A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab

Palmoplantar Pustulosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04493424
• Other study ID #: 1368-0024
• Secondary ID: 2020-000189-41
• Status: Terminated
• Phase: Phase 2
• Start date: September 4, 2020
• Est. completion date: May 15, 2023

Study information

• Verified date: February 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: May 15, 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Palmoplantar Pustulosis
• Psoriasis

Intervention

Drug:
• Spesolimab
Spesolimab

Locations

Country	Name	City	State
Australia	Skin Health Institute Inc	Carlton	Victoria
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Paratus Clinical Research Woden	Phillip	Australian Capital Territory
Australia	Westmead Hospital	Westmead	New South Wales
Belgium	Brussels - UNIV Saint-Luc	Bruxelles
Belgium	UZ Leuven	Leuven
Canada	SimcoDerm Medical and Surgical Dermatology Centre	Barrie	Ontario
Canada	Dr. Irina Turchin PC Inc.	Fredericton	New Brunswick
Canada	The Guenther Dermatology Research Centre	London	Ontario
Canada	Innovaderm Research Inc.	Montreal	Quebec
Czechia	CCBR Czech a.s.	Pardubice
Czechia	Sanatorium Prof. Arenebergera	Prague
Czechia	Univ. Hospital Kralovske Vinohrady	Praha
France	HOP l'Archet	Nice
France	HOP Saint-Louis	Paris
France	HOP Larrey	Toulouse
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Universitätsklinikum Frankfurt	Frankfurt am Main
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Universitätsklinikum Schleswig-Holstein, Campus Kiel	Kiel
Hungary	University of Pecs	Pecs
Hungary	Markusovszky University Teaching Hospital	Szombathely
Japan	Fujita Health University Hospital	Aichi, Toyoake
Japan	Tokyo Dental College Ichikawa General Hospital	Chiba, Ichikawa
Japan	Fukuoka University Hospital	Fukuoka, Fukuoka
Japan	Gifu University Hospital	Gifu, Gifu
Japan	Asahikawa Medical University Hospital	Hokkaido, Asahikawa
Japan	Takagi Dermatological Clinic	Hokkaido, Obihiro
Japan	Takamatsu Red Cross Hospital	Kagawa, Takamatsu
Japan	Sagamihara National Hospital	Kanagawa, Sagamihara
Japan	Kumamoto University Hospital	Kumamoto, Kumamoto
Japan	University Hospital Kyoto Prefectural University of Medicine	Kyoto, Kyoto
Japan	Tohoku University Hospital	Miyagi, Sendai
Japan	Shinshu University Hospital	Nagano, Matsumoto
Japan	Okayama University Hospital	Okayama, Okayama
Japan	University of the Ryukyus Hospital	Okinawa, Nakagami-gun
Japan	Nakatsu Dermatology Clinic	Osaka, Osaka
Japan	Osaka Metropolitan University Hospital	Osaka, Osaka
Japan	Osaka University Hospital	Osaka, Suita
Japan	Shiga University of Medical Science Hospital	Shiga, Otsu
Japan	Jichi Medical University Hospital	Tochigi, Shimotsuke
Japan	Nihon University Itabashi Hospital	Tokyo, Itabashi-ku
Japan	Teikyo University Hospital	Tokyo, Itabashi-ku
Japan	Tokyo Medical University Hospital	Tokyo, Shinjuku-ku
Japan	Wakayama Medical University Hospital	Wakayama, Wakayama
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Seoul National University Hospital	Seoul
Poland	Barbara Rewerska Diamond Clinic, Krakow	Krakow
Poland	Dermoklinika medical center, Lodz	Lodz
Poland	Independent Public Clin.Hosp.no1 Lublin	Lublin
Poland	Municipal Hospital Complex in Olsztyn	Olsztyn
Poland	Dermmedica Sp. z o.o., Wroclaw	Wroclaw
Russian Federation	SBHI Chelyabinsk Reg.Clin.Derma.Dispen.	Chelyabinsk
Russian Federation	LLC "Medical Center Azbuka Zdorovia"	Kazan
Russian Federation	Dermatovenereological Dispensary #10, St. Petersburg	Saint-Petersburg
Taiwan	National Taiwan University Hospital	Taipei
United Kingdom	Royal Devon and Exeter Hospital	Exeter
United Kingdom	Guy's Hospital	London
United States	Total Skin and Beauty Dermatology Center, PC	Birmingham	Alabama
United States	University of Missouri Health System	Columbia	Missouri
United States	Menter Dermatology Research Institute	Dallas	Texas
