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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004572-21 | EudraCT Number |
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The objectives of this trial are safety and efficacy (proof-of-concept) of induction of mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite pre-existing TNFi treatment.
This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to achieve the similar exposures as the highest exposures tested and found safe and tolerable in preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing TNFi (Tumor necrosis factor inhibitor) treatment. Secondary and further objectives include assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help understand BI 655130's mode of action.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spesolimab | Experimental | 1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively). |
|
| Placebo | Placebo Comparator | Matching placebo was administered via intravenous infusion over 12 weeks of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spesolimab | Drug | 12 weeks treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Endoscopic Improvement (MCS mESS ≤1) at Week 12 | Proportion of participants with endoscopic improvement (Mayo clinical score (MCS) modified endoscopic sub-score (mESS) ≤1) at Week 12 was reported. The endoscopic improvement (mucosal healing) was defined as the Mayo clinical score (MCS) modified endoscopic sub-score (mESS) ≤ 1 point. The MCS mESS ranged from 0 (normal) to 3 (severe disease). The mESS was assessed by a central reader who was independent from the investigator. The 95% confidence intervals (in the descriptive statistics part) were calculated using the method of Wilson. | At Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Total Clinical Remission (tCR) Based on Total Mayo Clinical Score at Week 12 | Proportion of participants with total clinical remission based on total Mayo clinical score at Week 12 was reported. The total clinical remission based on total Mayo clinical score was defined as the total Mayo clinical score ≤ 2 points and all sub-scores ≤ 1 point. The total Mayo clinical score was a composite disease activity score consisting of 4 sub-scores: stool frequency, rectal bleeding, physician's global assessment, and modified endoscopic appearance. Each sub-score ranged from 0 (normal) to 3 (severe disease/worse disease status). The total Mayo score was by summing up the four sub-scores and ranged from 0 to 12 with higher score indicating worse disease. The 95% confidence intervals (in the descriptive statistics part) were calculated using the method of Wilson. |
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Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Sygehus Syd | Aalborg | 9100 | Denmark | |||
| Sanos Clinic |
| 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 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 randomized, placebo-controlled, double-blind, parallel-group trial over 36 weeks, including a 24-week follow-up period evaluated safety and efficacy of induction of mucosal healing by Spesolimab (BI 655130) add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite pre-existing tumor necrosis factor inhibitor treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo - Randomized | Matching placebo was administered via intravenous infusion over 12 weeks of treatment. Participants who were randomized into the Placebo treatment were included in this arm. |
| FG001 | Spesolimab 1200 mg - Randomized |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 4, 2019 | May 3, 2021 |
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| Placebo | Drug | 12 weeks treatment |
|
| At Week 12 |
| Proportion of Participants With Histological Remission at Week 12 | Proportion of participants with histological remission at Week 12 was reported. The histological remission was defined as the Robarts histology index score ≤ 6. The Robarts histopathology index (RHI) was a histologic activity score, scoring the components chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium and erosion or ulceration on a scale of 0 to 3. The 4 components were weighted differently to calculate the RHI, with RHI = 1 × chronic inflammatory infiltrate level + 2 × lamina propria neutrophils + 3 × neutrophils in epithelium + 5 × erosion or ulceration. The resulting RHI score ranged from 0 (no disease activity) to 33 (severe disease activity). The 95% confidence intervals (in descriptive statistics part) were calculated using the method of Wilson. | At Week 12 |
| Proportion of Participants With Clinical Remission (CR) Based on Mayo Clinical Score at Week 12 | Proportion of participants with clinical remission (CR) based on Mayo clinical score at Week 12 was reported. The clinical remission based on Mayo clinical score was defined as the total Mayo clinical Score ≤ 2 and Rectal Bleeding Subscore = 0, Stool Frequency Score =0 or 1 and drop ≥ 1 from baseline, and Modified endoscopic sub-score (mESS) ≤ 1. The total Mayo clinical score was a composite disease activity score consisting of 4 sub-scores: stool frequency, rectal bleeding, physician's global assessment, and modified endoscopic appearance. Each sub-score ranged from 0 (normal) to 3 (severe disease/worse disease status). The total Mayo clinical score was by summing up the four sub-scores and ranged from 0 to 12 with higher score indicating worse disease. The 95% confidence intervals (in the descriptive statistics part) were calculated using the method of Wilson. | At Week 12 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Number of participants with any treatment-emergent adverse events (TEAEs) was reported. | From first does of study medication until end of the follow-up period, up to 36 weeks. |
