Psoriasis
Conditions
Brief summary
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.
Interventions
DRUGIxekizumab
Administered as subcutaneous (SC) injection
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females aged ≥18 years. * Diagnosis of chronic plaque psoriasis for ≥6 months before baseline. * Candidates for phototherapy and/or systemic therapy. * ≥10% body surface area (BSA) involvement at screening and baseline. * static Physician's Global Assessment (sPGA) score ≥3, and Psoriasis Area and Severity Index (PASI) score ≥12 at screening and baseline.
Exclusion criteria
* Clinically significant flare of psoriasis during the 12 weeks before baseline. * Systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks. prior to baseline or topical psoriasis treatment or medicated shampoo within 2 weeks prior to baseline . * Current or recent use of any biologic agent within the required washout periods. * Clinical evidence or suspicion of active tuberculosis or previously had evidence of active tuberculosis and did not receive appropriate and documented treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose) | Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141 | Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum. |
| Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose) | Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141 | Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported. |
| Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose) | day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197 | Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum. |
| Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose) | day 57 (Pre-dose), 59, 61, 64, 67, 71 | Pharmacokinetics: Area under concentration of Ixekizumab from time Zero to 336h (AUC 0 to 336h) was reported (Multiple dose). |
| Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose) | day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85 | Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose). |
Countries
China
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Ixekizumab Single Dose Participants received single dose of 80mg Ixekizumab by subcutaneous injection. | 12 |
| 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. | 14 |
| 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. | 15 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Multiple Dose Period | Protocol Violation | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Ixekizumab 80mg Q2W Multiple Dose | Ixekizumab 80mg Q4W Multiple Dose | Total | Ixekizumab Single Dose |
|---|---|---|---|---|
| Age, Continuous Multiple Dose | 45.6 years STANDARD_DEVIATION 12.5 | 45.5 years STANDARD_DEVIATION 16.1 | 45.6 years STANDARD_DEVIATION 14.2 | — |
| Age, Continuous Single Dose | — | — | 49.0 years STANDARD_DEVIATION 12.1 | 49.0 years STANDARD_DEVIATION 12.1 |
| Ethnicity (NIH/OMB) Multiple Dose Phase Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Multiple Dose Phase Not Hispanic or Latino | 14 Participants | 15 Participants | 29 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Multiple Dose Phase Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Single Dose Phase Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Single Dose Phase Not Hispanic or Latino | 0 Participants | 0 Participants | 12 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Single Dose Phase Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Multiple Dose Phase American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Multiple Dose Phase Asian | 14 Participants | 15 Participants | 29 Participants | 0 Participants |
| Race (NIH/OMB) Multiple Dose Phase Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Multiple Dose Phase More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Multiple Dose Phase Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Multiple Dose Phase Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Multiple Dose Phase White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Single Dose Phase American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Single Dose Phase Asian | 0 Participants | 0 Participants | 12 Participants | 12 Participants |
| Race (NIH/OMB) Single Dose Phase Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Single Dose Phase More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Single Dose Phase Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Single Dose Phase Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Single Dose Phase White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China Multiple Dose | 14 Participants | 15 Participants | 29 Participants | 0 Participants |
| Region of Enrollment China Single Dose | 0 Participants | 0 Participants | 12 Participants | 12 Participants |
| Sex: Female, Male Multiple Dose Female | 3 Participants | 5 Participants | 8 Participants | 0 Participants |
| Sex: Female, Male Multiple Dose Male | 11 Participants | 10 Participants | 21 Participants | 0 Participants |
| Sex: Female, Male Single Dose Female | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Single Dose Male | 0 Participants | 0 Participants | 10 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 14 | 0 / 15 |
| other Total, other adverse events | 11 / 12 | 11 / 14 | 12 / 15 |
| serious Total, serious adverse events | 0 / 12 | 1 / 14 | 0 / 15 |
Outcome results
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).
Time frame: day 57 (Pre-dose), 59, 61, 64, 67, 71
Population: All randomized participants multiple dose period who received at least one dose of Ixekizumab and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ixekizumab Single Dose | Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose) | 224 Microgram*day per milliliter (ug*day/mL) | Geometric Coefficient of Variation 25 |
| Ixekizumab 80mg Q4W Multiple Dose | Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose) | 136 Microgram*day per milliliter (ug*day/mL) | Geometric Coefficient of Variation 31 |
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).
Time frame: day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85
Population: All randomized participants in Ixekizumab Q4W arm who received at least one dose of Ixekizumab and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ixekizumab Single Dose | Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose) | 213 Microgram*day per milliliter (ug*day/mL) | Geometric Coefficient of Variation 29 |
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.
Time frame: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141
Population: All randomized participants who received at least one dose of Ixekizumab in single dose group and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ixekizumab Single Dose | Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose) | 147 Microgram*day per milliliter (ug*day/mL) | Geometric Coefficient of Variation 48 |
Primary
Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose)
Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum.
Time frame: day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197
Population: All randomized participants who received at least one dose of Ixekizumab in multiple dose group and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ixekizumab Single Dose | Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose) | 19.9 Microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 27 |
| Ixekizumab 80mg Q4W Multiple Dose | Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose) | 13.4 Microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 32 |
Primary
Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose)
Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum.
Time frame: Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141
Population: All randomized participants who received at least one dose of Ixekizumab in single dose group and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Ixekizumab Single Dose | Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose) | 6.90 Microgram per milliliter (ug/mL) | Geometric Coefficient of Variation 43 |