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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004573-40 | EudraCT Number |
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The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in patients with PPP following multiple intravenous administrations compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spesolimab (low dose) | Experimental |
| |
| Spesolimab (high dose) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spesolimab (low dose) | Drug | 12 weeks treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Palmoplantar (pp) Pustular Psoriasis Area and Severity Index 50 (PASI) (ppPASI50) at Week 16 | Percentage of participants who achieved 50% reduction in ppPASI score was assessed by ppPASI50. ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): [(E+P+D) x A x 0.2 (right palm)] + [(E+P+D) x A x 0.2 (left palm)] + [(E+P+D) x A x 0.3 (right sole)] + [(E+P+D) x A x 0.3 (left sole)]. | Week 16 |
| Number of Participants With Drug-related Adverse Events (AEs) | Number of participants with drug-related AEs are presented. | From first drug administration until 16 weeks after the last drug administration, up to 32 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Palmoplantar Pustular Psoriasis Area and Severity Index 75 (ppPASI75) at Week 16 | Percentage of participants who achieved >75% reduction in ppPASI score was assessed by ppPASI75. ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): [(E+P+D) x A x 0.2 (right palm)] + [(E+P+D) x A x 0.2 (left palm)] + [(E+P+D) x A x 0.3 (right sole)] + [(E+P+D) x A x 0.3 (left sole)]. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Irina Turchin PC Inc. | Fredericton | New Brunswick | E3B 1G9 | Canada | ||
| York Dermatology Clinic and Research Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39216969 | Derived | Lebwohl MG, Thoma C, Haeufel T. Spesolimab use in generalised pustular psoriasis flares - Authors' reply. Lancet. 2024 Aug 31;404(10455):847-848. doi: 10.1016/S0140-6736(24)01557-5. No abstract available. |
| Label | URL |
|---|---|
| Related Info | View source |
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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
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All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensured that all participants met all inclusion/exclusion criteria. Participants were not to be randomised to trial treatment if any one of the specific entry criteria were not met.
This was a randomised, double-blind, placebo-controlled, parallel-design trial to investigate the safety and efficacy of BI 655130 in patients with Palmoplantar Pustulosis (PPP) following multiple intravenous administrations of either low dose or high dose compared with placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | BI 655130 Low Dose | Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks. |
| FG001 | BI 655130 High Dose | Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks. |
| FG002 | Placebo Matching to BI 655130 | Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set (SAF): SAF included all randomised patients who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | BI 655130 Low Dose | Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks. |
| BG001 | BI 655130 High Dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants With Palmoplantar (pp) Pustular Psoriasis Area and Severity Index 50 (PASI) (ppPASI50) at Week 16 | Percentage of participants who achieved 50% reduction in ppPASI score was assessed by ppPASI50. ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): [(E+P+D) x A x 0.2 (right palm)] + [(E+P+D) x A x 0.2 (left palm)] + [(E+P+D) x A x 0.3 (right sole)] + [(E+P+D) x A x 0.3 (left sole)]. | Full analysis set (FAS): FAS included all patients in the Safety analysis set (SAF) (SAF included all randomised patients who received at least one dose of study drug) who had a baseline measurement available for the primary endpoint. Patients from FAS with no response imputation (NRI) were included for analysis of this endpoint. (FAS (NRI)) | Posted | Number | Percentage of participants (%) | Week 16 |
From first drug administration until 16 weeks after the last drug administration, up to 32 weeks.
Analysis set for safety presentation was Safety analysis set (SAF). SAF included all randomised patients who received at least one dose of study drug.
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 | BI 655130 Low Dose | Participants were administered low dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VIth nerve paralysis | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2018 | Oct 22, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2018 | Oct 22, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000712973 | spesolimab |
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| Placebo |
| Drug |
12 weeks treatment |
|
| Spesolimab (high dose) | Drug | 12 weeks treatment |
|
| Week 16 |
| Percent Change From Baseline in the ppPASI at Week 16 | The percentage change in the ppPASI score from Baseline to Week 16 was measured. ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): [(E+P+D) x A x 0.2 (right palm)] + [(E+P+D) x A x 0.2 (left palm)] + [(E+P+D) x A x 0.3 (right sole)] + [(E+P+D) x A x 0.3 (left sole)]. | Baseline and Week 16 |
| Percentage of Participants Achieving Treatment Success (Treatment Success Defined as Achieving a Clinical Response of 0 or 1=Clear/Almost Clear) Via Palmoplantar Pustulosis Physicians Global Assessment (pppPGA) at Week 16 | pppPGA was relied on the participant's overall skin lesions status on the lesions of the most severely affected palmoplantar surface of the palms and sole was assessed by investigator as clear (0), almost clear (1), mild (2), moderate (3) and severe (4) at week 16. Score Wording were: 0 = Clear = No signs of PPP; no scaling or crusts or pustule remains.
