Psoriasis Clinical Trial

A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares

Summary

This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP.

Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares.

During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients with a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 or 1 and a known and documented history of Generalized Pustular Psoriasis (GPP) (per European Rare And Severe Psoriasis Expert Network - ERASPEN - criteria), regardless of Interleukin 36 Receptor Antagonist (IL-36RN) gene mutation status or Patients with a GPP flare and a known and documented history of GPP (per ERASPEN criteria) regardless of IL-36RN gene mutation status.
Patients must have a history of frequent GPP flares in the past
Male or female patients, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening
Signed and dated written informed consent prior to admission to the trial in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to start of any screening procedures
Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly

Exclusion Criteria:

Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP)
Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques
Patients with primary erythrodermic psoriasis vulgaris
Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome
Immediate life-threatening flare of GPP or requiring intensive care treatment, according to the investigator's judgement. Life-threatening complications mainly include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary distress syndrome, or acute renal failure
Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold upper limit normal (ULN) elevation in Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or >2-fold ULN elevation in total bilirubin
Presence of acute demyelinating neuropathy
Treatment with any drug considered likely to interfere with the safe conduct of the trial, as assessed by the investigator
Further exclusion criteria apply.

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

40

Study ID:

NCT06013969

Recruitment Status:

Recruiting

Sponsor:

Boehringer Ingelheim

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 51 Locations for this study

