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

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)

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.

Study Overview

• Status: Completed
• Conditions: Palmoplantar Pustulosis (PPP)
• Intervention / Treatment: Drug: Spesolimab; Drug: Placebo; Drug: Spesolimab; Drug: Spesolimab; Drug: Spesolimab; Drug: Spesolimab

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Woden Dermatology
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Wooloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute Inc
    • Parkville, Victoria, Australia, 3050
      • Royal Melbourne Hospital
• Belgium
  • Bruxelles, Belgium, 1200
    • Brussels - UNIV Saint-Luc
  • Leuven, Belgium, 3000
    • UZ Leuven
• Canada
  • Alberta
    • Red Deer, Alberta, Canada, T4P 1K4
      • Care Clinic
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Dr. Irina Turchin PC Inc.
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • SimcoDerm Medical and Surgical Dermatology Centre
    • London, Ontario, Canada, N6A 3H7
      • The Guenther Dermatology Research Centre
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • York Dermatology Clinic and Research Centre
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research Inc.
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc.
• Czechia
  • Pardubice, Czechia, 530 02
    • CCBR Czech a.s.
  • Prague, Czechia, 11000
    • Sanatorium Prof. Arenebergera
  • Prague 3, Czechia, 130 00
    • CCBR Czech Prague s.r.o.
• France
  • Nice, France, 06202
    • HOP l'Archet
  • Paris, France, 75010
    • HOP Saint-Louis
  • Toulouse, France, 31059
    • HOP Larrey
• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen
  • Frankfurt am Main, Germany, 60596
    • Universitatsklinikum Frankfurt
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein, Campus Kiel
• Hungary
  • Miskolc, Hungary, 3529
    • CRU Hungary Ltd, Private Practice, Miskolc
  • Pecs, Hungary, 7632
    • University of Pecs
  • Szombathely, Hungary, 9700
    • Markusovszky University Teaching Hospital
  • Veszprem, Hungary, 8200
    • Veszprém County Csolnoky Ferenc Hospital
• Japan
  • Aichi, Nagoya, Japan, 467-8602
    • Nagoya City University Hospital
  • Aichi, Toyoake, Japan, 470-1192
    • Fujita Health University Hospital
  • Chiba, Ichikawa, Japan, 272-8513
    • Tokyo Dental College Ichikawa General Hospital
  • Ehime, Toon, Japan, 791-0295
    • Ehime University Hospital
  • Fukuoka, Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Gifu, Gifu, Japan, 501-1194
    • Gifu University Hospital
  • Hokkaido, Asahikawa, Japan, 078-8510
    • Asahikawa Medical University Hospital
  • Hokkaido, Asahikawa, Japan, 078-8211
    • Asahikawa Kosei General Hospital
  • Hokkaido, Obihiro, Japan, 080-0013
    • Takagi Dermatological Clinic
  • Hokkaido, Sapporo, Japan, 064-0807
    • Hosui General Medical Clinic
  • Kagawa, Takamatsu, Japan, 760-0017
    • Takamatsu Red Cross Hospital
  • Kanagawa, Sagamihara, Japan, 252-0392
    • Sagamihara National Hospital
  • Kumamoto, Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital
  • Kyoto, Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • Miyagi, Sendai, Japan, 980-8574
    • Tohoku University Hospital
  • Nagano, Matsumoto, Japan, 390-8621
    • Shinshu University Hospital
  • Okayama, Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Okinawa, Nakagami-gun, Japan, 903-0215
    • University of the Ryukyus Hospital
  • Osaka, Osaka, Japan, 531-0072
    • Nakatsu Dermatology Clinic
  • Osaka, Osaka, Japan, 545-8586
    • Osaka City University Hospital
  • Osaka, Osaka-sayama, Japan, 589-8511
    • Kindai University Hospital
  • Osaka, Suita, Japan, 565-0871
    • Osaka University Hospital
  • Shiga, Otsu, Japan, 520-2192
    • Shiga University Of Medical Science Hospital
  • Tochigi, Shimotsuke, Japan, 329-0498
    • Jichi Medical University Hospital
  • Tokyo, Itabashi-ku, Japan, 173-8606
    • Teikyo University Hospital
  • Tokyo, Itabashi-ku, Japan, 173-8610
    • Nihon University Itabashi Hospital
  • Tokyo, Shinjuku, Japan, 161-8521
    • Seibo Hospital
  • Tokyo, Shinjuku-ku, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Toyama, Takaoka, Japan, 933-0871
    • Shirasaki Dermatology and Neurology Clinic
  • Wakayama, Wakayama, Japan, 641-8509
    • Wakayama Medical University Hospital
• Korea, Republic of
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Seongnam, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis
• Poland
  • Krakow, Poland, 31-559
    • Barbara Rewerska Diamond Clinic, Krakow
  • Lodz, Poland, 90-436
    • Dermoklinika medical center, Lodz
  • Lublin, Poland, 20-081
    • Independent Public Clin.Hosp.no1 Lublin
  • Olsztyn, Poland, 10-229
    • Municipal Hospital Complex in Olsztyn
  • Wroclaw, Poland, 51-318
    • Dermmedica Sp. z o.o., Wroclaw
• Russian Federation
  • Chelyabinsk, Russian Federation, 454048
    • SBHI Chelyabinsk Reg.Clin.Derma.Dispen.
  • Kazan, Russian Federation, 420111
    • LLC "Medical Center Azbuka Zdorovia"
  • Saint-Petersburg, Russian Federation, 194021
    • Dermatovenereological Dispensary #10, St. Petersburg
• Taiwan
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
• United Kingdom
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon and Exeter Hospital
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center, PC
  • California
    • Beverly Hills, California, United States, 90211
      • Wallace Medical Group
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research Pc
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Epiphany Dermatology of Kansas, LLC
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health System
    • Saint Louis, Missouri, United States, 63108
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, P.C.
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • The Psoriasis Treatment Center of Central New Jersey
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Co., Inc.
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Menter Dermatology Research Institute
  • Utah
    • Murray, Utah, United States, 84107
      • University of Utah Health
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Spesolimab; Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.; Drug: Placebo; Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a high dose scheme 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.	Drug: Spesolimab; Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a high 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.	Drug: Spesolimab; Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a high 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.	Drug: Spesolimab; Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a 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.	Drug: Spesolimab; Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.; Drug: Spesolimab; Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline	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.	week 0 (baseline) and week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4	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.	week 0 (baseline) and week 4.
Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 16	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.	week 0 (baseline) and week 16.
Palmoplantar Pustulosis Severity Index (PPP SI) Change From Baseline at Week 16	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.	week 0 (baseline) and week 16.
Number of Patients Achieving a 50% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI50)	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.	week 0 (baseline) and week 16
Number of Patients Achieving a 75% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI75)	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.	week 0 (baseline) and week 16
Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Clear/Almost Clear (0 or 1) at Week 16	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.	week 0 (baseline) and week 16
Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Pustules Clear/Almost Clear (0 or 1) at Week 16	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.	week 0 (baseline) and week 16
The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 52 From Baseline	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.	week 0 (baseline) and week 52

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2019
• Primary Completion (Actual): August 6, 2020
• Study Completion (Actual): July 28, 2021

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 1368-0016; 2018-003078-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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.

• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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'.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No