Trial Outcomes & Findings for Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis (NCT NCT03668613)

Last Updated: 2025-05-16

Results Overview

Psoriasis Area and Severity Index (PASI):Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs and lower limbs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, Erythema,Thickening (plaque elevation, induration) \& Scaling(desquamation). Scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section(head: 0.1, upper limbs: 0.2 body: 0.3 lower limbs: 0.4). Psoriasis Area and Severity Index (PASI) will be assessed/calculated as per standard procedure. PASI 75 represents the percentage (or number)of patients who have achieved a 75% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

84 participants

Primary outcome timeframe

Week 12

Results posted on

2025-05-16

Participant Flow

A total of 92 subjects were screened of which 84 subjects completed the screening phase and were randomized to the Secukinumab Low dose and High dose groups in a 1:1 ratio.

Participant milestones

Participant milestones
Measure	AIN457 Low Dose Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 50kg) or 150 mg (if weighing \>= 50kg)	AIN457 High Dose Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 25kg) or 150mg (if weighing 25 to \< 50kg) or 300 mg (if weighing \>=50 kg)
Overall Study STARTED	42	42
Overall Study COMPLETED	31	36
Overall Study NOT COMPLETED	11	6

Reasons for withdrawal

Reasons for withdrawal
Measure	AIN457 Low Dose Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 50kg) or 150 mg (if weighing \>= 50kg)	AIN457 High Dose Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 25kg) or 150mg (if weighing 25 to \< 50kg) or 300 mg (if weighing \>=50 kg)
Overall Study Adverse Event	1	2
Overall Study Lack of Efficacy	5	1
Overall Study Pregnancy	0	2
Overall Study Protocol Violation	1	0
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	2	1
Overall Study Guardian decision	1	0

Baseline Characteristics

Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AIN457 Low Dose n=42 Participants Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 50kg) or 150 mg (if weighing \>= 50kg)	AIN457 High Dose n=42 Participants Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 25kg) or 150mg (if weighing 25 to \< 50kg) or 300 mg (if weighing \>=50 kg)	Total n=84 Participants Total of all reporting groups
Age, Customized 6 to <12 years	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Age, Customized 12 to <18 years	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	25 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Race/Ethnicity, Customized White	39 Participants n=5 Participants	38 Participants n=7 Participants	77 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full Analysis Set: The FAS comprised all patients from the randomized set to whom study treatment had been assigned

Outcome measures

Outcome measures
Measure	AIN457 Low Dose n=42 Participants Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 50kg) or 150 mg (if weighing \>= 50kg)	AIN457 High Dose n=42 Participants Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 25kg) or 150mg (if weighing 25 to \< 50kg) or 300 mg (if weighing \>=50 kg)
Number and Percentage of Participants With PASI 75 Response	39 Participants	39 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full Analysis Set: The FAS comprised all patients from the randomized set to whom study treatment had been assigned

Investigator will assess the disease using the validated Investigator Global Assessment (IGA) mod 2011 and rate the disease from a score of 0 (clear skin) to 4 (severe disease)

Outcome measures

Outcome measures
Measure	AIN457 Low Dose n=42 Participants Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 50kg) or 150 mg (if weighing \>= 50kg)	AIN457 High Dose n=42 Participants Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 25kg) or 150mg (if weighing 25 to \< 50kg) or 300 mg (if weighing \>=50 kg)
Number and Percentage of Participants With IGA Mod 2011 0 or 1 Response	33 Participants	35 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set: The FAS comprised all patients from the randomized set to whom study treatment had been assigned

Psoriasis Area and Severity Index (PASI) was assessed/calculated as per the standard procedure. PASI 90 represents the percentage (or number) of patients who have achieved a 90% or more reduction in their PASI score from baseline. PASI 100 indicates patients who have achieved a complete resolution of all disease.

Outcome measures

Outcome measures
Measure	AIN457 Low Dose n=42 Participants Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 50kg) or 150 mg (if weighing \>= 50kg)	AIN457 High Dose n=42 Participants Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 25kg) or 150mg (if weighing 25 to \< 50kg) or 300 mg (if weighing \>=50 kg)
Number and Percentage of Participants With PASI 90 Response	29 Participants	32 Participants

SECONDARY outcome

Timeframe: Baleine, Weeks 4, 12, 13, 14, 15, 16, 24, 52, 104, 156, 208

Population: Full analysis set

Mean (Standard Deviation) Secukinumab concentration levels in serum over time.

Outcome measures

Outcome measures
Measure	AIN457 Low Dose n=42 Participants Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 50kg) or 150 mg (if weighing \>= 50kg)	AIN457 High Dose n=42 Participants Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 25kg) or 150mg (if weighing 25 to \< 50kg) or 300 mg (if weighing \>=50 kg)
Secukinumab Concentration in Serum Baseline	0.00 mcg/mL Standard Deviation 0.00	0.00 mcg/mL Standard Deviation 0.00
Secukinumab Concentration in Serum Week 4 (n=40,40)	74.2 mcg/mL Standard Deviation 33.0	135 mcg/mL Standard Deviation 45.3
Secukinumab Concentration in Serum Week 12 (n=40, 39)	34.8 mcg/mL Standard Deviation 10.9	69.6 mcg/mL Standard Deviation 29.2
Secukinumab Concentration in Serum Week 13 (n=38,33)	47.1 mcg/mL Standard Deviation 17.4	91.2 mcg/mL Standard Deviation 34.1
Secukinumab Concentration in Serum Week 14 (n=40, 39)	40.9 mcg/mL Standard Deviation 15.5	78.4 mcg/mL Standard Deviation 29.8
Secukinumab Concentration in Serum Week 15 (n=38,35)	34.6 mcg/mL Standard Deviation 12.4	65.7 mcg/mL Standard Deviation 28.9
Secukinumab Concentration in Serum Week 16 (n=40,37)	30.9 mcg/mL Standard Deviation 11.2	55.2 mcg/mL Standard Deviation 24.9
Secukinumab Concentration in Serum Week 24 (n=42, 38)	26.0 mcg/mL Standard Deviation 10.8	48.0 mcg/mL Standard Deviation 21.4
Secukinumab Concentration in Serum Week 52 (n=37,38)	25.0 mcg/mL Standard Deviation 9.01	42.7 mcg/mL Standard Deviation 17.0
Secukinumab Concentration in Serum Week 104 (n=39,33)	21.9 mcg/mL Standard Deviation 10.8	39.3 mcg/mL Standard Deviation 12.1
Secukinumab Concentration in Serum Week 156 (n=34,32)	19.3 mcg/mL Standard Deviation 8.68	35.0 mcg/mL Standard Deviation 14.1
Secukinumab Concentration in Serum Week 208 (n=25,28)	16.7 mcg/mL Standard Deviation 6.25	38.8 mcg/mL Standard Deviation 17.2

SECONDARY outcome

Timeframe: Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks.

Population: Safety set

An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.

Outcome measures

Outcome measures
Measure	AIN457 Low Dose n=42 Participants Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 50kg) or 150 mg (if weighing \>= 50kg)	AIN457 High Dose n=42 Participants Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 25kg) or 150mg (if weighing 25 to \< 50kg) or 300 mg (if weighing \>=50 kg)
Summary Table of Adverse Events Subjects with any AE(s)	33 Participants	35 Participants
Summary Table of Adverse Events Subjects with serious or other significant events - Death	0 Participants	0 Participants
Summary Table of Adverse Events Subjects with serious or other significant events - Non-fatal SAE(s)	4 Participants	2 Participants
Summary Table of Adverse Events Subjects with serious or other significant events - Discontinued study treatment due to any AE(s)	1 Participants	2 Participants

Adverse Events

AIN457 Low Dose

Serious events: 4 serious events

Other events: 30 other events

Deaths: 0 deaths

AIN457 High Dose

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AIN457 Low Dose n=42 participants at risk Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 50kg) or 150 mg (if weighing \>= 50kg)	AIN457 High Dose n=42 participants at risk Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 25kg) or 150mg (if weighing 25 to \< 50kg) or 300 mg (if weighing \>=50 kg)
Gastrointestinal disorders Crohn's disease	2.4% 1/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	0.00% 0/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Infections and infestations Appendicitis	0.00% 0/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	2.4% 1/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Infections and infestations COVID-19	2.4% 1/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	0.00% 0/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Infections and infestations Infectious mononucleosis	2.4% 1/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	0.00% 0/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Infections and infestations Tonsillitis	0.00% 0/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	2.4% 1/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Injury, poisoning and procedural complications Tibia fracture	2.4% 1/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	0.00% 0/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Psychiatric disorders Intentional self-injury	2.4% 1/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	0.00% 0/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

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 (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	AIN457 Low Dose n=42 participants at risk Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 50kg) or 150 mg (if weighing \>= 50kg)	AIN457 High Dose n=42 participants at risk Subcutaneous (s.c.) secukinumab injections at randomization and weekly until Week 4, thereafter every 4 weeks until Wk 204. Patients received secukinumab 75 mg (if weighing \< 25kg) or 150mg (if weighing 25 to \< 50kg) or 300 mg (if weighing \>=50 kg)
Blood and lymphatic system disorders Leukopenia	7.1% 3/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	2.4% 1/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Blood and lymphatic system disorders Neutropenia	7.1% 3/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	2.4% 1/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Gastrointestinal disorders Abdominal pain	9.5% 4/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	4.8% 2/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Gastrointestinal disorders Diarrhoea	4.8% 2/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	7.1% 3/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Gastrointestinal disorders Vomiting	7.1% 3/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	4.8% 2/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
General disorders Pyrexia	14.3% 6/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	2.4% 1/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Infections and infestations COVID-19	26.2% 11/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	21.4% 9/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Infections and infestations Influenza	7.1% 3/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	2.4% 1/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Infections and infestations Nasopharyngitis	31.0% 13/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	16.7% 7/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Infections and infestations Rhinitis	2.4% 1/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	7.1% 3/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Infections and infestations Tonsillitis	4.8% 2/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	9.5% 4/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	14.3% 6/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Infections and infestations Viral upper respiratory tract infection	2.4% 1/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	16.7% 7/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 3/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	2.4% 1/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Nervous system disorders Headache	7.1% 3/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	4.8% 2/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Skin and subcutaneous tissue disorders Acne	16.7% 7/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	4.8% 2/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.
Skin and subcutaneous tissue disorders Eczema	9.5% 4/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.	0.00% 0/42 • Adverse events are reported from the first dose of study-drug until the end of the treatment period (at Week 208) plus 16 weeks additional follow up reporting, for a maximum timeframe of approximately 224 weeks. Treatment emergent adverse events in this study are events that started after the first dose of study treatment and until 84 days after the last study treatment, or events present prior to the first dose of treatment which increased in severity based on preferred term within 84 days after the last study treatment.