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

• Sponsor: UCB Biopharma SRL (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03025542
• Collaborator: Parexel (Industry)
• Enrollment: 49
• Locations: 8
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site: 6.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This is a Phase 2a, multicenter, randomized, subject-blind, investigator-blind, study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis

Condition or Disease	Intervention/Treatment	Phase
Chronic Plaque Psoriasis	Drug: Bimekizumab; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: This is an Investigator- and Subject-blind study.
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Subject-Blind, Investigator-Blind Study to Evaluate the Time Course of Pharmacodynamic Response, Safety and Pharmacokinetics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
• Actual Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm 1 Subjects randomized in this arm will receive a combination of Bimekizumab and Placebo injections.	Drug: Bimekizumab; Based on their randomization subjects will receive a combination of several injections of Bimekizumab.; Other Names: UCB4940 ; Other: Placebo; Subjects will receive injections of Placebo.
Experimental: Treatment Arm 2 Subjects randomized in this arm will receive Bimekizumab injections.	Drug: Bimekizumab; Based on their randomization subjects will receive a combination of several injections of Bimekizumab.; Other Names: UCB4940

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28 [From Baseline to Week 28]

   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.

2. Plasma Concentration of Bimekizumab at Baseline [at 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.

3. Plasma Concentration of Bimekizumab at Week 2 [at Week 2]

   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.

4. Plasma Concentration of Bimekizumab at Week 4 [at Week 4]

   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.

5. Plasma Concentration of Bimekizumab at Week 8 [at Week 8]

   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.

6. Plasma Concentration of Bimekizumab at Week 12 [at Week 12]

   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.

7. Plasma Concentration of Bimekizumab at Week 16 [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.

8. Plasma Concentration of Bimekizumab at Week 20 [at Week 20]

   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.

9. Plasma Concentration of Bimekizumab at Week 24 [at Week 24]

   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.

10. Plasma Concentration of Bimekizumab at Week 28 [at Week 28]

    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.

11. Plasma Concentration of Bimekizumab at Week 36 [at Week 36]

    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.

12. Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline [at Baseline]

    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.

13. Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab [From Baseline to Safety Follow-Up Visit (Week 36)]

    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.

14. Percentage of Participants Who Experienced at Least One Adverse Events (AEs) [From Screening to Safety Follow-Up Visit (Week 36)]

    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).

Secondary Outcome Measures

1. Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16 [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.

2. Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16 [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.

3. Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16 [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.

4. Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female at least 18 years of age and less than or equal to 70

• Chronic plaque psoriasis for at least 6 months prior to Screening

• Psoriasis Area and Severity Index (PASI) >=12 and body surface area (BSA) >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale

• Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy

• Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose

• Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication (anticipated 5 half-lives)

Exclusion Criteria:

• Subjects previously participating in a bimekizumab study

• Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis

• History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster)

• High risk of infection in the Investigator's opinion

• Current sign or symptom that may indicate an active infection

• Concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection

• Live (includes attenuated) vaccination within the 8 weeks prior to Baseline

• Subjects with concurrent malignancy or history of malignancy during the past 5 years (except for specific malignant condition as defined in the protocol)

• Primary immunosuppressive conditions

• TB infection, high risk of acquiring TB infection, latent TB infection (LTBI), or current or history of NTMB infection

• Laboratory abnormalities, as defined in the study protocol

• Any condition which, in the Investigator's judgement, would make the subject unsuitable for inclusion in the study

• Exposure to more than 1 biological response modifier (limited to anti-TNF or IL-12/-23) or any biologic response modifier during the three months prior to the Baseline Visit

• Subjects have received previous treatment with any anti-IL-17 therapy for the treatment of psoriasis or psoriatic arthritis

• Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic lupus erythematosus. Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease at Screening or Baseline

• Subjects taking psoriatic arthritis medications other than nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ps0016 704	Bexley	Ohio	United States
2	Ps0016 102	Kogarah		Australia
3	Ps0016 101	Melbourne		Australia
4	Ps0016 104	Woolloongabba		Australia
5	Ps0016 201	Ajax		Canada
6	Ps0016 203	London		Canada
7	Ps0016 202	Windsor		Canada
8	Ps0016 501	Chisinau		Moldova, Republic of

Sponsors and Collaborators

• UCB Biopharma SRL
• Parexel

Investigators

• Study Director: UCB Cares, [phone](UCB)

Study Documents (Full-Text)

• Study Protocol - Sep 23, 2016
• Statistical Analysis Plan - Nov 30, 2017

More Information

Publications

None provided.

