A Phase 2b Study of the Efficacy, Safety, and Tolerabilit... | NCT03384745

NCT03384745

Status Module

Sponsor/Collaborators Module

Name	Class
Avillion LLP	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
M1095 (Sonelokimab) 30mg	Experimental	M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.	Drug: M1095 (Sonelokimab)
M1095 (Sonelokimab) 60mg	Experimental	M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks.	Drug: M1095 (Sonelokimab)
M1095 (Sonelokimab) 120mg - regimen 1	Experimental	M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks.	Drug: M1095 (Sonelokimab)
M1095 (Sonelokimab) 120mg - regimen 2	Experimental	M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks.	Drug: M1095 (Sonelokimab)
Placebo / M1095 (Sonelokimab) 120mg	Placebo Comparator	Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks.	Drug: M1095 (Sonelokimab) Drug: Placebo
Secukinumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
M1095 (Sonelokimab)	Drug	M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	M1095 (Sonelokimab) 120mg - regimen 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1	The primary endpoint is achievement of an IGA score of 0 or 1 at Week 12, with an IGA reduction of at least 2 points from baseline. The percentage of subjects in the Intent to Treat (ITT) Analysis Set with an IGA score of 0 or 1 at Week 12 will be used to compare treatment arms. IGA is the Investigator's Global Assessment of the extent of psoriasis, with 0 = clear of psoriasis, 1 = almost clear, 2 = mild psoriasis, 3 = moderate psoriasis, and 4 = severe psoriasis (the worst assessment on this scale). Higher scores in the IGA indicate a worse outcome.	Week 12, as compared to Week 0 (baseline)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)	PASI 100, i.e. a subject's psoriasis has completely cleared at Week 12, compared to baseline.	Week 12, as compared to Week 0 (baseline)
Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Dr. Kim Papp	Probity Medical Research Inc	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Investigative Site		Birmingham	Alabama	35205	United States
Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33894834	Result	Papp KA, Weinberg MA, Morris A, Reich K. IL17A/F nanobody sonelokimab in patients with plaque psoriasis: a multicentre, randomised, placebo-controlled, phase 2b study. Lancet. 2021 Apr 24;397(10284):1564-1575. doi: 10.1016/S0140-6736(21)00440-2.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	M1095 30mg	M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks. Subjects with IGA>1 at Week 12 were escalated to receive M1095, 120mg M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
FG001	M1095 60mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 16, 2018	Apr 1, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

M1095 (Sonelokimab) 120mg - regimen 2

M1095 (Sonelokimab) 30mg

M1095 (Sonelokimab) 60mg

Placebo / M1095 (Sonelokimab) 120mg

FG00052 subjects
FG00152 subjects
FG00253 subjects
FG00351 subjects
FG00452 subjects
FG00553 subjects

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	M1095 30mg	M1095, 30 mg, given at Week 0, 2, 4, 8, 12 and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
BG001	M1095 60mg	M1095, 60 mg, given at Week 0, 2, 4, 8, 12 and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
BG002	M1095 120mg - Regimen 1	M1095, 120 mg, given at Week 0, 2, 4, 8, 12 and every eight weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
BG003	M1095 120mg - Regimen 2	M1095, 120 mg, given at Week 0, 2, 4, 6, 8, 10, 12 and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
BG004	Placebo / M1095 120mg	Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10, then M1095, 120mg, given at Week 12, 14, 16, and every four weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F. Placebo: Placebo contains no active drug.
BG005	Secukinumab	Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, 8, 12 and every four weeks. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
BG006	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG00152 ParticipantsBG00253 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG00152 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG00152 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG00152 ParticipantsBG002

Region of Enrollment

Number

participants

Title	Denominators	Categories
Canada	ParticipantsBG00052 ParticipantsBG00152 ParticipantsBG002

Height (cm)

Height was not captured for one subject at baseline.

Mean

Standard Deviation

centimetres

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG00152 ParticipantsBG002

Weight at baseline (kg)

Mean

Standard Deviation

kilograms

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG00152 ParticipantsBG002

Prior biological use (actual)

Prior biological use included treatment with ustekinumab (stopping at least six months prior to randomization), tumour necrosis factor (TNF) targeting therapies (stopping at least 12 weeks prior to randomization), or investigational therapies (stopping at least 12 weeks, or 5 half lives, whichever is the longer, prior to randomization).

Subjects treated with more than 2 biological therapies as above were excluded from the study.

Subjects receiving prior treatment at any time with any compound (marketed or investigational) targeting interleukin-17 were excluded from the study.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG001

Duration of psoriasis (years)

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG00152 ParticipantsBG002

Presence of psoriatic arthritis

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG00152 ParticipantsBG002

Investigator's Global Assessment (IGA) at baseline

Investigator's Global Assessment is a rating scale for overall psoriatic disease. Assessment ranges from 0 (clear of psoriasis), 1 (almost clear), 2 (mild), 3 (moderate) or 4 (severe).

