Spesolimab

Spesolimab-sbzo is a humanized monoclonal immunoglobulin G1 antibody that inhibits interleukin-36 (IL-36) signaling by specifically binding to the IL36R. Binding of spesolimab-sbzo to IL36R prevents the subsequent activation of IL36R by its ligands (IL-36 α, β and γ) and downstream activation of pro-inflammatory and pro-fibrotic pathways.

• SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. SPEVIGO is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.ICD-10: L40.9

• SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO. Reported hypersensitivity reactions have included drug reaction with eosinophilia and systemic symptoms (DRESS) and anaphylaxis [see Warnings and Precautions (5.3) and Adverse Reactions (6) ] .contraindicated

Subcutaneous Dosage for Treatment of GPP When Not Experiencing a Flare Administer a subcutaneous loading dose of 600 mg, followed by 300 mg subcutaneously 4 weeks later and every 4 weeks thereafter. ( 2.3 ) Subcutaneous Use After Intravenous SPEVIGO for Treatment of GPP Flare: Four weeks after treatment with intravenous SPEVIGO, initiate or reinitiate subcutaneous SPEVIGO at a dose of 300 mg administered every 4 weeks. A loading dose is not required following treatment of a GPP flare with intravenous SPEVIGO. ( 2.3 ) See full prescribing information for preparation and administration instructions. ( 2.2 , 2.5 ) Intravenous Dosage for Treatment of GPP Flare Must be diluted before intravenous use. Administer as a single 900 mg dose by intravenous infusion over 90 minutes. If flare symptoms persist, may administer an additional intravenous 900 mg dose one week after the initial dose. ( 2.4 ) See full prescribing information for preparation and administration instructions and storage of the diluted solution. ( 2.2 , 2.5 ) 2.1 Testing and Procedures Prior to Treatment Initiation Evaluate patients for active or latent tuberculosis (TB) infection. SPEVIGO initiation is not recommended in patients with active TB infection. Consider initiating treatment of latent TB prior to initiation of SPEVIGO [see Warnings and Precautions (5.2) ] . Complete all age-appropriate vaccinations according to current immunization guidelines prior to initiating SPEVIGO for treatment of GPP [see Warnings and Precautions (5.4) ] .

Infections: SPEVIGO may increase the risk of infections. Treatment with SPEVIGO is not recommended during any clinically important active infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur during or after treatment. If a clinically important active infection develops, discontinue SPEVIGO until the infection resolves or is adequately treated. ( 5.1 ) Risk of Tuberculosis (TB): Evaluate patients for TB prior to initiating treatment with SPEVIGO. ( 5.2 ) Hypersensitivity and Infusion-Related Reactions: Hypersensitivity reactions, including anaphylaxis and drug reaction with eosinophilia and systemic symptoms (DRESS), and infusion-related reactions may occur. Discontinue SPEVIGO immediately and initiate appropriate treatment if a serious hypersensitivity reaction occurs. ( 5.3 ) Vaccinations: Avoid use of live vaccines during and for at least 16 weeks after treatment with SPEVIGO. ( 5.4 ) 5.1 Infections SPEVIGO may increase the risk of infections. During the one-week placebo-controlled period in the Effisayil-1 trial, infections were reported in 14% of subjects treated with SPEVIGO compared with 6% of subjects treated with placebo [see Adverse Reactions (6.1) ] . In patients with a chronic infection or a history of recurrent infection, consider the potential risks and expected clinical benefits of treatment prior to prescribing SPEVIGO. Treatment with SPEVIGO is not recommended in patients with any clinically important active infection until the infection resolves or is adequately treated.

The following adverse reactions are discussed in greater detail in other sections of the labeling: Infections [see Warnings and Precautions (5.1) ] Hypersensitivity and Infusion-Related Reactions [see Warnings and Precautions (5.3) ] Treatment of GPP When Not Experiencing a Flare: SPEVIGO has been associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus. ( 6.1 ) Treatment of GPP Flare: The most common adverse reactions (≥5%) are asthenia and fatigue, headache, nausea, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma, Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions with Intravenous SPEVIGO for Treatment of GPP Flare (Study Effisayil-1) SPEVIGO was studied in Study Effisayil-1, a randomized, double-blind, placebo-controlled study comparing a single intravenous 900 mg dose of SPEVIGO (n=35) with placebo (n=18) in subjects with generalized pustular psoriasis (GPP) flare.

