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Last update 16 Jul 2025

Spesolimab

Last update 16 Jul 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Immunoglobulin G1, anti-(human interleukin 36 receptor) (humanized monoclonal BI 655130 gamma1-chain), disulfide with humanized monoclonal BI 655130 kappa-chain, dimer, Spesolimab (genetical recombination) (JAN), Spesolimab (INN)

+ [9]

Target

IL-36R

Action

inhibitors

Mechanism

IL-36R inhibitors(Interleukin-36 receptor inhibitors)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal DiseasesOther Diseases+ [2]

Active Indication

Pustular psoriasisGeneralized Pustular PsoriasisPyoderma Gangrenosum+ [2]

Inactive Indication

Colitis, UlcerativeCrohn DiseaseIntestinal Obstruction+ [4]

Originator Organization

Boehringer Ingelheim International GmbH

Active Organization

Boehringer Ingelheim GmbHBoehringer Ingelheim International GmbHBoehringer Ingelheim Pharma GmbH & Co., KG

+ [6]

Inactive Organization-

License Organization

Boehringer Ingelheim GmbH

LEO Pharma A/S

Drug Highest PhaseApproved

First Approval Date

United States (01 Sep 2022),

Generalized Pustular Psoriasis

RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Breakthrough Therapy (China), Orphan Drug (South Korea), Orphan Drug (Australia), Orphan Drug (Switzerland), Breakthrough Therapy (Taiwan Province), Priority Review (China)

Structure/Sequence

Sequence Code 176702L

Source: *****

Sequence Code 9071670H

Source: *****

Clinical Trials associated with Spesolimab

NCT06886009

/ Not yet recruitingNot Applicable

A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Spesolimab in Korean Patients With Flares With Generalized Pustular Psoriasis

The primary and secondary objectives are to respectively monitor the safety and effectiveness of Spesolimab IV in Korean patients with flares with generalized pustular psoriasis (GPP) in a routine medical practice.

Start Date29 Aug 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

CTR20244695

/ RecruitingPhase 3

一项在需要全身治疗的成人溃疡型坏疽性脓皮病（PG）患者中评价佩索利单抗（BI 655130）的安全性和有效性的多中心、随机、安慰剂对照、双盲、平行组试验

[Translation] A multicenter, randomized, placebo-controlled, double-blind, parallel-group trial to evaluate the safety and efficacy of pesolimumab (BI 655130) in adult patients with ulcerative pyoderma gangrenosum (PG) requiring systemic therapy

本试验拟在溃疡型PG试验受试者中评价佩索利单抗重复给药相比安慰剂（两种药物均联合口服皮质类固醇：天泼尼松或泼尼松龙）的安全性、有效性、PK和免疫原性。主要目的是证明在第26周前任何时间目标PG溃疡达到完全闭合（PG面积减少100%，PGAR-100）的试验受试者比例差异方面，佩索利单抗优效于安慰剂。次要目的是证明佩索利单抗在（关键）次要终点方面优效于安慰剂。

[Translation]

This trial is intended to evaluate the safety, efficacy, PK, and immunogenicity of repeated dosing of pesolizumab versus placebo (both drugs combined with oral corticosteroids: prednisone or prednisolone) in ulcerative PG trial subjects. The primary objective is to demonstrate the superiority of pesolizumab to placebo in the difference in the proportion of trial subjects with complete closure of the target PG ulcer (100% reduction in PG area, PGAR-100) at any time before Week 26. The secondary objective is to demonstrate the superiority of pesolizumab to placebo in (key) secondary endpoints.

Start Date20 Feb 2025

Sponsor / Collaborator

Boehringer Ingelheim (China) Investment Co., Ltd.

[+2]

NCT06624670

/ RecruitingPhase 3

A Multi-centre, Randomised, Placebo-controlled, Double-blind, Parallel-group Trial to Evaluate Safety and Efficacy of Spesolimab (BI 655130) in Adult Patients With Ulcerative Pyoderma Gangrenosum (PG) Who Require Systemic Therapy

The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm^2 to 80 cm^2 in size.
This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth.
In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab.
In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks.
Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.

Start Date04 Feb 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with Spesolimab

100 Translational Medicine associated with Spesolimab

100 Patents (Medical) associated with Spesolimab

147

Literatures (Medical) associated with Spesolimab

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Successful treatment of generalized pustular psoriasis during pregnancy with secukinumab in a patient hypersensitive to spesolimab: a case report

Article

Author: Zhang, Yun ; Peng, Guoyao ; Nie, Xinyi ; Zhang, Hongwei ; Yu, Tao ; Liao, Chengcheng ; Li, Xia ; Xiang, Jie ; Luo, Jiaxin ; Luo, Liping ; Li, You ; Zhang, Shuang

OBJECTIVE:

Generalized pustular psoriasis (GPP) is a rare autoinflammatory skin disease characterized by recurrent, widespread eruption of sterile pustules rich in neutrophils. In addition to skin manifestations, this condition may be accompanied by fever, muscle pain, joint pain, systemic inflammation, or organ failure. GPP during pregnancy poses a serious threat to both mother and fetus, with limited options for medication. This study aimed to evaluate the safety of secukinumab during pregnancy as a treatment option for psoriasis.

MATERIALS AND METHODS:

We report the case of a 35-year-old pregnant woman presenting with extensive, confluent erythematous scaly plaques and numerous pustules, accompanied by fever. Over the past few years, her lesions showed remission following treatment with corticosteroids, traditional Chinese medicine, and secukinumab. However, after a brief remission with spesolimab, the lesions recurred and no significant improvement was obtained with glucocorticoid therapy. Secukinumab treatment was then initiated.

RESULTS:

Secukinumab was administered subcutaneously at a dose of 300 mg at weeks 0, 1, 2, 3, 4, and 8. Following treatment, GPP symptoms were reduced, and fetal development remained normal. A healthy boy was delivered vaginally at term.

CONCLUSION:

Our findings provide evidence that secukinumab is an effective and safe treatment option for GPP during pregnancy.

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Expanding the therapeutic horizons of spesolimab: a review of off-label applications for inflammatory skin diseases

Review

Author: Zhang, Hanlin ; Tang, Keyun ; Zhang, Xinyi ; Zhou, Jia ; Jin, Hongzhong

PURPOSE:

This review aims to outline the crucial role of IL-36 signaling in inflammatory skin diseases and summarize the therapeutic potential of spesolimab. Our goal is to provide insights into the off-label applications of spesolimab and future directions for its use in treating other challenging skin diseases.

MATERIALS AND METHODS:

We conducted a comprehensive literature search across PubMed, Embase, Web of Science, MEDLINE, Scopus, and the Cochrane Library to identify relevant studies. For RCTs, we additionally searched the ClinicalTrials.gov database.

RESULTS:

In this review, we examine its off-label applications for conditions such as palmoplantar pustulosis, acrodermatitis continua of Hallopeau, hidradenitis suppurativa, pyoderma gangrenosum, and acute generalized exanthematous pustulosis. This review also explores the role of IL-36 in the pathophysiology of these disorders and discusses how spesolimab may address the limitations of current therapies for refractory cases. Randomized controlled trials and case reports are summarized to highlight the efficacy and tolerability of spesolimab across various inflammatory skin conditions. We highlight the challenges presented by the absence of standardized treatment guidelines and the need for larger clinical trials.

CONCLUSIONS:

This review underscores the potential of spesolimab to enhance treatment strategies for inflammatory skin diseases.

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Successful treatment of etanercept- and adalimumab-resistant pyoderma gangrenosum with spesolimab, moderate-dose corticosteroids, and minocycline

Article

Author: Zhang, Hanlin ; Wu, Chao ; Jin, Hongzhong

PURPOSE:

Pyoderma gangrenosum (PG) is a rare, neutrophilic dermatosis characterized by rapidly developing, painful ulcers. This study explores the potential of spesolimab, an anti-IL-36R antibody, as a therapeutic option for refractory PG.

MATERIALS AND METHODS:

We report a case of a 48-year-old male with refractory PG who failed to respond to etanercept and adalimumab. Upon admission, the patient presented with extensive, painful ulcerations on the trunk and extremities. He was started on oral methylprednisolone (32 mg/day) and minocycline (50 mg twice daily). After a week, minimal improvement was observed. After reviewing the screening results and discussing treatment options, the patient received two doses of spesolimab (900 mg intravenously) administered two weeks apart.

RESULTS:

Marked clinical improvement was observed after spesolimab initiation. Complete ulcer healing was achieved within six weeks of starting spesolimab, with no adverse effects reported.

