Psoriasis
Conditions
Brief summary
To detect onset of activity of ixekizumab in participants with moderate-to-severe plaque psoriasis and to document the same using sequential photographic images.
Interventions
DRUGIxekizumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Present with chronic moderate-to-severe plaque psoriasis based on a confirmed (by a dermatologist) diagnosis of chronic plaque psoriasis for at least 6 months prior to baseline * Active psoriatic skin lesions of plaque psoriasis (Ps) * Are a candidate for phototherapy and/or systemic therapy * Men must agree to use a reliable method of birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment * Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Exclusion criteria
* Are unable to commit to the photography schedule for the duration of the study * Have participated in any study with interleukin 17 (IL-17) or (IL-23) antagonists, including ixekizumab * Serious disorder or illness other than psoriasis * Serious infection within the last 3 months * Breastfeeding or nursing (lactating) women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score | Baseline through Week 12 | The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 Numeric Rating Score (NRS) the severity of their psoriasis today from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score | Baseline, Week 12 | The Itch NRS is a patient-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching from psoriasis (Ps) is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Least Square Means (LS means) are from analysis of mixed-effects model for repeated measures (MMRM) and model includes treatment group, baseline value and timepoint. |
| Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) | Baseline, Week 12 | The DLQI is a simple, patient-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include Not at all, A little, A lot, and Very much, with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of Not relevant which is scored as 0. For all questions, if unanswered the question is scored as 0. Totals range from 0 to 30 (less to more impairment). LS means are from analysis of MMRM and model includes treatment group, baseline value and timepoint. |
| Mean Change From Baseline in Percent Body Surface Area (%BSA) | Baseline, Week 12 | The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction |
| Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI) | Baseline, Week 12 | The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in PASI scores compared to baseline. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction. |
| Time to at Least a 2 Point Improvement on the PatGA Score | Baseline though Week 12 | The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 NRS the severity of their psoriasis today from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been. |
Countries
United States
Participant flow
Recruitment details
Induction Dosing Period (Weeks 0 up to 12), Maintenance Dosing Period (Weeks 12 up to 48), Minimum Post Treatment Follow-Up Period up to 12 weeks after last visit.
Pre-assignment details
Participants were randomized to ixekizumab (ixe) 80 mg Q2W or Q4W during the Induction Dosing Period from Week 0 to Week 12. Participants received ixe Q4W in the Maintenance Dosing Period from Week 12 to Week 48, and then to the Post Follow up Treatment Period for at least 12 weeks.
Participants by arm
| Arm | Count |
|---|---|
| Ixekizumab Q2W 160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44. | 6 |
| Ixekizumab Q4W 160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Ixekizumab Q2W | Total | Ixekizumab Q4W |
|---|---|---|---|
| Age, Continuous | 41.8 years STANDARD_DEVIATION 12.54 | 48.5 years STANDARD_DEVIATION 12.03 | 55.2 years STANDARD_DEVIATION 7.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 9 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 9 Participants | 5 Participants |
| Region of Enrollment United States | 6 participants | 12 participants | 6 participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 6 | 5 / 6 | 9 / 12 | 1 / 12 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score
The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 Numeric Rating Score (NRS) the severity of their psoriasis today from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.
Time frame: Baseline through Week 12
Population: All randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ixekizumab Q2W | Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score | 5.0 Days |
| Ixekizumab Q4W | Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score | 6.0 Days |
Secondary
Mean Change From Baseline in Percent Body Surface Area (%BSA)
The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction
Time frame: Baseline, Week 12
Population: All randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ixekizumab Q2W | Mean Change From Baseline in Percent Body Surface Area (%BSA) | -26.1 percentage of body surface area | Standard Error 1.39 |
| Ixekizumab Q4W | Mean Change From Baseline in Percent Body Surface Area (%BSA) | -28.0 percentage of body surface area | Standard Error 1.39 |
Secondary
Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score
The Itch NRS is a patient-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching from psoriasis (Ps) is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Least Square Means (LS means) are from analysis of mixed-effects model for repeated measures (MMRM) and model includes treatment group, baseline value and timepoint.
Time frame: Baseline, Week 12
Population: All randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ixekizumab Q2W | Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score | -6.2 units on a scale | Standard Error 0.53 |
| Ixekizumab Q4W | Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score | -6.6 units on a scale | Standard Error 0.55 |
Secondary
Mean Change From Baseline on the Dermatology Life Quality Index (DLQI)
The DLQI is a simple, patient-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include Not at all, A little, A lot, and Very much, with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of Not relevant which is scored as 0. For all questions, if unanswered the question is scored as 0. Totals range from 0 to 30 (less to more impairment). LS means are from analysis of MMRM and model includes treatment group, baseline value and timepoint.
Time frame: Baseline, Week 12
Population: All randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ixekizumab Q2W | Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) | -13.4 units on a scale | Standard Error 1.56 |
| Ixekizumab Q4W | Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) | -14.3 units on a scale | Standard Error 1.59 |
Secondary
Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI)
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in PASI scores compared to baseline. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction.
Time frame: Baseline, Week 12
Population: All randomized participants.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ixekizumab Q2W | Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI) | -22.00 units on a scale | Standard Error 0.456 |
| Ixekizumab Q4W | Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI) | -22.72 units on a scale | Standard Error 0.456 |
Secondary
Time to at Least a 2 Point Improvement on the PatGA Score
The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 NRS the severity of their psoriasis today from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been.
Time frame: Baseline though Week 12
Population: All randomized participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ixekizumab Q2W | Time to at Least a 2 Point Improvement on the PatGA Score | 10.0 Days |
| Ixekizumab Q4W | Time to at Least a 2 Point Improvement on the PatGA Score | 13.5 Days |