Trial Outcomes & Findings for A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants (NCT NCT04316585)

Last Updated: 2024-03-18

Results Overview

The Psoriasis area severity index (PASI) is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, induration, and scaling (each scored separately), and the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6= ≥ 90% skin with psoriasis). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. The PASI is a composite scoring assessed by the investigator for the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Note: The 95% credible interval (CrI) was reported as a method of dispersion.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

29 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2024-03-18

Participant Flow

A total of 39 participants were screened, of which 29 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	GSK2982772 960 mg Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Overall Study STARTED	19	10
Overall Study COMPLETED	13	5
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK2982772 960 mg Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Overall Study Adverse Event	2	1
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	2	3
Overall Study SUBJECT REACHED PROTOCOL-DEFINED STOPPING CRITERIA	0	1
Overall Study INVESTIGATOR DISCRETION	1	0

Baseline Characteristics

A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK2982772 960 mg n=19 Participants Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo n=10 Participants Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.	Total n=29 Participants Total of all reporting groups
Age, Continuous	50.1 YEARS STANDARD_DEVIATION 15.97 • n=93 Participants	46.5 YEARS STANDARD_DEVIATION 12.52 • n=4 Participants	48.8 YEARS STANDARD_DEVIATION 14.74 • n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	5 Participants n=4 Participants	21 Participants n=27 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Mixed White race	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Mixed race	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	17 Participants n=93 Participants	9 Participants n=4 Participants	26 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: The analysis was performed on the Intent to Treat Set that includes all participants who were randomized to study intervention in the study and who received at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	GSK2982772 960 mg n=19 Participants Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo n=10 Participants Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Percentage (%) of Participants Who Achieved Greater Than or Equal (>=) to 75% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12	5 Percentage of Participants Interval 0.4 to 21.0	0 Percentage of Participants Interval 0.0 to 18.2

SECONDARY outcome

Timeframe: Baseline and Week 12

The PASI is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, induration, and scaling (each scored separately), and the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6= ≥ 90% skin with psoriasis). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. The PASI is a composite scoring assessed by the investigator for the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Note: The 95% CrI was reported as a method of dispersion.

Outcome measures

Outcome measures
Measure	GSK2982772 960 mg n=19 Participants Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo n=10 Participants Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Percentage of Participants Who Achieved >=50% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12	42 Percentage of Participants Interval 22.1 to 64.2	20 Percentage of Participants Interval 3.9 to 49.7

SECONDARY outcome

Timeframe: Baseline and Week 12

Outcome measures

Outcome measures
Measure	GSK2982772 960 mg n=19 Participants Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo n=10 Participants Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Percentage of Participants Who Achieved >=90% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12	0 Percentage of Participants Interval 0.0 to 10.1	0 Percentage of Participants Interval 0.0 to 18.2

SECONDARY outcome

Timeframe: Baseline and Week 12

Outcome measures

Outcome measures
Measure	GSK2982772 960 mg n=19 Participants Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo n=10 Participants Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Percentage of Participants Who Achieved >=100% Improvement From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 12	0 Percentage of Participants Interval 0.0 to 10.1	0 Percentage of Participants Interval 0.0 to 18.2

SECONDARY outcome

Timeframe: Baseline and Week 12

The PASI is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, induration, and scaling (each scored separately), and the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6= ≥ 90% skin with psoriasis). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. The PASI is a composite scoring assessed by the investigator for the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.

Outcome measures

Outcome measures
Measure	GSK2982772 960 mg n=19 Participants Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo n=10 Participants Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Change From Baseline in Psoriasis Area Severity Index (PASI) Scores at Week 12	-8.82 Scores on a Scale Standard Deviation 4.501	-6.98 Scores on a Scale Standard Deviation 5.228

SECONDARY outcome

Timeframe: At Week 12

Either investigator or his designee completed a global assessment of disease activity using the physician global assessment item. A 5-point scoring system was used to measure the severity of psoriatic lesions over the entire body at the time of evaluation. The 5-point scoring system ranging from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. Percentage of participants who have a sIGA score of 0=clear or 1=almost clear at Week 12 was summarized. Note: The 95% CrI was reported as a method of dispersion.

Outcome measures

Outcome measures
Measure	GSK2982772 960 mg n=19 Participants Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo n=10 Participants Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Percentage of Participants Who Have a Static Investigator's Global Assessment (sIGA) Score of 0 or 1 at Week 12	11 Percentage of Participants Interval 1.9 to 28.9	0 Percentage of Participants Interval 0.0 to 18.2

SECONDARY outcome

Timeframe: Baseline and Week 12

The BSA affected with psoriasis was evaluated at all study visits by the Investigator or suitably trained delegate. As a reference, the area of the whole palm was counted as 1% BSA. Change from Baseline was calculated as Post-Baseline visit values minus Baseline value.

Outcome measures

Outcome measures
Measure	GSK2982772 960 mg n=19 Participants Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo n=10 Participants Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Change From Baseline in Psoriatic Body Surface Area (BSA) at Week 12	-5.2 Percentage of Body Surface Area Standard Deviation 6.30	-3.7 Percentage of Body Surface Area Standard Deviation 4.41

SECONDARY outcome

Timeframe: Up to Day 120

Population: The analysis was performed on the Safety Set that included all participants in the enrolled population who received at least one dose of study intervention.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

Outcome measures

Outcome measures
Measure	GSK2982772 960 mg n=19 Participants Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo n=10 Participants Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Number of Participants With Any Adverse Events (AEs)	12 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to Day 120

Population: The analysis was performed on the Safety Set that included all participants in the enrolled population who received at least one dose of study intervention.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The investigator was obligated to assess the relationship between study intervention and each occurrence of each AE.

