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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06013969




Registration number
NCT06013969
Ethics application status
Date submitted
23/08/2023
Date registered
28/08/2023

Titles & IDs
Public title
A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares
Scientific title
Effisayil® REP:An Open-label, Multicenter, Single-arm, Post-marketing Trial (in Select Countries) to Evaluate Efficacy and Safety and the Impact of Immunogenicity on Efficacy, Safety, and Pharmacokinetics of Spesolimab i.v. in Treatment of Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Recurrent Flare Following Their Initial GPP Flare Treatment With Spesolimab i.v.
Secondary ID [1] 0 0
2022-502128-38-00
Secondary ID [2] 0 0
1368-0120
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalized Pustular Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Spesolimab

Experimental: GPP Patients - Generalized Pustular Psoriasis (GPP) patients with a recurrent flare following initial GPP flare treatment with intravenous (i.v.) spesolimab.


Treatment: Drugs: Spesolimab
Spesolimab intravenous (i.v.) infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Achievement of a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 1
Timepoint [1] 0 0
Up to week 1
Secondary outcome [1] 0 0
Achievement of a GPPGA pustulation sub-score of 0 or 1, with a =2-point reduction from baseline at Week 1
Timepoint [1] 0 0
Up to week 1

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/04/2027
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
North Dakota
Country [3] 0 0
Belgium
State/province [3] 0 0
Bruxelles
Country [4] 0 0
Brazil
State/province [4] 0 0
Curitiba
Country [5] 0 0
Brazil
State/province [5] 0 0
Santo André
Country [6] 0 0
China
State/province [6] 0 0
Guangzhou
Country [7] 0 0
China
State/province [7] 0 0
Shanghai
Country [8] 0 0
France
State/province [8] 0 0
Chambray-lès-Tours
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
Germany
State/province [10] 0 0
Frankfurt am Main
Country [11] 0 0
Germany
State/province [11] 0 0
München
Country [12] 0 0
India
State/province [12] 0 0
Bikaner
Country [13] 0 0
India
State/province [13] 0 0
Manipal
Country [14] 0 0
India
State/province [14] 0 0
Nagpur
Country [15] 0 0
Italy
State/province [15] 0 0
Brescia
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Busan
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul
Country [18] 0 0
Malaysia
State/province [18] 0 0
Batu Caves
Country [19] 0 0
Malaysia
State/province [19] 0 0
Georgetown Pulau Pinang
Country [20] 0 0
Malaysia
State/province [20] 0 0
Ipoh
Country [21] 0 0
Malaysia
State/province [21] 0 0
Johor Bahru
Country [22] 0 0
Malaysia
State/province [22] 0 0
Kota Bharu
Country [23] 0 0
Malaysia
State/province [23] 0 0
Kota Kinabalu
Country [24] 0 0
Malaysia
State/province [24] 0 0
Kuala Lumpur
Country [25] 0 0
Malaysia
State/province [25] 0 0
Putrajaya
Country [26] 0 0
Malaysia
State/province [26] 0 0
Selangor Darul Ehsan
Country [27] 0 0
Singapore
State/province [27] 0 0
Singapore
Country [28] 0 0
South Africa
State/province [28] 0 0
Mthatha, Eastern Cape
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona
Country [30] 0 0
Spain
State/province [30] 0 0
Madrid
Country [31] 0 0
Taiwan
State/province [31] 0 0
Taipei
Country [32] 0 0
Taiwan
State/province [32] 0 0
Taoyuan
Country [33] 0 0
Thailand
State/province [33] 0 0
Khon Kaen
Country [34] 0 0
Thailand
State/province [34] 0 0
Muang Chiang Mai
Country [35] 0 0
Tunisia
State/province [35] 0 0
Sfax
Country [36] 0 0
Tunisia
State/province [36] 0 0
Sousse
Country [37] 0 0
Tunisia
State/province [37] 0 0
Tunis
Country [38] 0 0
Turkey
State/province [38] 0 0
Ankara

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'.

For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06013969