Clinical trial NCT04493424: A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
Official title: An Open-label, Long Term Safety Trial of Spesolimab Treatment in Patients With Palmoplantar Pustulosis (PPP) Who Have Completed Previous BI Spesolimab Trials
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Palmoplantar Pustulosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-07-30
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Secondary outcomes:
measure: Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96
timeFrame: Week 0 (baseline) and Week 48, Week 96
measure: Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96
timeFrame: Week 0 (baseline) and Week 48, Week 96
measure: Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96
timeFrame: Week 48 and Week 96
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Columbia
country: United States
facility: University of Missouri Health System
state: Missouri
city: East Windsor
country: United States
facility: The Psoriasis Treatment Center of Central New Jersey
state: New Jersey
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: Phillip
country: Australia
facility: Paratus Clinical Research Woden
state: Australian Capital Territory
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
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: 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: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Pardubice
country: Czechia
facility: CCBR Czech a.s.
city: Prague
country: Czechia
facility: Sanatorium Prof. Arenebergera
city: Praha
country: Czechia
facility: Univ. Hospital Kralovske Vinohrady
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: Pecs
country: Hungary
facility: University of Pecs
city: Szombathely
country: Hungary
facility: Markusovszky University Teaching Hospital
city: Aichi, Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Chiba, Ichikawa
country: Japan
facility: Tokyo Dental College Ichikawa General 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 Medical University Hospital
city: Hokkaido, Obihiro
country: Japan
facility: Takagi Dermatological 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
country: Japan
facility: Nakatsu Dermatology Clinic
city: Osaka, Osaka
country: Japan
facility: Osaka Metropolitan 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: 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: 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: