Trial Outcomes & Findings for Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines (NCT NCT05024058)

NCT ID: NCT05024058

Last Updated: 2024-06-18

Results Overview

Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width) None of the participants completed Week 12 and hence at Week 12 was not analyzed

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 39 participants
• Primary outcome timeframe: Baseline, Week 12
• Results posted on: 2024-06-18

Participant Flow

39 participants were randomized. None completed study.

There were no pre-assignment details for this study.

Participant milestones

Measure	72 mg Ligelizumab, Symptomatic Dermographism 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism	120 mg Ligelizumab, Symptomatic Dermographism 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism	Placebo - 72 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism	Placebo - 120 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism	72 mg Ligelizumab Cold Urticaria 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria	120 mg Ligelizumab, Cold Urticaria 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria	Placebo - 72 mg Ligelizumab, Cold Urticaria Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria	Placebo - 120 mg Ligelizumab, Cold Urticaria Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cold urticaria	120 mg Ligelizumab, Cholinergic Urticaria 120 mg ligelizumab subcutaneous injection every 4 weeks in participants with cholinergic urticaria	Placebo - 120 mg Ligelizumab, Cholinergic Urticaria Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria
Treatment STARTED	5	6	4	2	3	3	1	3	6	6
Treatment COMPLETED	0	0	0	0	0	0	0	0	0	0
Treatment NOT COMPLETED	5	6	4	2	3	3	1	3	6	6
Follow-up STARTED	2	5	4	0	3	2	0	2	5	6
Follow-up COMPLETED	1	5	3	0	3	2	0	1	5	5
Follow-up NOT COMPLETED	1	0	1	0	0	0	0	1	0	1

Reasons for withdrawal

Measure	72 mg Ligelizumab, Symptomatic Dermographism 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism	120 mg Ligelizumab, Symptomatic Dermographism 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism	Placebo - 72 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism	Placebo - 120 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism	72 mg Ligelizumab Cold Urticaria 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria	120 mg Ligelizumab, Cold Urticaria 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria	Placebo - 72 mg Ligelizumab, Cold Urticaria Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria	Placebo - 120 mg Ligelizumab, Cold Urticaria Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cold urticaria	120 mg Ligelizumab, Cholinergic Urticaria 120 mg ligelizumab subcutaneous injection every 4 weeks in participants with cholinergic urticaria	Placebo - 120 mg Ligelizumab, Cholinergic Urticaria Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria
Treatment Study terminated by sponsor	5	6	4	2	3	3	1	3	6	6
Follow-up Withdrawal by Subject	1	0	1	0	0	0	0	1	0	1

Baseline Characteristics

Study of Efficacy and Safety of Ligelizumab in Adolescents and Adults With Chronic Inducible Urticaria Who Remain Symptomatic Despite Treatment With H1- Antihistamines

Baseline characteristics by cohort

Measure	72 mg Ligelizumab, Symptomatic Dermographism n=5 Participants 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism	120 mg Ligelizumab, Symptomatic Dermographism n=6 Participants 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism	Placebo - 72 mg Ligelizumab, Symptomatic Dermographism n=4 Participants Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism	Placebo - 120 mg Ligelizumab, Symptomatic Dermographism n=2 Participants Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism	72 mg Ligelizumab Cold Urticaria n=3 Participants 72 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria	120 mg Ligelizumab, Cold Urticaria n=3 Participants 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with cold urticaria	Placebo - 72 mg Ligelizumab, Cold Urticaria n=1 Participants Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria	Placebo - 120 mg Ligelizumab, Cold Urticaria n=3 Participants Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with cold urticaria	120 mg Ligelizumab, Cholinergic Urticaria n=6 Participants 120 mg ligelizumab subcutaneous injection every 4 weeks in participants with cholinergic urticaria	Placebo - 120 mg Ligelizumab, Cholinergic Urticaria n=6 Participants Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with cholinergic urticaria	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	5 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	6 Participants n=42 Participants	6 Participants n=42 Participants	34 Participants n=42 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Continuous	30.4 years STANDARD_DEVIATION 9.81 • n=5 Participants	28.3 years STANDARD_DEVIATION 12.74 • n=7 Participants	40.8 years STANDARD_DEVIATION 18.86 • n=5 Participants	36.5 years STANDARD_DEVIATION 12.02 • n=4 Participants	35.3 years STANDARD_DEVIATION 12.50 • n=21 Participants	31.7 years STANDARD_DEVIATION 16.17 • n=8 Participants	60.0 years STANDARD_DEVIATION NA • n=8 Participants	32.3 years STANDARD_DEVIATION 26.58 • n=24 Participants	28.8 years STANDARD_DEVIATION 9.62 • n=42 Participants	25.2 years STANDARD_DEVIATION 5.56 • n=42 Participants	27.0 years STANDARD_DEVIATION 7.73 • n=42 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	19 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	4 Participants n=42 Participants	6 Participants n=42 Participants	20 Participants n=42 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	36 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The Randomized Analysis Set (RAN) consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.

Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width)

None of the participants completed Week 12 and hence at Week 12 was not analyzed

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.

The TempTest is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms.

Outcome measures

Measure	72 mg Ligelizumab, Symptomatic Dermographism n=1 Participants 72 mg ligelizumab subcutaneous injection every 4 weeks in participants with symptomatic dermographism	120 mg Ligelizumab, Symptomatic Dermographism n=1 Participants 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism	Placebo - 72 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism	Placebo -120 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism
Change From Baseline in Critical Temperature Threshold in Participants With Cold Urticaria	-26 Temperature (degrees celcius)	-15 Temperature (degrees celcius)	—	—

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.

Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement.

Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")

Outcome measures

Measure	72 mg Ligelizumab, Symptomatic Dermographism n=1 Participants 72 mg ligelizumab subcutaneous injection every 4 weeks in participants with symptomatic dermographism	120 mg Ligelizumab, Symptomatic Dermographism 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism	Placebo - 72 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism	Placebo -120 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism
Change From Baseline in Itch Numerical Rating Scale in Participants With Cholinergic Urticaria	-7 Scores on a scale	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.

Total Fric score (a scale of 0-4 where 0= no linear hive ≥ 3mm in width, 1= one linear hive ≥ 3mm in width, 2= two linear hives ≥ 3mm in width, 3= three linear hives ≥ 3mm in width and 4 = four linear hives ≥ 3mm in width)

None of the participants completed Week 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. No participants completed week 12.

Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement.

Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.

The TempTest® is used to induce itch and hives in participants with cold urticaria. Critical temperature threshold (CTT), as measured by the TempTest, determines the highest temperature sufficient for inducing symptoms.

Outcome measures

Measure	72 mg Ligelizumab, Symptomatic Dermographism n=1 Participants 72 mg ligelizumab subcutaneous injection every 4 weeks in participants with symptomatic dermographism	120 mg Ligelizumab, Symptomatic Dermographism n=1 Participants 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism	Placebo - 72 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism	Placebo -120 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism
Proportion of Participants With Cold Urticaria With Complete Response (no Itch or Hives) to the TempTest	1 Proportion of participants	0 Proportion of participants	—	—

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.

Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement.

Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")

Outcome measures

Measure	72 mg Ligelizumab, Symptomatic Dermographism n=1 Participants 72 mg ligelizumab subcutaneous injection every 4 weeks in participants with symptomatic dermographism	120 mg Ligelizumab, Symptomatic Dermographism n=1 Participants 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism	Placebo - 72 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism	Placebo -120 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism
Change From Baseline in Itch Numerical Rating Scale in Participants With Cold Urticaria	-9 Scores on a scale	0 Scores on a scale	—	—

SECONDARY outcome

Timeframe: Week 12

Population: RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.

Itch numerical rating scale, a scale from 0 to 10. Negative change from baseline indicates improvement.

