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The study was terminated based on the primary efficacy endpoint analysis after the first data lock.
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The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients with Immune-Mediated Necrotizing Myopathy (IMNM). Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.3 mg/kg zilucoplan | Experimental | Daily subcutaneous (SC) injection |
|
| Placebo | Placebo Comparator | Daily subcutaneous (SC) injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zilucoplan | Drug | Daily subcutaneous (SC) inection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline to Week 8 in Serum Creatine Kinase (CK) Levels | All laboratory samples were obtained prior to administration of study drug at applicable visits. CK levels were measured by a central laboratory. | Baseline (Day 1) and end of Main Portion (Week 8) |
| Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) | A TEAE was defined as:
| Baseline (Day 1) to end of Main Portion (Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieve at Least Minimal Response Based on the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Response Criteria Scale | The ACR/EULAR scale utilized a conjoint analysis-based continuous model using absolute percent change from Baseline in core set measures (physician, patient, and Myositis Disease Activity Assessment Tool (MDAAT); muscle strength; Health Assessment Questionnaire (HAQ); and muscle enzyme levels). A total improvement score (range 0-100) was determined by summing scores for each core set measure and comparing improvement in each respective core set measure. The threshold for minimal improvement was ≥20 in the total improvement score with higher scores indicating a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | UCB Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90095 | United States | ||
| University of California Irvine |
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Of the 37 participants who were screened, 10 participants were deemed ineligible and were screen failures. 27 participants with immune-mediated necrotizing myopathy were randomized in a 1:1 ratio to receive zilucoplan 0.3 mg/kg or a matching placebo for the 8-week Treatment Period in the Main Portion of the study. All eligible participants were given the option to receive daily subcutaneous (SC) zilucoplan 0.3 mg/kg in the Extension Portion of the study.
This study was performed in 4 countries (France, the Netherlands, the United Kingdom, and the United States of America) between 07 November 2019 and 14 June 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants were randomized to receive daily SC doses of matching placebo during the 8-week Main Portion of the study. All eligible participants were given the option to receive daily SC zilucoplan 0.3 mg/kg in the Extension Portion of the study. |
| FG001 | Zilucoplan 0.3 mg/kg |
| 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 | Feb 16, 2021 | Mar 2, 2022 |
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| Placebo |
| Other |
Daily subcutaneous (SC) inection |
|
| Baseline (Day 1) and end of Main Portion (Week 8) |
| Change From Baseline to Week 8 in Triple Timed Up and Go Test (3TUG) Time | The 3TUG test involved the ambulatory participant getting up from a seated position in a chair, walking at their normal pace for 3 meters, turning around, walking back to the chair, and sitting down. This sequence was repeated 3 times without rest, and the 3TUG test time is the average of the 3 lap times. A negative change from baseline indicated a better outcome. | Baseline (Day 1) and end of Main Portion (Week 8) |
| Change From Baseline to Week 8 in Proximal Manual Muscle Testing (MMT) Score | The proximal MMT assessed muscle strength using manual muscle testing in 7 muscle groups (left and right sides assessed separately). The total MMT score for this study, inclusive of both sides, could range from 0-140, where 0 means no strength in any muscles and 140 means full strength in all the muscles examined. A negative change from Baseline indicated a worse outcome. | Baseline (Day 1) and end of Main Portion (Week 8) |
| Change From Baseline to Week 8 in Physician Global Activity Visual Analogue Scale (VAS) Score | The Physician Global Activity VAS Score measured the treating physician's global evaluation of the participant's overall disease activity using a 10 cm VAS labelled with "no activity" at the left end and "maximum activity" at the right end. The Physician Global Activity VAS Score ranged from 0 (absent extramuscular disease activity) to 10 (maximum extramuscular disease activity). A negative change from Baseline indicated a better outcome. | Baseline (Day 1) and end of Main Portion (Week 8) |
| Change From Baseline to Week 8 in Patient Global Activity VAS Score | The Patient Global Activity VAS Score measured the treating participant's global evaluation of their overall disease activity using a 10 cm VAS labelled with "no activity" at the left end and "maximum activity" at the right end. The Patient Global Activity VAS score ranged from 0 (absent extramuscular disease activity) to 10 (maximum extramuscular disease activity). A negative change from Baseline indicated a better outcome. | Baseline (Day 1) and end of Main Portion (Week 8) |
| Change From Baseline to Week 8 in HAQ Score | The HAQ had 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities with 2 to 3 questions for each section. Scoring within each section ranged from 0 (without any difficulty) to 3 (unable to do). The total HAQ score was then calculated by summing the scores and dividing by the number of categories answered. The total HAQ score for this study could range from 0-3, where 0 means no functional impairment and 3 means complete functional impairment. A negative change from Baseline indicated a better outcome. | Baseline (Day 1) and end of Main Portion (Week 8) |
