Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000189-41 | EudraCT Number |
Not provided
Not provided
Not provided
Sponsor decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Up to 260 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spesolimab | Drug | Spesolimab |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama | 35205 | United States | ||
| University of Missouri Health System |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Not provided
Not provided
Not provided
Not provided
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This study was a phase II, open-label, single arm, to test the safety and efficacy of long-term treatment with Spesolimab in patients with Palmoplantar Pustulosis (PPP) who took part in previous studies with Spesolimab
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Spesolimab (BI 655130) | The patients were administered 600 milligram (mg) Spesolimab (BI 655130) prefilled syringes subcutaneously in thighs or abdomen every 4 weeks for up to 5 years (260 weeks). Patients were to continue the treatment until no longer benefited under the patient opinion or investigator assessment, or withdrawal of consent, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 23, 2022 | Dec 22, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Week 0 (baseline) and Week 48, Week 96 |
| 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 |
| 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:
| Week 48 and Week 96 |
| Columbia |
| Missouri |
| 65212 |
| United States |
| The Psoriasis Treatment Center of Central New Jersey | East Windsor | New Jersey | 08520 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Menter Dermatology Research Institute | Dallas | Texas | 75246 | United States |
| University of Utah Health | Murray | Utah | 84107 | United States |
| Paratus Clinical Research Woden | Phillip | Australian Capital Territory | 2606 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Skin Health Institute Inc | Carlton | Victoria | 3053 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Brussels - UNIV Saint-Luc | Brussels | 1200 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Dr. Irina Turchin PC Inc. | Fredericton | New Brunswick | E3B 1G9 | Canada |
| SimcoDerm Medical and Surgical Dermatology Centre | Barrie | Ontario | L4M 7G1 | Canada |
| The Guenther Dermatology Research Centre | London | Ontario | N6A 3H7 | Canada |
| Innovaderm Research Inc. | Montreal | Quebec | H2X 2V1 | Canada |
| CCBR Czech a.s. | Pardubice | 530 02 | Czechia |
| Univ. Hospital Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Sanatorium Prof. Arenebergera | Prague | 11000 | Czechia |
| HOP l'Archet | Nice | 06200 | France |
| HOP Saint-Louis | Paris | 75010 | France |
| HOP Larrey | Toulouse | 31059 | France |
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | 60596 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24105 | Germany |
| University of Pecs | Pécs | 7632 | Hungary |
| Markusovszky University Teaching Hospital | Szombathely | 9700 | Hungary |
| Fujita Health University Hospital | Aichi, Toyoake | 470-1192 | Japan |
| Tokyo Dental College Ichikawa General Hospital | Chiba, Ichikawa | 272-8513 | Japan |
| Fukuoka University Hospital | Fukuoka, Fukuoka | 814-0180 | Japan |
| Gifu University Hospital | Gifu, Gifu | 501-1194 | Japan |
| Asahikawa Medical University Hospital | Hokkaido, Asahikawa | 078-8510 | Japan |
| Takagi Dermatological Clinic | Hokkaido, Obihiro | 080-0013 | Japan |
| Takamatsu Red Cross Hospital | Kagawa, Takamatsu | 760-0017 | Japan |
| Sagamihara National Hospital | Kanagawa, Sagamihara | 252-0392 | Japan |
| Kumamoto University Hospital | Kumamoto, Kumamoto | 860-8556 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto, Kyoto | 602-8566 | Japan |
| Tohoku University Hospital | Miyagi, Sendai | 980-8574 | Japan |
| Shinshu University Hospital | Nagano, Matsumoto | 390-8621 | Japan |
| Okayama University Hospital | Okayama, Okayama | 700-8558 | Japan |
| University of the Ryukyus Hospital | Okinawa, Nakagami-gun | 903-0215 | Japan |
| Nakatsu Dermatology Clinic | Osaka, Osaka | 531-0071 | Japan |
| Osaka Metropolitan University Hospital | Osaka, Osaka | 545-8586 | Japan |
| Osaka University Hospital | Osaka, Suita | 565-0871 | Japan |
| Shiga University of Medical Science Hospital | Shiga, Otsu | 520-2192 | Japan |
| Jichi Medical University Hospital | Tochigi, Shimotsuke | 329-0498 | Japan |
| Teikyo University Hospital | Tokyo, Itabashi-ku | 173-8606 | Japan |