CONCLUSIONS:

This case demonstrates the potential efficacy of spesolimab for treating refractory PG, particularly in patients unresponsive to TNF-α inhibitors. Despite the added complexity of the patient's underlying HBV infection and elevated M-protein, no HBV reactivation or other hematologic complications occurred. Further studies are needed to validate its role in managing PG and other neutrophilic dermatoses.

News (Medical) associated with Spesolimab

15 Jul 2025

·pipelinereview.com

Boehringer Ingelheim and LEO Pharma Enter Partnership to Commercialize and Further Develop SPEVIGO® (spesolimab)

INGELHEIM, Germany & BALLERUP, Denmark I July 14, 2025 I Boehringer Ingelheim and LEO Pharma today announced an exclusive global license and transfer agreement to commercialize and advance the development of SPEVIGO ® (spesolimab). SPEVIGO ® is an innovative, humanized, and selective monoclonal antibody that targets and blocks the activation of the interleukin-36 (IL-36) receptor – a key signaling pathway in the immune system implicated in the pathogenesis of several autoinflammatory diseases, including generalized pustular psoriasis (GPP). 123 This partnership extends beyond GPP, with an opportunity to investigate the potential of spesolimab in additional skin conditions with high unmet medical need in which IL-36 is implicated. Under the terms of the agreement, LEO Pharma will be responsible for commercialization and further development of SPEVIGO® leveraging its global commercial platform within medical dermatology to raise disease awareness and secure access for patients with GPP. The addition of Boehringer Ingelheim’s flagship dermatology product, SPEVIGO ® , for the treatment of GPP, complements LEO Pharma’s existing strategic dermatology portfolio and reinforces its long-standing commitment to delivering transformational medicines to patients. “We are immensely proud of what SPEVIGO ® represents for people living with GPP and bringing innovation to this community of patients has been a powerful reflection of our purpose to transform lives,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. “SPEVIGO ® holds a significant promise, and ensuring it reaches its full potential requires continued focus, and expertise in medical dermatology. With over six decades of singular dedication to this field, LEO Pharma is exceptionally well-positioned to build on the strong foundation we’ve laid. We remain profoundly grateful to the patients, caregivers, and healthcare professionals who have walked this journey with us.” “Skin diseases can profoundly impact people’s lives – and at LEO Pharma, we are here to change that,” said Christophe Bourdon, CEO of LEO Pharma. “Partnering to bring SPEVIGO® to more patients is more than a strategic step – it means the opportunity to help people living with GPP by addressing a disease with limited treatment options and aiming to improve their quality of life. We are inspired by Boehringer Ingelheim’s pioneering efforts and thrilled to build on that foundation. Together, we have a powerful opportunity to expand access to innovative care and deliver meaningful progress for patients who have long been underserved.” GPP is a rare, heterogeneous, and potentially life-threatening skin disease. It is characterized by the accumulation of neutrophils (a type of white blood cell) in the skin, leading to painful, sterile pustules across the body. The disease course varies, with some patients experiencing relapsing episodes with recurrent flares – often accompanied by fever, malaise, fatigue, and a risk of organ failure – while others endure persistent disease with intermittent flares. 7891011 SPEVIGO ® is available in more than 40 countries including the U.S., Japan, China, and most European countries to treat GPP flares in adults. 4 It is the first approved treatment for GPP flares that specifically targets the IL-36 pathway and that has been evaluated in a statistically powered, randomized, placebo-controlled trial. 5 Additionally, SPEVIGO® has also been approved for expanded indications in generalized pustular psoriasis in the EU, U.S. and China. 6 SPEVIGO ® is also under investigation for the treatment of other IL-36 mediated skin diseases. The transaction is anticipated to close in the second half of 2025, subject to merger control clearance, with Boehringer Ingelheim set to receive EUR 90 million as upfront payment, along with milestone payments and tiered royalties. July, 2025 About Spevigo SPEVIGO® is a novel, humanized, selective antibody that specifically blocks the activation of the IL-36R, a signalling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. It is the first targeted therapy for the treatment of GPP and has been evaluated in the largest clinical program specifically for the treatment of patients with GPP. 123 About generalized pustular psoriasis (GPP) GPP is a chronic, heterogenous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment. 78 GPP can become life-threatening (mortality rates ranging from 2% to 16%) due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems. 89 GPP symptoms appear unpredictable and present on a continuum, which greatly impacts a patient’s quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities, and finances. 81011 About Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com . About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serve close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com . 1 Morita A, Strober B, Burden AD, et al. Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial. Lancet. 2023;402:1541–1551. 2 Choon SE, Lebwohl MG, Marrakchi S, et al. Study protocol of the global Effisayil 1 Phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. BMJ Open. 2021;11:e043666. 3 Bachelez H, Choon SE, Marrakchi S, et al. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385:2431–2440. 4 Record on file. 5 Boehringer Ingelheim. Spesolimab prevented generalized pustular psoriasis flares in Effisayil™ 2 trial. 2023. https://www.boehringer-ingelheim.com/human-health/skin-and-inflammatory-diseases/gpp/spesolimab-prevents-gpp-flares (Accessed 22 July 2024). 6 Boehringer Ingelheim. European Commission approves SPEVIGO® for new and expanded indications in generalized pustular psoriasis. 2024. https://www.boehringer-ingelheim.com/human-health/european-commission-approves-spevigo-new-and-expanded-indications-generalized-pustular-psoriasis (Accessed 29 June 2025). 7 Marrakchi S, Puig L. Pathophysiology of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:13–19. 8 Prinz JC, Choon SE, Griffiths CEM, et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. J Eur Acad Dermatol Venereol. 2023;37:256–273. 9 Choon SE, Navarini AA, Pinter A. Clinical course and characteristics of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:21–29. 10 Gooderham MJ, Van Voorhees AS, Lebwohl MG. An update on generalized pustular psoriasis. Expert Rev Clin Immunol. 2019;15:907–919. 11 Reisner DV, Johnsson FD, Kotowsky N, et al. Impact of generalized pustular psoriasis from the perspective of people living with the condition: Results of an online survey. Am J Clin Dermatol. 2022;23:65–71. SOURCE: LEO Pharma