| Week 16 |
| Richmond Hill |
| Ontario |
| L4C 9M7 |
| Canada |
| Innovaderm Research Inc. | Montreal | Quebec | H2K 4L5 | Canada |
| Aarhus University Hospital, Skejby | Aarhus | 8200 | Denmark |
| Gentofte Hospital | Hellerup | 2900 | Denmark |
| Bispebjerg og Frederiksberg Hospital | København NV | 2400 | Denmark |
| Charité - Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | 60596 | Germany |
| TFS Trial Form Support GmbH | Hamburg | 20537 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24105 | Germany |
| Ospedale San Giovanni di Dio | Cagliari | 09124 | Italy |
| Pol. Universitario Tor Vergata | Roma | 00133 | Italy |
| Hospital Santa Creu i Sant Pau | Barcelona | 08026 | Spain |
| Hospital Universitario Infanta Leonor | Madrid | 28031 | Spain |
| Hospital Ramón y Cajal | Madrid | 28034 | Spain |
| Sahlgrenska US, Göteborg | Gothenburg | 413 45 | Sweden |
| Karolinska Univ. sjukhuset | Stockholm | 171 76 | Sweden |
| Other than listed |
|
Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks.
| BG002 | Placebo Matching to BI 655130 | Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
|
| Primary | Number of Participants With Drug-related Adverse Events (AEs) | Number of participants with drug-related AEs are presented. | Safety analysis set (SAF): This set included all randomised patients who received at least one dose of study drug. | Posted | Number | Participants | From first drug administration until 16 weeks after the last drug administration, up to 32 weeks. |
|
|
|
| Secondary | Percentage of Participants With Palmoplantar Pustular Psoriasis Area and Severity Index 75 (ppPASI75) at Week 16 | Percentage of participants who achieved >75% reduction in ppPASI score was assessed by ppPASI75. ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): [(E+P+D) x A x 0.2 (right palm)] + [(E+P+D) x A x 0.2 (left palm)] + [(E+P+D) x A x 0.3 (right sole)] + [(E+P+D) x A x 0.3 (left sole)]. | FAS (NRI) | Posted | Number | Percentage of participnats (%) | Week 16 |
|
|
|
|
| Secondary | Percent Change From Baseline in the ppPASI at Week 16 | The percentage change in the ppPASI score from Baseline to Week 16 was measured. ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed. ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): [(E+P+D) x A x 0.2 (right palm)] + [(E+P+D) x A x 0.2 (left palm)] + [(E+P+D) x A x 0.3 (right sole)] + [(E+P+D) x A x 0.3 (left sole)]. | Patients from FAS with observed cases (OC) were included for analysis of this endpoint. (FAS (OC)) | Posted | Mean | Standard Deviation | Unit on scale | Baseline and Week 16 |
|
|
|
|
| Secondary | Percentage of Participants Achieving Treatment Success (Treatment Success Defined as Achieving a Clinical Response of 0 or 1=Clear/Almost Clear) Via Palmoplantar Pustulosis Physicians Global Assessment (pppPGA) at Week 16 | pppPGA was relied on the participant's overall skin lesions status on the lesions of the most severely affected palmoplantar surface of the palms and sole was assessed by investigator as clear (0), almost clear (1), mild (2), moderate (3) and severe (4) at week 16. Score Wording were: 0 = Clear = No signs of PPP; no scaling or crusts or pustule remains.
| FAS (NRI) | Posted | Number | Percentage of participants (%) | Week 16 |
|
|
|
|
| 0 |
| 19 |
| 1 |
| 19 |
| 17 |
| 19 |
| EG001 | BI 655130 High Dose | Participants were administered high dose of BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks. | 0 | 19 | 0 | 19 | 17 | 19 |
| EG002 | Placebo Matching to BI 655130 | Participants were administered placebo matching to BI 655130 solution for infusion intravenously every 4 weeks at Day 1, 29, 57 and 85 until 12 weeks. | 0 | 21 | 1 | 21 | 15 | 21 |
| Palmoplantar pustulosis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Alcohol intolerance | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Eye inflammation | Eye disorders | MedDRA 21.1 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 21.1 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 21.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
|
| Bundle branch block | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Palmoplantar pustulosis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
|
| Administration site extravasation | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
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.
| Wilson/Newcombe | 95% CIs are calculated using the method of Wilson/Newcombe. | Risk Difference (RD) | 0.115 | 2-Sided | 95 | -0.116 | 0.348 | Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS. | Other | No formal hypothesis testing was performed in this trial. |
| Student's t-distribution |
CIs were based on Student's t-distribution. |
| Mean Difference (Final Values) |
| -5.82 |
| 2-Sided |
| 95 |
| -28.35 |
| 16.70 |
| Other |
No formal hypothesis testing was performed in this trial. |
| Wilson/Newcombe |
95% CIs are calculated using the method of Wilson/Newcombe. |
| Risk Difference (RD) |
| 0.015 |
| 2-Sided |
| 95 |
| -0.213 |
| 0.252 |
| Other |
No formal hypothesis testing was performed in this trial. |