Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002262-31 | EudraCT Number |
Not provided
Not provided
Not provided
Study was terminated early as per sponsor decision due to unexpectedly slow enrollment.
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Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This main purpose of this study was to evaluate the safety, tolerability, dose response and efficacy of Atacicept in participants with IgA nephropathy and persistent proteinuria. The study hypothesis was that treatment with Atacicept would reduce proteinuria compared to placebo.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental |
| |
| Atacicept 25 mg | Experimental |
| |
| Atacicept 75 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Adverse Event (AE): any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE: AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: AEs that developed or worsened/became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 96]). TEAEs included serious AEs and non- serous AEs. AESIs included infections, cardiac failure, cardiomyopathy/ ischemic heart disease, hypersensitivity reaction (including anaphylactic/anaphylactoid shock conditions, asthma/bronchospasm, and angioedema), injection site reactions (ISRs) and demyelinating disorders. Investigator or his /her designee assessed ISRs as local reactions (redness, bruising, swelling, induration and itching). | Baseline up to 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Atacicept Concentrations | Serum Atacicept Concentrations was to be performed; however; as per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed. | Week 0 Day 1 (pre-dose), Weeks 1, 2, 4, 8, 12, 16, 24, 40, 48, 72, Early Termination (up to Week 72) and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKDHC Medical Research Services, LLC. | Glendale | Arizona | 85308 | United States | ||
| California Institute of Renal Research - Chula Vista Location |
Not provided
| Label | URL |
|---|---|
| US Medical Information website, Medical Resources | View source |
| Trial Awareness and Transparency website | View source |
Not provided
Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website.
Not provided
Not provided
Not provided
This study was to be conducted in 2 parts; Part A and Part B. However, study was terminated early as per sponsor decision due to unexpectedly slow enrollment and Part B was not initiated.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks. |
| FG001 | Atacicept 25 mg |
| 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 | Nov 27, 2018 | Feb 4, 2021 |
Not provided
Not provided
Not provided
Not provided
| Atacicept 25 mg | Drug | Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks. |
|
| Atacicept 75 mg | Drug | Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks. |
|
| Change From Baseline Levels in Serum Immunoglobulin A (IgA) | The change in serum levels of IgA from baseline was reported. | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and PT FU Weeks 4, 12 and 24 |
| Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | The change in serum levels of IgG from baseline was reported. | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and PT FU Weeks 4, 12 and 24 |
| Change From Baseline Levels in Serum Immunoglobulin M (IgM) | The change in serum levels of IgM from baseline was reported. | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and at PT FU Weeks 4, 12 and 24 |
| Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | The change in serum Gd-IgA1 from baseline was reported. | Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72 and at PT FU Weeks 12 and 24 |
| Change From Baseline in Serum Complement C3 and C4 Levels | The change in serum component C3 and C4 from baseline were reported. | Baseline, Week 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Weeks 12 and 24 |
| Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Change from baseline in immune cell subsets included total T cells, helper T cells, cytotoxic T cells, total B cells (assay with [AW] CD45 or assay without [AWO] CD45), mature naïve B cells, memory B cells, plasma cells, plasma blasts, and natural killer (NK) cells and were reported. Analysis was performed by flow cytometry analysis. | Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Week 24 |
| Change From Baseline in Urinary IgG, IgA, and IgM Levels | Urinary IgG, IgA and IgM levels to be measured by Immuno-Electrophoresis. | Baseline (Day1), Weeks 24, 48 and Early Termination (up to earlier than Week 72) |
| Percentage of Participants With Positive Anti-Drug Antibody (ADA) | Percentage of participants with positive ADA were reported. | Baseline up to safety follow-up (96 weeks) |
| Percentage of Participants With Clinical Significant Abnormalities in Laboratory Assessments | Laboratory investigation included hematology, biochemistry, urinalysis and Urine sediment analysis. Clinical significance was to be decided by the investigator. | Baseline up to safety follow-up (96 weeks) |
| Percentage of Participants With Clinical Significant Abnormalities in Vital Signs | Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate, weight and height. The systolic and diastolic blood pressure and pulse rate was measured after the participants have in a rested at least 3 minutes in seated position. Clinical significance was to be decided by the investigator. | Baseline up to safety follow-up (96 weeks) |
| Percentage of Participants With Clinical Significant Abnormalities in 12-Lead Electrocardiograms (ECGs) | 12-lead ECG were recorded after the participants have rested for at least 15 minutes in supine position. Clinically significance was decided by the investigator. The number of participants with clinically significant abnormalities in 12-lead ECG were reported. | Baseline up to safety follow-up (96 weeks) |
| Chula Vista |
| California |
| 91910 |
| United States |
| Colorado Kidney Care PC - Dr. Marder | Denver | Colorado | 80218 | United States |
| Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
| Southeastern Clinical Research Institute, LLC | Augusta | Georgia | 30909 | United States |
| GA Nephrology Associates | Lawrenceville | Georgia | 30046 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Brookview Hills Research Associates, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Ohio State University Clinical Trials Management Office - Ohio State CTMO Parent | Columbus | Ohio | 43210 | United States |
| Northeast Clinical Research Center, LLC | Bethlehem | Pennsylvania | 18017 | United States |
| Southeast Renal Research Institute | Chattanooga | Tennessee | 37404 | United States |
| Nephrotex Research Group | Dallas | Texas | 75231 | United States |
| Providence Sacred Heart Medical Center & Children's Hospital | Spokane | Washington | 99204 | United States |
| Juntendo University Hospital - Dept of Nephrology/Hypertension | Bunkyō City | 113-8431 | Japan |
| University Hospitals of Leicester NHS Trust - ULTIMATE PARENT | Leicester | LE5 4PW | United Kingdom |
Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
| FG002 | Atacicept 75 mg | Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The modified intent-to-treat (mITT) population included all randomized participants who had received at least 1 dose of the Investigational Medicinal Product (IMP).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks. |
| BG001 | Atacicept 25 mg | Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks. |
| BG002 | Atacicept 75 mg | Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks. |
| BG003 | 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 | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death | Adverse Event (AE): any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE: AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: AEs that developed or worsened/became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 96]). TEAEs included serious AEs and non- serous AEs. AESIs included infections, cardiac failure, cardiomyopathy/ ischemic heart disease, hypersensitivity reaction (including anaphylactic/anaphylactoid shock conditions, asthma/bronchospasm, and angioedema), injection site reactions (ISRs) and demyelinating disorders. Investigator or his /her designee assessed ISRs as local reactions (redness, bruising, swelling, induration and itching). | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. | Posted | Number | percentage of participants | Baseline up to 96 weeks |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Serum Atacicept Concentrations | Serum Atacicept Concentrations was to be performed; however; as per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed. | As per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed. | Posted | Week 0 Day 1 (pre-dose), Weeks 1, 2, 4, 8, 12, 16, 24, 40, 48, 72, Early Termination (up to Week 72) and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline Levels in Serum Immunoglobulin A (IgA) | The change in serum levels of IgA from baseline was reported. | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here "number analyzed" = participants who were evaluable for this outcome measure at given time points. | Posted | Mean | Standard Deviation | gram per liter | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and PT FU Weeks 4, 12 and 24 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline Levels in Serum Iimmunoglobulin G (IgG) | The change in serum levels of IgG from baseline was reported. | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here "number analyzed" = participants who were evaluable for this outcome measure at given time points. | Posted | Mean | Standard Deviation | gram per liter | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and PT FU Weeks 4, 12 and 24 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline Levels in Serum Immunoglobulin M (IgM) | The change in serum levels of IgM from baseline was reported. | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here "number analyzed" = participants who were evaluable for this outcome measure at given time points. | Posted | Mean | Standard Deviation | gram per liter | Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, Early Termination (up to Week 72) and at PT FU Weeks 4, 12 and 24 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Galactose Deficient-IgA1 (Gd-IgA1) Levels | The change in serum Gd-IgA1 from baseline was reported. | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. Here "number analyzed" = participants who were evaluable for this outcome measure at given time points. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72 and at PT FU Weeks 12 and 24 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Complement C3 and C4 Levels | The change in serum component C3 and C4 from baseline were reported. | The safety population set (SAF) consisted of all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. "Number of participants analyzed" signifies participants who were evaluable for this outcome measure and "Number Analyzed" signifies those participants who were evaluable for specified category. | Posted | Mean | Standard Deviation | milligram per liter | Baseline, Week 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Weeks 12 and 24 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Immune Cell Subsets by Flow Cytometry Analysis | Change from baseline in immune cell subsets included total T cells, helper T cells, cytotoxic T cells, total B cells (assay with [AW] CD45 or assay without [AWO] CD45), mature naïve B cells, memory B cells, plasma cells, plasma blasts, and natural killer (NK) cells and were reported. Analysis was performed by flow cytometry analysis. | Flow Cytometry (FC) Set: all participants in SAF set who were part of the selected sites for FC analysis and who had at least 1 sample taken for FC analysis. Here "Number of participants analyzed" signifies those participants who were evaluable for this outcome measure. and "number analyzed" signifies those participants who were evaluable for specified category. | Posted | Mean | Standard Deviation | cells per microliter | Baseline, Weeks 4, 12, 24, 48, 72, Early Termination (up to Week 72) and at PT FU Week 24 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Urinary IgG, IgA, and IgM Levels | Urinary IgG, IgA and IgM levels to be measured by Immuno-Electrophoresis. | As per changed in planned analysis the outcome measure related to Urinary Immunoglobulins was not assessed. | Posted | Baseline (Day1), Weeks 24, 48 and Early Termination (up to earlier than Week 72) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Positive Anti-Drug Antibody (ADA) | Percentage of participants with positive ADA were reported. | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. | Posted | Number | percentage of participants | Baseline up to safety follow-up (96 weeks) |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Significant Abnormalities in Laboratory Assessments | Laboratory investigation included hematology, biochemistry, urinalysis and Urine sediment analysis. Clinical significance was to be decided by the investigator. | As per changed in planned analysis the outcome measure related to clinically significant abnormalities in laboratory assessments was not assessed. | Posted | Baseline up to safety follow-up (96 weeks) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Significant Abnormalities in Vital Signs | Vital signs included body temperature, systolic and diastolic blood pressure, pulse rate, weight and height. The systolic and diastolic blood pressure and pulse rate was measured after the participants have in a rested at least 3 minutes in seated position. Clinical significance was to be decided by the investigator. | As per changed in planned analysis the outcome measure related to clinically significant abnormalities in vital signs was not assessed. | Posted | Baseline up to safety follow-up (96 weeks) |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Significant Abnormalities in 12-Lead Electrocardiograms (ECGs) | 12-lead ECG were recorded after the participants have rested for at least 15 minutes in supine position. Clinically significance was decided by the investigator. The number of participants with clinically significant abnormalities in 12-lead ECG were reported. | The safety population set (SAF) included all randomized participants who received at least 1 dose of IMP and had at least one post-dose assessment. | Posted | Number | percentage of participants | Baseline up to safety follow-up (96 weeks) |
|
Baseline up to safety follow up period (96 weeks)
Not provided
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 | Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks. | 0 | 5 | 1 | 5 | 5 | 5 |
| EG001 | Atacicept 25 mg | Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks. | 0 | 6 | 3 | 6 | 6 | 6 |
| EG002 | Atacicept 75 mg | Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks. | 0 | 5 | 0 | 5 | 3 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Urinary bladder haemorrhage | Renal and urinary disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Paratracheal lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Ear congestion | Ear and labyrinth disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Allergy to chemicals | Immune system disorders | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 22.1 | Non-systematic Assessment |
|
The study was prematurely terminated due to poor enrollment and Part B was not conducted as per Sponsor decision. This decision was not related to any safety or efficacy findings regarding Atacicept.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@emdgroup.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2019 | Feb 4, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| D005921 | Glomerulonephritis |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C524618 | TACI receptor-IgG Fc fragment fusion protein |
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 |
|
|
| Participants with AESI: Ischaemic heart disease |
|
| Participants with AESI: Cardiac arrhythmia |
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| Partcipants with AESI: Hypersensitivity reactions |
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| Partcipants with AESI: Demyalinating disorders |
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| Partcipants with AESI: Injection site reactions |
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| Partcipants with AESI: Infections |
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| Participants with serious TEAEs |
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| Participants with TEAEs leading to discontinuation |
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| Participants with TEAEs leading to death |
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| Counts |
|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks. |
|
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|
|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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