License out/inDrug ApprovalPhase 2

14 Jul 2025

·www.fiercepharma.com

On heels of Gilead deal, Leo pays Boehringer Ingelheim €90 million up front for Spevigo

Dermatology specialist Leo Pharma has struck a transfer deal with Boehringer Ingelheim, paying 90 million euros ($105 million) up front for rare disease drug Spevigo, which was approved in 2022. For the second time this year, Leo Pharma has struck a partnership with a major drugmaker, this time paying Boehringer Ingelheim 90 million euros ($105 million) up front for the rare disease drug Spevigo.Specializing in dermatology, Denmark-based Leo is well equipped to take control of Spevigo, which treats flares that accompany generalized pustular psoriasis (GPP), a skin condition so debilitating that it can become fatal.With the transfer agreement, Leo will take responsibility for the development and commercialization of Spevigo around the world. The companies, which are both private, did not reveal full terms of the agreement, though we do know Leo is on the hook for undisclosed milestone and royalty payments.The transaction comes on top of Leo signing a $1.7 billion deal back in January with Gilead, in which it got $250 million up front for part of its STAT6 transcription factor program.In adding and subtracting assets, Leo is transforming its business, trying to zero in on what it does best.“Boehringer Ingelheim has picked us as the best owner of the asset,” Bourdon told Fierce Pharma. “Beyond the work they have done, which is tremendous, we can be a better owner through our medical market access, commercial, dermatology-focused expertise.” Spevigo was approved in 2022 and gained a label expansion last year to treat patients as young as age 12. It is currently available in more than 40 countries and can be used to both treat flare-ups and to prevent them, with injections every four weeks.The selective antibody, which blocks the activation of the IL-36 signaling pathway, is the first targeted therapy for the treatment of GPP. While sales figures are not available, Bourdon said that Spevigo has the potential to become “one of our largest products.”“(Boehringer) has built this medical, commercial footprint globally but they also realized that we at Leo do only one thing, which is to interact with dermatologists,” Bourdon said. “We came up with a plan where they were confident that we could create more value with the asset.”Spevigo is under investigation in a pivotal phase 3 trial in another rare autoimmune skin condition, pyoderma gangrenosum (PG), which causes painful ulcers.“It fits nicely to where we want to go—high unmet need, no available treatment and a transformative treatment that can really help patients,” Leo’s Chief Scientific Officer Pontoppidan Thyssen, Ph.D., added in the interview. “It’s worth a shot on goal.” One shot on goal that was off the mark was Leo’s 2023 buyout of Timber Pharmaceuticals and its late-stage candidate for another rare dermatological condition for $14 million. In August of last year, the company revealed that the asset had flunked a phase 3 trial.Bourdon came to Leo three years ago when it was in dire financial straits and in need of a slim down. The company reduced its costs and adjusted its innovation model, pursuing external innovation as opposed to its long-held focus on internal R&D.For now, the company is depending on the growth of IL-13 eczema treatment Adbry, which was approved in 2021, and the progression of topical JAK inhibitor delgocitinib, which is under review by the FDA as a treatment for chronic hand eczema. In earlier-stage development are topical therapies that Leo is developing in its STAT6 program. In making its deal with Gilead in January, Leo held onto those candidates while the California company is placing a bet on its ability to develop oral STAT6 therapies for inflammatory diseases as an alternative to injectable biologics such as Regeneron and Sanofi’s Dupixent and AbbVie’s duo of Rinvoq and Skyrizi.“Three years ago, two years ago, when we talked about transforming the company, about inventing a new innovation model, I think it was a wild ambition,” Bourdon said. “And now in less than six months, we have Gilead knocking at your door, we have Boehringer knocking at your door.”

