22 completed, 7 terminated, 2 active not recruiting, 1 recruiting. 19 Phase 2, 8 Phase 1, 6 Phase 3, 1 Phase 4.
By phase and status
Follow spesolimab: new trials by email Literature Review of spesolimab trials Research Report on spesolimab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|
Spesolimab Post-marketing Surveillance in Korean Patients With Flares With Generalized Pustular Psoriasis
Spevigo® - Generalized Pustular Psoriasis | | Withdrawn | Boehringer Ingelheim | | 2026-03-31 | 2026-03-31 |
A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
Spesolimab, Placebo matching to spesolimab, Prednisone - Pyoderma Gangrenosum | Phase 3 | Recruiting | LEO Pharma | 90 | 2025-02-05 | 2026-09-02 |
A Study to Test How Well Healthy People Tolerate Spesolimab When Given in 2 Different Ways
Spesolimab - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 60 | 2024-08-07 | 2025-06-29 |
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
Spesolimab, Placebo - Hidradenitis Suppurativa (HS) | Phase 2 / Phase 3 | Terminated | Boehringer Ingelheim | 39 | 2024-05-08 | 2026-06-17 |
A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares
Spesolimab - Generalized Pustular Psoriasis | Phase 4 | Active not recruiting | LEO Pharma | 42 | 2023-10-22 | 2026-09-02 |
Spesolimab in Pyoderma Gangrenosum
Spesolimab - Pyoderma Gangrenosum | Phase 2 | Terminated | Icahn School of Medicine at Mount Sinai | 5 | 2023-09-23 | 2026-03-31 |
A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Netherton Syndrome
Spesolimab - solution for infusion, Placebo matching to spesolimab - solution for infusion, Spesolimab - solution for injection - Netherton Syndrome | Phase 2 / Phase 3 | Terminated | Boehringer Ingelheim | 43 | 2023-06-12 | 2026-03-12 |
PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms
Spesolimab - Generalized Pustular Psoriasis | | Completed | Boehringer Ingelheim | 52 | 2023-04-18 | 2025-10-20 |
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
spesolimab - Generalized Pustular Psoriasis | Phase 3 | Completed | Boehringer Ingelheim | 39 | 2022-03-15 | 2025-10-20 |
An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options
spesolimab - Generalized Pustular Psoriasis | Phase 3 | Completed | Boehringer Ingelheim | 11 | 2022-02-17 | 2025-02-25 |
A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction
Spesolimab, Placebo - Fibrostenotic Crohn´s Disease | Phase 2 | Terminated | Boehringer Ingelheim | 5 | 2021-11-09 | 2025-02-24 |
A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial
Spesolimab 1200 mg, Spesolimab 600 mg, Placebo matching 600 mg Spesolimab - Hidradenitis Suppurativa | Phase 2 | Completed | Boehringer Ingelheim | 45 | 2021-08-24 | 2025-11-14 |
A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
Spesolimab - Palmoplantar Pustulosis | Phase 2 | Terminated | Boehringer Ingelheim | 108 | 2020-09-04 | 2025-10-20 |
A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis
Spesolimab, Placebo - Generalized Pustular Psoriasis | Phase 2 | Completed | Boehringer Ingelheim | 123 | 2020-06-04 | 2025-10-20 |
A Trial in Healthy Chinese Volunteers to Test How Different Doses of BI 655130 Are Taken up in the Body
Spesolimap - Healthy | Phase 1 | Completed | Boehringer Ingelheim | 50 | 2020-05-21 | 2023-08-07 |
A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials
Spesolimab - Crohn Disease | Phase 2 | Terminated | Boehringer Ingelheim | 12 | 2020-05-15 | 2025-02-24 |
A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032
Spesolimab - Dermatitis, Atopic | Phase 2 | Terminated | Boehringer Ingelheim | 14 | 2019-09-24 | 2025-02-24 |
A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis
Spesolimab, Placebo - Palmoplantar Pustulosis (PPP) | Phase 2 | Completed | Boehringer Ingelheim | 152 | 2019-07-31 | 2025-10-16 |
Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study
Spesolimab - Generalized Pustular Psoriasis | Phase 2 | Active not recruiting | LEO Pharma | 131 | 2019-05-29 | 2026-09-01 |
A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated
BI 655130, Placebo - Dermatitis, Atopic | Phase 2 | Completed | Boehringer Ingelheim | 51 | 2019-02-12 | 2025-10-20 |
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Conditions studied
Psoriasis (12) · Colitis, Ulcerative (4) · Crohn Disease (2) · Dermatitis, Atopic (2) · Hidradenitis Suppurativa (2) · Pyoderma Gangrenosum (2) · Netherton Syndrome (1)
Sponsors
Boehringer Ingelheim (29) · LEO Pharma (3) · Icahn School of Medicine at Mount Sinai (1)
Countries
Belgium (17) · Germany (17) · Japan (16) · United States (16) · South Korea (14) · Canada (11) · France (11) · Spain (11) · Italy (9) · China (8) · Malaysia (8) · Taiwan (8) · Australia (7) · Netherlands (7) · Poland (7)
Top investigators
Saakshi Khattri, MD (1)
Results publications
PMID 36451029, PMID 39104539, PMID 33785490, PMID 34936739, PMID 36333618, PMID 37731086, PMID 37840119, PMID 39039387, PMID 40057892
NIH funding
2016 (5), 2018 (5), 2017 (4), 2023 (3), 2015 (1), 2019 (1)