Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis (NCT NCT03025542)

Last Updated: 2022-10-28

Results Overview

An ADA status of positive was concluded for any participant with an ADA level that was above cut point (ACP) and 'confirmed positive' (CP) at any time point. A participant was classified as having treatment-induced ADA positivity when meeting one of the following criteria: -The Baseline result was either below cut point (BCP) or ACP and 'not confirmed positive' (NCP), and at least 1 post Baseline time point was ACP and CP. -The Baseline result was positive (ACP and CP) and at least one post-Baseline measurement showed a pre-defined fold increase in titre from the Baseline value. Note: The overall status of a participant is 'Positive' if at any post-Baseline visit the result was ACP and confirmed positive.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

49 participants

Primary outcome timeframe

at Baseline

Results posted on

2022-10-28

Participant Flow

The study started to enroll patients in December 2016 and concluded in December 2017.

Participant Flow refers to the Safety Set (SS).

Participant milestones

Participant milestones
Measure	Bimekizumab 320 mg + PBO Bimekizumab 320 milligrams (mg) administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.	Bimekizumab 320 mg Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16.
Overall Study STARTED	32	17
Overall Study COMPLETED	30	15
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Bimekizumab 320 mg + PBO Bimekizumab 320 milligrams (mg) administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.	Bimekizumab 320 mg Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16.
Overall Study Adverse Event	0	2
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Bimekizumab in Patients With Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bimekizumab 320 mg + PBO n=32 Participants Bimekizumab 320 milligrams (mg) administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.	Bimekizumab 320 mg n=17 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16.	Total Title n=49 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	16 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	41.8 years STANDARD_DEVIATION 14.1 • n=5 Participants	45.9 years STANDARD_DEVIATION 10.4 • n=7 Participants	43.2 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	6 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	30 Participants n=5 Participants	12 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 28

Population: The Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of the study medication and have a valid measurement of the primary efficacy variable post Baseline.

The PASI is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. The PASI quantifies the severity and extent of the disease and weighs these with the percentage of body surface area (BSA) involvement. The percent area of involvement (BSA%) is estimated across 4 body areas; head (10%), upper limbs (20%), trunk (30%), and lower limbs (40%) and then transferred into a grade. The Investigator assesses the average redness, thickness, and scaliness of lesions in each body area (each on a 5 point scale); 0=none, 1=slight, 2=moderate, 3=marked, and 4=very marked. The PASI score ranges from 0 to 72 with a higher score indicating increased disease severity.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=32 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=17 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28	-10.76 scores on a scale Standard Deviation 7.58	-19.74 scores on a scale Standard Deviation 8.77

PRIMARY outcome

Timeframe: at Baseline

Population: The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all randomized participants who received at least 1 dose of the study medication and provided at least 1 quantifiable plasma concentration post-dose. Number of participants analyzed reflects Baseline.

Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (μg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=32 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=17 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Plasma Concentration of Bimekizumab at Baseline	NA μg/mL Values were below the level of detection; Participants had no prior BKZ treatment.	NA μg/mL Values were below the level of detection; Participants had no prior BKZ treatment.

PRIMARY outcome

Timeframe: at Week 2

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=32 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=16 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Plasma Concentration of Bimekizumab at Week 2	19.749 μg/mL Interval 17.0 to 23.0	14.437 μg/mL Interval 10.8 to 19.3

PRIMARY outcome

Timeframe: at Week 4

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=31 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=17 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Plasma Concentration of Bimekizumab at Week 4	11.402 μg/mL Interval 9.7 to 13.4	9.077 μg/mL Interval 7.2 to 11.5

PRIMARY outcome

Timeframe: at Week 8

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=31 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=16 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Plasma Concentration of Bimekizumab at Week 8	16.728 μg/mL Interval 14.4 to 19.5	13.969 μg/mL Interval 11.1 to 17.6

PRIMARY outcome

Timeframe: at Week 12

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=31 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=15 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Plasma Concentration of Bimekizumab at Week 12	5.972 μg/mL Interval 4.9 to 7.3	5.466 μg/mL Interval 3.9 to 7.7

