Plaque Psoriasis, Psoriatic Arthritis
Conditions
Brief summary
The main purpose of this study is to investigate the safety and tolerability of ixekizumab in participants in India with moderate-to-severe plaque psoriasis (PsO) or active psoriatic arthritis (PsA)
Interventions
DRUGIxekizumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All participants: * Male or nonpregnant, nonbreastfeeding female participants. For PsO Participants: * Present with chronic PsO based on a confirmed diagnosis of chronic PsO vulgaris for at least 6 months prior to baseline * Have ≥10% Body Surface Area (BSA) of psoriasis at screening (Visit 1) and baseline * Have both an static Physician's Global Assessment (sPGA) score of ≥3 and Psoriasis Area and Severity Index (PASI) score ≥12 at screening and baseline For PsA Participants * Have a diagnosis of active PsA for at least 6 months (based on a detailed medical history provided by the patient, and a physical exam by the Study Investigator, and/or other evidence such as that provided by joint x-rays, that establishes a history consistent with a diagnosis of active PsA of at least 6 months' duration) and currently meet the Classification for PsA (CASPAR) criteria. * Have active PsA defined as the presence of at least 3/68 tender and at least 3/66 swollen joints, as determined by the Tender and Swollen Joint Count Assessment Form at screening and baseline. * Presence of active PsO or a documented history of psoriasis.
Exclusion criteria
* Have previously completed or withdrawn from this study, participated in any other study with ixekizumab, or have participated in any study investigating other IL-17 antagonists. * Have a history of drug-induced PsO. * Have a known allergy or hypersensitivity to any biologic therapy that would pose an unacceptable risk to the patient if participating in this study. * Had any major surgery within 8 weeks prior to baseline (Week 0; Visit 2), or will require such during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant * Have diagnosis or history of malignant disease within the 5 years prior to baseline * Have any other active or recent infection within 4 weeks of baseline For PsO Participants: * Have received systemic non-biologic PsO therapy (within 4 weeks prior to baseline) * Have pustular, erythrodermic, and/or guttate forms of PsO * Had a clinically significant flare of PsO during the 12 weeks prior to baseline (Week 0). * Have allergy to rubber or latex. For PsA Participants: * Have used conventional synthetic disease-modifying antirheumatic drug (csDMARDs) other than methotrexate (MTX), leflunomide, sulfasalazine, or cyclosporine in the 8 weeks prior to baseline * Have received treatment with interleukin (IL)17 or IL-12/23 targeted Mab therapy * Are currently receiving treatment with any biologic or small molecule therapy for PsA or PsO, including investigational therapies (such as, but not limited to, a tumor necrosis factor inhibitor (TNFi), IL-1 receptor antagonists, IL-6 inhibitor, anti-IL12/23p40, T cell or B cell targeted therapies, phosphodiesterase (PDE) 4 inhibitors, or Janus Kinase (JAK) inhibitors), or have received denosumab. * Have had surgical treatment of a joint within 8 weeks prior to baseline or will require such up to Week 24.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs) From Week 0 to Week 24 | Week 0 to Week 24 | * An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect. * TEAE is defined as an event that first occurred or worsened in severity after baseline and on or prior to the date of the last visit within the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PsO With no Active PsA: Percentage of Participants With PsO Achieving ≥75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 | Week 12 | Participants achieving a PASI-75 without the use of other background antipsoriasis therapy were considered responders. The PASI quantifies the severity of a psoriasis based on lesion severity and the percent of body surface area (BSA) affected. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity. |
| PsO With no Active PsA: Percentage of PsO Participants With a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Minimal) | Week 12 | The sPGA is an assessment by the physician to determine participant's overall psoriatic lesions, at a given time point. For the analysis of responses, the participant's psoriasis indication is assessed on a 5-point scale as: 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe) incorporating an assessment of the severity of the three primary signs of the disease: induration, erythema, and degree of scaling. The investigator examines all of the lesions on the participant and assigns a score ranging from 0 to 5 for induration, erythema and degree of scaling. Scores for induration, erythema and scaling are then summed, and the mean of these 3 scores produces the overall sPGA score. Participants with an sPGA score of 0 (clear) or 1 (minimal) were considered responders and are reported here. |
| Active PsA: Percentage of Active Psoriatic Arthritis Participants Who Achieved 20% Improvement From Baseline in American College of Rheumatology 20 (ACR20) at Week 24 | Week 24 | The ACR 20 is defined as: * 20% improvement from baseline in both tender joint count (68 counts) and swollen joint count (66 counts) * 20% improvements improvement in at least three of the following five items: Patient's global assessment of arthritis pain (measured on a 100-mm visual analog scale \[VAS\]); Patient's global assessment of disease activity (measured on a 100-mm VAS); Physician's global assessment of disease activity (measured on a 100-mm VAS); Patient's assessment of physical function as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI); Acute-phase reactant as measured by high-sensitivity C-reactive protein (hs-CRP) assay. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ixekizumab - PsO With no Active PsA Participants with plaque psoriasis (PsO) with no active psoriatic arthritis (PsA) received:
* Ixekizumab 160 mg SC injection as loading dose at Week 0, followed by;
* Ixekizumab 80 mg SC injection Q2W at Week 2, 4, 6, 8, and 10
* Ixekizumab 80 mg SC injection Q4W at Week 12, 16, and 20 | 150 |
| Ixekizumab - Active PsA Participants with active psoriatic arthritis (PsA) with moderate to severe plaque psoriasis (PsO) received:
* Ixekizumab 160 mg SC injection as loading dose at Week 0, followed by;
* Ixekizumab 80 mg SC injection Q2W at Week 2, 4, 6, 8, and 10
* Ixekizumab 80 mg SC injection Q4W at Week 12, 16, and 20
Participants with active PsA without moderate to severe PsO received:
* Ixekizumab 160 mg SC injection as loading dose at Week 0, followed by
* Ixekizumab 80 mg SC injection Q4W at Week 4, 8, 12, 16, and 20. | 100 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 5 |
Baseline characteristics
| Characteristic | Ixekizumab - PsO With no Active PsA | Ixekizumab - Active PsA | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 8 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 141 Participants | 92 Participants | 233 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 20 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 142 Participants | 80 Participants | 222 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 150 Participants | 100 Participants | 250 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment India | 150 Participants | 100 Participants | 250 Participants |
| Sex: Female, Male Female | 28 Participants | 33 Participants | 61 Participants |
| Sex: Female, Male Male | 122 Participants | 67 Participants | 189 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 209 | 0 / 41 |
| other Total, other adverse events | 66 / 209 | 9 / 41 |
| serious Total, serious adverse events | 1 / 209 | 0 / 41 |
Outcome results
Primary
Number of Participants Reporting Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs) From Week 0 to Week 24
* An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect. * TEAE is defined as an event that first occurred or worsened in severity after baseline and on or prior to the date of the last visit within the treatment period.