| Nihon University Itabashi Hospital | Tokyo, Itabashi-ku | 173-8610 | Japan |
| Tokyo Medical University Hospital | Tokyo, Shinjuku-ku | 160-0023 | Japan |
| Wakayama Medical University Hospital | Wakayama, Wakayama | 641-8509 | Japan |
| Barbara Rewerska Diamond Clinic, Krakow | Krakow | 31-559 | Poland |
| Dermoklinika medical center, Lodz | Lodz | 90-436 | Poland |
| Independent Public Clin.Hosp.no1 Lublin | Lublin | 20-081 | Poland |
| Municipal Hospital Complex in Olsztyn | Olsztyn | 10-229 | Poland |
| Dermmedica Sp. z o.o., Wroclaw | Wroclaw | 51-318 | Poland |
| SBHI Chelyabinsk Reg.Clin.Derma.Dispen. | Chelyabinsk | 454048 | Russia |
| LLC "Medical Center Azbuka Zdorovia" | Kazan' | 420111 | Russia |
| Dermatovenereological Dispensary #10, St. Petersburg | Saint Petersburg | 194021 | Russia |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Royal Devon and Exeter Hospital | Exeter | EX2 5DW | United Kingdom |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety analysis set for maintenance treatment (SAF-MT): Included all patients who received at least one dose of the maintenance treatment Spesolimab (BI 655130).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Spesolimab (BI 655130) | The patients were administered 600 milligram (mg) Spesolimab (BI 655130) prefilled syringes subcutaneously in thighs or abdomen every 4 weeks for up to 5 years (260 weeks). Patients were to continue the treatment until no longer benefited under the patient opinion or investigator assessment, or withdrawal of consent, whichever occurred first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Palmoplantar Pustulosis Area and Severity Index (PPP ASI) | The PPP ASI is an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles. 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). | Mean | Standard Deviation | Score in a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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'. | Treated Set for Maintenance Treatment (TS-MT): This patient set included all patients who received at least one dose of the maintenance treatment 600 mg s.c. every 4 weeks. | Posted | Count of Participants | Participants | 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%. | Safety analysis set for maintenance treatment (SAF-MT) This patient set included all patients who received at least one dose of the maintenance treatment. | Posted | Mean | Standard Deviation | Percent change | 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. | Safety analysis set for maintenance treatment (SAF-MT) This patient set included all patients who received at least one dose of the maintenance treatment. | Posted | Number | 95% Confidence Interval | Proportion of participants | 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:
| Safety analysis set for maintenance treatment (SAF-MT) This patient set included all patients who received at least one dose of the maintenance treatment. | Posted | Number | 95% Confidence Interval | Proportion of participants | Week 48 and Week 96 |
|
From first administration of study drug until last administration of study drug + 112 days, up to 869 days.
Safety analysis set for maintenance treatment (SAF-MT): This patient set includes all patients who received at least one dose of the maintenance treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spesolimab (BI 655130) | The patients were administered 600 milligram (mg) Spesolimab (BI 655130) prefilled syringes subcutaneously in thighs or abdomen every 4 weeks for up to 5 years (260 weeks). Patients were to continue the treatment until no longer benefited under the patient opinion or investigator assessment, or withdrawal of consent, whichever occurred first. | 0 | 108 | 19 | 108 | 77 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure chronic | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Paraspinal abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Toxic shock syndrome | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Scleroderma | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Palmoplantar pustulosis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
|
The trial was prematurely discontinued due to the sponsor's (Boehringer Ingelheim) decision to terminate the clinical program studying spesolimab in patients with PPP. This decision was not based on any safety finding in the clinical trials.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2022 | Dec 22, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000712973 | spesolimab |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|