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG00152 ParticipantsBG002

Psoriasis Area and Severity Index (PASI) at baseline

The Psoriasis Area and Severity Index (PASI) combines assessments of the extent of body-surface area involvement in four anatomical regions (head, trunk, arms, legs) and the severity of desquamation, erythema and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72.0 for the most severe disease.

Mean

Standard Deviation

units on a scale

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG00152 Participants

Percentage of total Body Surface Area (BSA) affected at baseline

The percentage of total Body Surface Area (BSA) affected by plaque-type psoriasis was estimated from the percentages of areas affected, including head, trunk, upper limbs and lower limbs.

Mean

Standard Deviation

% of body surface area affected

Title	Denominators	Categories
	ParticipantsBG00052 ParticipantsBG00152 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1

The primary endpoint is achievement of an IGA score of 0 or 1 at Week 12, with an IGA reduction of at least 2 points from baseline. The percentage of subjects in the Intent to Treat (ITT) Analysis Set with an IGA score of 0 or 1 at Week 12 will be used to compare treatment arms. IGA is the Investigator's Global Assessment of the extent of psoriasis, with 0 = clear of psoriasis, 1 = almost clear, 2 = mild psoriasis, 3 = moderate psoriasis, and 4 = severe psoriasis (the worst assessment on this scale). Higher scores in the IGA indicate a worse outcome.

Posted

Count of Participants

Participants

Week 12, as compared to Week 0 (baseline)

ID	Title	Description
OG000	M1095 30mg	M1095, 30 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
OG001	M1095 60mg	M1095, 60 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
OG002	M1095 120mg - Normal Load Group	M1095, 120 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
OG003	M1095 120mg - Augmented Load Group	M1095, 120 mg, given at Week 0, 2, 4, 6, 8, and 10 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
OG004	Placebo	Placebo, given at Week 0, 1, 2, 3, 4, 6, 8 and 10 weeks. Placebo: Placebo contains no active drug.
OG005	Secukinumab	Secukinumab, 300mg, given at Week 0, 1, 2, 3, 4, and 8 weeks. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.

Units	Counts
Participants	OG00052 OG00152 OG00253 OG003

Title

Denominators

Categories

Title	Measurements
	OG00025 OG00144 OG00241 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG004	Null hypotheses were tested at Week 12 (individual M1095 treatment arms would not be different from placebo with respect to achievement of IGA scores of 0 or 1). The primary analysis was based on the intent-to-treat (ITT) population using a non-responder imputation (NRI) for missing values. Primary treatment comparisons versus placebo were made with the two-sided Cochran-Mantel-Haenszel (CMH) test stratified by actual prior biologic use (yes/no) and body weight (<=90; >90kg).	Cochran-Mantel-Haenszel		<0.0001														Superiority	A sample size of 300 subjects has 99% power to detect a statistically significant difference between any treatment arm and placebo in the IGA score of 0 or 1 rate at Week 12, with a two-sided, unadjusted type I error of 0.05. Calculations assume IGA score 0 or 1 rates >88% for study drug and <=7% for placebo.

Secondary

Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 100% (i.e. Clear of Psoriasis)

PASI 100, i.e. a subject's psoriasis has completely cleared at Week 12, compared to baseline.

Posted

Count of Participants

Participants

Week 12, as compared to Week 0 (baseline)

ID	Title	Description
OG000	M1095 30mg	M1095, 30 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
OG001	M1095 60mg	M1095, 60 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
OG002	M1095 120mg - Regimen 1	M1095, 120 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
OG003	M1095 120mg - Regimen 2	M1095, 120 mg, given at Week 0, 2, 4, 6, 8, and 10 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.

Secondary

Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 90% (i.e. a 90% Improvement in Psoriasis)

PASI 90, i.e. a subject's psoriasis has cleared by 90% at Week 12, compared to baseline

Posted

Count of Participants

Participants

Week 12, as compared to baseline

ID	Title	Description
OG000	M1095 30mg	M1095, 30 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
OG001	M1095 60mg	M1095, 60 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
OG002	M1095 120mg - Regimen 1	M1095, 120 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
OG003	M1095 120mg - Regimen 2	M1095, 120 mg, given at Week 0, 2, 4, 6, 8, and 10 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.