• Responsible Party: UCB Biopharma SRL
• ClinicalTrials.gov Identifier: NCT03025542
• Other Study ID Numbers: PS0016; 2016-002368-15
• First Posted: Jan 19, 2017
• Last Update Posted: Aug 23, 2022
• Last Verified: Aug 1, 2022

• Keywords provided by UCB Biopharma SRL: Psoriasis; Chronic Plaque Psoriasis; Bimekizumab
• Additional relevant MeSH terms: Psoriasis

Study Results

Participant Flow

Recruitment Details	The study started to enroll patients in December 2016 and concluded in December 2017.
Pre-assignment Detail	Participant Flow refers to the Safety Set (SS).

Arm/Group Title	Bimekizumab + PBO	Bimekizumab
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.	Bimekizumab administered sc at Baseline and Weeks 4 and 16.
Period Title: Overall Study
STARTED	32	17
COMPLETED	30	15
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Bimekizumab + PBO	Bimekizumab	Total Title
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16.	Bimekizumab administered sc at Baseline and Weeks 4 and 16.
Overall Participants	32	17	49
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	30 93.8%	16 94.1%	46 93.9%
>=65 years	2 6.3%	1 5.9%	3 6.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.8 (14.1)	45.9 (10.4)	43.2 (13.0)
Sex: Female, Male (Count of Participants)
Female	17 53.1%	6 35.3%	23 46.9%
Male	15 46.9%	11 64.7%	26 53.1%
Race/Ethnicity, Customized (Count of Participants)
Asian	1 3.1%	4 23.5%	5 10.2%
Black or African American	1 3.1%	0 0%	1 2%
Native Hawaiian or Other Pacific Islander	0 0%	1 5.9%	1 2%
White	30 93.8%	12 70.6%	42 85.7%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 28
Description	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.
Time Frame	From Baseline to Week 28

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab + PBO (FAS)	Bimekizumab (FAS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Measure Participants	32	17
Mean (Standard Deviation) [scores on a scale]	-10.76 (7.58)	-19.74 (8.77)

2. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Baseline
Description	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.
Time Frame	at Baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab + PBO (PK-PPS)	Bimekizumab (PK-PPS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Measure Participants	32	17
Geometric Mean (95% Confidence Interval) [μg/mL]	NA	NA

3. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 2
Description	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.
Time Frame	at Week 2

Outcome Measure Data

Analysis Population Description

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 Week 2.

Arm/Group Title	Bimekizumab + PBO (PK-PPS)	Bimekizumab (PK-PPS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Measure Participants	32	16
Geometric Mean (95% Confidence Interval) [μg/mL]	19.749	14.437

4. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 4
Description	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.
Time Frame	at Week 4

Outcome Measure Data

Analysis Population Description

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 Week 4.

Arm/Group Title	Bimekizumab + PBO (PK-PPS)	Bimekizumab (PK-PPS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Measure Participants	31	17
Geometric Mean (95% Confidence Interval) [μg/mL]	11.402	9.077

5. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 8
Description	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.
Time Frame	at Week 8

Outcome Measure Data

Analysis Population Description

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 Week 8.

Arm/Group Title	Bimekizumab + PBO (PK-PPS)	Bimekizumab (PK-PPS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Measure Participants	31	16
Geometric Mean (95% Confidence Interval) [μg/mL]	16.728	13.969

6. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 12
Description	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.
Time Frame	at Week 12

Outcome Measure Data

Analysis Population Description

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 Week 12.

Arm/Group Title	Bimekizumab + PBO (PK-PPS)	Bimekizumab (PK-PPS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Measure Participants	31	15
Geometric Mean (95% Confidence Interval) [μg/mL]	5.972	5.466

7. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 16
Description	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.
Time Frame	at Week 16

Outcome Measure Data

Analysis Population Description

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 Week 16.

Arm/Group Title	Bimekizumab + PBO (PK-PPS)	Bimekizumab (PK-PPS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Measure Participants	31	15
Geometric Mean (95% Confidence Interval) [µg/mL]	2.200	2.293

8. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 20
Description	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.
Time Frame	at Week 20

Outcome Measure Data

Analysis Population Description

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 Week 20.

Arm/Group Title	Bimekizumab + PBO (PK-PPS)	Bimekizumab (PK-PPS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Measure Participants	31	15
Geometric Mean (95% Confidence Interval) [μg/mL]	0.798	9.702

9. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 24
Description	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.
Time Frame	at Week 24

Outcome Measure Data

Analysis Population Description

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 Week 24.

