Genital Psoriasis, Psoriasis
Conditions
Keywords
genital
Brief summary
The main purpose of this study is to evaluate the efficacy and safety of the study drug ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.
Interventions
DRUGIxekizumab
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have chronic plaque psoriasis based on a diagnosis of chronic plaque psoriasis for at least 6 months before baseline. * Have moderate-to-severe psoriasis in the genital area at screening and baseline. * Have plaque psoriasis in a nongenital area at screening and baseline. * Have failed to respond to, or are intolerant of, at least 1 topical therapy used for treatment of psoriasis affecting the genital area. * Must agree to use reliable method of birth control, which could include abstinence, during the study and for at least 12 weeks following the last dose of study drug.
Exclusion criteria
* Pustular, erythrodermic, and/or guttate forms of psoriasis. * History of drug-induced psoriasis. * Have recently received certain treatments for psoriasis (in particular, within the past 4 weeks but the restriction can go up to 12 months for some treatments). * Have ever received treatment with ixekizumab, secukinumab, brodalumab, or another drug with a similar mode of action. * Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study. * Are currently enrolled in any other clinical trial involving an investigational product. * Serious disorder or illness other than plaque psoriasis. * Active or history of malignant disease within 5 years prior to baseline. * Serious infection within the last 3 months. * Have received a live vaccine within 3 months of baseline or plan to do so during the study. * Have received a vaccination with Bacillus Calmette-Guérin (BCG) within the past year. * Pregnant or breastfeeding (lactating) women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) | Week 12 | sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least a 3 Point Improvement in Genital Psoriasis Itch Numeric Rating Scale (NRS) Item Within the Genital Psoriasis Symptom Scale (GPSS) | Week 12 | GPSS is a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (= no severity) and 10 (worst imaginable severity). |
| Number of Participants Whose Frequency of Sexual Activity is Never or Rarely Limited by Genital Psoriasis, Utilizing the Genital Psoriasis Sexual Frequency Questionnaire (SFQ) Item 2 | Week 12 | The SFQ is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual frequency. It consists of 2 items that assess the impact of genital psoriasis symptoms on the frequency of sexual activity. Respondents were asked to answer the questions based on their psoriasis symptoms in the genital area. Item 2 assesses how often genital psoriasis symptoms limited the frequency of sexual activity with the following response options: 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always. \*The SFQ is also referred to as the GenPs-SFQ (genital psoriasis sexual frequency questionnaire). |
| Number of Participants Whose Frequency of Avoiding Sexual Activity is Either Never or Rarely Limited by Genital Psoriasis in the Sexual Activity Avoidance Subscale Score of the Genital Psoriasis Sexual Impact Scale (GPSIS) | Week 12 | GPSIS is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual activity. The GPSIS Sexual Activity Avoidance Subscale includes 2 items: Item 1 asks whether the participant has been sexually active in the past week. (No due to other reasons = 1, No due to genital Ps = 5) Item 2 asks how often the participant avoided sexual activity in the past week due to Genital Psoriasis. (Never = 1, rarely = 2, Sometimes = 3, Often = 4) |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score | Baseline, Week 12 | DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: 1) Symptoms and feelings 2) Daily activities 3) Leisure 4) Work and school 5) Personal relationships 6) Treatment. Response categories include: 0 = not at all; 1 = a little; 2 = a lot; 3 = very much; not relevant responses scored as 0 and total score range of 0 to 30; higher scores indicate poor quality of life. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, baseline body surface area (BSA) category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects. |
| Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score | Baseline, Week 12 | mGPASI determines participants psoriasis severity in the genital region at a given time point yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. scoring index incorporates the degree of erythema (or redness), induration (or thickness), and scaling) of the genital plaques as well as erosion, fissure, and/or ulcer as a product of the genital area involved. LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects. |
| Number of Participants Achieving Overall sPGA (0,1) | Week 12 | The overall sPGA is the physician's global assessment of the participant's psoriasis (Ps) lesions at a given time point. Plaques were assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity was given using the anchors of 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. Overall sPGA (0,1) : An overall sPGA assessed as either 0 or 1. |
| Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS) | Baseline, Week 12 | SF-36 is a participant-reported outcome measure evaluating a participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, baseline BSA category, & baseline value and modified baseline observation carried forward (mBOCF) imputation method. |
| Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS) | Baseline, Week 12 | SF-36 is a participant-reported outcome measure evaluating a participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the MCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, baseline BSA category, & baseline value and modified baseline observation carried forward (mBOCF) imputation method. |
| Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Baseline, Week 12 | GPSS is a participant's-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (no severity) and 10 (worst imaginable severity). total score ranges from 0 (no severity) - 80 (worst imaginable severity) LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects. |
| Number of Participants Achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) Status and by Neutralizing Antibody (NAb) Status | Week 12 | sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1. |
| Number of Participants With at Least a 2-Point Change in Patient's Global Assessment of Genital Psoriasis (PatGA-Genital) | Week 12 | Patient's Global Assessment of Genital Psoriasis (PatGA-Genital) is a participant-administered, single-item scale on which participants are asked to rank the severity of their genital psoriasis today by circling a number on a 0 to 5 NRS, as follows: from 0 (clear), no genital psoriasis; to 5 (severe). |
Countries
Australia, Austria, Belgium, Canada, Netherlands, Puerto Rico, Turkey (Türkiye), United States
Participant flow
Pre-assignment details
12 week Blinded Treatment period, followed by 40 week Open Label Treatment Period, followed by 12 week Post treatment follow-up period. ttt = treatment, Pt = Participant.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo subcutaneously at baseline and every 2 weeks (Q2W) from week 2 to week 10. At week 12, 160 mg Ixekizumab given SC. | 74 |
| Ixekizumab 80mg Q2W Participants received 160 milligrams (mg) Ixekizumab subcutaneously (SC) at baseline followed by 80 mg Ixekizumab every 2 weeks (Q2W) from week 2 to week 10. At week 12, 80 mg Ixekizumab and placebo was given SC during blinded treatment period. | 75 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Blinded Treatment Period | Adverse Event | 5 | 1 | 0 | 0 | 0 | 0 | 0 |
| Blinded Treatment Period | Lack of Efficacy | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Blinded Treatment Period | Lost to Follow-up | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Blinded Treatment Period | Physician Decision | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Open Label Treatment Period (OLTP) | Adverse Event | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| Open Label Treatment Period (OLTP) | Lack of Efficacy | 0 | 0 | 1 | 2 | 0 | 0 | 0 |
| Open Label Treatment Period (OLTP) | Lost to Follow-up | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Open Label Treatment Period (OLTP) | Subject discontinued in OLTP | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Open Label Treatment Period (OLTP) | Ttt of undisclosed addiction-Pt withdrew | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Open Label Treatment Period (OLTP) | Withdrawal by Subject | 0 | 0 | 1 | 3 | 0 | 0 | 0 |
| Post Treatment Follow-up Period | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Post Treatment Follow-up Period | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 5 | 1 |
| Post Treatment Follow-up Period | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 5 | 3 |
Baseline characteristics
| Characteristic | Placebo | Ixekizumab 80mg Q2W | Total |
|---|---|---|---|
| Age, Continuous | 44.4 years STANDARD_DEVIATION 12.55 | 43.1 years STANDARD_DEVIATION 12.95 | 43.7 years STANDARD_DEVIATION 12.72 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 13 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 60 Participants | 117 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 5 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 | 64 Participants | 67 Participants | 131 Participants |
| Region of Enrollment Australia | 11 Participants | 9 Participants | 20 Participants |
| Region of Enrollment Austria | 4 Participants | 4 Participants | 8 Participants |
| Region of Enrollment Belgium | 3 Participants | 4 Participants | 7 Participants |
| Region of Enrollment Canada | 16 Participants | 13 Participants | 29 Participants |
| Region of Enrollment Netherlands | 2 Participants | 3 Participants | 5 Participants |
| Region of Enrollment Puerto Rico | 4 Participants | 7 Participants | 11 Participants |
| Region of Enrollment Turkey | 3 Participants | 4 Participants | 7 Participants |
| Region of Enrollment United States | 31 Participants | 31 Participants | 62 Participants |
| Sex: Female, Male Female | 17 Participants | 19 Participants | 36 Participants |
| Sex: Female, Male Male | 57 Participants | 56 Participants | 113 Participants |
| sPGA of Genitalia | 3.5 units on a scale STANDARD_DEVIATION 0.53 | 3.4 units on a scale STANDARD_DEVIATION 0.61 | 3.4 units on a scale STANDARD_DEVIATION 0.57 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 75 | 0 / 65 | 0 / 74 | 0 / 1 | 0 / 49 | 0 / 78 |
| other Total, other adverse events | 19 / 74 | 21 / 75 | 28 / 65 | 27 / 74 | 0 / 1 | 1 / 49 | 0 / 78 |
| serious Total, serious adverse events | 1 / 74 | 0 / 75 | 2 / 65 | 5 / 74 | 0 / 1 | 2 / 49 | 1 / 78 |
Outcome results
Primary
Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)
sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1.