Time frame: Week 0 to Week 24
Population: All participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were collected and analyzed by ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Q2W/Q4W Ixekizumab Dosing Regimen | Number of Participants Reporting Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs) From Week 0 to Week 24 | SAEs | 1 Participants |
| Q2W/Q4W Ixekizumab Dosing Regimen | Number of Participants Reporting Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs) From Week 0 to Week 24 | TEAEs | 60 Participants |
| Q2W/Q4W Ixekizumab Dosing Regimen | Number of Participants Reporting Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs) From Week 0 to Week 24 | AESIs | 39 Participants |
| Q4W Ixekizumab Dosing Regimen | Number of Participants Reporting Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs) From Week 0 to Week 24 | SAEs | 0 Participants |
| Q4W Ixekizumab Dosing Regimen | Number of Participants Reporting Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs) From Week 0 to Week 24 | TEAEs | 8 Participants |
| Q4W Ixekizumab Dosing Regimen | Number of Participants Reporting Serious Adverse Events (SAEs), and Treatment Emergent Adverse Events (TEAEs) and AEs of Special Interests (AESIs) From Week 0 to Week 24 | AESIs | 6 Participants |
Secondary
Active PsA: Percentage of Active Psoriatic Arthritis Participants Who Achieved 20% Improvement From Baseline in American College of Rheumatology 20 (ACR20) at Week 24
The ACR 20 is defined as: * 20% improvement from baseline in both tender joint count (68 counts) and swollen joint count (66 counts) * 20% improvements improvement in at least three of the following five items: Patient's global assessment of arthritis pain (measured on a 100-mm visual analog scale \[VAS\]); Patient's global assessment of disease activity (measured on a 100-mm VAS); Physician's global assessment of disease activity (measured on a 100-mm VAS); Patient's assessment of physical function as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI); Acute-phase reactant as measured by high-sensitivity C-reactive protein (hs-CRP) assay.
Time frame: Week 24
Population: All participants with an active psoriatic arthritis indication who received at least 1 dose of study treatment. As per planned analysis, the outcome measure was planned to be analyzed for participants with active psoriatic Arthritis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q2W/Q4W Ixekizumab Dosing Regimen | Active PsA: Percentage of Active Psoriatic Arthritis Participants Who Achieved 20% Improvement From Baseline in American College of Rheumatology 20 (ACR20) at Week 24 | 84.0 percentage of participants |
Secondary
PsO With no Active PsA: Percentage of Participants With PsO Achieving ≥75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12
Participants achieving a PASI-75 without the use of other background antipsoriasis therapy were considered responders. The PASI quantifies the severity of a psoriasis based on lesion severity and the percent of body surface area (BSA) affected. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity.
Time frame: Week 12
Population: All participants with a psoriasis indication, who do not qualify for active psoriatic arthritis (PsA) and had received at least 1 dose of study treatment. As per planned analysis, the outcome measure was planned to be analyzed for participants with plaque psoriasis (PsO) and with no active psoriatic arthritis (PsA).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q2W/Q4W Ixekizumab Dosing Regimen | PsO With no Active PsA: Percentage of Participants With PsO Achieving ≥75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI-75) at Week 12 | 86.0 percentage of participant |
Secondary
PsO With no Active PsA: Percentage of PsO Participants With a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Minimal)
The sPGA is an assessment by the physician to determine participant's overall psoriatic lesions, at a given time point. For the analysis of responses, the participant's psoriasis indication is assessed on a 5-point scale as: 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe) incorporating an assessment of the severity of the three primary signs of the disease: induration, erythema, and degree of scaling. The investigator examines all of the lesions on the participant and assigns a score ranging from 0 to 5 for induration, erythema and degree of scaling. Scores for induration, erythema and scaling are then summed, and the mean of these 3 scores produces the overall sPGA score. Participants with an sPGA score of 0 (clear) or 1 (minimal) were considered responders and are reported here.
Time frame: Week 12
Population: All participants with a psoriasis indication, who do not qualify for active psoriatic arthritis (PsA) and had received at least 1 dose of study treatment. As per planned analysis, the outcome measure was planned to be analyzed for participants with plaque psoriasis (PsO) and with no active psoriatic arthritis (PsA).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Q2W/Q4W Ixekizumab Dosing Regimen | PsO With no Active PsA: Percentage of PsO Participants With a Static Physician Global Assessment (sPGA) Score of 0 (Clear) or 1 (Minimal) | 65.3 percentage of participants |