Phase 3Drug ApprovalLicense out/inAcquisition

14 Jul 2025

·firstwordpharma.com

LEO Pharma ponies up €90M for Boehringer's psoriasis drug

LEO Pharma on Monday agreed to pay Boehringer Ingelheim €90 million ($105 million) upfront for a global license to the German pharma's dermatology drug, Spevigo (spesolimab).Boehringer is eligible for additional milestone payments and tiered royalties, which were undisclosed. The deal is expected to close this half. Under the deal, LEO Pharma will be responsible for commercialising the anti–IL-36 antibody, which is approved in more than 40 countries, including the US and EU, to treat generalised pustular psoriasis (GPP) flares in adults. In 2023, Boehringer presented long-term, 48-week data showing that Spevigo reduced the risk of GPP flares by 84% versus placebo.The drugmaker will also explore the potential of Spevigo to treat other skin conditions associated with IL-36, an immune system signaling pathway that's been tied to several autoinflammatory diseases. "LEO Pharma is exceptionally well-positioned to build on the strong foundation we’ve laid," Boehringer Chairman and Head of Human Pharma Shashank Deshpande commented in a release."Partnering to bring Spevigo to more patients is more than a strategic step — it means the opportunity to help people living with GPP by addressing a disease with limited treatment options and aiming to improve their quality of life," said LEO Pharma CEO Christophe Bourdon. "Together, we have a powerful opportunity to expand access to innovative care and deliver meaningful progress for patients who have long been underserved."The licensing agreement comes about six months after another dermatology deal from LEO Pharma. In January, the company out-licensed rights to its preclinical oral STAT6 programme to Gilead Sciences in a $1.7-billion partnership (see – Spotlight On: STAT6 emerges as key target in post-Dupixent future).