Secondary

Number of Participants With a Psoriasis Area and Severity Index (PASI) Reduction of 75% (i.e. a 75% Improvement in Psoriasis)

PASI 75, i.e. a subject's psoriasis has cleared by 75% at Week 12, compared to baseline

Posted

Count of Participants

Participants

Week 12, as compared to Week 0 (baseline)

ID	Title	Description
OG000	M1095 30mg	M1095, 30 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
OG001	M1095 60mg	M1095, 60 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
OG002	M1095 120mg - Regimen 1	M1095, 120 mg, given at Week 0, 2, 4, and 8 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
OG003	M1095 120mg - Regimen 2	M1095, 120 mg, given at Week 0, 2, 4, 6, 8, and 10 weeks. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo (Week 0 to Week 12)	Placebo given at Weeks 0, 2, 4 and 8. Placebo: Placebo contains no active drug.	0	52	1	52	11	52
EG001	M1095 30mg (Week 0 to Week 12)	M1095, 30mg, given at Weeks 0, 2, 4 and 8. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	0	52	2	52	13	52
EG002	M1095 60 mg (Week 0 to Week 12)	M1095, 60mg, given at Weeks 0, 2, 4 and 8. M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	0	52	1	52	16	52
EG003	M1095 120mg - Normal Load Group (Week 0 to Week 12)	M1095, 120 mg, given at Weeks 0, 2, 4 and 8. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	0	53	1	53	18	53
EG004	M1095 120mg - Augmented Load Group (Week 0 to Week 12)	M1095, 120 mg, given at Weeks 0, 2, 4, 6, 8 and 10. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	0	51	1	51	15	51
EG005	Secukinumab (Week 0 to Week 12)	Secukinumab, 300mg, given at Weeks 0, 1, 2, 3, 4 and 8. Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.	0	53	0	53	14	53
EG006	M1095 - All Participants (Week 0 to Week 12 )	All participants receiving M1095, 30mg, 60mg, or 120mg from Week 0 to Week 12. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	0	208	5	208	62	208
EG007	M1095 - All Participants (Week 12 to Week 52)	All participants receiving M1095, 30mg, 60mg, or 120mg from Week 12 to Week 44, including subjects randomised to placebo, who received M1095 120mg from Weeks 12, 14, 16, 20, etc. M1095: M1095 is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.	1	251	12	251	57	251
EG008	Secukinumab (Week 12 to Week 52)	Secukinumab, 300mg, given at Weeks 12, 16, 20 and every 4 weeks to week 44) Secukinumab: Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.	0	51	2	51	16	51

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Deep vein thrombosis	Vascular disorders	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG0030 events0 affected53 at risk EG0040 events0 affected51 at risk EG0050 events0 affected53 at risk EG0060 events0 affected208 at risk EG0071 events1 affected251 at risk EG0080 events0 affected51 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0021 events1 affected52 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected52 at risk EG0020 events0 affected52 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0011 events1 affected52 at risk EG0020 events0 affected52 at risk EG003
Neuroglycopenia	Nervous system disorders	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Optic ischaemic neuropathy	Eye disorders	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Salivary gland calculus	Gastrointestinal disorders	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Erysipelas	Infections and infestations	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Infectious pleural effusion	Infections and infestations	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Oropharyngeal candidiasis	Infections and infestations	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Pneumonia	Infections and infestations	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (22.1)	Non-systematic Assessment	EG0000 events0 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003
Hypertension	Vascular disorders	MedDRA (22.1)	Non-systematic Assessment	EG0001 events1 affected52 at risk EG0010 events0 affected52 at risk EG0020 events0 affected52 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (22.1)	Non-systematic Assessment	EG0004 affected52 at risk EG0014 affected52 at risk EG00211 affected52 at risk EG0039 affected53 at risk EG0044 affected51 at risk EG0056 affected53 at risk EG00628 affected208 at risk EG00726 affected251 at risk EG0087 affected51 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (22.1)	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected52 at risk EG0023 affected52 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (22.1)	Non-systematic Assessment	EG0002 affected52 at risk EG0013 affected52 at risk EG0024 affected52 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA (22.1)	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected52 at risk EG0021 affected52 at risk EG003
Headache	Nervous system disorders	MedDRA (22.1)	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected52 at risk EG0023 affected52 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (22.1)	Non-systematic Assessment	EG0001 affected52 at risk EG0013 affected52 at risk EG0020 affected52 at risk EG003
Hypertension	Vascular disorders	MedDRA (22.1)	Non-systematic Assessment	EG0002 affected52 at risk EG0013 affected52 at risk EG0021 affected52 at risk EG003

First MCP Posted Date

ID	Term
D011565	Psoriasis

ID	Term
C000720946	sonelokimab
C555450	secukinumab

ParticipantsBG006313

ParticipantsBG006312

ParticipantsBG006313

EG0040 events0 affected51 at risk