PRIMARY outcome

Timeframe: at Week 16

Plasma concentration was expressed as geometric mean concentrations (GMCs) and measured in micrograms per milliliter (µg/mL). Note: Means, Lower confidence interval (LCI), Upper confidence interval (UCI) are only calculated if at least 2/3 of the concentrations were quantified at the respective time point. Values below limit of quantification (BLQ) are replaced by value of lower limit of quantification (LLOQ)/2 (=0.075ug/mL) in calculations of means.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=31 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=15 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Plasma Concentration of Bimekizumab at Week 16	2.200 µg/mL Interval 1.6 to 3.0	2.293 µg/mL Interval 1.4 to 3.7

PRIMARY outcome

Timeframe: at Week 20

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=31 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=15 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Plasma Concentration of Bimekizumab at Week 20	0.798 μg/mL Interval 0.5 to 1.2	9.702 μg/mL Interval 7.3 to 13.0

PRIMARY outcome

Timeframe: at Week 24

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=29 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=15 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Plasma Concentration of Bimekizumab at Week 24	NA μg/mL Values were below the level of detection.	4.377 μg/mL Interval 3.2 to 6.0

PRIMARY outcome

Timeframe: at Week 28

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=26 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=13 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Plasma Concentration of Bimekizumab at Week 28	NA μg/mL Values were below the level of detection.	1.933 μg/mL Interval 1.2 to 3.1

PRIMARY outcome

Timeframe: at Week 36

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=24 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=14 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Plasma Concentration of Bimekizumab at Week 36	NA μg/mL Values were below the level of detection.	0.322 μg/mL Interval 0.2 to 0.6

PRIMARY outcome

Timeframe: at Baseline

Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication. Percentages were based on the number of participants with a non-missing measurement at Baseline.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=32 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=17 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline	3.1 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: From Baseline to Safety Follow-Up Visit (Week 36)

Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=32 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=17 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab	34.4 percentage of participants	47.1 percentage of participants

PRIMARY outcome

Timeframe: From Screening to Safety Follow-Up Visit (Week 36)

Population: The Safety Set (SS) consisted of all participants who received at least 1 dose of the study medication.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Within the Safety Set, this trial reported a total of 164 occurences of adverse events, of which 7 were pre-treatment adverse events and 157 were treatment-emergent adverse events (TEAEs).

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=32 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=17 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Percentage of Participants Who Experienced at Least One Adverse Events (AEs)	87.5 percentage of participants	88.2 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Week 16

The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=32 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=17 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16	93.8 percentage of participants	88.2 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Week 16

The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=32 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=17 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16	84.4 percentage of participants	70.6 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Week 16

The PASI100 response assessments are based on at least 100% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=32 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=17 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16	46.9 percentage of participants	52.9 percentage of participants

SECONDARY outcome

Timeframe: at Week 16

The Investigator's Global Assessment (IGA) measures the overall psoriasis severity following a 5-point scale (0-4), where scale 0= clear, no signs of psoriasis; presence of post-inflammatory hyperpigmentation, scale 1= almost clear, no thickening; normal to pink coloration; no to minimal focal scaling, scale 2= mild thickening, pink to light red coloration and predominately fine scaling, 3= moderate, clearly distinguishable to moderate thickening; dull to bright red, clearly distinguishable to moderate thickening; moderate scaling and 4= severe thickening with hard edges; bright to deep dark red coloration; severe/coarse scaling covering almost all or all lesions.

Outcome measures

Outcome measures
Measure	Bimekizumab 320 mg + PBO (FAS) n=32 Participants Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab 320 mg (FAS) n=17 Participants Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16	81.3 percentage of participants	64.7 percentage of participants

Adverse Events

Bimekizumab 320 mg + PBO (SS)

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Bimekizumab 320 mg (SS)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bimekizumab 320 mg + PBO (SS) n=32 participants at risk Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).	Bimekizumab 320 mg (SS) n=17 participants at risk Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).
Gastrointestinal disorders Pancreatitis	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Hepatobiliary disorders Cholecystitis acute	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Nervous system disorders Syncope	3.1% 1/32 • Number of events 1 • From Baseline to Week 36	0.00% 0/17 • From Baseline to Week 36
Nervous system disorders Peripheral sensorimotor neuropathy	3.1% 1/32 • Number of events 1 • From Baseline to Week 36	0.00% 0/17 • From Baseline to Week 36

