Trial Outcomes & Findings for A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India (NCT NCT05855967)
NCT ID: NCT05855967
Last Updated: 2025-08-22
Results Overview
* 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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
250 participants
Primary outcome timeframe
Week 0 to Week 24
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
Ixekizumab - PsO With no Active PsA
Participants with plaque psoriasis (PsO) with no active psoriatic arthritis (PsA) received:
* Ixekizumab 160 milligram (mg) subcutaneous (SC) injection as loading dose at Week 0, followed by;
* Ixekizumab 80 mg SC injection every 2 weeks (Q2W) at Week 2, 4, 6, 8, and 10
* Ixekizumab 80 mg SC injection every 4 weeks (Q4W) at Week 12, 16, and 20
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
100
|
|
Overall Study
Received at Least One Dose of Study Drug
|
150
|
100
|
|
Overall Study
Q2W/Q4W Ixekizumab Dosing Regimen
|
150
|
59
|
|
Overall Study
Q4W Ixekizumab Dosing Regimen
|
0
|
41
|
|
Overall Study
COMPLETED
|
141
|
94
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
Ixekizumab - PsO With no Active PsA
Participants with plaque psoriasis (PsO) with no active psoriatic arthritis (PsA) received:
* Ixekizumab 160 milligram (mg) subcutaneous (SC) injection as loading dose at Week 0, followed by;
* Ixekizumab 80 mg SC injection every 2 weeks (Q2W) at Week 2, 4, 6, 8, and 10
* Ixekizumab 80 mg SC injection every 4 weeks (Q4W) at Week 12, 16, and 20
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
A Study of Ixekizumab (LY2439821) in Participants Aged ≥18 Years With Moderate-to-Severe Plaque or Active Psoriatic Arthritis in India
Baseline characteristics by cohort
| Measure |
Ixekizumab - PsO With no Active PsA
n=150 Participants
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
|
Ixekizumab - Active PsA
n=100 Participants
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.
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
141 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
142 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
150 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
150 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 to Week 24Population: 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 \[that is, Q2W/Q4W and Q4W\].
* 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.
Outcome measures
| Measure |
Q2W/Q4W Ixekizumab Dosing Regimen
n=209 Participants
Participants from PsO With no Active PsA arm and Active PsA arm with moderate to severe plaque psoriasis (PsO) who received Q2W/Q4W Ixekizumab dosing regimen.
|
Q4W Ixekizumab Dosing Regimen
n=41 Participants
Participants from Active PsA arm without moderate to severe PsO who received 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
|
0 Participants
|
|
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
|
8 Participants
|
|
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
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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).
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.
Outcome measures
| Measure |
Q2W/Q4W Ixekizumab Dosing Regimen
n=150 Participants
Participants from PsO With no Active PsA arm and Active PsA arm with moderate to severe plaque psoriasis (PsO) who received Q2W/Q4W Ixekizumab dosing regimen.
|
Q4W Ixekizumab Dosing Regimen
Participants from Active PsA arm without moderate to severe PsO who received 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 outcome
Timeframe: Week 12Population: 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).
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.
Outcome measures
| Measure |
Q2W/Q4W Ixekizumab Dosing Regimen
n=150 Participants
Participants from PsO With no Active PsA arm and Active PsA arm with moderate to severe plaque psoriasis (PsO) who received Q2W/Q4W Ixekizumab dosing regimen.
|
Q4W Ixekizumab Dosing Regimen
Participants from Active PsA arm without moderate to severe PsO who received 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
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: 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.
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.
Outcome measures
| Measure |
Q2W/Q4W Ixekizumab Dosing Regimen
n=100 Participants
Participants from PsO With no Active PsA arm and Active PsA arm with moderate to severe plaque psoriasis (PsO) who received Q2W/Q4W Ixekizumab dosing regimen.
|
Q4W Ixekizumab Dosing Regimen
Participants from Active PsA arm without moderate to severe PsO who received 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
|
—
|
Adverse Events
Q2W/Q4W Ixekizumab Dosing Regimen
Serious events: 1 serious events
Other events: 66 other events
Deaths: 0 deaths
Q4W Ixekizumab Dosing Regimen
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Q2W/Q4W Ixekizumab Dosing Regimen
n=209 participants at risk
Participants from PsO with no active PsA arm and active PsA arm with moderate to severe plaque psoriasis (PsO) received Q2W/Q4W Ixekizumab dosing regimen.
|
Q4W Ixekizumab Dosing Regimen
n=41 participants at risk
Participants from Active PsA arm without moderate to severe PsO who received Q4W Ixekizumab dosing regimen.
|
|---|---|---|
|
Infections and infestations
Gastroenteritis viral
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
Other adverse events
| Measure |
Q2W/Q4W Ixekizumab Dosing Regimen
n=209 participants at risk
Participants from PsO with no active PsA arm and active PsA arm with moderate to severe plaque psoriasis (PsO) received Q2W/Q4W Ixekizumab dosing regimen.
|
Q4W Ixekizumab Dosing Regimen
n=41 participants at risk
Participants from Active PsA arm without moderate to severe PsO who received Q4W Ixekizumab dosing regimen.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Gastrointestinal disorders
Dental caries
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
General disorders
Injection site erythema
|
1.9%
4/209 • Number of events 4 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
2.4%
1/41 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
General disorders
Pain
|
0.00%
0/209 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
2.4%
1/41 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
General disorders
Pyrexia
|
8.6%
18/209 • Number of events 18 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
2.4%
1/41 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Infections and infestations
Appendicitis
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Infections and infestations
Body tinea
|
0.96%
2/209 • Number of events 2 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Infections and infestations
Gastroenteritis
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Infections and infestations
Influenza
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Infections and infestations
Latent tuberculosis
|
8.6%
18/209 • Number of events 18 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
9.8%
4/41 • Number of events 4 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Infections and infestations
Localised infection
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
3/209 • Number of events 3 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
2.4%
1/41 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Infections and infestations
Oral candidiasis
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Infections and infestations
Pyoderma
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Infections and infestations
Tinea cruris
|
1.4%
3/209 • Number of events 3 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Infections and infestations
Typhoid fever
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Infections and infestations
Upper respiratory tract infection
|
0.96%
2/209 • Number of events 2 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
2.4%
1/41 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/209 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
4.9%
2/41 • Number of events 2 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Investigations
Alanine aminotransferase increased
|
0.96%
2/209 • Number of events 2 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Investigations
Blood creatine phosphokinase increased
|
1.4%
3/209 • Number of events 3 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Investigations
Blood triglycerides increased
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Investigations
C-reactive protein increased
|
0.00%
0/209 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
2.4%
1/41 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Investigations
Weight decreased
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Investigations
Weight increased
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.4%
3/209 • Number of events 3 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.96%
2/209 • Number of events 2 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
2.4%
1/41 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.48%
1/209 • Number of events 1 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
|
Vascular disorders
Hypertension
|
0.96%
2/209 • Number of events 2 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
0.00%
0/41 • Week 0 up to 36 Weeks
All enrolled participants who received at least 1 dose of study treatment. As per prespecified analysis in the statistical analysis plan, adverse events were reported by Ixekizumab dosing regimen \[that is, Q2W/Q4W and Q4W\].
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60