| Herlev |
| 2730 |
| Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24105 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Amsterdam UMC, Locatie AMC | Amsterdam | 1105 AZ | Netherlands |
| Akershus Universitetssykehus HF | Lørenskog | N-1478 | Norway |
| Hospital Puerta de Hierro | Majadahonda | 28222 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Politècnic La Fe | Valencia | 46026 | Spain |
| St James's University Hospital | Leeds | LS9 7TF | United Kingdom |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| Whiston Hospital | Prescot | L35 5DR | United Kingdom |
1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively). Participants who were randomized into the Spesolimab 1200 mg treatment were included in this arm. |
| Safety Analysis Set (SAF) | 1 patient who was randomized to placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group in the SAF |
|
| COMPLETED | Completed planned observation time. |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS): This patient set includes all patients in the safety analysis set who had a baseline measurement available for the primary endpoint. Treatment assignment will be as randomized. Patients who were randomized but not treated were excluded from the FAS.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo - Randomized | Matching placebo was administered via intravenous infusion over 12 weeks of treatment. Participants who were randomized into the Placebo treatment were included in this arm. |
| BG001 | Spesolimab 1200 mg - Randomized | 1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively). Participants who were randomized into the Spesolimab 1200 mg treatment were included in this arm. |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Mayo clinical score (MCS) modified endoscopic subscore (mESS) | The Mayo clinical score (MCS) modified endoscopic subscore (mESS) at baseline was reported. The MCS mESS ranged from 0 (normal) to 3 (severe disease). The MCS mESS was assessed by a central reader who was independent from the investigator. | Mean | Standard Deviation | Score on a scale |
| ||||||||||||||
| Number of participants per Mayo clinical score modified endoscopic subscore value group | The number of participants per Mayo clinical score (MCS) modified endoscopic subscore (mESS) value group was reported. The MCS mESS ranged from 0 (normal) to 3 (severe disease). The MCS mESS was assessed by a central reader who was independent from the investigator. | Count of Participants | Participants |
|
| 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 | Proportion of Participants With Endoscopic Improvement (MCS mESS ≤1) at Week 12 | Proportion of participants with endoscopic improvement (Mayo clinical score (MCS) modified endoscopic sub-score (mESS) ≤1) at Week 12 was reported. The endoscopic improvement (mucosal healing) was defined as the Mayo clinical score (MCS) modified endoscopic sub-score (mESS) ≤ 1 point. The MCS mESS ranged from 0 (normal) to 3 (severe disease). The mESS was assessed by a central reader who was independent from the investigator. The 95% confidence intervals (in the descriptive statistics part) were calculated using the method of Wilson. | Full analysis set (FAS): This patient set includes all patients in the safety analysis set who had a baseline measurement available for the primary endpoint. Treatment assignment will be as randomized. Patients who were randomized but not treated were excluded from the FAS. | Posted | Number | 95% Confidence Interval | Proportion of participants | At Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Total Clinical Remission (tCR) Based on Total Mayo Clinical Score at Week 12 | Proportion of participants with total clinical remission based on total Mayo clinical score at Week 12 was reported. The total clinical remission based on total Mayo clinical score was defined as the total Mayo clinical score ≤ 2 points and all sub-scores ≤ 1 point. The total Mayo clinical score was a composite disease activity score consisting of 4 sub-scores: stool frequency, rectal bleeding, physician's global assessment, and modified endoscopic appearance. Each sub-score ranged from 0 (normal) to 3 (severe disease/worse disease status). The total Mayo score was by summing up the four sub-scores and ranged from 0 to 12 with higher score indicating worse disease. The 95% confidence intervals (in the descriptive statistics part) were calculated using the method of Wilson. | Full analysis set (FAS): This patient set includes all patients in the safety analysis set who had a baseline measurement available for the primary endpoint. Treatment assignment will be as randomized. Patients who were randomized but not treated were excluded from the FAS. | Posted | Number | 95% Confidence Interval | Proportion of participants | At Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Histological Remission at Week 12 | Proportion of participants with