Psoriatic Arthritis Study of Izokibep | NCT05623345

ID	Type	Description	Link
2022-501362-22	Other Identifier	EU Trial Number

Label	Type	Description	Intervention Names
Group 1	Experimental	Placebo from Day 1/Week 0 to Week 15, then izokibep from Week 16 to Week 51	Drug: Izokibep Drug: Placebo to izokibep
Group 2	Experimental	Izokibep Dose 1 from Day 1/Week 0 to Week 51	Drug: Izokibep
Group 3	Experimental	Izokibep Dose 2 from Day 1/Week 0 to Week 51	Drug: Izokibep Drug: Placebo to izokibep
Group 4	Experimental	Izokibep Dose 3 from Day 1/Week 0 to Week 51	Drug: Izokibep Drug: Placebo to izokibep

Name	Type	Description	Arm Group Labels	Other Names
Izokibep	Drug	Biologic: IL-17A inhibitor Form: Solution for injection Route of administration: Subcutaneous (SC)	Group 1 Group 2 Group 3

Measure	Description	Time Frame
Number of Participants Who Achieved 50% Improvement in American College of Rheumatology (ACR50) at Week 16	ACR50 is a clinical trial measure for PsA, indicating a 50% improvement in symptoms. To qualify, participants must show a 50% reduction in tender and swollen joint counts plus improvements in three of five additional criteria, including pain, global assessments, physical function, and inflammatory markers. ACR50 is binary-patients either meet it or not.	Week 16

Measure	Description	Time Frame
Number of Participants With Baseline ≥ 3% Body Surface Area (BSA) Psoriasis Who Achieved a 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI90) at Week 16	PASI is a tool used in clinical trials to measure the severity and extent of psoriasis. Scores range from a minimum of 0 to a maximum of 72, with higher scores indicating more severe disease.	Baseline and Week 16

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

General

Subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Subject must be ≥18 (or the legal age of consent in the jurisdiction in which the study is taking place) and ≤75 years of age, at the time of signing the informed consent.

Type of Subject and Disease Characteristics

Clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to first dose of study drug and fulfillment of the ClASsification for Psoriatic ARthritis (CASPAR) criteria at Screening.
Active PsA defined as ≥3 tender joints (based on 68 joint counts) and ≥3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) negative at screening.
Subject must have had an inadequate response, intolerance, or contraindication to at least one of the following:
1. nonsteroidal anti-inflammatory drug (NSAID)
2. conventional-synthetic disease-modifying anti-rheumatic drugs (csDMARD) (i.e. methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, cyclosporine A)
3. tumor necrosis factor-alpha inhibitor(s) (TNFi) (e.g. adalimumab, infliximab, etanercept, golimumab, certolizumab).
For subjects using methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, or apremilast, treated for ≥3 months and a stable dose (not to exceed 25 mg methotrexate per week, 20 mg leflunomide per day, sulfasalazine 3 g per day, hydroxychloroquine 400 mg per day, or apremilast 60 mg per day) for ≥4 weeks prior to first dose of study drug.
For subjects using corticosteroids, must have been on a stable dose and regimen and not to exceed 7.5 mg per day of prednisone (or other corticosteroid equivalent to 7.5 mg per day of prednisone) for ≥4 weeks prior to first dose of study drug.
Subjects using NSAIDs, or low potency opioid medications (tramadol, paracetamol in combination with hydrocodone or with codeine) must have been on a stable dose and regimen for ≥2 weeks prior to first dose of study drug.

Other Inclusions

No known history of active tuberculosis (TB).
Subject has a negative TB test at screening

Exclusion Criteria:

Disease-related Medical Conditions

Any history or current confirmed diagnosis of inflammatory bowel disease (IBD)

Any of the following symptoms (of unknown etiology) or any signs or symptoms within the last year that in the opinion of the Investigator may be suggestive of IBD, with fecal calprotectin ≥ 500 μg/g; OR if fecal calprotectin >150 to <500 μg/g without confirmed approval from a GI consult that an IBD diagnosis is clinically unlikely when the following clinical signs and symptoms are present:
1. prolonged or recurrent diarrhea
2. prolonged or recurrent abdominal pain
3. blood in stool
History of fibromyalgia, or any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than psoriatic arthritis (PsA) (including, but not limited to rheumatoid arthritis, gout, connective tissue diseases). Prior history of axial spondyloarthritis or fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis was made incorrectly. Prior history of reactive arthritis or axial spondyloarthritis is permitted if an additional diagnosis of PsA is made. Chronic osteoarthritis symptoms that in the Investigator's opinion may interfere with study assessments.
Uncontrolled, clinically significant system disease
Malignancy within 5 years
Severe, uncontrolled, medically unstable mood disorder, such as severe depression.
History or evidence of any clinically significant disorder (including psychiatric), condition, or disease that, in the opinion of the investigator, may pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Active infection or history of certain infections
Candida infection requiring systemic treatment within 3 months prior to first dose of study drug.
Tuberculosis or fungal infection seen on available chest x-ray taken within 3 months prior to first dose of study drug or at screening (Exception: documented evidence of completed treatment and clinically resolved).
Known history of human immunodeficiency virus (HIV) or positive HIV test at screening.

Other protocol defined Inclusion/Exclusion criteria may apply

Name	Affiliation	Role
Shepard Mpofu, MD, Clinical Development	ACELYRIN Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Site		Flagstaff	Arizona	86001	United States
Clinical Research Site

ID	Title	Description
FG000	Period 1: Placebo QW ; Period 2: Izokibep 160 mg QW	Participants received placebo as a subcutaneous (SC) injection QW for up to Week 16. Then, participants received izokibep 160 mg as a SC injection QW from Week 16 up to Week 52.
FG001	Izokibep 80 mg Q4W

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 29, 2024	Mar 25, 2025

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 Who Achieved 50% Improvement in American College of Rheumatology (ACR50) at Week 16

ACR50 is a clinical trial measure for PsA, indicating a 50% improvement in symptoms. To qualify, participants must show a 50% reduction in tender and swollen joint counts plus improvements in three of five additional criteria, including pain, global assessments, physical function, and inflammatory markers. ACR50 is binary-patients either meet it or not.

