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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04015518




Registration number
NCT04015518
Ethics application status
Date submitted
9/07/2019
Date registered
11/07/2019
Date last updated
28/07/2022

Titles & IDs
Public title
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
Scientific title
Multi-center, Double-blind, Randomised, Placebo-controlled, Phase IIb Dose-finding Study to Evaluate Safety and Efficacy of Different Subcutaneous Doses of BI 655130 in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP)
Secondary ID [1] 0 0
2018-003078-28
Secondary ID [2] 0 0
1368-0016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palmoplantar Pustulosis (PPP) 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
Treatment: Drugs - Placebo
Treatment: Drugs - Spesolimab
Treatment: Drugs - Spesolimab
Treatment: Drugs - Spesolimab
Treatment: Drugs - Spesolimab

Other: Placebo & Spesolimab - Subcutaneous injections of placebo matching Spesolimab, with subcutaneous injections of Spesolimab starting at week 16, for a total treatment time of 52 weeks.

Experimental: Spesolimab 'Speso Low' - Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.

Experimental: Spesolimab 'Speso Medium-low' - Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.

Experimental: Spesolimab 'Speso Medium-high' - Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.

Experimental: Spesolimab 'Speso High' - Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.


Treatment: Drugs: Spesolimab
Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.

Treatment: Drugs: Placebo
Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.

Treatment: Drugs: Spesolimab
Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.

Treatment: Drugs: Spesolimab
Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.

Treatment: Drugs: Spesolimab
Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.

Treatment: Drugs: Spesolimab
Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline
Timepoint [1] 0 0
week 0 (baseline) and week 16
Secondary outcome [1] 0 0
Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4
Timepoint [1] 0 0
week 0 (baseline) and week 4.
Secondary outcome [2] 0 0
Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 16
Timepoint [2] 0 0
week 0 (baseline) and week 16.
Secondary outcome [3] 0 0
Palmoplantar Pustulosis Severity Index (PPP SI) Change From Baseline at Week 16
Timepoint [3] 0 0
week 0 (baseline) and week 16.
Secondary outcome [4] 0 0
Number of Patients Achieving a 50% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI50)
Timepoint [4] 0 0
week 0 (baseline) and week 16
Secondary outcome [5] 0 0
Number of Patients Achieving a 75% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI75)
Timepoint [5] 0 0
week 0 (baseline) and week 16
Secondary outcome [6] 0 0
Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Clear/Almost Clear (0 or 1) at Week 16
Timepoint [6] 0 0
week 0 (baseline) and week 16
Secondary outcome [7] 0 0
Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Pustules Clear/Almost Clear (0 or 1) at Week 16
Timepoint [7] 0 0
week 0 (baseline) and week 16
Secondary outcome [8] 0 0
The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 52 From Baseline
Timepoint [8] 0 0
week 0 (baseline) and week 52

Eligibility
Key inclusion criteria
* 18 to 75 years of legal age (according to local legislation) at screening.
* Diagnosis of Palmoplantar Pustulosis defined as presence of primary, persistent (>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, without or with plaque psoriasis elsewhere on the body.
* PPP PGA of at least moderate severity (=3) at screening and baseline.
* A minimum PPP ASI score of 12 at screening and baseline.
* Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).
* Signed and dated written informed consent in accordance with ICH GCP and local legislation prior to admission to the trial.
* Further criteria apply.
Minimum age
18 Years
Maximum age
75 Years
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.
* Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
* Presence or known history of anti-TNF-induced PPP-like disease.
* Patient with a transplanted organ (with exception of a corneal transplant >12 weeks Prior to screening) 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, such as lymphadenopathy and/or splenomegaly.
* Further criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/07/2021
Sample size
Target
Accrual to date
Final
152
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Woden Dermatology - Phillip
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Veracity Clinical Research - Wooloongabba
Recruitment hospital [4] 0 0
Skin Health Institute Inc - Carlton
Recruitment hospital [5] 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
4102 - Wooloongabba
Recruitment postcode(s) [4] 0 0
3053 - Carlton
Recruitment postcode(s) [5] 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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Nebraska
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Leuven
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
New Brunswick
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Czechia
State/province [18] 0 0
Pardubice
Country [19] 0 0
Czechia
State/province [19] 0 0
Prague 3
Country [20] 0 0
Czechia
State/province [20] 0 0
Prague
Country [21] 0 0
France
State/province [21] 0 0
Nice
Country [22] 0 0
France
State/province [22] 0 0
Paris
Country [23] 0 0
France
State/province [23] 0 0
Toulouse
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Erlangen
Country [26] 0 0
Germany
State/province [26] 0 0
Frankfurt am Main
Country [27] 0 0
Germany
State/province [27] 0 0
Heidelberg
Country [28] 0 0
Germany
State/province [28] 0 0
Kiel
Country [29] 0 0
Hungary
State/province [29] 0 0
Miskolc
Country [30] 0 0
Hungary
State/province [30] 0 0
Pecs
Country [31] 0 0
Hungary
State/province [31] 0 0
Szombathely
Country [32] 0 0
Hungary
State/province [32] 0 0
Veszprem
Country [33] 0 0
Japan
State/province [33] 0 0
Aichi, Nagoya
Country [34] 0 0
Japan
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Aichi, Toyoake
Country [35] 0 0
Japan
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Chiba, Ichikawa
Country [36] 0 0
Japan
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Ehime, Toon
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Japan
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Fukuoka, Fukuoka
Country [38] 0 0
Japan
State/province [38] 0 0
Gifu, Gifu
Country [39] 0 0
Japan
State/province [39] 0 0
Hokkaido, Asahikawa
Country [40] 0 0
Japan
State/province [40] 0 0
Hokkaido, Obihiro
Country [41] 0 0
Japan
State/province [41] 0 0
Hokkaido, Sapporo
Country [42] 0 0
Japan
State/province [42] 0 0
Kagawa, Takamatsu
Country [43] 0 0
Japan
State/province [43] 0 0
Kanagawa, Sagamihara
Country [44] 0 0
Japan
State/province [44] 0 0
Kumamoto, Kumamoto
Country [45] 0 0
Japan
State/province [45] 0 0
Kyoto, Kyoto
Country [46] 0 0
Japan
State/province [46] 0 0
Miyagi, Sendai
Country [47] 0 0
Japan
State/province [47] 0 0
Nagano, Matsumoto
Country [48] 0 0
Japan
State/province [48] 0 0
Okayama, Okayama
Country [49] 0 0
Japan
State/province [49] 0 0
Okinawa, Nakagami-gun
Country [50] 0 0
Japan
State/province [50] 0 0
Osaka, Osaka-sayama
Country [51] 0 0
Japan
State/province [51] 0 0
Osaka, Osaka
Country [52] 0 0
Japan
State/province [52] 0 0
Osaka, Suita
Country [53] 0 0
Japan
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Shiga, Otsu
Country [54] 0 0
Japan
State/province [54] 0 0
Tochigi, Shimotsuke
Country [55] 0 0
Japan
State/province [55] 0 0
Tokyo, Itabashi-ku
Country [56] 0 0
Japan
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Tokyo, Shinjuku-ku
Country [57] 0 0
Japan
State/province [57] 0 0
Tokyo, Shinjuku
Country [58] 0 0
Japan
State/province [58] 0 0
Toyama, Takaoka
Country [59] 0 0
Japan
State/province [59] 0 0
Wakayama, Wakayama
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Incheon
Country [61] 0 0
Korea, Republic of
State/province [61] 0 0
Seongnam
Country [62] 0 0
Korea, Republic of
State/province [62] 0 0
Seoul
Country [63] 0 0
Netherlands
State/province [63] 0 0
Breda
Country [64] 0 0
Poland
State/province [64] 0 0
Krakow
Country [65] 0 0
Poland
State/province [65] 0 0
Lodz
Country [66] 0 0
Poland
State/province [66] 0 0
Lublin
Country [67] 0 0
Poland
State/province [67] 0 0
Olsztyn
Country [68] 0 0
Poland
State/province [68] 0 0
Wroclaw
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Chelyabinsk
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Kazan
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Saint-Petersburg
Country [72] 0 0
Taiwan
State/province [72] 0 0
Taipei
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Exeter
Country [74] 0 0
United Kingdom
State/province [74] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130 compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at Week 16. The target dose(s) will be estimated from the model by incorporating information on the minimum clinically relevant effect and accounting for safety.

Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.
Trial website
https://clinicaltrials.gov/study/NCT04015518
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04015518