Other adverse events

Other adverse events
Measure	Bimekizumab 320 mg + PBO (SS) n=32 participants at risk Bimekizumab 320 mg administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).	Bimekizumab 320 mg (SS) n=17 participants at risk Bimekizumab 320 mg administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Gastrointestinal disorders Nausea	3.1% 1/32 • Number of events 1 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Gastrointestinal disorders Abdominal discomfort	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Gastrointestinal disorders Anal pruritus	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Gastrointestinal disorders Dental necrosis	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Hepatobiliary disorders Non-alcoholic fatty liver	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Immune system disorders Seasonal allergy	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 2 • From Baseline to Week 36
Infections and infestations Upper respiratory tract infection	18.8% 6/32 • Number of events 8 • From Baseline to Week 36	17.6% 3/17 • Number of events 3 • From Baseline to Week 36
Infections and infestations Nasopharyngitis	6.2% 2/32 • Number of events 2 • From Baseline to Week 36	23.5% 4/17 • Number of events 4 • From Baseline to Week 36
Infections and infestations Urinary tract infection	12.5% 4/32 • Number of events 4 • From Baseline to Week 36	0.00% 0/17 • From Baseline to Week 36
Infections and infestations Viral upper respiratory tract infection	6.2% 2/32 • Number of events 2 • From Baseline to Week 36	11.8% 2/17 • Number of events 3 • From Baseline to Week 36
Infections and infestations Gastroenteritis viral	6.2% 2/32 • Number of events 2 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Infections and infestations Oral candidiasis	6.2% 2/32 • Number of events 2 • From Baseline to Week 36	0.00% 0/17 • From Baseline to Week 36
Infections and infestations Viral infection	0.00% 0/32 • From Baseline to Week 36	11.8% 2/17 • Number of events 2 • From Baseline to Week 36
Infections and infestations Bacterial diarrhoea	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Infections and infestations Conjunctivitis	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Infections and infestations Conjunctivitis bacterial	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Infections and infestations Ear infection	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Infections and infestations Localised infection	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Infections and infestations Postoperative wound infection	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Investigations Alanine aminotransferase increased	6.2% 2/32 • Number of events 3 • From Baseline to Week 36	17.6% 3/17 • Number of events 3 • From Baseline to Week 36
Investigations Gamma-glutamyltransferase increased	6.2% 2/32 • Number of events 4 • From Baseline to Week 36	17.6% 3/17 • Number of events 7 • From Baseline to Week 36
Metabolism and nutrition disorders White blood cell count decreased	6.2% 2/32 • Number of events 2 • From Baseline to Week 36	17.6% 3/17 • Number of events 5 • From Baseline to Week 36
Investigations Aspartate aminotransferase increased	6.2% 2/32 • Number of events 2 • From Baseline to Week 36	11.8% 2/17 • Number of events 4 • From Baseline to Week 36
Investigations Neutrophil count decreased	3.1% 1/32 • Number of events 1 • From Baseline to Week 36	17.6% 3/17 • Number of events 3 • From Baseline to Week 36
Investigations Blood cholesterol increased	3.1% 1/32 • Number of events 1 • From Baseline to Week 36	11.8% 2/17 • Number of events 2 • From Baseline to Week 36
Investigations Blood bilirubin increased	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Investigations Lymphocyte count decreased	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Investigations Mean cell haemoglobin concentration decreased	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Investigations Platelet count decreased	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 3 • From Baseline to Week 36
Metabolism and nutrition disorders Hyperkalaemia	12.5% 4/32 • Number of events 6 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Musculoskeletal and connective tissue disorders Arthralgia	3.1% 1/32 • Number of events 1 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Musculoskeletal and connective tissue disorders Back pain	3.1% 1/32 • Number of events 1 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 2 • From Baseline to Week 36
Nervous system disorders Headache	9.4% 3/32 • Number of events 3 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Nervous system disorders Tension headache	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Skin and subcutaneous tissue disorders Pruritus generalised	3.1% 1/32 • Number of events 1 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Skin and subcutaneous tissue disorders Psoriasis	3.1% 1/32 • Number of events 1 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/32 • From Baseline to Week 36	5.9% 1/17 • Number of events 1 • From Baseline to Week 36

Additional Information

UCB

Cares

Phone: 001 844 599 2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60