Time frame: Week 12
Population: All randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) | 6 Participants |
| Ixekizumab 80mg Q2W | Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) | 55 Participants |
p-value: <0.00195% CI: [12.39, 92.23]Regression, Logistic
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: 1) Symptoms and feelings 2) Daily activities 3) Leisure 4) Work and school 5) Personal relationships 6) Treatment. Response categories include: 0 = not at all; 1 = a little; 2 = a lot; 3 = very much; not relevant responses scored as 0 and total score range of 0 to 30; higher scores indicate poor quality of life. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, baseline body surface area (BSA) category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.
Time frame: Baseline, Week 12
Population: All randomized participants with baseline and post baseline observation for DLQI.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score | -1.4 units on a scale | Standard Error 0.62 |
| Ixekizumab 80mg Q2W | Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score | -9.7 units on a scale | Standard Error 0.59 |
p-value: <0.00195% CI: [-10.1, -6.7]Mixed Models Analysis
Secondary
Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items
GPSS is a participant's-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (no severity) and 10 (worst imaginable severity). total score ranges from 0 (no severity) - 80 (worst imaginable severity) LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.
Time frame: Baseline, Week 12
Population: All randomized participants with baseline and post baseline observation for GPSS total or individual item scores.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Total Score | -2.82 units on a scale | Standard Error 2.19 |
| Placebo | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Itch | -0.21 units on a scale | Standard Error 0.29 |
| Placebo | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Discomfort | -0.42 units on a scale | Standard Error 0.298 |
| Placebo | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Burning | -0.53 units on a scale | Standard Error 0.289 |
| Placebo | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Scaling | -0.02 units on a scale | Standard Error 0.273 |
| Placebo | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Cracking | -0.19 units on a scale | Standard Error 0.28 |
| Placebo | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Pain | -0.34 units on a scale | Standard Error 0.294 |
| Placebo | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Stinging | -0.51 units on a scale | Standard Error 0.298 |
| Placebo | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Redness | -0.63 units on a scale | Standard Error 0.287 |
| Ixekizumab 80mg Q2W | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Redness | -4.45 units on a scale | Standard Error 0.272 |
| Ixekizumab 80mg Q2W | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Total Score | -31.57 units on a scale | Standard Error 2.07 |
| Ixekizumab 80mg Q2W | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Cracking | -3.74 units on a scale | Standard Error 0.264 |
| Ixekizumab 80mg Q2W | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Itch | -4.02 units on a scale | Standard Error 0.274 |
| Ixekizumab 80mg Q2W | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Scaling | -3.80 units on a scale | Standard Error 0.259 |
| Ixekizumab 80mg Q2W | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Discomfort | -4.27 units on a scale | Standard Error 0.282 |
| Ixekizumab 80mg Q2W | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Stinging | -3.74 units on a scale | Standard Error 0.281 |
| Ixekizumab 80mg Q2W | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Pain | -3.84 units on a scale | Standard Error 0.278 |
| Ixekizumab 80mg Q2W | Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items | Burning | -3.73 units on a scale | Standard Error 0.273 |
Comparison: Total Scorep-value: <0.00195% CI: [-34.72, -22.78]Mixed Models Analysis
Comparison: Itchp-value: <0.00195% CI: [-4.6, -3.02]Mixed Models Analysis
Comparison: Painp-value: <0.00195% CI: [-4.3, -2.7]Mixed Models Analysis
Comparison: Discomfortp-value: <0.00195% CI: [-4.66, -3.04]Mixed Models Analysis
Comparison: Stingingp-value: <0.00195% CI: [-4.04, -2.42]Mixed Models Analysis
Comparison: Burningp-value: <0.00195% CI: [-3.99, -2.41]Mixed Models Analysis
Comparison: Rednessp-value: <0.00195% CI: [-4.59, -3.03]Mixed Models Analysis
Comparison: Scalingp-value: <0.00195% CI: [-4.53, -3.03]Mixed Models Analysis
Comparison: Crackingp-value: <0.00195% CI: [-4.31, -2.79]Mixed Models Analysis
Secondary
Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score
mGPASI determines participants psoriasis severity in the genital region at a given time point yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. scoring index incorporates the degree of erythema (or redness), induration (or thickness), and scaling) of the genital plaques as well as erosion, fissure, and/or ulcer as a product of the genital area involved. LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.
Time frame: Baseline, Week 12
Population: All randomized participants with baseline and post baseline observation for mGPASI.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score | -3.9 units on a scale | Standard Error 1.56 |
| Ixekizumab 80mg Q2W | Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score | -23.9 units on a scale | Standard Error 1.48 |
p-value: <0.00195% CI: [-24.3, -15.8]Mixed Models Analysis
Secondary
Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)
SF-36 is a participant-reported outcome measure evaluating a participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the MCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, baseline BSA category, & baseline value and modified baseline observation carried forward (mBOCF) imputation method.
Time frame: Baseline, Week 12
Population: All randomized participants with baseline and post baseline measurement for SF-36 MCS.~mBOCF: Participants with or without post baseline measurement who discontinued treatment due to Adverse Event (AE) or death were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS) | 2.186 units on a scale | Standard Error 0.7333 |
| Ixekizumab 80mg Q2W | Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS) | 3.982 units on a scale | Standard Error 0.7281 |
p-value: 0.08595% CI: [-0.253, 3.847]ANCOVA
Secondary
Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
SF-36 is a participant-reported outcome measure evaluating a participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, baseline BSA category, & baseline value and modified baseline observation carried forward (mBOCF) imputation method.
Time frame: Baseline, Week 12
Population: All randomized participants with baseline and post baseline measurement for SF-36 PCS.~mBOCF: Participants with or without post baseline measurement who discontinued treatment due to Adverse Event (AE) or death were imputed by their baseline observation , Participants who discontinued due to other reasons were imputed by their last observation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS) | 0.687 units on a scale | Standard Error 0.7998 |
| Ixekizumab 80mg Q2W | Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS) | 5.193 units on a scale | Standard Error 0.7942 |
p-value: <0.00195% CI: [2.264, 6.748]ANCOVA
Secondary
Number of Participants Achieving Overall sPGA (0,1)
The overall sPGA is the physician's global assessment of the participant's psoriasis (Ps) lesions at a given time point. Plaques were assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity was given using the anchors of 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. Overall sPGA (0,1) : An overall sPGA assessed as either 0 or 1.
Time frame: Week 12
Population: All randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Achieving Overall sPGA (0,1) | 2 Participants |
| Ixekizumab 80mg Q2W | Number of Participants Achieving Overall sPGA (0,1) | 55 Participants |
p-value: <0.00195% CI: [22.79, 461.43]Regression, Logistic
Secondary
Number of Participants Achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) Status and by Neutralizing Antibody (NAb) Status
sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe. sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1.
