Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Query!
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
Query!
Secondary ID [1]
0
0
2020-000189-41
Query!
Secondary ID [2]
0
0
1368-0024
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Palmoplantar Pustulosis
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Spesolimab
Experimental: Treatment group - Up to 260 weeks
Treatment: Drugs: Spesolimab
Spesolimab
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Query!
Assessment method [1]
0
0
TEAEs were defined as all adverse events (AEs) occurring between start of treatment in this extension trial and the end of its residual effect period. Adverse events that started before first intake of trial medication in the extension trial and deteriorated under treatment during the extension trial were also considered as 'treatment-emergent'.
Query!
Timepoint [1]
0
0
From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Query!
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
Query!
Assessment method [1]
0
0
Percent change in PPP ASI from baseline in parent trial is reported. The adaptation from Psoriasis Area and Severity Index was used in this trial. The index is a linear combination of the percent of surface area of skin affected on the palms and soles of the body and the severity of erythema (E), pustules (P) and scaling / desquamation (D), providing a numeric score for the overall PPP disease state, ranging from 0 (best outcome) to 72 (worst outcome), calculated as: PPP ASI = \[(E+P+D) Area x 0.2 (right palm)\] + \[(E+P+D) Area x 0.2 (left palm)\] + \[(E+P+D) Area x 0.3 (right sole)\] + \[(E+P+D) Area x 0.3 (left sole)\]. The weighted sum of the scores obtained for Erythema (E), Pustules (P), desquamation (D) (scaling) were based on a score range from 0: None to 4: Very severe, and the area affected on a score range from 0 (0%) to 6 (90-100%). Percent change was calculated as: (PPP ASI at Week X - PPP ASI at baseline in parent trial)/PPP ASI at baseline in parent trial \* 100%.
Query!
Timepoint [1]
0
0
Week 0 (baseline) and Week 48, Week 96
Query!
Secondary outcome [2]
0
0
Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96
Query!
Assessment method [2]
0
0
Proportion of patients achieving a 50% decrease in PPP ASI compared to baseline in the parent trial at Weeks 48 and 96 is reported. The calculated index is a linear combination of the percent of surface area of skin affected on the palms and soles of the body and the severity of erythema, pustules and scaling / desquamation, providing a numeric score for the overall PPP disease state, ranging from 0 (best outcome) to 72 (worst outcome), calculated as: PPP ASI = \[(E+P+D) Area x 0.2 (right palm)\] + \[(E+P+D) Area x 0.2 (left palm)\] + \[(E+P+D) Area x 0.3 (right sole)\] + \[(E+P+D) Area x 0.3 (left sole)\]. The weighted sum of the scores obtained for Erythema (E), Pustules (P), desquamation (D) (scaling) were based on a score range from 0: None to 4: Very severe, and the area affected from 0 (0%) to 6 (90-100%). Proportion was calculated as: Patients with PPP ASI50 at Week X/number of evaluable patients at Week X. Non-response imputation (NRI) was used for missing data imputation.
Query!
Timepoint [2]
0
0
Week 0 (baseline) and Week 48, Week 96
Query!
Secondary outcome [3]
0
0
Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96
Query!
Assessment method [3]
0
0
Proportion of patients with PPP PGA of 0 (clear) or 1 (almost clear) is reported. The Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) was used to assess the patient's skin presentation on the palms and soles. The investigator scored the individual components (erythema, pustules and scaling/crusting) from 0 to 4 as clear, almost clear, mild, moderate or severe. The PPP PGA was analyzed as PPP PGA total score including erythema, pustules and scaling, and as PPP PGA pustules score for pustules only. Number of patients with PPP PGA of 0/1 at Week X/number of evaluable patients at Week X was calculated. NRI approach was used for missing data imputation.
The PPP PGA total score was derived as the mean of all individual components:
0 = If mean=0, for all three components:
1. = If 0 \< mean \<1.5
2. = If 1.5 \<= mean \<2.5
3. = If 2.5 \<= mean \<3.5
4. = If mean \>=3.5
Query!
Timepoint [3]
0
0
Week 48 and Week 96
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
4/09/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
15/05/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
108
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Query!
Recruitment hospital [1]
0
0
Paratus Clinical Research Woden - Phillip
Query!
Recruitment hospital [2]
0
0
Westmead Hospital - Westmead
Query!
Recruitment hospital [3]
0
0
Skin Health Institute Inc - Carlton
Query!
Recruitment hospital [4]
0
0
Royal Melbourne Hospital - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2606 - Phillip
Query!
Recruitment postcode(s) [2]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [3]
0
0
3053 - Carlton
Query!
Recruitment postcode(s) [4]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Missouri
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
New Jersey
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Pennsylvania
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Texas
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Utah
Query!
Country [7]
0
0
Belgium
Query!
State/province [7]
0
0
Bruxelles
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Leuven
Query!
Country [9]
0
0
Canada
Query!
State/province [9]
0
0
New Brunswick
Query!
Country [10]
0
0
Canada
Query!
State/province [10]
0
0
Ontario
Query!
Country [11]
0
0
Canada
Query!
State/province [11]
0
0
Quebec
Query!
Country [12]
0
0
Czechia
Query!
State/province [12]
0
0
Pardubice
Query!
Country [13]
0
0
Czechia
Query!
State/province [13]
0
0
Prague
Query!
Country [14]
0
0
Czechia
Query!
State/province [14]
0
0
Praha
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Nice
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Paris
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Toulouse
Query!
Country [18]
0
0
Germany
Query!
State/province [18]
0
0
Berlin
Query!
Country [19]
0
0
Germany
Query!
State/province [19]
0
0
Erlangen
Query!
Country [20]
0
0
Germany
Query!
State/province [20]
0
0
Frankfurt am Main
Query!
Country [21]
0
0
Germany
Query!
State/province [21]
0
0
Heidelberg
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
Kiel
Query!
Country [23]
0
0
Hungary
Query!
State/province [23]
0
0
Pecs
Query!
Country [24]
0
0
Hungary
Query!
State/province [24]
0
0
Szombathely
Query!
Country [25]
0
0
Japan
Query!
State/province [25]
0
0
Aichi, Toyoake
Query!
Country [26]
0
0
Japan
Query!
State/province [26]
0
0
Chiba, Ichikawa
Query!
Country [27]
0
0
Japan
Query!
State/province [27]
0
0
Fukuoka, Fukuoka
Query!
Country [28]
0
0
Japan
Query!
State/province [28]
0
0
Gifu, Gifu
Query!
Country [29]
0
0
Japan
Query!
State/province [29]
0
0
Hokkaido, Asahikawa
Query!
Country [30]
0
0
Japan
Query!
State/province [30]
0
0
Hokkaido, Obihiro
Query!
Country [31]
0
0
Japan
Query!
State/province [31]
0
0
Kagawa, Takamatsu
Query!
Country [32]
0
0
Japan
Query!
State/province [32]
0
0
Kanagawa, Sagamihara
Query!
Country [33]
0
0
Japan
Query!
State/province [33]
0
0
Kumamoto, Kumamoto
Query!
Country [34]
0
0
Japan
Query!
State/province [34]
0
0
Kyoto, Kyoto
Query!
Country [35]
0
0
Japan
Query!
State/province [35]
0
0
Miyagi, Sendai
Query!
Country [36]
0
0
Japan
Query!
State/province [36]
0
0
Nagano, Matsumoto
Query!
Country [37]
0
0
Japan
Query!
State/province [37]
0
0
Okayama, Okayama
Query!
Country [38]
0
0
Japan
Query!
State/province [38]
0
0
Okinawa, Nakagami-gun
Query!
Country [39]
0
0
Japan
Query!
State/province [39]
0
0
Osaka, Osaka
Query!
Country [40]
0
0
Japan
Query!
State/province [40]
0
0
Osaka, Suita
Query!
Country [41]
0
0
Japan
Query!
State/province [41]
0
0
Shiga, Otsu
Query!
Country [42]
0
0
Japan
Query!
State/province [42]
0
0
Tochigi, Shimotsuke
Query!
Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Tokyo, Itabashi-ku
Query!
Country [44]
0
0
Japan
Query!
State/province [44]
0
0
Tokyo, Shinjuku-ku
Query!
Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Wakayama, Wakayama
Query!
Country [46]
0
0
Korea, Republic of
Query!
State/province [46]
0
0
Incheon
Query!
Country [47]
0
0
Korea, Republic of
Query!
State/province [47]
0
0
Seongnam
Query!
Country [48]
0
0
Korea, Republic of
Query!
State/province [48]
0
0
Seoul
Query!
Country [49]
0
0
Poland
Query!
State/province [49]
0
0
Krakow
Query!
Country [50]
0
0
Poland
Query!
State/province [50]
0
0
Lodz
Query!
Country [51]
0
0
Poland
Query!
State/province [51]
0
0
Lublin
Query!
Country [52]
0
0
Poland
Query!
State/province [52]
0
0
Olsztyn
Query!
Country [53]
0
0
Poland
Query!
State/province [53]
0
0
Wroclaw
Query!
Country [54]
0
0
Russian Federation
Query!
State/province [54]
0
0
Chelyabinsk
Query!
Country [55]
0
0
Russian Federation
Query!
State/province [55]
0
0
Kazan
Query!
Country [56]
0
0
Russian Federation
Query!
State/province [56]
0
0
Saint-Petersburg
Query!
Country [57]
0
0
Taiwan
Query!
State/province [57]
0
0
Taipei
Query!
Country [58]
0
0
United Kingdom
Query!
State/province [58]
0
0
Exeter
Query!
Country [59]
0
0
United Kingdom
Query!
State/province [59]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study is open to people with palmoplantar pustulosis who took part in previous clinical studies of a medicine called spesolimab. Participants who benefited from spesolimab treatment in the previous studies can join this study. The purpose of this study is to find out how safe spesolimab is and whether it helps people with palmoplantar pustulosis in the long-term. Participants are in this study for up to 5 years. During this time they visit the study site every month to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' palmoplantar pustulosis and collect information on any health problems of the participants.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04493424
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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)
Query!
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.
Query!
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'.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/24/NCT04493424/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/24/NCT04493424/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04493424