8.1 Pregnancy Risk Summary The limited data on the use of SPEVIGO in pregnant women are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. Human IgG is known to cross the placental barrier; therefore, SPEVIGO may be transmitted from the mother to the developing fetus. In an animal reproduction study, intravenous administration of a surrogate antibody against IL36R in mice during the period of organogenesis did not elicit any reproductive toxicity (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Embryo-fetal development and pre- and postnatal development toxicity studies were performed in mice using a surrogate mouse specific IL36R antagonist monoclonal antibody. In the embryo-fetal development study, the surrogate was administered intravenously at doses up to 50 mg/kg to pregnant female mice twice weekly during the period of organogenesis. The surrogate was not associated with embryo-fetal lethality or fetal malformations.

Metabolism

A population pharmacokinetic model was developed based on data collected from healthy subjects, patients with GPP, and patients with other diseases. After a single intravenous dose of 900 mg of SPEVIGO, the population PK model-estimated AUC 0-∞ (95% CI) and C max (95% CI) in a typical anti-drug antibody (ADA)-negative patient with GPP were 4750 (4510, 4970) mcg∙day/mL and 238 (218, 256) mcg/mL, respectively.

• Sep 1, 2022BLABLA761244Boehringer Ingelheim Pharmaceuticals Inc

1. 1Generalised Pustular Psoriasis5917%
2. 2Drug Ineffective4413%
3. 3Pruritus205.8%
4. 4Off Label Use195.5%
5. 5Pustular Psoriasis185.2%
6. 6Rash175.0%
7. 7Fatigue164.7%
8. 8Psoriasis164.7%
9. 9Pustule144.1%
10. 10Diarrhoea123.5%
11. 11Maternal Exposure During Pregnancy123.5%
12. 12Pyrexia113.2%
13. 13Therapeutic Product Effect Incomplete113.2%
14. 14Headache102.9%
15. 15Urinary Tract Infection102.9%

The 10 most recently updated of 35 ClinicalTrials.gov registrations naming Spesolimab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares
  Active not recruiting · Phase 4 · Interventional · 42 enrolled · Boehringer Ingelheim
  NCT06013969updated 2026-06-11
• A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
  Recruiting · Phase 3 · Interventional · 90 enrolled · Boehringer Ingelheim
  NCT06624670updated 2026-06-10
• Spesolimab in Pyoderma Gangrenosum
  Terminated · Phase 2 · Interventional · 5 enrolled · Icahn School of Medicine at Mount Sinai
  NCT06092216updated 2026-03-31
• Spesolimab Post-marketing Surveillance in Korean Patients With Flares With Generalized Pustular Psoriasis
  Withdrawn · Observational · 0 enrolled · Boehringer Ingelheim
  NCT06886009updated 2026-03-31
• Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study
  Active not recruiting · Phase 2 · Interventional · 131 enrolled · Boehringer Ingelheim
  NCT03886246updated 2026-03-31
• A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome
  Terminated · Phase 2 · Phase 3 · Interventional · 43 enrolled · Boehringer Ingelheim
  NCT05856526updated 2026-03-12
• A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab
  Terminated · Phase 2 · Phase 3 · Interventional · 39 enrolled · Boehringer Ingelheim
  NCT06241573updated 2026-02-02
• A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
  Completed · Phase 2 · Interventional · 45 enrolled · Boehringer Ingelheim
  NCT04876391updated 2025-11-14
• Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa
  Completed · Phase 2 · Phase 3 · Interventional · 209 enrolled · Boehringer Ingelheim
  NCT05819398updated 2025-11-05
• An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options
  Completed · Phase 3 · Interventional · 39 enrolled · Boehringer Ingelheim
  NCT05239039updated 2025-10-20

Frequently asked questions

How does Spesolimab work?

Spesolimab-sbzo is a humanized monoclonal immunoglobulin G1 antibody that inhibits interleukin-36 (IL-36) signaling by specifically binding to the IL36R. Binding of spesolimab-sbzo to IL36R prevents the subsequent activation of IL36R by its ligands (IL-36 α, β and γ) and downstream activation of pro-inflammatory and pro-fibrotic pathways.

What is Spesolimab used for?

According to FDA labeling, Spesolimab carries indications including: SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. SPEVIGO is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Spesolimab?

Spesolimab is classified as Interleukin inhibitors, Interleukin-36 Receptor Antagonist, Antibody Interactions, Interleukin-36 Receptor Antagonists.

What are the brand names for Spesolimab?

Spesolimab is marketed under brand names including Spevigo.

What are the contraindications for Spesolimab?

Spesolimab labeling lists contraindications including: SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO. Reported hypersensitivity reactions have included drug reaction with eosinophilia and systemic symptoms (DRESS) and anaphylaxis [see Warnings and Precautions (5.3) and Adverse Reactions (6) ] .. Always consult the full prescribing information and a clinician.