Patients were asked to rate itching severity based on the worst level of itching in the past 24 h using an 11-point scale from 0 ("no itch") to 10 ("worst possible itch")

Outcome measures

Measure	72 mg Ligelizumab, Symptomatic Dermographism n=1 Participants 72 mg ligelizumab subcutaneous injection every 4 weeks in participants with symptomatic dermographism	120 mg Ligelizumab, Symptomatic Dermographism n=1 Participants 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism	Placebo - 72 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism	Placebo -120 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism
Proportion of Participants With Cholinergic Urticaria With Itch Numerical Rating Scale =0	0 Proportion of participants	0 Proportion of participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: RAN consisted of all randomized participants, regardless of whether or not they received a dose of drug. Participants were analyzed according to the treatment they were assigned. Due to the limited number of participants who completed the primary endpoint timepoint (Week 12), no inferential statistical analysis was done for primary and secondary endpoints.

Physician global assessment of severity of hives

PGA is an assessment of all lesions scored on a scale from 0-5 (with 0 = No hives and 5 = Very severe hives)

Outcome measures

Measure	72 mg Ligelizumab, Symptomatic Dermographism n=1 Participants 72 mg ligelizumab subcutaneous injection every 4 weeks in participants with symptomatic dermographism	120 mg Ligelizumab, Symptomatic Dermographism 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic dermographism	Placebo - 72 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism	Placebo -120 mg Ligelizumab, Symptomatic Dermographism Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism
Proportion of Participants With Cholinergic Urticaria With Physician Global Assessment of Severity of Hives (PGA - Hive Score) =0	0 Proportion of participants	—	—	—

Adverse Events

Ligelizumab 72mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Ligelizumab 120mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo - Ligelizumab 72mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo - Ligelizumab 120mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Total

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ligelizumab 72mg n=8 participants at risk 72 mg ligelizumab subcutaneous injection every 4 weeks in participants with symptomatic dermographism	Ligelizumab 120mg n=15 participants at risk symptomatic dermographism 120 mg ligelizumab subcutaneous injections every 4 weeks in participants with symptomatic	Placebo - Ligelizumab 72mg n=5 participants at risk symptomatic dermographism Placebo every 4 weeks until week 12 followed by 72 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism	Placebo - Ligelizumab 120mg n=11 participants at risk symptomatic dermographism Placebo every 4 weeks until week 12 followed by 120 mg ligelizumab subcutaneous injections in participants with symptomatic dermographism	Total n=39 participants at risk Total number of participants who participated in the trial
Ear and labyrinth disorders Vertigo	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	6.7% 1/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Cardiac disorders Bradycardia	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	20.0% 1/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Ear and labyrinth disorders Tinnitus	12.5% 1/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Endocrine disorders Hypopituitarism	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	6.7% 1/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	6.7% 1/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Gastrointestinal disorders Nausea	12.5% 1/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Infections and infestations COVID-19	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	6.7% 1/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Infections and infestations Herpes simplex	12.5% 1/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Infections and infestations Influenza	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	6.7% 1/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Infections and infestations Nasopharyngitis	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	13.3% 2/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	5.1% 2/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Infections and infestations Peritonsillar abscess	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	20.0% 1/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Infections and infestations Post-acute COVID-19 syndrome	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	6.7% 1/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Infections and infestations Respiratory tract infection	12.5% 1/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	6.7% 1/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Infections and infestations Urinary tract infection	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	6.7% 1/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	6.7% 1/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	6.7% 1/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	6.7% 1/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	20.0% 1/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Musculoskeletal and connective tissue disorders Groin pain	12.5% 1/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Musculoskeletal and connective tissue disorders Muscle spasms	12.5% 1/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	6.7% 1/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Nervous system disorders Headache	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	20.0% 1/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Nervous system disorders Migraine	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	9.1% 1/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Nervous system disorders Tension headache	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	6.7% 1/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/8 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	6.7% 1/15 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/5 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	0.00% 0/11 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.	2.6% 1/39 • Adverse Events (AEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). Treatment period was 24 weeks. Serious Adverse Events (SAEs) were collected after signature of the informed consent form until 16 weeks from last dose (12 weeks from end of treatment). AEs are any sign or symptom that occurs during conduct of trial and safety follow-up. AEs were reported per intervention and not combined. All AEs reported during Placebo-Ligelizumab 72mg and Placebo-Ligelizumab 120 mg occurred in placebo duration.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: (862) 778-8300

Email: novartis.email@novartis.com

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