See Locations Near You

University of California Irvine
Irvine California, 92697, United States More Info
Boehringer Ingelheim
Contact
833-602-2368
[email protected]
Oakland Hills Dermatology, PC
Auburn Hills Michigan, 48326, United States More Info
Boehringer Ingelheim
Contact
833-602-2368
[email protected]
AXIS Clinicals
Fargo North Dakota, 58103, United States More Info
Boehringer Ingelheim
Contact
833-602-2368
[email protected]
Liverpool Hospital
Liverpool New South Wales, 2170, Australia More Info
Boehringer Ingelheim
Contact
1800271035
[email protected]
Westmead Hospital
Westmead New South Wales, 2145, Australia More Info
Boehringer Ingelheim
Contact
1800271035
[email protected]
Brussels - UNIV Saint-Luc
Bruxelles , 1200, Belgium More Info
Boehringer Ingelheim
Contact
080049616
[email protected]
Hospital Universitario Evangelico Mackenzie
Curitiba , 80440, Brazil More Info
Boehringer Ingelheim
Contact
08008919295
[email protected]
Faculdade de Medicina do ABC
Santo André , 09060, Brazil More Info
Boehringer Ingelheim
Contact
08008919295
[email protected]
Southern Medical University Dermatology Hospital
Guangzhou , 51009, China More Info
Boehringer Ingelheim
Contact
4001200553
[email protected]
Shandong Provincial Hospital of Dermatology
Jinan , 25006, China More Info
Boehringer Ingelheim
Contact
4001200553
[email protected]
Shanghai Skin Disease Hospital
Shanghai , 20000, China More Info
Boehringer Ingelheim
Contact
4001200553
[email protected]
Shanghai Tenth People's Hospital
Shanghai , 20007, China More Info
Boehringer Ingelheim
Contact
4001200553
[email protected]
Second Affiliated Hospital of Xi'an JiaoTong University
Xi'an , 71000, China More Info
Boehringer Ingelheim
Contact
4001200553
[email protected]
HOP Trousseau
Chambray-lès-Tours , 37170, France More Info
Boehringer Ingelheim
Contact
0805102354
[email protected]
HOP François Mitterrand
Dijon , 21079, France More Info
Boehringer Ingelheim
Contact
0805102354
[email protected]
HOP Saint-Louis
Paris , 75010, France More Info
Boehringer Ingelheim
Contact
0805102354
[email protected]
Universitätsklinikum Frankfurt
Frankfurt am Main , 60596, Germany More Info
Boehringer Ingelheim
Contact
08007234742
[email protected]
Klinikum der Universität München AÖR
München , 80337, Germany More Info
Boehringer Ingelheim
Contact
08007234742
[email protected]
SP medical college and associated group of hospitals
Bikaner , 33400, India More Info
Boehringer Ingelheim
Contact
0008000501442
[email protected]
Kasturba Medical College and Hospital
Manipal , 57610, India More Info
Boehringer Ingelheim
Contact
0008000501442
[email protected]
Nkp Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
Nagpur , 44001, India More Info
Boehringer Ingelheim
Contact
0008000501442
[email protected]
ASST degli Spedali Civili di Brescia
Brescia , 25123, Italy More Info
Boehringer Ingelheim
Contact
800977373
[email protected]
Presidio Ospedaliero Palagi
Firenze , 50125, Italy More Info
Boehringer Ingelheim
Contact
800977373
[email protected]
AOU Università degli Studi della Campania Luigi Vanvitelli
Napoli , 80131, Italy More Info
Boehringer Ingelheim
Contact
800977373
[email protected]
Fondazione Policlinico Universitario Agostino Gemelli
Roma , 00168, Italy More Info
Boehringer Ingelheim
Contact
800977373
[email protected]
Pusan National Univ. Hosp
Busan , 602-7, Korea, Republic of More Info
Boehringer Ingelheim
Contact
0808802084
[email protected]
Seoul National University Hospital
Seoul , 03080, Korea, Republic of More Info
Boehringer Ingelheim
Contact
0808802084
[email protected]
Severance Hospital
Seoul , 03722, Korea, Republic of More Info
Boehringer Ingelheim
Contact
0808802084
[email protected]
Hospital Selayang
Batu Caves , 68100, Malaysia More Info
Boehringer Ingelheim
Contact
1800814353
[email protected]
Hospital Pulau Pinang
Georgetown Pulau Pinang , 10990, Malaysia More Info
Boehringer Ingelheim
Contact
1800814353
[email protected]
Hospital Raja Permaisuri Bainun
Ipoh , 30450, Malaysia More Info
Boehringer Ingelheim
Contact
1800814353
[email protected]
Hospital Sultanah Aminah
Johor Bahru , 80100, Malaysia More Info
Boehringer Ingelheim
Contact
1800814353
[email protected]
Hospital Sultan Ismail
Johor Bahru , 81100, Malaysia More Info
Boehringer Ingelheim
Contact
1800814353
[email protected]
Hospital Raja Perempuan Zainab II, Kota Bharu
Kota Bharu , 15200, Malaysia More Info
Boehringer Ingelheim
Contact
1800814353
[email protected]
Queen Elizabeth Hospital
Kota Kinabalu , 88586, Malaysia More Info
Boehringer Ingelheim
Contact
1800814353
[email protected]
Hospital Kuala Lumpur
Kuala Lumpur , 50586, Malaysia More Info
Boehringer Ingelheim
Contact
1800814353
[email protected]
Hospital Putrajaya
Putrajaya , 62250, Malaysia More Info
Boehringer Ingelheim
Contact
1800814353
[email protected]
Sunway Medical Centre
Selangor Darul Ehsan , 47500, Malaysia More Info
Boehringer Ingelheim
Contact
1800814353
[email protected]
National University Hospital
Singapore , 11922, Singapore More Info
Boehringer Ingelheim
Contact
8001207344
[email protected]
Changi General Hospital
Singapore , 52988, Singapore More Info
Boehringer Ingelheim
Contact
8001207344
[email protected]
Nelson Mandela Academic Clinical Research Unit (NeMACRU)
Mthatha, Eastern Cape , 5099, South Africa More Info
Boehringer Ingelheim
Contact
0800988886
[email protected]
Hospital Vall d'Hebron
Barcelona , 08035, Spain More Info
Boehringer Ingelheim
Contact
900876092
[email protected]
Hospital Ramón y Cajal
Madrid , 28034, Spain More Info
Boehringer Ingelheim
Contact
900876092
[email protected]
National Taiwan University Hospital
Taipei , 100, Taiwan More Info
Boehringer Ingelheim
Contact
0809092098
[email protected]
Chang Gung Memorial Hospital(Linkou)
Taoyuan , 330, Taiwan More Info
Boehringer Ingelheim
Contact
0809092098
[email protected]
Srinagarind Hospital
Khon Kaen , 40000, Thailand More Info
Boehringer Ingelheim
Contact
1800019059
[email protected]
Maharat Nakhonchiangmai Hospital
Muang Chiang Mai , 50200, Thailand More Info
Boehringer Ingelheim
Contact
1800019059
[email protected]
Hedi Chaker Hospital, Department of Dermatology
Sfax , 1053, Tunisia More Info
Boehringer Ingelheim
Contact
031365917
[email protected]
Farhat Hached Hospital
Sousse , 4000, Tunisia More Info
Boehringer Ingelheim
Contact
031365917
[email protected]
La Rabta Hospital
Tunis , 1007, Tunisia More Info
Boehringer Ingelheim
Contact
031365917
[email protected]
Gazi University Medical Faculty
Ankara , 06500, Turkey More Info
Boehringer Ingelheim
Contact
08006212470
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 4

Estimated Enrollment:

40

Study ID:

NCT06013969

Recruitment Status:

Recruiting

Sponsor:


Boehringer Ingelheim

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider