A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab
- Registration Number
- NCT04493424
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 108
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment group Spesolimab Up to 260 weeks
- Primary Outcome Measures
Name Time Method Number of Subjects With Treatment Emergent Adverse Events (TEAEs) From first administration of study drug until last administration of study drug + 112 days, up to 869 days. 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'.
- Secondary Outcome Measures
Name Time Method Proportion of Patients With PPP PGA of 0 (Clear) or 1 (Almost Clear) at Week 48, 96 Week 48 and Week 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:
1. = If 0 \< mean \<1.5
2. = If 1.5 \<= mean \<2.5
3. = If 2.5 \<= mean \<3.5
4. = If mean \>=3.5Percent Change in Palmoplantar Pustulosis Area and Severity Index (PPP ASI) From Baseline in Parent Trial (NCT04015518) at Weeks 48 and 96 Week 0 (baseline) and Week 48, Week 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%.
Proportion of Patients With PPP ASI50 Compared to Baseline in Parent Trial (NCT04015518) at Weeks 48, 96 Week 0 (baseline) and Week 48, Week 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.
Trial Locations
- Locations (66)
Dermoklinika medical center, Lodz
🇵🇱Lodz, Poland
Universitätsklinikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
The Psoriasis Treatment Center of Central New Jersey
🇺🇸East Windsor, New Jersey, United States
University of Utah Health
🇺🇸Murray, Utah, United States
Paratus Clinical Research Woden
🇦🇺Phillip, Australian Capital Territory, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Skin Health Institute Inc
🇦🇺Carlton, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Brussels - UNIV Saint-Luc
🇧🇪Bruxelles, Belgium
Dr. Irina Turchin PC Inc.
🇨🇦Fredericton, New Brunswick, Canada
UZ Leuven
🇧🇪Leuven, Belgium
SimcoDerm Medical and Surgical Dermatology Centre
🇨🇦Barrie, Ontario, Canada
The Guenther Dermatology Research Centre
🇨🇦London, Ontario, Canada
Innovaderm Research Inc.
🇨🇦Montreal, Quebec, Canada
CCBR Czech a.s.
🇨🇿Pardubice, Czechia
Sanatorium Prof. Arenebergera
🇨🇿Prague, Czechia
Univ. Hospital Kralovske Vinohrady
🇨🇿Praha, Czechia
HOP Saint-Louis
🇫🇷Paris, France
HOP l'Archet
🇫🇷Nice, France
HOP Larrey
🇫🇷Toulouse, France
Royal Devon and Exeter Hospital
🇬🇧Exeter, United Kingdom
University of Missouri Health System
🇺🇸Columbia, Missouri, United States
Total Skin and Beauty Dermatology Center, PC
🇺🇸Birmingham, Alabama, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Menter Dermatology Research Institute
🇺🇸Dallas, Texas, United States
Fujita Health University Hospital
🇯🇵Aichi, Toyoake, Japan
Tokyo Dental College Ichikawa General Hospital
🇯🇵Chiba, Ichikawa, Japan
Asahikawa Medical University Hospital
🇯🇵Hokkaido, Asahikawa, Japan
Takamatsu Red Cross Hospital
🇯🇵Kagawa, Takamatsu, Japan
Nakatsu Dermatology Clinic
🇯🇵Osaka, Osaka, Japan
Shinshu University Hospital
🇯🇵Nagano, Matsumoto, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Shiga University of Medical Science Hospital
🇯🇵Shiga, Otsu, Japan
Independent Public Clin.Hosp.no1 Lublin
🇵🇱Lublin, Poland
Dermatovenereological Dispensary #10, St. Petersburg
🇷🇺Saint-Petersburg, Russian Federation
Universitätsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
University of Pecs
🇭🇺Pecs, Hungary
Okayama University Hospital
🇯🇵Okayama, Okayama, Japan
Teikyo University Hospital
🇯🇵Tokyo, Itabashi-ku, Japan
Tokyo Medical University Hospital
🇯🇵Tokyo, Shinjuku-ku, Japan
SBHI Chelyabinsk Reg.Clin.Derma.Dispen.
🇷🇺Chelyabinsk, Russian Federation
LLC "Medical Center Azbuka Zdorovia"
🇷🇺Kazan, Russian Federation
Takagi Dermatological Clinic
🇯🇵Hokkaido, Obihiro, Japan
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Kyoto, Japan
Osaka Metropolitan University Hospital
🇯🇵Osaka, Osaka, Japan
Jichi Medical University Hospital
🇯🇵Tochigi, Shimotsuke, Japan
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Kumamoto University Hospital
🇯🇵Kumamoto, Kumamoto, Japan
University of the Ryukyus Hospital
🇯🇵Okinawa, Nakagami-gun, Japan
Osaka University Hospital
🇯🇵Osaka, Suita, Japan
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Markusovszky University Teaching Hospital
🇭🇺Szombathely, Hungary
Fukuoka University Hospital
🇯🇵Fukuoka, Fukuoka, Japan
Gifu University Hospital
🇯🇵Gifu, Gifu, Japan
Sagamihara National Hospital
🇯🇵Kanagawa, Sagamihara, Japan
Tohoku University Hospital
🇯🇵Miyagi, Sendai, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama, Wakayama, Japan
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Municipal Hospital Complex in Olsztyn
🇵🇱Olsztyn, Poland
Dermmedica Sp. z o.o., Wroclaw
🇵🇱Wroclaw, Poland
Nihon University Itabashi Hospital
🇯🇵Tokyo, Itabashi-ku, Japan
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Barbara Rewerska Diamond Clinic, Krakow
🇵🇱Krakow, Poland
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Guy's Hospital
🇬🇧London, United Kingdom