Trial Outcomes & Findings for Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis (NCT NCT03020199)
NCT ID: NCT03020199
Last Updated: 2025-01-28
Results Overview
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of Body Surface Area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 90 response is a binary measure defined as at least a 90% improvement in PASI score at Week 52, relative to baseline PASI score.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
196 participants
Primary outcome timeframe
Baseline, Week 52
Results posted on
2025-01-28
Participant Flow
Subjects were enrolled in 2 study sites in Argentina, 4 in Bulgaria, 2 in Canada, 4 in Germany, 1 in Denmark, 3 in Estonia, 2 in Finland, 2 in Hungary, 6 in Poland, 8 in Spain, 2 in Sweden, 1 in Switzerland, and 4 in the United Kingdom.
Participant milestones
| Measure |
Secukinumab 300 mg
Eligible patients received 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks) OR every 4 weeks until Week 100 inclusive (last dose administered at Week 100) (treatment duration = 104 weeks).
|
Narrow-band Ultraviolet B (Nb-UVB)
Eligible patients received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks).
|
|---|---|---|
|
Treatment Period
STARTED
|
116
|
80
|
|
Treatment Period
Modified Full Analysis Set (mFAS)
|
77
|
76
|
|
Treatment Period
Subjects Not Treated
|
3
|
4
|
|
Treatment Period
Main Study
|
80
|
80
|
|
Treatment Period
Mechanistic Sub-study
|
36
|
0
|
|
Treatment Period
COMPLETED
|
103
|
46
|
|
Treatment Period
NOT COMPLETED
|
13
|
34
|
|
Follow-up Period
STARTED
|
73
|
39
|
|
Follow-up Period
Main Study
|
67
|
39
|
|
Follow-up Period
Mechanistic Sub-study
|
6
|
0
|
|
Follow-up Period
COMPLETED
|
13
|
8
|
|
Follow-up Period
NOT COMPLETED
|
60
|
31
|
Reasons for withdrawal
| Measure |
Secukinumab 300 mg
Eligible patients received 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks) OR every 4 weeks until Week 100 inclusive (last dose administered at Week 100) (treatment duration = 104 weeks).
|
Narrow-band Ultraviolet B (Nb-UVB)
Eligible patients received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks).
|
|---|---|---|
|
Treatment Period
Adverse Event
|
0
|
2
|
|
Treatment Period
Lack of Efficacy
|
1
|
6
|
|
Treatment Period
Lost to Follow-up
|
1
|
6
|
|
Treatment Period
Physician Decision
|
0
|
1
|
|
Treatment Period
Subject/guardian decision
|
8
|
15
|
|
Treatment Period
Subjects not treated
|
3
|
4
|
|
Follow-up Period
Disease relapse
|
32
|
7
|
|
Follow-up Period
Lack of Efficacy
|
1
|
2
|
|
Follow-up Period
Lost to Follow-up
|
4
|
6
|
|
Follow-up Period
Physician Decision
|
2
|
2
|
|
Follow-up Period
Protocol Violation
|
1
|
2
|
|
Follow-up Period
Study terminated by Sponsor
|
6
|
3
|
|
Follow-up Period
Subject/guardian decision
|
14
|
9
|
Baseline Characteristics
Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Narrow-band Ultraviolet B (Nb-UVB)
n=80 Participants
Eligible patients received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks).
|
Total
n=196 Participants
Total of all reporting groups
|
Secukinumab 300 mg
n=116 Participants
Eligible patients received 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks) OR every 4 weeks until Week 100 inclusive (last dose administered at Week 100) (treatment duration = 104 weeks).
|
|---|---|---|---|
|
Age, Customized
18 to 30 years
|
30 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
56 Participants
n=5 Participants
|
|
Age, Customized
31 to 50 years
|
50 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
81 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
72 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
113 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 52Population: Modified Full Analysis Set (mFAS) from the Main Study: all randomized subjects who received at least one dose of study treatment during the Treatment Period
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of Body Surface Area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 90 response is a binary measure defined as at least a 90% improvement in PASI score at Week 52, relative to baseline PASI score.
Outcome measures
| Measure |
Secukinumab 300 mg A1 (A1a+A1b)
n=77 Participants
80 patients (68 in Arm A1a and 12 in Arm A1b) with new-onset psoriasis will receive 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks).
|
Narrow-band Ultraviolet B (Nb-UVB) B1 (B1a+B1b)
n=76 Participants
80 patients (68 in Arm B1a and 12 in Arm B1b) with new-onset psoriasis received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks).
|
|---|---|---|
|
Number of Participants Who Achieved Pain Assessment Severity Index (PASI) 90 at Week 52.
|
70 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Modified Full Analysis Set (mFAS) from the Main Study: all randomized subjects who received at least one dose of study treatment during the Treatment Period
The PASI quantifies the severity of a participant's psoriasis based on both "lesion severity" and the "percent of Body Surface Area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI composite score varies in increments of 0.1 and range from 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. PASI 90 response is a binary measure defined as at least a 90% improvement in PASI score at Week 104, relative to baseline PASI score.
