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| ID | Type | Description | Link |
|---|---|---|---|
| I1F-MC-RHBN | Other Identifier | Eli Lilly and Company |
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The purpose of the study is to research how much ixekizumab enters the bloodstream and how long the body takes to get rid of the drug and the safety of ixekizumab and any side effects that might be associated with it. The study has two parts: A single-dose part and multiple-dose part. The single dose part of this study will last up to 24 weeks, including the screening period. The multiple dose part of this study will last up to 32 weeks including the screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixekizumab single dose | Experimental | Participants received single dose of 80mg Ixekizumab by subcutaneous injection. |
|
| Ixekizumab Multiple Regimen 1 (80mg Q2W) | Experimental | Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection. |
|
| Ixekizumab Multiple Regimen 2 (80mg Q4W) | Experimental | Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixekizumab | Drug | Administered as subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose) | Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum. | Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141 |
| Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose) | Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported. | Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141 |
| Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose) | Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum. | day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197 |
| Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose) | Pharmacokinetics: Area under concentration of Ixekizumab from time Zero to 336h (AUC 0 to 336h) was reported (Multiple dose). | day 57 (Pre-dose), 59, 61, 64, 67, 71 |
| Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose) | Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose). | day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital, Central South University | Changsha | Hunan | China | |||
| Second Affiliate Hospital of Zhejiang Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37356077 | Derived | Zheng M, Chen X, Wang F, Chen J, Jackson K, Yang F, Payne C, Li H, Wang Y, Xiao Z, Zheng J. Pharmacokinetics, Safety, and Efficacy of Ixekizumab in Chinese Patients with Moderate-to-Severe Plaque Psoriasis: A Phase 1, Single- and Multiple-Dose Study. Adv Ther. 2023 Sep;40(9):3804-3816. doi: 10.1007/s12325-023-02575-1. Epub 2023 Jun 25. |
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All the re-enrolled participants from single dose period (SDP) to multiple dose period (MDP) have been washed out and screened for eligibility to MDP.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ixekizumab Single Dose | Participants received single dose of 80mg Ixekizumab by subcutaneous injection. |
| FG001 | Ixekizumab 80mg Q2W Multiple Dose | Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection. |
| FG002 | Ixekizumab 80mg Q4W Multiple Dose | Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Single Dose Period |
| |||||||||||||
| Multiple Dose Period |
|
All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ixekizumab Single Dose | Participants received single dose of 80mg Ixekizumab by subcutaneous injection. |
| BG001 | Ixekizumab 80mg Q2W Multiple Dose | Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP. |
| 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 | Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose) | Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum. | All randomized participants who received at least one dose of Ixekizumab in single dose group and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter (ug/mL) | Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141 |
|
|
Baseline to end of the study (up to 20 weeks)
All Randomized participants.
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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 | Ixekizumab Single Dose | Participants received single dose of 80mg Ixekizumab by subcutaneous injection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bile duct stone | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.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 | Jun 20, 2017 | Mar 31, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 28, 2018 | Mar 31, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C549079 | ixekizumab |
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|
| Hangzhou |
| Zhejiang |
| 310009 |
| China |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University | Shanghai | 200025 | China |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Ixekizumab 80mg Q4W Multiple Dose | Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP. | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP. | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | All the re-enrolled participants from SDP to MDP have been washed out and screened for eligibility to MDP. | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Participants |
|
|
| Primary | Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose) | Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported. | All randomized participants who received at least one dose of Ixekizumab in single dose group and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram*day per milliliter (ug*day/mL) | Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141 |
|
|
|
| Primary | Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose) | Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum. | All randomized participants who received at least one dose of Ixekizumab in multiple dose group and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter (ug/mL) | day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197 |
|
|
|
| Primary | Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose) | Pharmacokinetics: Area under concentration of Ixekizumab from time Zero to 336h (AUC 0 to 336h) was reported (Multiple dose). | All randomized participants multiple dose period who received at least one dose of Ixekizumab and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram*day per milliliter (ug*day/mL) | day 57 (Pre-dose), 59, 61, 64, 67, 71 |
|
|
|
| Primary | Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose) | Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose). | All randomized participants in Ixekizumab Q4W arm who received at least one dose of Ixekizumab and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram*day per milliliter (ug*day/mL) | day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 11 |
| 12 |
| EG001 | Ixekizumab 80mg Q2W Multiple Dose | Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection. | 0 | 14 | 1 | 14 | 11 | 14 |
| EG002 | Ixekizumab 80mg Q4W Multiple Dose | Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection. | 0 | 15 | 0 | 15 | 12 | 15 |
| Cholecystitis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dental discomfort | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nodule | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Tinea manuum | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Echocardiogram abnormal | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Urine leukocyte esterase positive | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| Menstruation delayed | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| Bronchial disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nail psoriasis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
Not provided
| Title | Measurements |
|---|---|
|
| Male |
|
| Title | Measurements |
|---|---|
| Female |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
| Hispanic or Latino |
|
| 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 |
|
| Title | Measurements |
|---|---|
| American Indian or Alaska Native |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Multiple Dose |
|