Time frame: Week 12
Population: All randomized participants who received at least one dose of study drug and either had baseline and at least 1 post-baseline evaluable samples or had no evaluable baseline and all negative post-baseline anti-drug antibody negative samples.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) Status and by Neutralizing Antibody (NAb) Status | TE-ADA negative | 6 Participants |
| Ixekizumab 80mg Q2W | Number of Participants Achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) Status and by Neutralizing Antibody (NAb) Status | TE-ADA positive | 5 Participants |
| Ixekizumab 80mg Q2W | Number of Participants Achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) Status and by Neutralizing Antibody (NAb) Status | TE-ADA negative | 50 Participants |
| Ixekizumab 80mg Q2W | Number of Participants Achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) Status and by Neutralizing Antibody (NAb) Status | NAb inconclusive | 5 Participants |
Secondary
Number of Participants Whose Frequency of Avoiding Sexual Activity is Either Never or Rarely Limited by Genital Psoriasis in the Sexual Activity Avoidance Subscale Score of the Genital Psoriasis Sexual Impact Scale (GPSIS)
GPSIS is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual activity. The GPSIS Sexual Activity Avoidance Subscale includes 2 items: Item 1 asks whether the participant has been sexually active in the past week. (No due to other reasons = 1, No due to genital Ps = 5) Item 2 asks how often the participant avoided sexual activity in the past week due to Genital Psoriasis. (Never = 1, rarely = 2, Sometimes = 3, Often = 4)
Time frame: Week 12
Population: All randomized participants with baseline GPSIS sexual activity avoidance subscale score \>= 3.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Whose Frequency of Avoiding Sexual Activity is Either Never or Rarely Limited by Genital Psoriasis in the Sexual Activity Avoidance Subscale Score of the Genital Psoriasis Sexual Impact Scale (GPSIS) | 9 Participants |
| Ixekizumab 80mg Q2W | Number of Participants Whose Frequency of Avoiding Sexual Activity is Either Never or Rarely Limited by Genital Psoriasis in the Sexual Activity Avoidance Subscale Score of the Genital Psoriasis Sexual Impact Scale (GPSIS) | 23 Participants |
p-value: <0.00195% CI: [3.08, 31.4]Regression, Logistic
Secondary
Number of Participants Whose Frequency of Sexual Activity is Never or Rarely Limited by Genital Psoriasis, Utilizing the Genital Psoriasis Sexual Frequency Questionnaire (SFQ) Item 2
The SFQ is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual frequency. It consists of 2 items that assess the impact of genital psoriasis symptoms on the frequency of sexual activity. Respondents were asked to answer the questions based on their psoriasis symptoms in the genital area. Item 2 assesses how often genital psoriasis symptoms limited the frequency of sexual activity with the following response options: 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always. \*The SFQ is also referred to as the GenPs-SFQ (genital psoriasis sexual frequency questionnaire).
Time frame: Week 12
Population: All randomized participants with baseline GenPs-SFQ Item 2 Score \>= 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Whose Frequency of Sexual Activity is Never or Rarely Limited by Genital Psoriasis, Utilizing the Genital Psoriasis Sexual Frequency Questionnaire (SFQ) Item 2 | 9 Participants |
| Ixekizumab 80mg Q2W | Number of Participants Whose Frequency of Sexual Activity is Never or Rarely Limited by Genital Psoriasis, Utilizing the Genital Psoriasis Sexual Frequency Questionnaire (SFQ) Item 2 | 29 Participants |
p-value: <0.00195% CI: [4.57, 40.29]Regression, Logistic
Secondary
Number of Participants With at Least a 2-Point Change in Patient's Global Assessment of Genital Psoriasis (PatGA-Genital)
Patient's Global Assessment of Genital Psoriasis (PatGA-Genital) is a participant-administered, single-item scale on which participants are asked to rank the severity of their genital psoriasis today by circling a number on a 0 to 5 NRS, as follows: from 0 (clear), no genital psoriasis; to 5 (severe).
Time frame: Week 12
Population: All randomized participants with baseline PatGA-Genital score \>= 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With at Least a 2-Point Change in Patient's Global Assessment of Genital Psoriasis (PatGA-Genital) | 11 Participants |
| Ixekizumab 80mg Q2W | Number of Participants With at Least a 2-Point Change in Patient's Global Assessment of Genital Psoriasis (PatGA-Genital) | 51 Participants |
p-value: <0.00195% CI: [6.12, 31.8]Regression, Logistic
Secondary
Number of Participants With at Least a 3 Point Improvement in Genital Psoriasis Itch Numeric Rating Scale (NRS) Item Within the Genital Psoriasis Symptom Scale (GPSS)
GPSS is a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (= no severity) and 10 (worst imaginable severity).
Time frame: Week 12
Population: All randomized participants with baseline GPSS Itch NRS Score \>= 3.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With at Least a 3 Point Improvement in Genital Psoriasis Itch Numeric Rating Scale (NRS) Item Within the Genital Psoriasis Symptom Scale (GPSS) | 5 Participants |
| Ixekizumab 80mg Q2W | Number of Participants With at Least a 3 Point Improvement in Genital Psoriasis Itch Numeric Rating Scale (NRS) Item Within the Genital Psoriasis Symptom Scale (GPSS) | 37 Participants |
p-value: <0.00195% CI: [5.71, 46.4]Regression, Logistic