPP symptoms. The psychological impact of GPP contributes to greater healthcare resource utilization and costs than plaque PsO (see other EADV 2025 abstract) and highlights the significant need for targeted management of GPP to reduce the potentially distal impact of this chronic condition, with putative severe flares, on patients.
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma
    Real-World Experience with Spesolimab for Generalized Pustular Psoriasis: A Four-Case Series (Poster Area) -  Jul 23, 2025 - Abstract #EADV2025EADV_5342;    
    Furthermore, for patients with GPP who did not experience a flare, spesolimab improved the overall QoL burden, with pain/discomfort, mental health, and the ability to perform daily activities all improving following treatment. Our real-world data confirm the rapid and sustained efficacy of spesolimab in GPP flares, with responses seen within hours
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma, Humira (adalimumab) / AbbVie
    Care of Patients with GPP: Analyses from the German PPBest Registry (Poster Area) -  Jul 23, 2025 - Abstract #EADV2025EADV_4258;    
    GPP is a rare skin disease with severe clinical courses, particularly characterized by a deterioration in quality of life during flare-ups and challenging treatment selection. With the increasing volume of data, PPBest significantly contributes to the acquisition of further insights.
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma
    Long-term management of chronic generalized pustular psoriasis with subcutaneous spesolimab: A case report (Poster Area) -  Jul 23, 2025 - Abstract #EADV2025EADV_3886;    
    These findings suggest SC spesolimab can effectively control GPP and improve patient QoL. However, her hospital course was complicated by a severe leukemoid reaction, new onset hypothermia, acute kidney injury, elevated lactic acid levels, and pulmonary edema, which were attributed to unchecked systemic inflammation due to her prolonged untreated flare, and were treated with a short course of cyclosporine from Days 5
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma
    Spesolimab as treatment option for refractory Acrodermatitis Continua of Hallopeau (Poster Area) -  Jul 23, 2025 - Abstract #EADV2025EADV_3034;    
    To the best of our knowledge, this is the first case of treating acrodermatitis continua of Hallopeau (ACH) with subcutaneous spesolimab.The emergence of effluvium as a potential side effect following treatment necessitates careful monitoring and emphasizes the importance of reporting such findings. To enhance our understanding of the long-term safety and efficacy of spesolimab in ACH and related dermatological conditions, further investigations and the establishment of patient registries are essential.
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim
    Journal:  IL-36 signaling as a drug target in Crohn's disease patients with IL36RN mutations. (Pubmed Central) -  Jul 12, 2025   
    Administration of the IL-36R-blocking antibody spesolimab to this patient resulted in a reduction of intestinal inflammation and alterations in immune cell composition and function. Our findings indicate that pathogenic IL36RN mutations may contribute to the pathogenesis of Crohn's disease in a subset of patients and that inhibiting IL-36 signaling could offer a personalized therapeutic approach for these patients.
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim
    Review, Journal:  Spesolimab for generalised pustular psoriasis. (Pubmed Central) -  Jun 26, 2025   
    Our findings indicate that pathogenic IL36RN mutations may contribute to the pathogenesis of Crohn's disease in a subset of patients and that inhibiting IL-36 signaling could offer a personalized therapeutic approach for these patients. No abstract available
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma
    Spesolimab for the treatment of generalised pustular psoriasis flares: Preliminary analysis of the EFFISAYIL REP study (W05-W06) -  Jun 12, 2025 - Abstract #EADV2025EADV_894;    
    P4
    Concomitant medication use for GPP (discontinued unless deemed necessary by the investigator) and/or other comorbidities included systemic steroids, methotrexate, cyclosporine, acitretin and biologics (including secukinumab [IL-17 inhibitor] and adalimumab [tumour necrosis factor-alpha inhibitor]). In this preliminary analysis of the ongoing EFFISAYIL REP study, spesolimab demonstrated rapid control of flares in patients with GPP, with no new safety risks identified.
  • ||||||||||  Spevigo (spesolimab-sbzo) / Boehringer Ingelheim, LEO Pharma
    Trial completion date:  A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome (clinicaltrials.gov) -  Jun 12, 2025   
    P2/3,  N=43, Active, not recruiting, 
    These findings highlight the need for GPP-targeted treatments that improve patient outcomes and reduce the burden on healthcare systems. Trial completion date: Jan 2028 --> Jul 2025