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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004230-28 | EudraCT Number |
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This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- Placebo Group | Experimental |
| |
| Group 2- Small Dose Group | Experimental |
| |
| Group 3- Medium Dose Group | Experimental |
| |
| Group 4 - High Dose Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spesolimab | Drug | Solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Clinical Remission at Week 12 | Proportion of patients with clinical remission (defined as modified Mayo Clinical Score (MCS) ≤ 2, with Stool Frequency Score (SFS) = 0 or 1 [if drop ≥1 from baseline] and Rectal Bleeding Score (RBS) = 0 and modified Endoscopic Subscore (mESS) ≤ 1) at week 12. Proportion of patients was calculated as n/N, with n=number of patients with clinical remission at week 12 and N=number analyzed. 95% Confidence Intervals (CI) were calculated using the method of Wilson. | At week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Clinical Response at Week 12 | Proportion of patients with clinical response (defined as Rectal Bleeding Score (RBS) ≤ 1 or decrease by ≥1 from baseline; and total Mayo Clinical Score (MCS) decrease by ≥ 3 and 30% from baseline) at week 12. Proportion of patients is calculated as n/N, with n=number of patients with clinical response at week 12 and N=number of patients analyzed. 95% Confidence Intervals (CI) are 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 |
|---|---|---|---|---|---|---|
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | United States | ||
| University of Miami |
| 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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Only subjects that met all the study inclusion and non of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.
Phase II/III randomized, placebo-controlled, double-blind trial to assess the safety and efficacy of spesolimab induction therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy. Phase III was not conducted, due to recruitment issues in Phase II.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
| FG001 | 300 mg Spesolimab (BI 655130) SD |
| 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 | Oct 9, 2019 | May 18, 2021 |
Not provided
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| Placebo | Drug | Solution for infusion |
|
| At week 12. |
| Proportion of Patients With Endoscopic Improvement at Week 12 | Proportion of patients with endoscopic improvement at week 12 (defined as modified Endoscopic Subscore (mESS) ≤ 1) Proportion of patients was calculated as n/N, with n=number of patients with Endoscopic Improvment at Week 12 and N=number analysed. 95% Confidence Intervals (CI) were calculated using the method of Wilson. | At week 12. |
| Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12 | Proportion of patients with combined endoscopic improvement and histologic remission at week 12 (defined as modified Endoscopic Subscore (mESS) ≤ 1 and Robarts Histology Index ≤ 6). Proportion of patients was calculated as n/N, with n= number of patients with Endoscopic Improvement and histologic remission at week 12 and N=number of patients analysed. | At week 12. |
| Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12 | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline at Week 12. The IBDQ is a 32-item self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The response options describe the magnitude or frequency of impairment from 1 (most severe) to 7 (no impairment). The items are summed up, resulting in a sum score ranging from 32 to 224 points, with higher scores indicating better outcomes. A score change of 16 is reported to reflect the minimal clinically important difference (MCID). Mean is adjusted mean. | At baseline and at week 12. |
| Miami |
| Florida |
| 33136 |
| United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia | 30033 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Columbia University Medical Center-New York Presbyterian Hospital | New York | New York | 10032 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Digestive Disease Specialists Inc | Oklahoma City | Oklahoma | 73112 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Southern Star Research Institute, LLC | San Antonio | Texas | 78229 | United States |
| Texas Digestive Disease Consultants - Southlake | Southlake | Texas | 76092 | United States |
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| Ordensklinikum Linz GmbH - Barmherzige Schwestern | Linz | A-4010 | Austria |
| AKH - Medical University of Vienna | Vienna | 1090 | Austria |
| UZ Leuven | Leuven | 3000 | Belgium |
| Centre Hospitalier Universitaire de Liège | Liège | 4000 | Belgium |
