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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04493424




Registration number
NCT04493424
Ethics application status
Date submitted
28/07/2020
Date registered
30/07/2020

Titles & IDs
Public title
A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
Scientific title
An Open-label, Long Term Safety Trial of Spesolimab Treatment in Patients With Palmoplantar Pustulosis (PPP) Who Have Completed Previous BI Spesolimab Trials
Secondary ID [1] 0 0
2020-000189-41
Secondary ID [2] 0 0
1368-0024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palmoplantar Pustulosis 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: Treatment group - Up to 260 weeks


Treatment: Drugs: Spesolimab
Spesolimab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Secondary outcome [1] 0 0
Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96
Timepoint [1] 0 0
Week 0 (baseline) and Week 48, Week 96
Secondary outcome [2] 0 0
Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96
Timepoint [2] 0 0
Week 0 (baseline) and Week 48, Week 96
Secondary outcome [3] 0 0
Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96
Timepoint [3] 0 0
Week 48 and Week 96

Eligibility
Key inclusion criteria
* Signed and dated written informed consent for the current trial 1368-0024, in accordance with ICH-GCP and local legislation prior to admission to the current trial
* Male or female patients who have completed the treatment period in one of the parent trials without premature discontinuation
* Patients who have obtained an individual health benefit, per investigator judgement (e.g. PPP PGA of 0 (clear) or 1 (almost clear) or other clinical improvement), from treatment in the parent trial
* Women of childbearing potential 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
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Patients who experienced study treatment-limiting adverse events during the parent trial
* Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof
* Patients with congestive heart disease, as assessed by the investigator
* Patient with a transplanted organ (with exception of a corneal transplant > 12 weeks prior to screening in parent trial) or who have ever received stem cell therapy (e.g., Prochymal)
* Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease (e.g. splenomegaly)
* Any documented active or suspected malignancy or history of malignancy at screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
* Patients who have developed active or severe infective disease and opportunistic infections/infective diseases
* 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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2023
Sample size
Target
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Woden - Phillip
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Skin Health Institute Inc - Carlton
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
Belgium
State/province [7] 0 0
Bruxelles
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Canada
State/province [9] 0 0
New Brunswick
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Czechia
State/province [12] 0 0
Pardubice
Country [13] 0 0
Czechia
State/province [13] 0 0
Prague
Country [14] 0 0
Czechia
State/province [14] 0 0
Praha
Country [15] 0 0
France
State/province [15] 0 0
Nice
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
France
State/province [17] 0 0
Toulouse
Country [18] 0 0
Germany
State/province [18] 0 0
Berlin
Country [19] 0 0
Germany
State/province [19] 0 0
Erlangen
Country [20] 0 0
Germany
State/province [20] 0 0
Frankfurt am Main
Country [21] 0 0
Germany
State/province [21] 0 0
Heidelberg
Country [22] 0 0
Germany
State/province [22] 0 0
Kiel
Country [23] 0 0
Hungary
State/province [23] 0 0
Pecs
Country [24] 0 0
Hungary
State/province [24] 0 0
Szombathely
Country [25] 0 0
Japan
State/province [25] 0 0
Aichi, Toyoake
Country [26] 0 0
Japan
State/province [26] 0 0
Chiba, Ichikawa
Country [27] 0 0
Japan
State/province [27] 0 0
Fukuoka, Fukuoka
Country [28] 0 0
Japan
State/province [28] 0 0
Gifu, Gifu
Country [29] 0 0
Japan
State/province [29] 0 0
Hokkaido, Asahikawa
Country [30] 0 0
Japan
State/province [30] 0 0
Hokkaido, Obihiro
Country [31] 0 0
Japan
State/province [31] 0 0
Kagawa, Takamatsu
Country [32] 0 0
Japan
State/province [32] 0 0
Kanagawa, Sagamihara
Country [33] 0 0
Japan
State/province [33] 0 0
Kumamoto, Kumamoto
Country [34] 0 0
Japan
State/province [34] 0 0
Kyoto, Kyoto
Country [35] 0 0
Japan
State/province [35] 0 0
Miyagi, Sendai
Country [36] 0 0
Japan
State/province [36] 0 0
Nagano, Matsumoto
Country [37] 0 0
Japan
State/province [37] 0 0
Okayama, Okayama
Country [38] 0 0
Japan
State/province [38] 0 0
Okinawa, Nakagami-gun
Country [39] 0 0
Japan
State/province [39] 0 0
Osaka, Osaka
Country [40] 0 0
Japan
State/province [40] 0 0
Osaka, Suita
Country [41] 0 0
Japan
State/province [41] 0 0
Shiga, Otsu
Country [42] 0 0
Japan
State/province [42] 0 0
Tochigi, Shimotsuke
Country [43] 0 0
Japan
State/province [43] 0 0
Tokyo, Itabashi-ku
Country [44] 0 0
Japan
State/province [44] 0 0
Tokyo, Shinjuku-ku
Country [45] 0 0
Japan
State/province [45] 0 0
Wakayama, Wakayama
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Incheon
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Seongnam
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Seoul
Country [49] 0 0
Poland
State/province [49] 0 0
Krakow
Country [50] 0 0
Poland
State/province [50] 0 0
Lodz
Country [51] 0 0
Poland
State/province [51] 0 0
Lublin
Country [52] 0 0
Poland
State/province [52] 0 0
Olsztyn
Country [53] 0 0
Poland
State/province [53] 0 0
Wroclaw
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Chelyabinsk
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Kazan
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Saint-Petersburg
Country [57] 0 0
Taiwan
State/province [57] 0 0
Taipei
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Exeter
Country [59] 0 0
United Kingdom
State/province [59] 0 0
London

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this 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".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to 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.

The data shared are the raw clinical study data sets.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
After 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 both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing 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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04493424