Clinical trial NCT04015518: 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
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Palmoplantar Pustulosis (PPP)
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-07-11
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 16 From Baseline
timeFrame: week 0 (baseline) and week 16
Secondary outcomes:
measure: Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 4
timeFrame: week 0 (baseline) and week 4.
measure: Change From Baseline in Palmoplantar Pustulosis Pain Visual Analogue Scale (VAS) Score at Week 16
timeFrame: week 0 (baseline) and week 16.
measure: Palmoplantar Pustulosis Severity Index (PPP SI) Change From Baseline at Week 16
timeFrame: week 0 (baseline) and week 16.
measure: Number of Patients Achieving a 50% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI50)
timeFrame: week 0 (baseline) and week 16
measure: Number of Patients Achieving a 75% Decrease From Baseline in Palmoplantar Pustulosis Area and Severity Index Score at Week 16 (PPP ASI75)
timeFrame: week 0 (baseline) and week 16
measure: Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Clear/Almost Clear (0 or 1) at Week 16
timeFrame: week 0 (baseline) and week 16
measure: Number of Patients With Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) Pustules Clear/Almost Clear (0 or 1) at Week 16
timeFrame: week 0 (baseline) and week 16
measure: The Percentage Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) at Week 52 From Baseline
timeFrame: week 0 (baseline) and week 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Beverly Hills
country: United States
facility: Wallace Medical Group
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Sandy Springs
country: United States
facility: Advanced Medical Research PC
state: Georgia
city: Overland Park
country: United States
facility: Epiphany Dermatology of Kansas, LLC
state: Kansas
city: Columbia
country: United States
facility: University of Missouri Health System
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, P.C.
state: Nebraska
city: East Windsor
country: United States
facility: The Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Philadelphia
country: United States
facility: Paddington Testing Co., Inc.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Murray
country: United States
facility: University of Utah Health
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Phillip
country: Australia
facility: Woden Dermatology
state: Australian Capital Territory
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Wooloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Carlton
country: Australia
facility: Skin Health Institute Inc
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Bruxelles
country: Belgium
facility: Brussels - UNIV Saint-Luc
city: Leuven
country: Belgium
facility: UZ Leuven
city: Red Deer
country: Canada
facility: CARe Clinic
state: Alberta
city: Fredericton
country: Canada
facility: Dr. Irina Turchin PC Inc.
state: New Brunswick
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Centre
state: Ontario
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc.
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Pardubice
country: Czechia
facility: CCBR Czech a.s.
city: Prague 3
country: Czechia
facility: CCBR Czech Prague s.r.o.
city: Prague
country: Czechia
facility: Sanatorium Prof. Arenebergera
city: Nice
country: France
facility: HOP l'Archet
city: Paris
country: France
facility: HOP Saint-Louis
city: Toulouse
country: France
facility: HOP Larrey
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel
city: Miskolc
country: Hungary
facility: CRU Hungary Ltd, Private Practice, Miskolc
city: Pecs
country: Hungary
facility: University of Pecs
city: Szombathely
country: Hungary
facility: Markusovszky University Teaching Hospital
city: Veszprem
country: Hungary
facility: Veszprem County Csolnoky Ferenc Hospital
city: Aichi, Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Aichi, Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Chiba, Ichikawa
country: Japan
facility: Tokyo Dental College Ichikawa General Hospital
city: Ehime, Toon
country: Japan
facility: Ehime University Hospital
city: Fukuoka, Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Gifu, Gifu
country: Japan
facility: Gifu University Hospital
city: Hokkaido, Asahikawa
country: Japan
facility: Asahikawa Kosei General Hospital
city: Hokkaido, Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital
city: Hokkaido, Obihiro
country: Japan
facility: Takagi Dermatological Clinic
city: Hokkaido, Sapporo
country: Japan
facility: Hosui General Medical Clinic
city: Kagawa, Takamatsu
country: Japan
facility: Takamatsu Red Cross Hospital
city: Kanagawa, Sagamihara
country: Japan
facility: Sagamihara National Hospital
city: Kumamoto, Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kyoto, Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Miyagi, Sendai
country: Japan
facility: Tohoku University Hospital
city: Nagano, Matsumoto
country: Japan
facility: Shinshu University Hospital
city: Okayama, Okayama
country: Japan
facility: Okayama University Hospital
city: Okinawa, Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital
city: Osaka, Osaka-sayama
country: Japan
facility: Kindai University Hospital
city: Osaka, Osaka
country: Japan
facility: Nakatsu Dermatology Clinic
city: Osaka, Osaka
country: Japan
facility: Osaka City University Hospital
city: Osaka, Suita
country: Japan
facility: Osaka University Hospital
city: Shiga, Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
city: Tochigi, Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
city: Tokyo, Itabashi-ku
country: Japan
facility: Teikyo University Hospital
city: Tokyo, Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
city: Tokyo, Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo, Shinjuku
country: Japan
facility: Seibo Hospital
city: Toyama, Takaoka
country: Japan
facility: Shirasaki Dermatology and Neurology Clinic
city: Wakayama, Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Krakow
country: Poland
facility: Barbara Rewerska Diamond Clinic, Krakow
city: Lodz
country: Poland
facility: Dermoklinika medical center, Lodz
city: Lublin
country: Poland
facility: Independent Public Clin.Hosp.no1 Lublin
city: Olsztyn
country: Poland
facility: Municipal Hospital Complex in Olsztyn
city: Wroclaw
country: Poland
facility: Dermmedica Sp. z o.o., Wroclaw
city: Chelyabinsk
country: Russian Federation
facility: SBHI Chelyabinsk Reg.Clin.Derma.Dispen.
city: Kazan
country: Russian Federation
facility: LLC "Medical Center Azbuka Zdorovia"
city: Saint-Petersburg
country: Russian Federation
facility: Dermatovenereological Dispensary #10, St. Petersburg
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
Study officials:
References: