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International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.
This multicentre, double-blind, placebo-controlled study will have a staggered approach (Part A and B).
In part A, eligible patients will be randomly assigned (1:1:1:1) to once daily oral administration of cenerimod (0.5, 1, 2 mg) or placebo. After all patients have completed 4 weeks of treatment during part A, an Independent Data Monitoring Committee will review non-blinded data in an interim analysis to evaluate the safety profile of cenerimod and recommend whether the study could proceed to part B.
In part B, additional patients will be randomized (3:1) to once daily oral administration of cenerimod 4 mg or placebo.
All participants will receive study medication for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cenerimod 0.5 mg (Part A) | Experimental | Participants will receive cenerimod 0.5 mg capsules orally once daily for 12 weeks. |
|
| Cenerimod 1 mg (Part A) | Experimental | Participants will receive cenerimod 1 mg capsules orally once daily for 12 weeks. |
|
| Cenerimod 2 mg (Part A) | Experimental | Participants will receive cenerimod 2 mg capsules orally once daily for 12 weeks. |
|
| Cenerimod 4 mg (Part B) | Experimental | Participants will received cenerimod 4 mg capsules orally once daily for 12 weeks. This treatment arm will start after all patients in Part A have completed 4 weeks of placebo, 0.5 mg, 1 mg and 2 mg cenerimod treatment. |
|
| Matching placebo (Part A and B) | Placebo Comparator | Capsules of matching placebo taken orally once daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Matching placebo | Drug | One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT) | The primary objective of the clinical study was to asses whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The change was defined as: Total lymphocyte count at end-of-treatment (EOT) minus total lymphocyte count at baseline. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake. End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12. | Baseline to end-of-treatment (EOT) (up to 12 weeks) |
| Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment | The primary objective of the clinical study was to assess whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The change was defined as: Total lymphocyte count at visit minus total lymphocyte count at baseline. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake. End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12. | Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment Visit (up to 12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Viatris Innovation GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Anniston | Alabama | 36207 | United States | ||
| Investigator Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31798918 | Result | Hermann V, Batalov A, Smakotina S, Juif PE, Cornelisse P. First use of cenerimod, a selective S1P1 receptor modulator, for the treatment of SLE: a double-blind, randomised, placebo-controlled, proof-of-concept study. Lupus Sci Med. 2019 Nov 9;6(1):e000354. doi: 10.1136/lupus-2019-000354. eCollection 2019. |
| Label | URL |
|---|---|
| Lay summary on results reference by Hermann V et al. First use of cenerimod, a selective S1P(1) receptor modulator, for the treatment of SLE: a double-blind, randomised, placebo-controlled, proof-of-concept study. Lupus Sci Med. 2019 Nov 9;6(1):e000354. | View source |
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The screening period started when the informed consent was signed (up to 30 days before randomization), and ended with randomization. The period included Visit 1 (screening) and the pre-randomization (pre-dose) assessments at Visit 2 (Day 1). Thirty-two patients did not meet the inclusion/exclusion criteria and 6 patients withdrew from the study.
This study was conducted at 18 sites in 6 countries between 1 June 2015 and 28 February 2017, 105 patients signed consent and 67 were randomized to a study treatment: 49 in part A (randomized 1:1:1:1 to receive cenerimod 0.5, 1, 2 mg or placebo) and 18 in part B (randomized 3:1 to receive cenerimod 4 mg or placebo).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cenerimod 0.5 mg (Part A) | Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks. |
| FG001 | Cenerimod 1 mg (Part A) | Participants received cenerimod 1 mg capsules orally once daily for 12 weeks. |
| 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 25, 2015 | Jan 17, 2020 |
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|
| Cenerimod | Drug | One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning). |
|
|
| Clearwater |
| Florida |
| 33765 |
| United States |
| Investigator Site | Minsk | 220116 | Belarus |
| Investigator Site | Minsk | 223041 | Belarus |
| Investigator Site | Vitebsk | 210037 | Belarus |
| Investigator Site | Plovdiv | 4000 | Bulgaria |
| Investigator Site | Plovdiv | 4002 | Bulgaria |
| Investigator Site | Sofia | 1612 | Bulgaria |
| Investigator Site | Tbilisi | 0186 | Georgia |
| Investigator Site | Kemerovo | 650066 | Russia |
| Investigator Site | Kursk | 305007 | Russia |
| Investigator Site | Omsk | 644111 | Russia |
| Investigator Site | Orenburg | 460018 | Russia |
| Investigator Site | Smolensk | 214025 | Russia |
| Investigator Site | Vladimir | 600023 | Russia |
| Investigator Site | Vinnytsia | 21018 | Ukraine |
| Investigator Site | Vinnytsia | 21029 | Ukraine |
| Investigator Site | Zaporizhia | 69600 | Ukraine |
| FG002 | Cenerimod 2 mg (Part A) | Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. |
| FG003 | Cenerimod 4 mg (Part B) | Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. |
| FG004 | Matching Placebo (Part A and B) | Participants received cenerimod matching placebo capsules orally once daily for 12 weeks. |
| Pharmacodynamic Set |
|
| Modified Pharmacodynamic Analysis Set |
|
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (N=67). Pharmacodynamic analysis set (PD set, N=64) at least 21 days of treatment, with lymphocyte count measurements at baseline and post-baseline.
Modified pharmacodynamic analysis set (N=60) excluded 4 patients from PD set with low, or below the lower limit of quantification (BLQ) Ctrough levels.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cenerimod 0.5 mg (Part A) | Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks. |
| BG001 | Cenerimod 1 mg (Part A) | Participants received cenerimod 1 mg capsules orally once daily for 12 weeks. |
| BG002 | Cenerimod 2 mg (Part A) | Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. |
| BG003 | Cenerimod 4 mg (Part B) | Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. |
| BG004 | Matching Placebo (Part A and Part B) | Participants received cenerimod matching placebo capsules orally once daily for 12 weeks. |
| BG005 | 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 | Different population analysis sets. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Different population analysis sets. | Count of Participants | Participants |
| ||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Different population analysis sets. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||
| Body mass index | Different population analysis sets. | Mean | Standard Deviation | kg/m^2 |
| |||||||||
| Disease history time from first Systemic Lupus Erythematosus symptoms | Different population analysis sets. | Median | Full Range | years |
| |||||||||
| Time from first Systemic Lupus Erythematosus diagnosis | Different population analysis sets. | Median | Full Range | years |
| |||||||||
| Number of American College of Rheumatology criteria ongoing at screening | The American College of Rheumatology (ACR) has designated 11 classification criteria incorporating major clinical features (mucocutaneous, articular, serosal, renal, and neurologic) and laboratory findings (hematologic and immunologic), which have been validated for the diagnosis of SLE. The presence of 4 or more criteria occurring either simultaneously or in succession is strongly suggestive of the diagnosis of SLE [Hochberg MC. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1997;40(9).] | Count of Participants | Participants |
| ||||||||||
| Systemic Lupus Erythematosus Disease Activity Index-2000, modified to exclude leucopenia | The SLEDAI-2K is a weighted, cumulative index of lupus disease activity scored by the physician. It is calculated from 24 individual descriptors across 9 organ systems, 0 indicates inactive disease and the maximum theoretical score is 105 (Gladman D et al. J Rheumatol 2002;29;288-291). In this study the SLEDAI-2K was modified, to exclude leucopenia (1 point), due to the mechanism of action of cenerimod. A score of 6 or greater is clinically relevant and associated with requiring lupus-directed therapy (Nuttall A et al. Best Pract Res Clin Rheumatol. 2013 Jun; 27(3):309-18). | Different population analysis sets. | Mean | Standard Deviation | units on a scale |
|
| 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 | Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT) | The primary objective of the clinical study was to asses whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The change was defined as: Total lymphocyte count at end-of-treatment (EOT) minus total lymphocyte count at baseline. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake. End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12. | Pharmacodynamics analysis (PD) set. The PD set includes all participants who received at least 21 days of study treatment, with lymphocyte count measurements at baseline and post-baseline. Last observation carried forward (using the Week 4 visit or later) was used for participants with a missing end-of-treatment (EOT) assessment. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline to end-of-treatment (EOT) (up to 12 weeks) |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment | The primary objective of the clinical study was to assess whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The change was defined as: Total lymphocyte count at visit minus total lymphocyte count at baseline. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake. End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12. | Pharmacodynamics analysis (PD) set. The PD set includes all participants who received at least 21 days of study treatment, with lymphocyte count measurements at baseline and post-baseline. Last observation carried forward (using the Week 4 visit or later) was used for participants with a missing end-of-treatment (EOT) assessment. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment Visit (up to 12 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT) Based on Pharmacokinetic Cthrough Profiles | The change was defined as: Total lymphocyte count at end-of-treatment (EOT) minus total lymphocyte count at baseline. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake. End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12. The modified pharmacodynamics analysis set includes all participants who:
| Ctrough levels were discovered to be low, or below the lower limit of quantification (BLQ), in four patients randomized to the cenerimod 4 mg group, a finding incompatible with compliance with study treatment. These patients were excluded from the pharmacodynamic analysis set to form a modified pharmacodynamics analysis set. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline to end-of-treatment (EOT) (up to 12 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Absolute Values of Total Lymphocyte Count at Each Analysis Visit | The primary objective of the clinical study was to see whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE). The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The modified pharmacodynamics analysis set includes all participants who:
| All participants for which data was available. Ctrough levels were discovered to be low, or below the lower limit of quantification (BLQ), in four patients randomised to the cenerimod 4 mg group, a finding incompatible with compliance with study treatment. These patients were excluded from the PD set to form a modified pharmacodynamic analysis set. | Posted | Mean | Standard Deviation | 10^9 cells/L | Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment (EOT - up to 12 weeks), end-of-study (6 weeks after EOT) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Total Lymphocyte Count Percent Change From Baseline to End-of-treatment (EOT) | Percentage change in total lymphocyte count from baseline to end-of-treatment (EOT). Percent change from baseline is defined as the absolute change from baseline divided by the baseline value (if the baseline value is > 0) and then multiplied by 100. A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased. The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect. The modified pharmacodynamics analysis set includes all participants who:
| Ctrough levels were discovered to be low, or below the lower limit of quantification (BLQ), in four patients randomized to the cenerimod 4 mg group, a finding incompatible with compliance with study treatment. These patients were excluded from the pharmacodynamic set to form a modified pharmacodynamic analysis set. | Posted | Mean | Standard Deviation | Percent change of total lymphocyte count | Baseline to End of Treatment (EOT) (up to 12 weeks) |
|
All Adverse Events and Serious Adverse Events that occurred after the intake of the first study treatment and up to 6 weeks after study treatment discontinuation are reported, assessed up to 18 weeks.