United States	The Psoriasis Treatment Center of Central New Jersey	East Windsor	New Jersey
United States	University of Utah Health	Murray	Utah
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  France,  Germany,  Hungary,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Treatment Emergent Adverse Events (TEAEs)	TEAEs were defined as all adverse events (AEs) occurring between start of treatment in this extension trial and the end of its residual effect period. Adverse events that started before first intake of trial medication in the extension trial and deteriorated under treatment during the extension trial were also considered as 'treatment-emergent'.	From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Secondary	Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96	Percent change in PPP ASI from baseline in parent trial is reported. The adaptation from Psoriasis Area and Severity Index was used in this trial. The index is a linear combination of the percent of surface area of skin affected on the palms and soles of the body and the severity of erythema (E), pustules (P) and scaling / desquamation (D), providing a numeric score for the overall PPP disease state, ranging from 0 (best outcome) to 72 (worst outcome), calculated as: PPP ASI = [(E+P+D) Area x 0.2 (right palm)] + [(E+P+D) Area x 0.2 (left palm)] + [(E+P+D) Area x 0.3 (right sole)] + [(E+P+D) Area x 0.3 (left sole)]. The weighted sum of the scores obtained for Erythema (E), Pustules (P), desquamation (D) (scaling) were based on a score range from 0: None to 4: Very severe, and the area affected on a score range from 0 (0%) to 6 (90-100%). Percent change was calculated as: (PPP ASI at Week X - PPP ASI at baseline in parent trial)/PPP ASI at baseline in parent trial * 100%.	Week 0 (baseline) and Week 48, Week 96
Secondary	Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96	Proportion of patients achieving a 50% decrease in PPP ASI compared to baseline in the parent trial at Weeks 48 and 96 is reported. The calculated index is a linear combination of the percent of surface area of skin affected on the palms and soles of the body and the severity of erythema, pustules and scaling / desquamation, providing a numeric score for the overall PPP disease state, ranging from 0 (best outcome) to 72 (worst outcome), calculated as: PPP ASI = [(E+P+D) Area x 0.2 (right palm)] + [(E+P+D) Area x 0.2 (left palm)] + [(E+P+D) Area x 0.3 (right sole)] + [(E+P+D) Area x 0.3 (left sole)]. The weighted sum of the scores obtained for Erythema (E), Pustules (P), desquamation (D) (scaling) were based on a score range from 0: None to 4: Very severe, and the area affected from 0 (0%) to 6 (90-100%). Proportion was calculated as: Patients with PPP ASI50 at Week X/number of evaluable patients at Week X. Non-response imputation (NRI) was used for missing data imputation.	Week 0 (baseline) and Week 48, Week 96
Secondary	Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96	Proportion of patients with PPP PGA of 0 (clear) or 1 (almost clear) is reported. The Palmoplantar Pustulosis Physician Global Assessment (PPP PGA) was used to assess the patient's skin presentation on the palms and soles. The investigator scored the individual components (erythema, pustules and scaling/crusting) from 0 to 4 as clear, almost clear, mild, moderate or severe. The PPP PGA was analyzed as PPP PGA total score including erythema, pustules and scaling, and as PPP PGA pustules score for pustules only. Number of patients with PPP PGA of 0/1 at Week X/number of evaluable patients at Week X was calculated. NRI approach was used for missing data imputation.; The PPP PGA total score was derived as the mean of all individual components: 0 = If mean=0, for all three components: = If 0 < mean <1.5; = If 1.5 <= mean <2.5; = If 2.5 <= mean <3.5; = If mean >=3.5	Week 48 and Week 96

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