Outcome measures
| Measure |
Secukinumab 300 mg A1 (A1a+A1b)
n=77 Participants
80 patients (68 in Arm A1a and 12 in Arm A1b) with new-onset psoriasis will receive 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks).
|
Narrow-band Ultraviolet B (Nb-UVB) B1 (B1a+B1b)
n=76 Participants
80 patients (68 in Arm B1a and 12 in Arm B1b) with new-onset psoriasis received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks).
|
|---|---|---|
|
Number of Participants Who Achieved PASI 90 at Week 104
|
23 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Modified Full Analysis Set (mFAS) from the Main Study: all randomized subjects who received at least one dose of study treatment during the Treatment Period
Investigators assessed the disease using the validated Investigator Global Assessment (IGA) mod 2011 and rated the disease from a score of 0 (clear skin) to 4 (severe disease). Response is defined as a score of 0 or 1 at Week 52.
Outcome measures
| Measure |
Secukinumab 300 mg A1 (A1a+A1b)
n=77 Participants
80 patients (68 in Arm A1a and 12 in Arm A1b) with new-onset psoriasis will receive 300 mg secukinumab by subcutaneous (s.c.) injection at baseline, Weeks 1, 2, 3, 4 and then every 4 weeks until Week 48 inclusive (treatment duration = 52 weeks).
|
Narrow-band Ultraviolet B (Nb-UVB) B1 (B1a+B1b)
n=76 Participants
80 patients (68 in Arm B1a and 12 in Arm B1b) with new-onset psoriasis received 1 or 2 cycles of narrow-band ultraviolet B (nb-UVB) of 12 weeks each with a maximum break of 28 weeks between cycles (patients with PASI 90 at Week 40 will not receive a second treatment cycle) (treatment duration = 52 weeks).
|
|---|---|---|
|
Number of Participants With IGA Mod 2011 0/1 Response at Week 52
|
85.7 Percentage of participants
Interval 75.5 to 92.3
|
36.8 Percentage of participants
Interval 26.3 to 48.7
|
Adverse Events
Secukinumab 300 mg - On Treatment
Serious events: 6 serious events
Other events: 29 other events
Deaths: 0 deaths
Narrow-band Ultraviolet B (Nb-UVB) - On Treatment
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Secukinumab 300 mg - Post Treatment Follow-up
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Narrow-band Ultraviolet B (Nb-UVB) - Post Treatment Follow-up
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Secukinumab 300 mg - On Treatment
n=112 participants at risk
AEs during on-treatment period (up to 84 days post-treatment)
|
Narrow-band Ultraviolet B (Nb-UVB) - On Treatment
n=76 participants at risk
AEs during on-treatment period (up to 84 days post-treatment)
|
Secukinumab 300 mg - Post Treatment Follow-up
n=88 participants at risk
AEs during follow-up period (starting from 85 days post-treatment)
|
Narrow-band Ultraviolet B (Nb-UVB) - Post Treatment Follow-up
n=76 participants at risk
AEs during follow-up period (starting from 85 days post-treatment)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/112 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/88 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
1.3%
1/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.89%
1/112 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/88 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.89%
1/112 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/88 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.89%
1/112 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/88 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.89%
1/112 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/88 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
|
Psychiatric disorders
Acute stress disorder
|
0.89%
1/112 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/88 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.89%
1/112 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/88 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/112 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
1.3%
1/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/88 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
Other adverse events
| Measure |
Secukinumab 300 mg - On Treatment
n=112 participants at risk
AEs during on-treatment period (up to 84 days post-treatment)
|
Narrow-band Ultraviolet B (Nb-UVB) - On Treatment
n=76 participants at risk
AEs during on-treatment period (up to 84 days post-treatment)
|
Secukinumab 300 mg - Post Treatment Follow-up
n=88 participants at risk
AEs during follow-up period (starting from 85 days post-treatment)
|
Narrow-band Ultraviolet B (Nb-UVB) - Post Treatment Follow-up
n=76 participants at risk
AEs during follow-up period (starting from 85 days post-treatment)
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.8%
11/112 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
6.6%
5/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
3.4%
3/88 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
1.3%
1/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
8/112 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
2.6%
2/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/88 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
2.6%
2/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
7/112 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
5.7%
5/88 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
1.3%
1/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
|
Nervous system disorders
Headache
|
9.8%
11/112 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
1.3%
1/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
1.1%
1/88 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
0.00%
0/76 • On-treatment adverse events were collected from first dose of study treatment to 84 days after last dose of study medication (on-treatment), up to approximately 104 weeks. Evaluation of AEs and SAEs were repeated after dosing with study treatment (starting 85 days after last dose of treatment) until study termination notification.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The safety analysis were done for the Main Study and Mechanistic Sub-study in the safety population, which included all randomized subjects who received at least one dose of study medication. Patients were analyzed according to the actual treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER