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This study was cancelled because of the limited efficacy demonstrated in the ContRAst phase III programme as a potential treatment for rheumatoid arthritis. GSK has decided not to progress with regulatory submissions
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This study will assess the safety, tolerability and pharmacokinetics (PK) profiles of otilimab in healthy Japanese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Japanese participants receiving otilimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Otilimab | Biological | Otilimab will be administered via pre-filled syringe. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum drug concentration (Cmax) following administration of otilimab | Up to 8 Weeks | |
| Area under the concentration-time curve from pre-dose to infinity (AUC[0-infinity]) following administration of otilimab | Up to 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from pre-dose to t (AUC[0-t]) following administration of otilimab | Up to 8 Weeks | |
| Time to maximum plasma concentration (Tmax) following administration of otilimab | Up to 8 Weeks |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000599766 | Otilimab |
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Eligible participants will receive treatment with otilimab.
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This is an open-label study.
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| Elimination half-life (t1/2) following administration of otilimab | Up to 8 Weeks |
| Time to reach the last quantifiable plasma concentration (Tlast) following administration of otilimab | Up to 8 Weeks |
| Number of participants with Adverse events (AEs), Serious adverse events (SAEs) and Adverse events of special interests (AESIs) | Up to 8 weeks |
| Change from Baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count (Giga cells per liter) | Baseline and up to 8 weeks |
| Change from Baseline in hematology parameter: Red blood cell (RBC) count (Trillion cells per liter) | Baseline and up to 8 weeks |
| Change from Baseline in hematology parameter: Hemoglobin (Grams per Liter) | Baseline and up to 8 weeks |
| Change from Baseline in hematology parameter: Hematocrit (Proportion of red blood cells in blood) | Baseline and up to 8 weeks |
| Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters) | Baseline and up to 8 weeks |
| Change from Baseline in hematology parameter: Mean corpuscular hemoglobin (MCH) (Picograms) | Baseline and up to 8 weeks |
| Change from Baseline in hematology parameter: Percentage of reticulocytes (Percentage of reticulocytes) | Baseline and up to 8 weeks |
| Change from Baseline in clinical chemistry parameters: Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST), Creatine kinase, Gamma Glutamyl transferase (GGT), Lactate Dehydrogenase (International units per Liter) | Baseline and up to 8 weeks |
| Change from Baseline in clinical chemistry parameters: Calcium, glucose, potassium, sodium, Chloride, Phosphate and Blood urea nitrogen (BUN) (Millimoles per Liter) | Baseline and up to 8 weeks |
| Change from Baseline in clinical chemistry parameters: Creatinine, direct bilirubin, total bilirubin and uric acid (Micromoles per liter) | Baseline and up to 8 weeks |
| Change from Baseline in clinical chemistry parameters: Albumin and Total protein (Grams per liter) | Baseline and up to 8 weeks |
| Change from Baseline in clinical chemistry parameter: C-reactive protein (CRP) (Milligrams per liter | Baseline and up to 8 weeks |
| Change from Baseline in clinical chemistry parameter: Amylase (Units per liter) | Baseline and up to 8 weeks |
| Change from Baseline in lipid panel parameters: Total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol and triglycerides (Millimoles per Liter) | Baseline and up to 8 weeks |
| Number of participants with abnormal urinalysis parameters by Dipstick Method | Baseline and up to 8 weeks |
| Change from Baseline in vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (Millimeters of mercury) | Baseline and up to 8 weeks |
| Change from Baseline in vital sign: Pulse rate (Beats per minute) | Baseline and up to 8 weeks |
| Change from Baseline in vital signs: Body temperature (Degrees Celsius) | Baseline and up to 8 weeks |
| Change from Baseline in Electrocardiogram (ECG) parameters: PR interval, QRS duration, QT interval and corrected QT (QTc) interval (Milliseconds) | Baseline and up to 8 weeks |
| Number of participants with anti-drug antibodies (ADAs) to otilimab | Up to Week 8 |
| Number of participants with drug-neutralizing antibodies to otilimab | Up to Week 8 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |