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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
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
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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)
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Secondary ID [1]
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2018-003078-28
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Secondary ID [2]
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1368-0016
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Palmoplantar Pustulosis (PPP)
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline
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Assessment method [1]
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The percentage change in PPP ASI at Week 16 from baseline. The PPP ASI is a tool that provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation): The percent change from baseline is calculated as (PPP ASI current - PPP ASI baseline) / PPP ASI baseline \* 100%.
Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based Mixed effect model for repeated measurements (MMRM) including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.
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Timepoint [1]
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week 0 (baseline) and week 16
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Secondary outcome [1]
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Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4
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Assessment method [1]
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Change from baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) score at Week 4. The PPP Pain VAS is a unidimensional measure of pain intensity due to palmoplantar pustulosis on palms and/or soles. It is a continuous scale comprised of a horizontal or vertical line, 10 centimeters (cm) in length, anchored by word descriptors at each end (score ranges from "no pain" at 0 cm to "very severe pain" at 10 cm). The patient was asked to place a vertical ( \| ) mark on the horizontal line to indicate the severity of the pain.
Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.
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Timepoint [1]
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week 0 (baseline) and week 4.
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Secondary outcome [2]
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Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 16
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Assessment method [2]
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Change from baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) score at Week 16. The PPP Pain VAS is a unidimensional measure of pain intensity due to palmoplantar pustulosis on palms and/or soles. It is a continuous scale comprised of a horizontal or vertical line, 10 centimeters (cm) in length, anchored by word descriptors at each end (score ranges from "no pain" at 0 cm to "very severe pain" at 10 cm). The patient was asked to place a vertical ( \| ) mark on the horizontal line to indicate the severity of the pain.
Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.
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Timepoint [2]
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week 0 (baseline) and week 16.
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Secondary outcome [3]
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Palmoplantar Pustulosis Severity Index (PPP SI) Change From Baseline at Week 16
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Assessment method [3]
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PPP SI change from baseline at Week 16. The PPP SI is based on the severity score of individual components (erythema, pustules, and scaling/desquamation) of PPP ASI assessments. The most severely affected area based on pustules was identified by the investigator at baseline and assessed at all subsequent visits. The PPP SI was calculated by summing up the individual components of PPP ASI assessment (range 0 (best) to 12 (worst)) at each visit for the identified location.
Least square (LS) means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based Mixed effect model for repeated measurements (MMRM) including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.
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Timepoint [3]
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week 0 (baseline) and week 16.
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Secondary outcome [4]
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Number of Patients Achieving a 50% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI50)
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Assessment method [4]
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Number of patients achieving a 50% decrease from baseline in Palmoplantar Pustulosis Area and Severity Index score at week 16 (PPP ASI50). The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). When (PPP ASI baseline - PPP ASI current)/ PPP ASI baseline \* 100% \>= 50%, PPP ASI50 = 1.
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Timepoint [4]
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week 0 (baseline) and week 16
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Secondary outcome [5]
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Number of Patients Achieving a 75% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI75)
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Assessment method [5]
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Number of patients achieving a 75% decrease from baseline in Palmoplantar Pustulosis Area and Severity Index score at week 16 (PPP ASI75). The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation). When (PPP ASI baseline - PPP ASI current)/ PPP ASI baseline \* 100% \>= 75%, PPP ASI75 = 1.
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Timepoint [5]
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week 0 (baseline) and week 16
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Secondary outcome [6]
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Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Clear/Almost Clear (0 or 1) at Week 16
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Assessment method [6]
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Number of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) clear/almost clear (0 or 1) at Week 16. The PPP PGA relies on investigator assessment of the patient's skin presentation on the palms and soles. The investigator scored the individual components (erythema, pustules, and scaling/crusting) from 0 (best) to 4 (worst) as clear, almost clear, mild, moderate or severe. PPP PGA categorization is based on the mean of the four individual components.
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Timepoint [6]
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week 0 (baseline) and week 16
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Secondary outcome [7]
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Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Pustules Clear/Almost Clear (0 or 1) at Week 16
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Assessment method [7]
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Number of patients with Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) pustules clear/almost clear (0 or 1) at Week 16. The PPP PGA relies on investigator assessment of the patient's skin presentation on the palms and soles. The investigator scored the pustules from 0 (best) to 4 (worst) as clear, almost clear, mild, moderate or severe.
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Timepoint [7]
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week 0 (baseline) and week 16
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Secondary outcome [8]
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The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 52 From Baseline
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Assessment method [8]
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The percentage change in PPP ASI at Week 52 from baseline. The PPP ASI is an investigator assessment of the extent and severity of palmoplantar pustulosis lesions on the palms and soles in PPP patients. This tool provides a numeric scoring for patients overall PPP disease state, ranging from 0 (best) to 72 (worst). It is a linear combination of the percent of surface area of skin that is affected on the palms and soles of the body and the severity of erythema, pustules, and scaling (desquamation).
LS means, differences and confidence intervals were estimated by (Restricted maximum likelihood)-based MMRM including the fixed, categorical effects of treatment at each visit, region and the continuous effect of baseline at each visit as well as random effects of subject. Values post rescue medication or 6 weeks following last study treatment before discontinuation were censored. Unstructured covariance matrix was used.
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Timepoint [8]
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week 0 (baseline) and week 52
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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.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/07/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/07/2021
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Sample size
Target
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Accrual to date
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Final
152
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
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Recruitment hospital [1]
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Woden Dermatology - Phillip
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Recruitment hospital [2]
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Westmead Hospital - Westmead
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Recruitment hospital [3]
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Veracity Clinical Research - Wooloongabba
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Recruitment hospital [4]
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Skin Health Institute Inc - Carlton
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Recruitment hospital [5]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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2606 - Phillip
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4102 - Wooloongabba
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Recruitment postcode(s) [4]
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3053 - Carlton
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Recruitment postcode(s) [5]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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Alabama
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Bruxelles
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Pardubice
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Kanagawa, Sagamihara
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Okayama, Okayama
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Tochigi, Shimotsuke
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Tokyo, Itabashi-ku
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Tokyo, Shinjuku-ku
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Tokyo, Shinjuku
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Wakayama, Wakayama
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Korea, Republic of
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Incheon
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Seongnam
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Breda
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Lublin
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Olsztyn
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Wroclaw
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kazan
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Russian Federation
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Saint-Petersburg
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Taipei
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United Kingdom
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Exeter
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04015518
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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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.
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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'.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/18/NCT04015518/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/18/NCT04015518/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04015518