| University of Manitoba - Health Sciences Centre | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Victoria Hospital (LHSC) | London | Ontario | N6A 5W9 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Universitätsklinikum Aachen, AöR | Aachen | 52074 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Universitätsklinikum Essen AöR | Essen | 45147 | Germany |
| Klinikum Esslingen GmbH | Esslingen am Neckar | 73730 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24105 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Azienda Ospedaliera Universitaria di Padova | Padova | 35128 | Italy |
| Istituto Clinico Humanitas | Rozzano (MI) | 20089 | Italy |
| Toho University Sakura Medical Center | Chiba, Sakura | 285-8741 | Japan |
| Sapporo Tokushukai Hospital | Hokkaido, Sapporo | 004-0041 | Japan |
| Sapporo Higashi Tokushukai Hospital | Hokkaido, Sapporo | 065-0033 | Japan |
| Hyogo College of Medicine Hospital | Hyogo, Nishinomiya | 663-8501 | Japan |
| Sameshima Hospital | Kagoshima, Kagoshima | 892-0846 | Japan |
| Ofuna Chuo Hospital | Kanagawa, Kamakura | 247-0056 | Japan |
| Tokyo Medical and Dental University | Tokyo, Bunkyo-ku | 113-8519 | Japan |
| Kitasato Institute Hospital | Tokyo, Minato-ku | 108-8642 | Japan |
| Tokyo Yamate Medical Center | Tokyo, Shinjuku | 169-0073 | Japan |
| Health Center of Mother, Child and Youth Sp.z o.o. | Warsaw | 00-632 | Poland |
| Central Clinical Hospital MSWiA, Internal Diseases, Warsaw | Warsaw | 02-507 | Poland |
| FSB Instit. HC Irkutsk Scient.Cent. Sibirian Branch of Russ. Acad. Scien. | Irkutsk | 664003 | Russia |
| Kirov State Med.Univ. of MoH RF | Kirov | 610027 | Russia |
| Federal State Budgetary Institution " State Scientific Center of Coloproctology" MOH Russia | Moscow | 123423 | Russia |
| Reg. Clin. Scientific Research Institute na Vladimiskiy | Moscow | 129110 | Russia |
| The limited liability company "Clinic USI 4D" | Pyatigorsk | 357502 | Russia |
| FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" | Saint Petersburg | 194044 | Russia |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Yeungnam University Medical Center | Daegu | 42415 | South Korea |
| Hospital Virgen del RocÃo | Seville | 41013 | Spain |
| Hospital Politècnic La Fe | Valencia | 46026 | Spain |
| Barnsley Hospital | Barnsley | S75 2EP | United Kingdom |
| Doncaster Royal Infirmary | Doncaster | DN2 5LT | United Kingdom |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| Whiston Hospital | Prescot | L35 5DR | United Kingdom |
A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
| FG002 | 450 mg Spesolimab (BI 655130) q4w | 450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
| FG003 | 1200 mg Spesolimab (BI 655130) q4w | 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
| Treated |
|
| COMPLETED | Completed trial medication |
|
| NOT COMPLETED |
|
|
Randomised Set: The RS included all randomised patients. Treatment assignment was as randomised. It was the main analysis set for presentation of efficacy on binary endpoints.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
| BG001 | 300 mg Spesolimab (BI 655130) SD | A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
| BG002 | 450 mg Spesolimab (BI 655130) q4w | 450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
| BG003 | 1200 mg Spesolimab (BI 655130) q4w | 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
| BG004 | 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 |
|
| 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 Patients With Clinical Remission at Week 12 | Proportion of patients with clinical remission (defined as modified Mayo Clinical Score (MCS) ≤ 2, with Stool Frequency Score (SFS) = 0 or 1 [if drop ≥1 from baseline] and Rectal Bleeding Score (RBS) = 0 and modified Endoscopic Subscore (mESS) ≤ 1) at week 12. Proportion of patients was calculated as n/N, with n=number of patients with clinical remission at week 12 and N=number analyzed. 95% Confidence Intervals (CI) were calculated using the method of Wilson. | Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation. | Posted | Number | 95% Confidence Interval | Proportion of Participants | At week 12. |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Clinical Response at Week 12 | Proportion of patients with clinical response (defined as Rectal Bleeding Score (RBS) ≤ 1 or decrease by ≥1 from baseline; and total Mayo Clinical Score (MCS) decrease by ≥ 3 and 30% from baseline) at week 12. Proportion of patients is calculated as n/N, with n=number of patients with clinical response at week 12 and N=number of patients analyzed. 95% Confidence Intervals (CI) are calculated using the method of Wilson. | Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation. | Posted | Number | 95% Confidence Interval | Proportion of participants | At week 12. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Endoscopic Improvement at Week 12 | Proportion of patients with endoscopic improvement at week 12 (defined as modified Endoscopic Subscore (mESS) ≤ 1) Proportion of patients was calculated as n/N, with n=number of patients with Endoscopic Improvment at Week 12 and N=number analysed. 95% Confidence Intervals (CI) were calculated using the method of Wilson. | Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation. | Posted | Number | 95% Confidence Interval | Proportion of participants | At week 12. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Combined Endoscopic Improvement and Histologic Remission at Week 12 | Proportion of patients with combined endoscopic improvement and histologic remission at week 12 (defined as modified Endoscopic Subscore (mESS) ≤ 1 and Robarts Histology Index ≤ 6). Proportion of patients was calculated as n/N, with n= number of patients with Endoscopic Improvement and histologic remission at week 12 and N=number of patients analysed. | Randomised Set - Non Response Imputation (RS-NRI): The randomised set included all randomised patients, including patients with non-response imputation. | Posted | Number | 95% Confidence Interval | Proportion of participants | At week 12. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score From Baseline at Week 12 | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline at Week 12. The IBDQ is a 32-item self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The response options describe the magnitude or frequency of impairment from 1 (most severe) to 7 (no impairment). The items are summed up, resulting in a sum score ranging from 32 to 224 points, with higher scores indicating better outcomes. A score change of 16 is reported to reflect the minimal clinically important difference (MCID). Mean is adjusted mean. | Modified Randomised Set (m-RS): The m-RS included all patients in the RS who had a baseline and at least 1 post-baseline measurement for the endpoint under consideration. Treatment assignment was randomised. | Posted | Mean | 95% Confidence Interval | Score on a scale | At baseline and at week 12. |
|
From screening until end of study, up to 29 weeks.
Safety Analysis Set (SAF): All patients who were randomised and 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 | Placebo | A solution of placebo was administered as intravenous infusion once every 4 weeks over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. | 0 | 23 | 4 | 23 | 5 | 23 |
| EG001 | 300 mg Spesolimab (BI 655130) SD | A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. | 0 | 24 | 3 | 24 | 7 | 24 |
| EG002 | 450 mg Spesolimab (BI 655130) q4w | 450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. | 0 | 23 | 2 | 23 | 7 | 23 |
| EG003 | 1200 mg Spesolimab (BI 655130) q4w | 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. | 0 | 27 | 3 | 27 | 17 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | 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 |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
Due to recruitment issues during phase II, the trial was prematurely ended according to a protocol defined option. Phase III was not conducted. The trial was completed as defined in the protocol.
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 of 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 Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2020 | May 18, 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 |
|
| Risk Difference (RD) |
| 0.087 |
| 2-Sided |
| 95 |
| -0.069 |
| 0.268 |
Unadjusted absolute risk difference to placebo, [Treatment - Placebo]. 95% CI for risk difference were calculated using the method of Newcombe. |
| Other |
| Risk Difference (RD) | 0.071 | 2-Sided | 95 | -0.081 | 0.226 | Unadjusted absolute risk difference to placebo, [Treatment - Placebo]. 95% CI for risk difference were calculated using the method of Newcombe. | Other |
450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
| OG003 | 1200 mg Spesolimab (BI 655130) q4w | 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
|
|
|
450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past.
| OG003 | 1200 mg Spesolimab (BI 655130) q4w | 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
|
|
|
450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
| OG003 | 1200 mg Spesolimab (BI 655130) q4w | 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
|
|
|
A single dose (SD) of 300 milligram (mg) solution of spesolimab was administered as intravenous infusion at week 0 in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
| OG002 | 450 mg Spesolimab (BI 655130) q4w | 450 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
| OG003 | 1200 mg Spesolimab (BI 655130) q4w | 1200 mg solution of spesolimab was administered, as intravenous infusion, once every 4 weeks (q4w) over a period of 12 weeks, (at week 0, week 4, week 8) in patients with moderate to severe ulcerative colitis who had failed previous biological treatments in the past. |
|
|
|