Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) (NCT NCT04501666)

Last Updated: 2024-07-10

Results Overview

The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as the average of 7 consecutive days of data up to the target study day (excluding) and set to missing if less than 4 days of data are available. Analysis window extension was applied to both timepoints, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

286 participants

Primary outcome timeframe

Baseline, Week 16

Results posted on

2024-07-10

Participant Flow

The study was conducted at 77 sites in 10 countries.

A total of 286 participants were randomized to receive either nemolizumab (CD14152) or placebo.

Participant milestones

Participant milestones
Measure	Nemolizumab Participants weighing less than (\<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Participants weighing greater than or equal to (\>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo Participants weighing \< 90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>= 90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Overall Study STARTED	190	96
Overall Study Treated	187	95
Overall Study COMPLETED	166	83
Overall Study NOT COMPLETED	24	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Nemolizumab Participants weighing less than (\<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Participants weighing greater than or equal to (\>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo Participants weighing \< 90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>= 90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Overall Study Physician Decision	0	1
Overall Study Adverse Event	12	4
Overall Study Subject's request	10	6
Overall Study Protocol Deviation	2	1
Overall Study Other-- site permanently closing	0	1

Baseline Characteristics

Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nemolizumab n=190 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=96 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.	Total n=286 Participants Total of all reporting groups
Age, Continuous	57.5 years STANDARD_DEVIATION 12.77 • n=5 Participants	57.6 years STANDARD_DEVIATION 13.36 • n=7 Participants	57.5 years STANDARD_DEVIATION 12.95 • n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants	56 Participants n=7 Participants	166 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	40 Participants n=7 Participants	120 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	184 Participants n=5 Participants	88 Participants n=7 Participants	272 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	18 Participants n=5 Participants	10 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized White	160 Participants n=5 Participants	81 Participants n=7 Participants	241 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Others	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Europe	141 participants n=5 Participants	71 participants n=7 Participants	212 participants n=5 Participants
Region of Enrollment North America	49 participants n=5 Participants	25 participants n=7 Participants	74 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: ITT population included all randomized participants.

Outcome measures

Outcome measures
Measure	Nemolizumab n=190 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=96 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16	111 Participants	16 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: ITT population included all randomized participants.

IGA success is defined as clear (0) or almost clear (1), and a reduction from baseline of greater than or equal to 2 points at week 16. Full scale is scored from 0-4, higher score indicates more severe symptoms. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.

Outcome measures

Outcome measures
Measure	Nemolizumab n=190 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=96 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16	50 Participants	7 Participants

SECONDARY outcome

Timeframe: From Baseline up to end of treatment period (24 weeks)

Population: Safety population included all randomized participants who received at least 1 administration of study drug.

AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs occurring after the first administration of the study drug until the last study visit. SAE was any untoward medical occurrence, in the view of either the Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. AESI was a noteworthy TEAE for the study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. Analysis was performed on safety population which included all randomised participants who received at least 1 administration of study drug.

Outcome measures

Outcome measures
Measure	Nemolizumab n=187 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=95 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) TEAEs	134 Participants	62 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) AESIs	32 Participants	18 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs) SAEs	16 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: ITT population included all randomized participants.

The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to baseline, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.

Outcome measures

Outcome measures
Measure	Nemolizumab n=190 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=96 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4	78 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 16

Population: ITT population included all randomized participants.

The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to week 16, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.

Outcome measures

Outcome measures
Measure	Nemolizumab n=190 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=96 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With PP NRS < 2 at Week 16	65 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: ITT population included all randomized participants.

The SD NRS is a scale to report the degree of participant sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to 10) during the 7 days up to the treatment start (including until treatment start time). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to both timepoints, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.

Outcome measures

Outcome measures
Measure	Nemolizumab n=190 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=96 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16	95 Participants	11 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: ITT population included all randomized participants.

SD NRS is a scale to be used by the participants to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to10) during the 7 days up to the treatment start (including until treatment start time). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to baseline, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responde

Outcome measures

Outcome measures
Measure	Nemolizumab n=190 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=96 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4	59 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 4

Population: ITT population included all randomized participants.

The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to baseline, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.

Outcome measures

Outcome measures
Measure	Nemolizumab n=190 Participants Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=96 Participants Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Number of Participants With PP NRS < 2 at Week 4	41 Participants	1 Participants

Adverse Events

Nemolizumab

Serious events: 16 serious events

Other events: 61 other events

Deaths: 0 deaths

Placebo

Serious events: 10 serious events

Other events: 38 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Nemolizumab n=187 participants at risk Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=95 participants at risk Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Nervous system disorders Headache	7.0% 13/187 • Number of events 16 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	2.1% 2/95 • Number of events 2 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Respiratory, thoracic and mediastinal disorders Cough	4.8% 9/187 • Number of events 11 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	5.3% 5/95 • Number of events 6 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Skin and subcutaneous tissue disorders Neurodermatitis	8.0% 15/187 • Number of events 17 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	18.9% 18/95 • Number of events 21 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Skin and subcutaneous tissue disorders Eczema	5.3% 10/187 • Number of events 10 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	1.1% 1/95 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Infections and infestations COVID-19	7.5% 14/187 • Number of events 14 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	14.7% 14/95 • Number of events 14 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Infections and infestations Nasopharyngitis	5.9% 11/187 • Number of events 12 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	8.4% 8/95 • Number of events 8 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.2% 6/187 • Number of events 12 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	5.3% 5/95 • Number of events 5 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.

Additional Information

Clinical Operations

Galderma

Phone: 817 961 5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Nemolizumab n=187 participants at risk Participants weighing \<90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Placebo n=95 participants at risk Participants weighing \<90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing \>=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	0.00% 0/95 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	0.00% 0/95 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
General disorders Oedema peripheral	0.00% 0/187 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	1.1% 1/95 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.00% 0/187 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	1.1% 1/95 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Psychiatric disorders Depressed mood	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	0.00% 0/95 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Psychiatric disorders Panic disorder	0.00% 0/187 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	1.1% 1/95 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Injury, poisoning and procedural complications Subdural haemorrhage	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	0.00% 0/95 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/187 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	1.1% 1/95 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Cardiac disorders Acute myocardial infarction	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	0.00% 0/95 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Cardiac disorders Coronary artery disease	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	0.00% 0/95 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Cardiac disorders Cardiac sarcoidosis	0.00% 0/187 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	1.1% 1/95 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Cardiac disorders Cardiogenic shock	0.00% 0/187 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	1.1% 1/95 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Nervous system disorders Arachnoid cyst	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	0.00% 0/95 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Nervous system disorders Tension headache	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	0.00% 0/95 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Hepatobiliary disorders Cholecystitis acute	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	0.00% 0/95 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Skin and subcutaneous tissue disorders Neurodermatitis	1.6% 3/187 • Number of events 3 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	2.1% 2/95 • Number of events 2 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Skin and subcutaneous tissue disorders Pemphigoid	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	0.00% 0/95 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	0.00% 0/95 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Infections and infestations Acarodermatitis	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	0.00% 0/95 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Infections and infestations Campylobacter colitis	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	0.00% 0/95 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Infections and infestations Cellulitis	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	1.1% 1/95 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Infections and infestations Urinary tract infection	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	0.00% 0/95 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Infections and infestations COVID-19 pneumonia	0.00% 0/187 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	1.1% 1/95 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.53% 1/187 • Number of events 1 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.	0.00% 0/95 • Baseline up to end of treatment period (24 weeks) Safety population included all randomized participants who received at least 1 administration of study drug.