License out/inDrug ApprovalClinical Result

100 Deals associated with Spesolimab

External Link

KEGG	Wiki	ATC	Drug Bank
D12066	-	-	DB15626

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pustular psoriasis	Japan	Nippon Boehringer Ingelheim Co., Ltd.	26 Sep 2022
Generalized Pustular Psoriasis	United States	Boehringer Ingelheim Pharmaceuticals, Inc.	01 Sep 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pyoderma Gangrenosum	Phase 3	United States	Boehringer Ingelheim International GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	United States	Boehringer Ingelheim GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	China	Boehringer Ingelheim GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	Japan	Boehringer Ingelheim GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	Japan	Boehringer Ingelheim International GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	Argentina	Boehringer Ingelheim GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	Argentina	Boehringer Ingelheim International GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	Australia	Boehringer Ingelheim GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	Australia	Boehringer Ingelheim International GmbH	04 Feb 2025
Pyoderma Gangrenosum	Phase 3	Austria	Boehringer Ingelheim International GmbH	04 Feb 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04876391 (CTgov)	Phase 2	Hidradenitis Suppurativa	45	Placebo matching 600 mg Spesolimab+Spesolimab 1200 mg (Prior Placebo (PP))	wblcsgeljh = aqvnipbsra grrshwohrf (urnshaqnpy, lovemgyhbw - hnowrogevj) View more	-	08 Jun 2025
				Placebo matching 1200 mg Spesolimab+Spesolimab 600 mg (Prior Spesolimab (PS))	wblcsgeljh = vvzikxaksp grrshwohrf (urnshaqnpy, ajmqpyclbe - mwtsmrtgru) View more
NCT04362254 (CTgov)	Phase 2	Crohn Disease	12	Spesolimab	azmuufooop = yaiyxdgiwx frrczulfeg (ewnbwrtrsk, tbshvksdyq - vctgsvgrbp) View more	-	05 Nov 2024
NCT05239039 (CTgov)	Phase 3	Generalized Pustular Psoriasis	39	spesolimab (Spesolimab Single Dose Treatment)	ibkkbvfocv = npkjudgwxd vsiifjalpz (qxiqaznazz, pgxpxrsawf - krytvlnopx) View more	-	09 Oct 2024
				spesolimab (Spesolimab Double Dose Treatment)	ibkkbvfocv = smmetxxmgo vsiifjalpz (qxiqaznazz, knxzdiycyb - pmvegujdzz) View more
NCT04762277 (CTgov)	Phase 2	Hidradenitis Suppurativa	52	Placebo matching spesolimab - solution for infusion (Placebo)	rdzvonuvnu(igunnxrvrw) = hjpjfutjwv wjthqejphy (liwgwdtcys, 11.1) View more	-	09 Oct 2024
				Spesolimab - solution for infusion (Spesolimab)	rdzvonuvnu(igunnxrvrw) = ckfdajcdks wjthqejphy (liwgwdtcys, 7.5) View more
NCT05200247 (CTgov)	Phase 3	Generalized Pustular Psoriasis	11	Spesolimab	ybfonbubee = azaufxhyrr xqzdlsdpel (bgdaknsdbs, pediaenvul - xhxurfghye) View more	-	15 Aug 2024
NCT03648541 (CTgov)	Phase 2	Colitis, Ulcerative	79	Spesolimab (300 mg Spesolimab s.c. Maintenance Treatment [q4w] for 336 Weeks)	muasjmjfjl = gvsntrgwvg uskupfdqvp (brbthjwplr, lwjpiyorba - pcijuctzqh) View more	-	03 Jul 2024
				Spesolimab (1200 mg Spesolimab i.v. Re-induction Treatment [q4w] for 12 Weeks)	ixdwnjkjeb(ugynoiajkb) = zeublwynsw axnlcnzzbg (dxsegcbjvh, skxsgustys - phxpjitika) View more
NCT04493424 (CTgov)	Phase 2	Pustulosis of Palms and Soles \| Pustular psoriasis	108	Spesolimab	svonneqebv = iuerawlnri hwkrckpvkv (ysktlbwatk, qmtgdwvcps - zvpoobctsk) View more	-	20 Mar 2024
NCT03100903 (CTgov)	Phase 1	-	36	BI 655130 (BI 655130 High Dose SC)	jcyaminxgw(qdfjfffxdw) = ynddxhfdpu xdoxlkwvwx (jcpvxvojcs, NA) View more	-	18 Mar 2024
				BI 655130 (BI 655130 High Dose IV)	jcyaminxgw(qdfjfffxdw) = foxqcyfczr xdoxlkwvwx (jcpvxvojcs, NA) View more
NCT02852824 (CTgov)	Phase 1	-	40	Placebo+BI 655130 (Placebo Matching to BI 655130 Multiple Dose (MD))	fcmtdkohre = txifvfelun pwcbxtsfzq (moirgundkp, trhpvmscmp - boqidfxltd) View more	-	18 Mar 2024
				BI 655130 (3 Milligram/Kilogram (mg/kg)] BI 655130 MD)	fcmtdkohre = qbwukcfxoo pwcbxtsfzq (moirgundkp, lcinpumubg - faapsfzlga) View more
NCT03617835 (CTgov)	Phase 1	-	48	R - Low dose of BI 655130 (R - Low Dose of BI 655130 Periumbilical)	rbuowlpjww(mrpqpojgfa) = zkgopbsjxd juahwydcsg (mjichzufit, NA) View more	-	15 Mar 2024
				T1 - Low dose of BI 655130 (T1 - Low Dose of BI 655130 Periumbilical (Left and Right))	rbuowlpjww(mrpqpojgfa) = uwcmhtlpol juahwydcsg (mjichzufit, NA) View more

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