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The primary objective of this study is to evaluate the pharmacokinetics (PK) of efavaleukin alfa after single subcutaneous (SC) administration in healthy Chinese, Japanese, and Caucasian participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Chinese participants - efavaleukin alfa dose level 1 | Experimental | Chinese participants will receive a single dose of efavaleukin alfa at dose level 1. |
|
| Group 2: Chinese participants - efavaleukin alfa dose level 2 | Experimental | Chinese participants will receive a single dose of efavaleukin alfa at dose level 2. |
|
| Group 3: Japanese participants - efavaleukin alfa dose level 2 | Experimental | Japanese participants will receive a single dose of efavaleukin alfa at dose level 2. |
|
| Group 4: Caucasian participants - efavaleukin alfa dose level 2 | Experimental | Caucasian participants will receive a single dose of efavaleukin alfa at dose level 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efavaleukin alfa | Drug | Administered as a single dose SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa | Blood samples were collected to determine PK parameters. | Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43 |
| Time of the Maximum Observed Serum Concentration (Tmax) of Efavaleukin Alfa | Blood samples were collected to determine PK parameters. | Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43 |
| Area Under the Serum Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Efavaleukin Alfa | Blood samples were collected to determine PK parameters. | Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43 |
| Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUCinf) of Efavaleukin Alfa | Blood samples were collected to determine PK parameters. | Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) | Adverse events (AEs) were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment. Any clinically significant changes in physical examinations, clinical laboratory tests and vital signs were recorded as TEAEs. Serious AEs (SAEs) were defined as any event that met at least 1 of the following serious criteria:
|
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Inclusion Criteria:
Healthy male or female participants, between 18 and 55 years of age (inclusive) at the time of Screening.
Chinese, Japanese, or Caucasian participant:
In good health, determined by no clinically significant findings from medical history, physical examinations, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) as assessed by the Investigator (or designee).
Body mass index between 17 and 30 kg/m^2 (inclusive) at the time of Screening.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit - Leeds | Leeds | LDS | LS2 9LH | United Kingdom |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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Participants were enrolled at 1 research center in the United Kingdom from August 2021 to October 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1) | Chinese participants who received efavaleukin alfa administered as one subcutaneous (SC) injection at dose level 1 (low). |
| FG001 | Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2) | Chinese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high). |
| FG002 | Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2) | Japanese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high). |
| FG003 | Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2) | Caucasian participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population: all participants who received at least 1 dose of efavaleukin alfa and had at least 1 postdose safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1) | Chinese participants who received efavaleukin alfa administered as one subcutaneous (SC) injection at dose level 1 (low). |
| BG001 | Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa | Blood samples were collected to determine PK parameters. | Pharmacokinetic (PK) population: all participants who received at least 1 dose of efavaleukin alfa and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43 |
|
Day 1 to Day 43
AEs were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment.
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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 | Group 1: Chinese Participants - Efavaleukin Alfa (Dose Level 1) | Chinese participants who received efavaleukin alfa administered as one subcutaneous (SC) injection at dose level 1 (low). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatocellular injury | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
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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 | Apr 28, 2022 | Oct 2, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2022 | Oct 2, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Day 1 to Day 43 |
| Number of Participants With Anti-Efavaleukin Alfa Antibodies and Anti-Interleukin 2 (IL-2) Antibodies | Number of participants who tested positive for developing anti-efavaleukin alfa antibodies and/or anti-IL2 antibodies at 1 or more post-baseline time points, who had a negative or no result at baseline. | Day 1 up to Day 43 |
Chinese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high). |
| BG002 | Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2) | Japanese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high). |
| BG003 | Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2) | Caucasian participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high). |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Chinese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high). |
| OG002 | Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2) | Japanese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high). |
| OG003 | Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2) | Caucasian participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high). |
|
|
| Primary | Time of the Maximum Observed Serum Concentration (Tmax) of Efavaleukin Alfa | Blood samples were collected to determine PK parameters. | PK population: all participants who received at least 1 dose of efavaleukin alfa and had evaluable PK data. | Posted | Median | Full Range | hours | Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43 |
|
|
|
| Primary | Area Under the Serum Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Efavaleukin Alfa | Blood samples were collected to determine PK parameters. | PK population: all participants who received at least 1 dose of efavaleukin alfa and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43 |
|
|
|
| Primary | Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUCinf) of Efavaleukin Alfa | Blood samples were collected to determine PK parameters. | PK population: all participants who received at least 1 dose of efavaleukin alfa and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43 |
|
|
|
| Secondary | Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) | Adverse events (AEs) were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment. Any clinically significant changes in physical examinations, clinical laboratory tests and vital signs were recorded as TEAEs. Serious AEs (SAEs) were defined as any event that met at least 1 of the following serious criteria:
| Safety population: all participants who received at least 1 dose of efavaleukin alfa and had at least 1 post-dose safety assessment. | Posted | Count of Participants | Participants | Day 1 to Day 43 |
|
|
|
| Secondary | Number of Participants With Anti-Efavaleukin Alfa Antibodies and Anti-Interleukin 2 (IL-2) Antibodies | Number of participants who tested positive for developing anti-efavaleukin alfa antibodies and/or anti-IL2 antibodies at 1 or more post-baseline time points, who had a negative or no result at baseline. | Safety population: all participants who received at least 1 dose of efavaleukin alfa and had at least 1 post-dose safety assessment. | Posted | Count of Participants | Participants | Day 1 up to Day 43 |
|
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| 8 |
| 8 |
| EG001 | Group 2: Chinese Participants - Efavaleukin Alfa (Dose Level 2) | Chinese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high). | 0 | 8 | 0 | 8 | 8 | 8 |
| EG002 | Group 3: Japanese Participants -Efavaleukin Alfa (Dose Level 2) | Japanese participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high). | 0 | 8 | 1 | 8 | 8 | 8 |
| EG003 | Group 4: Caucasian Participants - Efavaleukin Alfa (Dose Level 2) | Caucasian participants who received efavaleukin alfa administered as one SC injection at dose level 2 (high). | 0 | 8 | 0 | 8 | 8 | 8 |
| Hypersensitivity | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site discolouration | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site erythema | General 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 |
|
| Injection site rash | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Sars-cov-2 test positive | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urticaria papular | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Hyperaemia | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| Serious TEAEs |
|
| Anti-IL-2 Antibodies |
|