Outcome measures

Outcome measures
Measure	GSK2982772 960 mg n=19 Participants Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo n=10 Participants Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Number of Participants With Drug Related AEs	5 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to Day 120

Population: The analysis was performed on the Safety Set that included all participants in the enrolled population who received at least one dose of study intervention.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Non serious AEs are AEs that are not Serious Adverse Events (SAEs). All AEs occurring at least 5% in either arm were reported. Note: As both arms had small sample sizes, single occurrences of an AE met the 5% threshold for reporting.

Outcome measures

Outcome measures
Measure	GSK2982772 960 mg n=19 Participants Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo n=10 Participants Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Neutropenia	1 Participants	0 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Tinnitus	1 Participants	0 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Dry eye	1 Participants	0 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Diarrhea	1 Participants	1 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Allergy to arthropod sting	1 Participants	0 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Herpes zoster	1 Participants	0 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Alanine aminotransferase increased	0 Participants	1 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Aspartate aminotransferase increased	0 Participants	1 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Blood creatinine abnormal	1 Participants	0 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Creatinine renal clearance abnormal	2 Participants	0 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Hepatitis E antibody positive	0 Participants	1 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Neutrophil count decreased	1 Participants	0 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs White blood cell count decreased	1 Participants	0 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Back pain	2 Participants	1 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Headache	3 Participants	3 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Suicidal ideation	0 Participants	1 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Nasal congestion	0 Participants	1 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Intertrigo	0 Participants	1 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Pruritus	0 Participants	1 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Psoriasis	1 Participants	0 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Rash	0 Participants	1 Participants
Number of Participants With Common (Occurring at Least 5%) Non Serious AEs Hypertension	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Day 120

Population: The analysis was performed on the Safety Set that included all participants in the enrolled population who received at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	GSK2982772 960 mg n=19 Participants Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo n=10 Participants Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Number of Participants With AEs Leading to Permanent Discontinuation of Study Intervention	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Day 120

Population: The analysis was performed on the Safety Set that included all participants in the enrolled population who received at least one dose of study intervention.

An SAE is defined as any untoward medical occurrence that, at any dose, results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement. All SAEs, SAEs related to the study drug, and fatal SAEs were reported.

Outcome measures

Outcome measures
Measure	GSK2982772 960 mg n=19 Participants Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo n=10 Participants Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Number of Participants With SAEs Including Any SAEs, SAEs Related to Study Intervention, and Fatal SAEs All SAEs	1 Participants	0 Participants
Number of Participants With SAEs Including Any SAEs, SAEs Related to Study Intervention, and Fatal SAEs Study drug related SAE	1 Participants	0 Participants
Number of Participants With SAEs Including Any SAEs, SAEs Related to Study Intervention, and Fatal SAEs Fatal SAE	0 Participants	0 Participants

Adverse Events

GSK2982772 960 mg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK2982772 960 mg n=19 participants at risk Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo n=10 participants at risk Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Renal and urinary disorders Acute kidney injury	5.3% 1/19 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	0.00% 0/10 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	GSK2982772 960 mg n=19 participants at risk Participants received GSK2982772 960 mg oral tablets once daily for 12 weeks.	Placebo n=10 participants at risk Participants received GSK2982772 matching placebo oral tablets once daily for 12 weeks.
Blood and lymphatic system disorders Neutropenia	5.3% 1/19 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	0.00% 0/10 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Ear and labyrinth disorders Tinnitus	5.3% 1/19 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	0.00% 0/10 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Eye disorders Dry eye	5.3% 1/19 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	0.00% 0/10 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Gastrointestinal disorders Diarrhoea	5.3% 1/19 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	10.0% 1/10 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Immune system disorders Allergy to arthropod sting	5.3% 1/19 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	0.00% 0/10 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Infections and infestations Herpes zoster	5.3% 1/19 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	0.00% 0/10 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Investigations Alanine aminotransferase increased	0.00% 0/19 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	10.0% 1/10 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Investigations Aspartate aminotransferase increased	0.00% 0/19 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	10.0% 1/10 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Investigations Blood creatinine abnormal	5.3% 1/19 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	0.00% 0/10 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Investigations Creatinine renal clearance abnormal	10.5% 2/19 • Number of events 2 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	0.00% 0/10 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Investigations Hepatitis E antibody positive	0.00% 0/19 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	10.0% 1/10 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Investigations Neutrophil count decreased	5.3% 1/19 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	0.00% 0/10 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Investigations White blood cell count decreased	5.3% 1/19 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	0.00% 0/10 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Back pain	10.5% 2/19 • Number of events 2 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	10.0% 1/10 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Nervous system disorders Headache	15.8% 3/19 • Number of events 3 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	30.0% 3/10 • Number of events 6 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Psychiatric disorders Suicidal ideation	0.00% 0/19 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	10.0% 1/10 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/19 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	10.0% 1/10 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/19 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	10.0% 1/10 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/19 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	10.0% 1/10 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Psoriasis	5.3% 1/19 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	0.00% 0/10 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Rash	0.00% 0/19 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	10.0% 1/10 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.
Vascular disorders Hypertension	0.00% 0/19 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.	10.0% 1/10 • Number of events 1 • All-Cause Mortality, SAEs and non-serious AEs were collected from the start of study treatment including the Follow-up visit up to Day 120. All AEs and SAEs were reported for the Safety Population which comprised of all participants in the enrolled population who received at least one dose of study intervention.