Arm/Group Title	Bimekizumab + PBO (PK-PPS)	Bimekizumab (PK-PPS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Measure Participants	29	15
Geometric Mean (95% Confidence Interval) [μg/mL]	NA	4.377

10. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 28
Description	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.
Time Frame	at Week 28

Outcome Measure Data

Analysis Population Description

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 Week 28.

Arm/Group Title	Bimekizumab + PBO (PK-PPS)	Bimekizumab (PK-PPS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Measure Participants	26	13
Geometric Mean (95% Confidence Interval) [μg/mL]	NA	1.933

11. Primary Outcome

Title	Plasma Concentration of Bimekizumab at Week 36
Description	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.
Time Frame	at Week 36

Outcome Measure Data

Analysis Population Description

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 Week 36.

Arm/Group Title	Bimekizumab + PBO (PK-PPS)	Bimekizumab (PK-PPS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Pharmacokinetics Per-Protocol Set (PK-PPS).
Measure Participants	24	14
Geometric Mean (95% Confidence Interval) [μg/mL]	NA	0.322

12. Primary Outcome

Title	Percentage of Participants Reporting Positive Anti-Drug-Antibodies (ADA) Titre Prior to Study Treatment With Bimekizumab at Baseline
Description	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.
Time Frame	at Baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab + PBO (SS)	Bimekizumab (SS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).
Measure Participants	32	17
Number [percentage of participants]	3.1 9.7%	0 0%

13. Primary Outcome

Title	Percentage of Participants Reporting an Overall Positive Anti-Drug-Antibodies (ADA) Titre Following Study Treatment With Bimekizumab
Description	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.
Time Frame	From Baseline to Safety Follow-Up Visit (Week 36)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Bimekizumab + PBO (SS)	Bimekizumab (SS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).
Measure Participants	32	17
Number [percentage of participants]	34.4 107.5%	47.1 277.1%

14. Primary Outcome

Title	Percentage of Participants Who Experienced at Least One Adverse Events (AEs)
Description	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).
Time Frame	From Screening to Safety Follow-Up Visit (Week 36)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Bimekizumab + PBO (SS)	Bimekizumab (SS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).
Measure Participants	32	17
Number [percentage of participants]	87.5 273.4%	88.2 518.8%

15. Secondary Outcome

Title	Percentage of Participants Achieving a 75% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
Description	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.
Time Frame	From Baseline to Week 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab + PBO (FAS)	Bimekizumab (FAS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Measure Participants	32	17
Number [percentage of participants]	93.8 293.1%	88.2 518.8%

16. Secondary Outcome

Title	Percentage of Participants Achieving a 90% or Higher Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
Description	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.
Time Frame	From Baseline to Week 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab + PBO (FAS)	Bimekizumab (FAS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Measure Participants	32	17
Number [percentage of participants]	84.4 263.8%	70.6 415.3%

17. Secondary Outcome

Title	Percentage of Participants Achieving a 100% Improvement From Baseline in PASI (Psoriasis Area and Severity Index) Score at Week 16
Description	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.
Time Frame	From Baseline to Week 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab + PBO (FAS)	Bimekizumab (FAS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Measure Participants	32	17
Number [percentage of participants]	46.9 146.6%	52.9 311.2%

18. Secondary Outcome

Title	Percentage of Participants With IGA (Investigator´s Global Assessment) Response at Week 16
Description	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.
Time Frame	at Week 16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Bimekizumab + PBO (FAS)	Bimekizumab (FAS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Full Analysis Set (FAS).	Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Full Analysis Set (FAS).
Measure Participants	32	17
Number [percentage of participants]	81.3 254.1%	64.7 380.6%