histological remission at Week 12 was reported. The histological remission was defined as the Robarts histology index score ≤ 6. The Robarts histopathology index (RHI) was a histologic activity score, scoring the components chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium and erosion or ulceration on a scale of 0 to 3. The 4 components were weighted differently to calculate the RHI, with RHI = 1 × chronic inflammatory infiltrate level + 2 × lamina propria neutrophils + 3 × neutrophils in epithelium + 5 × erosion or ulceration. The resulting RHI score ranged from 0 (no disease activity) to 33 (severe disease activity). The 95% confidence intervals (in descriptive statistics part) were calculated using the method of Wilson. | Full analysis set (FAS): This patient set includes all patients in the safety analysis set who had a baseline measurement available for the primary endpoint. Treatment assignment will be as randomized. Patients who were randomized but not treated were excluded from the FAS. | Posted | Number | 95% Confidence Interval | Proportion of participants | At Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Clinical Remission (CR) Based on Mayo Clinical Score at Week 12 | Proportion of participants with clinical remission (CR) based on Mayo clinical score at Week 12 was reported. The clinical remission based on Mayo clinical score was defined as the total Mayo clinical Score ≤ 2 and Rectal Bleeding Subscore = 0, Stool Frequency Score =0 or 1 and drop ≥ 1 from baseline, and Modified endoscopic sub-score (mESS) ≤ 1. The total Mayo clinical score was a composite disease activity score consisting of 4 sub-scores: stool frequency, rectal bleeding, physician's global assessment, and modified endoscopic appearance. Each sub-score ranged from 0 (normal) to 3 (severe disease/worse disease status). The total Mayo clinical score was by summing up the four sub-scores and ranged from 0 to 12 with higher score indicating worse disease. The 95% confidence intervals (in the descriptive statistics part) were calculated using the method of Wilson. | Full analysis set (FAS): This patient set includes all patients in the safety analysis set who had a baseline measurement available for the primary endpoint. Treatment assignment will be as randomized. Patients who were randomized but not treated were excluded from the FAS. | Posted | Number | 95% Confidence Interval | Proportion of participants | At Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Number of participants with any treatment-emergent adverse events (TEAEs) was reported. | Safety Analysis Set (SAF): this patient set included all randomized patients who received at least one dose of trial drug. Treatment assignment was analyzed according to the actual treatment. 1 patient who was assigned to placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group in the SAF. | Posted | Count of Participants | Participants | From first does of study medication until end of the follow-up period, up to 36 weeks. |
|
From first does of study medication until end of the follow-up period, up to 36 weeks.
Safety Analysis Set (SAF): this patient set included all randomized patients who received at least one dose of trial drug. Treatment assignment was analyzed according to the actual treatment. 1 patient who was assigned to placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group in the SAF.
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 | Placebo - Actual | Matching placebo were administered via intravenous over 12 weeks of treatment. Participants who actually administered placebo during the study were included in this group. 1 patient who was assigned to placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group. | 0 | 7 | 1 | 7 | 6 | 7 |
| EG001 | Spesolimab 1200 mg - Actual | 1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment. Participants who actually administered Spesolimab during the study were included in this group. 1 patient who was assigned to Placebo accidentally received one dose of Spesolimab and was analyzed in the Spesolimab group. | 0 | 15 | 2 | 15 | 15 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Episcleritis | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Helicobacter gastritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Adjustment disorder | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | 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.
| 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 | Mar 4, 2020 | May 3, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000712973 | spesolimab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 |
|
| 2 |
|
| 3 |
|
1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively). Participants who were randomized into the Spesolimab 1200 mg treatment were included in this arm. |
|
|
|
1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively).
Participants who were randomized into the Spesolimab 1200 mg treatment were included in this arm.
|
|
|
1200 milligrams (mg) of Spesolimab (BI 655130) were administered every 4 weeks (q4w) via intravenous infusion over 12 weeks of treatment (3 injections of Spesolimab 1200 mg in total during the 12 weeks: at Week 0, 4, and 8 respectively). Participants who were randomized into the Spesolimab 1200 mg treatment were included in this arm. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|