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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 | Cenerimod 0.5 mg | Participants received cenerimod 0.5 mg capsules orally once daily for 12 weeks. | 0 | 12 | 0 | 12 | 5 | 12 |
| EG001 | Cenerimod 1 mg | Participants received cenerimod 1 mg capsules orally once daily for 12 weeks. | 0 | 12 | 0 | 12 | 5 | 12 |
| EG002 | Cenerimod 2 mg | Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. | 0 | 13 | 0 | 13 | 6 | 13 |
| EG003 | Cenerimod 4 mg | Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. | 0 | 13 | 0 | 13 | 5 | 13 |
| EG004 | Matching Placebo | Participants received cenerimod matching placebo capsules orally once daily for 12 weeks. | 0 | 17 | 1 | 17 | 9 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Post cholecystectomy syndrome | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Age-related macular degeneration | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dry age-related macular degeneration | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Chronic hepatitis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
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| Electrocardiogram T wave amplitude decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
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| Laboratory test abnormal | Investigations | MedDRA 19.0 | Non-systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Nitrituria | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Nail dystrophy | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Tooth extraction | Surgical and medical procedures | MedDRA 19.0 | Non-systematic Assessment |
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This study is the first to investigate short-term cenerimod treatment in patients with mild to moderate systemic lupus erythematosus (SLE).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Viatris Innovation Clinical Trial Information | Viatris Innovation GmbH | +1 908 435 2675 | viatrisinnovationclinicaltrials@viatris.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 20, 2017 | Jan 17, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000709569 | cenerimod |
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| Pharmacodynamic analysis set |
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| Modified pharmacodynamics analysis set |
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| Pharmacodynamic analysis set |
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| Modified pharmacodynamic analysis set |
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| Pharmacodynamic analysis set |
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| Modified pharmacodynamic analysis set |
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| Ukraine |
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| Georgia |
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| Belarus |
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| Bulgaria |
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| Russia |
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| Pharmacodynamic analysis set |
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| Modified pharmacodynamic analysis set |
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| Pharmacodynamic analysis set |
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| Modified pharmacodynamic analysis set |
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| Pharmacodynamic analysis set |
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| Modified pharmacodynamic analysis set |
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| 4 to 11 ACR criteria ongoing at screening |
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| 0 to 3 ACR criteria more than 6 months ago |
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| 4 to 11 ACR criteria more than 6 months ago |
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| Pharmacodynamic analysis set |
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| Modified pharmacodynamic analysis set |
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| Mean Difference (Final Values) |
| -0.5 |
| Standard Error of the Mean |
| 0.2 |
| 2-Sided |
| 95 |
| -0.91 |
| 0.09 |
| Superiority |
| ANCOVA | 0.004 | Mean Difference (Final Values) | -0.57 | Standard Error of the Mean | 0.19 | 2-Sided | 95 | -0.95 | -0.19 | Superiority |
| ANCOVA | 0.06 | Mean Difference (Final Values) | -0.37 | Standard Error of the Mean | 0.19 | 2-Sided | 95 | -0.75 | 0.02 | Superiority |
Participants received cenerimod 1 mg capsules orally once daily for 12 weeks.
| OG002 | Cenerimod 2 mg (Part A) | Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. |
| OG003 | Cenerimod 4 mg (Part B) | Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. |
| OG004 | Matching Placebo | Participants received cenerimod matching placebo capsules orally once daily for 12 weeks. |
|
|
| OG001 |
| Cenerimod 1 mg (Part A) |
Participants received cenerimod 1 mg capsules orally once daily for 12 weeks. |
| OG002 | Cenerimod 2 mg (Part A) | Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. |
| OG003 | Cenerimod 4 mg (Part B) | Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. |
| OG004 | Matching Placebo | Participants received cenerimod matching placebo capsules orally once daily for 12 weeks. |
|
|
|
Participants received cenerimod 1 mg capsules orally once daily for 12 weeks. |
| OG002 | Cenerimod 2 mg (Part A) | Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. |
| OG003 | Cenerimod 4 mg (Part B) | Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. |
| OG004 | Matching Placebo | Participants received cenerimod matching placebo capsules orally once daily for 12 weeks. |
|
|
| Cenerimod 1 mg (Part A) |
Participants received cenerimod 1 mg capsules orally once daily for 12 weeks. |
| OG002 | Cenerimod 2 mg (Part A) | Participants received cenerimod 2 mg capsules orally once daily for 12 weeks. |
| OG003 | Cenerimod 4 mg (Part B) | Participants received cenerimod 4 mg capsules orally once daily for 12 weeks. |
| OG004 | Matching Placebo | Participants received cenerimod matching placebo capsules orally once daily for 12 weeks. |
|
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| Male |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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