Adverse Events

Time Frame	From Baseline to Week 36
Arm/Group Title	Bimekizumab + PBO (SS)		Bimekizumab (SS)
Arm/Group Description	Bimekizumab administered subcutaneously (sc) at Baseline and Week 4, and placebo administered at Week 16. Participants formed the Safety Set (SS).		Bimekizumab administered sc at Baseline and Weeks 4 and 16. Participants formed the Safety Set (SS).
All Cause Mortality
	Bimekizumab + PBO (SS)		Bimekizumab (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/17 (0%)
Serious Adverse Events
	Bimekizumab + PBO (SS)		Bimekizumab (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/32 (6.3%)		1/17 (5.9%)
Gastrointestinal disorders
Pancreatitis	0/32 (0%)	0	1/17 (5.9%)	1
Hepatobiliary disorders
Cholecystitis acute	0/32 (0%)	0	1/17 (5.9%)	1
Nervous system disorders
Syncope	1/32 (3.1%)	1	0/17 (0%)	0
Peripheral sensorimotor neuropathy	1/32 (3.1%)	1	0/17 (0%)	0
Other (Not Including Serious) Adverse Events
	Bimekizumab + PBO (SS)		Bimekizumab (SS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/32 (87.5%)		15/17 (88.2%)
Blood and lymphatic system disorders
Hypochromic anaemia	0/32 (0%)	0	1/17 (5.9%)	1
Gastrointestinal disorders
Nausea	1/32 (3.1%)	1	1/17 (5.9%)	1
Abdominal discomfort	0/32 (0%)	0	1/17 (5.9%)	1
Anal pruritus	0/32 (0%)	0	1/17 (5.9%)	1
Dental necrosis	0/32 (0%)	0	1/17 (5.9%)	1
Irritable bowel syndrome	0/32 (0%)	0	1/17 (5.9%)	1
Hepatobiliary disorders
Non-alcoholic fatty liver	0/32 (0%)	0	1/17 (5.9%)	1
Immune system disorders
Seasonal allergy	0/32 (0%)	0	1/17 (5.9%)	2
Infections and infestations
Upper respiratory tract infection	6/32 (18.8%)	8	3/17 (17.6%)	3
Nasopharyngitis	2/32 (6.3%)	2	4/17 (23.5%)	4
Urinary tract infection	4/32 (12.5%)	4	0/17 (0%)	0
Viral upper respiratory tract infection	2/32 (6.3%)	2	2/17 (11.8%)	3
Gastroenteritis viral	2/32 (6.3%)	2	1/17 (5.9%)	1
Oral candidiasis	2/32 (6.3%)	2	0/17 (0%)	0
Viral infection	0/32 (0%)	0	2/17 (11.8%)	2
Bacterial diarrhoea	0/32 (0%)	0	1/17 (5.9%)	1
Conjunctivitis	0/32 (0%)	0	1/17 (5.9%)	1
Conjunctivitis bacterial	0/32 (0%)	0	1/17 (5.9%)	1
Ear infection	0/32 (0%)	0	1/17 (5.9%)	1
Localised infection	0/32 (0%)	0	1/17 (5.9%)	1
Postoperative wound infection	0/32 (0%)	0	1/17 (5.9%)	1
Investigations
Alanine aminotransferase increased	2/32 (6.3%)	3	3/17 (17.6%)	3
Gamma-glutamyltransferase increased	2/32 (6.3%)	4	3/17 (17.6%)	7
Aspartate aminotransferase increased	2/32 (6.3%)	2	2/17 (11.8%)	4
Neutrophil count decreased	1/32 (3.1%)	1	3/17 (17.6%)	3
Blood cholesterol increased	1/32 (3.1%)	1	2/17 (11.8%)	2
Blood bilirubin increased	0/32 (0%)	0	1/17 (5.9%)	1
Lymphocyte count decreased	0/32 (0%)	0	1/17 (5.9%)	1
Mean cell haemoglobin concentration decreased	0/32 (0%)	0	1/17 (5.9%)	1
Platelet count decreased	0/32 (0%)	0	1/17 (5.9%)	3
Metabolism and nutrition disorders
White blood cell count decreased	2/32 (6.3%)	2	3/17 (17.6%)	5
Hyperkalaemia	4/32 (12.5%)	6	1/17 (5.9%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/32 (3.1%)	1	1/17 (5.9%)	1
Back pain	1/32 (3.1%)	1	1/17 (5.9%)	1
Neck pain	0/32 (0%)	0	1/17 (5.9%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis	0/32 (0%)	0	1/17 (5.9%)	2
Nervous system disorders
Headache	3/32 (9.4%)	3	1/17 (5.9%)	1
Tension headache	0/32 (0%)	0	1/17 (5.9%)	1
Respiratory, thoracic and mediastinal disorders
Cough	0/32 (0%)	0	1/17 (5.9%)	1
Skin and subcutaneous tissue disorders
Pruritus generalised	1/32 (3.1%)	1	1/17 (5.9%)	1
Psoriasis	1/32 (3.1%)	1	1/17 (5.9%)	1
Dermatitis	0/32 (0%)	0	1/17 (5.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.