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Sponsor decision
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To assess the long term safety and efficacy of treatment with BI 655130 in patients with AD who have completed and have responded to treatment in the parent study 1368-0032
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spesolimab 600 mg | Experimental | 600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks. All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spesolimab | Drug | Solution for SC injection |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Treatment Emergent Adverse Events (AEs) at Week 48 | Number of patients with treatment emergent adverse events (AEs) at week 48. The treatment emergent adverse event refer to the adverse event with an onset between start of treatment and end of the 16-week residual effect period after the last dose of trial medication. | From first dose until Week 48, up to 48 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 48 | The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. The percent change from baseline in EASI is calculated as: (EASI at week 48 - EASI at baseline) / EASI at baseline * 100%. |
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Inclusion Criteria:
Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedures
Patients who completed the 1368-0032 trial and did not prematurely discontinue treatment prior to week 16, and; In the 1368-0032 re-allocation period (V7 to V11):
Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly for the duration of the trial and 16 weeks after last study drug administration. A list of contraception methods meeting these criteria is provided in the patient information.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCT Research | Scottsdale | Arizona | 85260 | United States | ||
| Clinical Physiology Associates |
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| 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 open label extension clinical trial was planned to offer all patients who completed the clinical trial 1368-0032 (NCT03822832) as planned, the option to continue to receive BI 655130 treatment if they have responded to treatment and meet all criteria for study entry.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spesolimab 600 mg | 600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks. All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit. |
| 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 23, 2020 | Apr 27, 2022 |
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| At baseline and at Week 48. |
| Percentage of Patients With a 50% Improvement From Baseline in EASI (EASI50) at Week 48 | The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. [(EASI at week 48 - EASI at baseline) / EASI at baseline * 100%] ≥ 50%, then EASI50 = 1. | At baseline and at Week 48. |
| Percentage of Patients With a 75% Improvement From Baseline in EASI (EASI75) at Week 48 | The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. [(EASI at week 48 - EASI at baseline) / EASI at baseline * 100%] ≥ 75%, then EASI75 = 1. | At baseline and at Week 48. |
| Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 48 | The SCORing of Atopic Dermatitis (SCORAD) index assesses elements: extent of disease, disease severity and subjective symptoms. The SCORAD consists of three elements: extent of disease, intensity of disease, and subjective symptoms (Pruritus and Sleep Loss). These 3 aspects: extent of disease (A: score range 0-1-2), disease severity (B: score range 0-18), and subjective symptoms (C: score range 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103 for SCORAD score. The SCORAD range from 0 (no disease) to 103 (severe disease). The higher the SCORAD score, the more severe the Atopic Dermatitis is. | At baseline and at Week 48. |
| Percentage of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator Global Assessment (IGA) at Week 48 | The IGA scale allows investigators to assess overall disease severity at one given time point, and it consists of a five-point severity scale from clear to very severe disease (0= clear,1 =almost clear, 2 = mild disease, 3 = moderate disease, 4= severe disease). The IGA scale uses clinical characteristics of erythema, infiltration, papulation, oozing and crusting as guidelines for the overall severity assessment. | At baseline and at Week 48. |
| Fort Myers |
| Florida |
| 33912 |
| United States |
| Finlay Medical Research Corp | Miami | Florida | 33126 | United States |
| ForCare Clinical Research, Inc. | Tampa | Florida | 33613 | United States |
| The Indiana Clinical Trials Center, PC | Plainfield | Indiana | 46168 | United States |
| Unity Clinical Research | Oklahoma City | Oklahoma | 73118 | United States |
| Dermatology Treatment and Research Center, PA | Dallas | Texas | 75230 | United States |
| Innovaderm Research Inc. | Montreal | Quebec | H2X 2V1 | Canada |
| Tennocho Ekimae Dermatology and Allergology | Kanagawa, Yokohama | 240-0004 | Japan |
| Tokyo Medical University Hachioji Medical Center | Tokyo, Hachioji | 193-0998 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Spesolimab 600 mg | 600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks. All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit. |
| 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 |
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| 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 Patients With Treatment Emergent Adverse Events (AEs) at Week 48 | Number of patients with treatment emergent adverse events (AEs) at week 48. The treatment emergent adverse event refer to the adverse event with an onset between start of treatment and end of the 16-week residual effect period after the last dose of trial medication. | Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug. | Posted | Count of Participants | Participants | From first dose until Week 48, up to 48 weeks. |