| Change From Baseline to Week 8 in MDAAT Extramuscular Disease Activity VAS Score | The MDAAT extramuscular disease activity VAS score measured the degree of disease activity of extramuscular organ systems and muscle. The scoring was performed by the physician and ranged from 0 (absent extramuscular disease activity) to 10 (maximum extramuscular disease activity). A negative change from Baseline indicated a better outcome. | Baseline (Day 1) and end of Main Portion (Week 8) |
| Change From Baseline to Week 8 in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score | The FACIT-Fatigue Scale is a 13-item tool which measured an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue was measured on a 4-point Likert scale. The total FACIT-Fatigue Scale score for this study could range from 0-52, where 0 means the participants were very much fatigued during their usual daily activities and 52 means the participants were not at all fatigued during their usual daily activities. A negative change from Baseline indicated a worse outcome. | Baseline (Day 1) and end of Main Portion (Week 8) |
| Orange |
| California |
| 92868 |
| United States |
| University of Florida Health Jacksonville | Jacksonville | Florida | 32209 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| National Institute of Health | Bethesda | Maryland | 20892 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Washington University School of Medicine in Saint Louis | St Louis | Missouri | 63110 | United States |
| Northwell Health Neuroscience Institute | Great Neck | New York | 11021 | United States |
| The Ohio State University | Columbus | Ohio | 43221 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Wesley Neurology Clinic | Memphis | Tennessee | 38018 | United States |
| Austin Neuromuscular Center | Austin | Texas | 78756 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Hôpital Universitaire Pitié Salpêtrière | Paris | 75013 | France |
| Amsterdam UMC | Amsterdam | 1105 AZ | Netherlands |
| University College London Hospitals NHS Foundation Trust | London | WC1N3BG | United Kingdom |
| Salford Royal NHS Barnes Clinical Research Facility | Manchester | M6 8HD | United Kingdom |
Participants were randomized to receive daily SC doses of zilucoplan 0.3 mg/kg during the 8-week Main Portion of the study. All eligible participants were given the option to receive daily SC zilucoplan 0.3 mg/kg in the Extension Portion of the study. |
| Completed Main Portion |
|
| Started Main Portion Safety Follow-up | Refers to study participants who completed the 8-week blinded treatment period in the Main Portion of the study and had not entered the Extension Portion. |
|
| Completed Main Portion Safety Follow-up | Refers to study participants who completed the 8-week blinded treatment period in the Main Portion of the study and had not entered the Extension Portion. |
|
| Started Extension Portion |
|
| COMPLETED | Completed Main Portion, Main Portion Safety Follow-up or Extension Portion. |
|
| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) Population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants were randomized to receive daily SC doses of matching placebo during the 8-week Main Portion of the study. All eligible participants were given the option to receive daily SC zilucoplan 0.3 mg/kg in the Extension Portion of the study. |
| BG001 | Zilucoplan 0.3 mg/kg | Participants were randomized to receive daily SC doses of zilucoplan 0.3 mg/kg during the 8-week Main Portion of the study. All eligible participants were given the option to receive daily SC zilucoplan 0.3 mg/kg in the Extension Portion of the study. |
| 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/Ethnicity, Customized | 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 | Percentage Change From Baseline to Week 8 in Serum Creatine Kinase (CK) Levels | All laboratory samples were obtained prior to administration of study drug at applicable visits. CK levels were measured by a central laboratory. | The ITT Population with no missing observations at Baseline and Week 8. | Posted | Mean | Standard Deviation | percentage change | Baseline (Day 1) and end of Main Portion (Week 8) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE) | A TEAE was defined as:
| The Safety Population included all participants who have received at least 1 dose of study drug, with participants analyzed based on the actual study treatment received. | Posted | Count of Participants | Participants | Baseline (Day 1) to end of Main Portion (Week 8) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Achieve at Least Minimal Response Based on the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Response Criteria Scale | The ACR/EULAR scale utilized a conjoint analysis-based continuous model using absolute percent change from Baseline in core set measures (physician, patient, and Myositis Disease Activity Assessment Tool (MDAAT); muscle strength; Health Assessment Questionnaire (HAQ); and muscle enzyme levels). A total improvement score (range 0-100) was determined by summing scores for each core set measure and comparing improvement in each respective core set measure. The threshold for minimal improvement was ≥20 in the total improvement score with higher scores indicating a better outcome. | The ITT Population with no missing observations at Baseline and Week 8. | Posted | Count of Participants | Participants | Baseline (Day 1) and end of Main Portion (Week 8) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 8 in Triple Timed Up and Go Test (3TUG) Time | The 3TUG test involved the ambulatory participant getting up from a seated position in a chair, walking at their normal pace for 3 meters, turning around, walking back to the chair, and sitting down. This sequence was repeated 3 times without rest, and the 3TUG test time is the average of the 3 lap times. A negative change from baseline indicated a better outcome. | The ITT Population with no missing observations at Baseline and Week 8. The test was also only performed in participants who were ambulatory. | Posted | Least Squares Mean | Standard Error | seconds | Baseline (Day 1) and end of Main Portion (Week 8) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 8 in Proximal Manual Muscle Testing (MMT) Score | The proximal MMT assessed muscle strength using manual muscle testing in 7 muscle groups (left and right sides assessed separately). The total MMT score for this study, inclusive of both sides, could range from 0-140, where 0 means no strength in any muscles and 140 means full strength in all the muscles examined. A negative change from Baseline indicated a worse outcome. | The ITT Population with no missing observations at Baseline and Week 8. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and end of Main Portion (Week 8) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 8 in Physician Global Activity Visual Analogue Scale (VAS) Score | The Physician Global Activity VAS Score measured the treating physician's global evaluation of the participant's overall disease activity using a 10 cm VAS labelled with "no activity" at the left end and "maximum activity" at the right end. The Physician Global Activity VAS Score ranged from 0 (absent extramuscular disease activity) to 10 (maximum extramuscular disease activity). A negative change from Baseline indicated a better outcome. | The ITT Population with no missing observations at Baseline and Week 8. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and end of Main Portion (Week 8) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 8 in Patient Global Activity VAS Score | The Patient Global Activity VAS Score measured the treating participant's global evaluation of their overall disease activity using a 10 cm VAS labelled with "no activity" at the left end and "maximum activity" at the right end. The Patient Global Activity VAS score ranged from 0 (absent extramuscular disease activity) to 10 (maximum extramuscular disease activity). A negative change from Baseline indicated a better outcome. | The ITT Population with no missing observations at Baseline and Week 8. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and end of Main Portion (Week 8) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 8 in HAQ Score | The HAQ had 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities with 2 to 3 questions for each section. Scoring within each section ranged from 0 (without any difficulty) to 3 (unable to do). The total HAQ score was then calculated by summing the scores and dividing by the number of categories answered. The total HAQ score for this study could range from 0-3, where 0 means no functional impairment and 3 means complete functional impairment. A negative change from Baseline indicated a better outcome. | The ITT Population with no missing observations at Baseline and Week 8. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and end of Main Portion (Week 8) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 8 in MDAAT Extramuscular Disease Activity VAS Score | The MDAAT extramuscular disease activity VAS score measured the degree of disease activity of extramuscular organ systems and muscle. The scoring was performed by the physician and ranged from 0 (absent extramuscular disease activity) to 10 (maximum extramuscular disease activity). A negative change from Baseline indicated a better outcome. | The ITT Population with no missing observations at Baseline and Week 8. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and end of Main Portion (Week 8) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 8 in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score | The FACIT-Fatigue Scale is a 13-item tool which measured an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue was measured on a 4-point Likert scale. The total FACIT-Fatigue Scale score for this study could range from 0-52, where 0 means the participants were very much fatigued during their usual daily activities and 52 means the participants were not at all fatigued during their usual daily activities. A negative change from Baseline indicated a worse outcome. | The ITT Population with no missing observations at Baseline and Week 8. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Day 1) and end of Main Portion (Week 8) |
|
Baseline (Day 1) to End of Safety Follow-up (Week 83)
The Safety Population included all participants who have received at least 1 dose of study drug, with participants analyzed based on the actual study treatment received.
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 | Main Portion: Placebo | Participants were randomized to receive daily SC doses of matching placebo during the 8-week Main Portion of the study. | 0 | 15 | 3 | 15 | 13 | 15 |
| EG001 | Main Portion: Zilucoplan 0.3 mg/kg | Participants were randomized to receive daily SC doses of zilucoplan 0.3 mg/kg during the 8-week Main Portion of the study. | 0 | 12 | 0 | 12 | 9 | 12 |
| EG002 | Extension Portion: Zilucoplan 0.3 mg/kg | Participants received daily SC doses of zilucoplan 0.3 mg/kg during the Extension Portion of the study. | 1 | 25 | 8 | 25 | 15 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vessel puncture site bruise | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Skin procedural complication | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
The study was terminated based on the primary efficacy endpoint analysis after the first data lock.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clin Trial Reg & Results Disclosure | UCB BIOSCIENCES GmbH | Please email | clinicaltrials@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2021 | Mar 2, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000719268 | zilucoplan |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or other Pacific Islander |
|
| White |
|
| Other/Mixed |
|
| Unknown or Not Reported |
|
| Missing |
|
|
|
|
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| Participants |
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| Participants |
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| Participants |
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