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| ||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 48 | The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. The percent change from baseline in EASI is calculated as: (EASI at week 48 - EASI at baseline) / EASI at baseline * 100%. | Full analysis set (FAS): This patient set includes all patients in the SAF who had a baseline measurement and at least one post-baseline measurement for the secondary endpoint, Eczema Area and Severity Index (EASI) Total Score. | Posted | Mean | Standard Deviation | Percent change | At baseline and at Week 48. |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Patients With a 50% Improvement From Baseline in EASI (EASI50) at Week 48 | The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. [(EASI at week 48 - EASI at baseline) / EASI at baseline * 100%] ≥ 50%, then EASI50 = 1. | Full analysis set (FAS): This patient set includes all patients in the SAF who had a baseline measurement and at least one post-baseline measurement for the secondary endpoint, Eczema Area and Severity Index (EASI) Total Score. | Posted | Number | Percentage of participants | At baseline and at Week 48. |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Patients With a 75% Improvement From Baseline in EASI (EASI75) at Week 48 | The EASI scoring system is used routinely in patients with psoriasis to describe signs and severity of the disease. It assesses the extent of disease at four body sites and measures four clinical signs: erythema, induration/papulation, excoriation, and lichenification (each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe)). The EASI score was obtained by weight-averaging these 4 scores, resulting in the EASI score ranges from 0 (clear) to 72 (very severe), with higher score indicating more severe disease extent and clinical signs. [(EASI at week 48 - EASI at baseline) / EASI at baseline * 100%] ≥ 75%, then EASI75 = 1. | Full analysis set (FAS): This patient set includes all patients in the SAF who had a baseline measurement and at least one post-baseline measurement for the secondary endpoint, Eczema Area and Severity Index (EASI) Total Score. | Posted | Number | Percentage of participants | At baseline and at Week 48. |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 48 | The SCORing of Atopic Dermatitis (SCORAD) index assesses elements: extent of disease, disease severity and subjective symptoms. The SCORAD consists of three elements: extent of disease, intensity of disease, and subjective symptoms (Pruritus and Sleep Loss). These 3 aspects: extent of disease (A: score range 0-1-2), disease severity (B: score range 0-18), and subjective symptoms (C: score range 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103 for SCORAD score. The SCORAD range from 0 (no disease) to 103 (severe disease). The higher the SCORAD score, the more severe the Atopic Dermatitis is. | Full analysis set (FAS): This patient set includes all patients in the SAF who had a baseline measurement and at least one post-baseline measurement for the secondary endpoint, Eczema Area and Severity Index (EASI) Total Score. | Posted | Mean | Standard Deviation | Score on a scale | At baseline and at Week 48. |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator Global Assessment (IGA) at Week 48 | The IGA scale allows investigators to assess overall disease severity at one given time point, and it consists of a five-point severity scale from clear to very severe disease (0= clear,1 =almost clear, 2 = mild disease, 3 = moderate disease, 4= severe disease). The IGA scale uses clinical characteristics of erythema, infiltration, papulation, oozing and crusting as guidelines for the overall severity assessment. | Full analysis set (FAS): This patient set includes all patients in the SAF who had a baseline measurement and at least one post-baseline measurement for the secondary endpoint, Eczema Area and Severity Index (EASI) Total Score. | Posted | Number | Percentage of participants | At baseline and at Week 48. |
|
|
From first dose until last dose + 16 weeks, up to 765 days.
Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spesolimab 600 mg | 600 milligrams (mg) solution for subcutaneous (SC) injection of BI 655130 (Spesolimab) were to administered subcutaneously every 4 weeks. All patients will return 16 weeks post the last treatment for an End of Study (EOS) visit. | 0 | 14 | 2 | 14 | 11 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
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| Asymptomatic COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Soft tissue infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Tinea pedis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Splinter | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Vitamin B12 decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Cervical radiculopathy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Diffuse alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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The study was terminated due to sponsor decision. The planned treatment period of 4 years was not reached.
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 | Dec 20, 2021 | Apr 27, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000712973 | spesolimab |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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| Participants |
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| Participants |
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