Full Analysis Set: all participants randomized who received at least one administration of test material was included in the summaries and analyses.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Period 1: Placebo QW	Participants received placebo as SC injection QW for up to Week 16.
OG001	Izokibep 80 mg Q4W	Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
OG002	Izokibep 160 mg Q2W	Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
OG003	Izokibep 160 mg QW	Participants received izokibep 160 mg as a SC injection QW for up to Week 52.

Units	Counts
Participants	OG000118 OG0018 OG002113 OG003

Title

Denominators

Categories

Title	Measurements
	OG00018 OG0014 OG00249 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 OG001		Cochran-Mantel-Haenszel		0.0377		Risk Difference (RD)	36.22	Standard Error of the Mean	17.43	2-Sided								Superiority
OG000 OG002		Cochran-Mantel-Haenszel		<.0001

Secondary

Number of Participants With Baseline ≥ 3% Body Surface Area (BSA) Psoriasis Who Achieved a 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI90) at Week 16

PASI is a tool used in clinical trials to measure the severity and extent of psoriasis. Scores range from a minimum of 0 to a maximum of 72, with higher scores indicating more severe disease.

Full Analysis Set: all participants randomized who received at least one administration of test material was included in the summaries and analyses.

Only participants with ≥ 3% BSA psoriasis at baseline were analyzed for this endpoint.

Posted

Count of Participants

Participants

Baseline and Week 16

ID	Title	Description
OG000	Period 1: Placebo QW	Participants received placebo as a SC injection QW for up to Week 16.
OG001	Izokibep 80 mg Q4W	Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
OG002	Izokibep 160 mg Q2W	Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.

Secondary

Number of Participants With Baseline Enthesitis > 0 With Resolution of Enthesitis (Leeds Enthesitis Index [LEI] = 0) at Week 16

LEI is a clinical tool used to assess enthesitis in conditions like psoriatic arthritis and spondyloarthritis. It evaluates six sites: bilateral lateral epicondyles, medial femoral condyles, and achilles tendons. Each site is scored 0 (no pain) or 1 (pain on pressure), with a total score ranging from a minimum of 0 to a maximum of 6, where higher scores indicate more severe enthesitis.

Full Analysis Set: all participants randomized who received at least one administration of test material was included in the summaries and analyses.

Only participants with LEI > 0 at baseline were analyzed for this endpoint.

Posted

Count of Participants

Participants

Baseline and Week 16

ID	Title	Description
OG000	Period 1: Placebo QW	Participants received placebo as a SC injection QW for up to Week 16.
OG001	Izokibep 80 mg Q4W	Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
OG002	Izokibep 160 mg Q2W	Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.

Secondary

Number of Participants Achieving Minimal Disease Activity (MDA) at Week 16

A participants was classified as being in MDA when at least five of the following seven criteria were met:

Tender joint count based on 68 joints (TJC68) ≤ 1
Swollen joint count based on 66 joints (SJC66) ≤ 1
PASI ≤ 1 or BSA ≤ 3%
Participant's Pain Assessment (Visual Analogue Scale [VAS]) ≤ 15 mm
Participant's Global Activity VAS ≤ 20 mm (corresponding to participant's Global Assessment of Disease Activity)
Health Assessment Questionnaire-Disability Index (HAQ-DI) ≤ 0.5
Tender enthesitis points ≤ 1 out of 6 sites assessed by the LEI.

Full Analysis Set: all participants randomized who received at least one administration of test material was included in the summaries and analyses.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Period 1: Placebo QW	Participants received placebo as a SC injection QW for up to Week 16.
OG001	Izokibep 80 mg Q4W	Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
OG002	Izokibep 160 mg Q2W

Secondary

Number of Participants Achieving 20% Improvement in ACR (ACR20) at Week 16

ACR20 is a clinical trial measure for PsA, indicating a 20% improvement in symptoms. To qualify, participants must show a 20% reduction in tender and swollen joint counts plus improvements in three of five additional criteria, including pain, global assessments, physical function, and inflammatory markers. ACR20 is binary-patients either meet it or not.

Full Analysis Set: all participants randomized who received at least one administration of test material was included in the summaries and analyses.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Period 1: Placebo QW	Participants received placebo as a SC injection QW for up to 16 Week.
OG001	Izokibep 80 mg Q4W	Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
OG002	Izokibep 160 mg Q2W	Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.

Secondary

Number of Participants With Baseline Psoriatic Arthritis Impact of Disease (PsAID) Score ≥ 3 With Improvement in PsAID Score at Week 16

The PsAID consists of nine items, each scored on a numeric rating scale (0-10), covering key aspects of disease burden, including pain, fatigue, skin problems, work/leisure activities, functional capacity, sleep disturbance, anxiety, coping, and social participation. The total score is calculated as a weighted sum of these individual items, with higher scores indicating a greater impact of the disease. The minimum score is 0 (no disease impact), while the maximum is 10 (worst possible disease impact). Reaching an improvement was considered an increase of 3 units from baseline score.

Full Analysis Set: all participants randomized who received at least one administration of test material was included in the summaries and analyses.

Only participants with PsAID ≥ 3 at baseline were analyzed for this endpoint.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Period 1: Placebo QW	Participants received placebo as a SC injection QW for up to Week 16.
OG001	Izokibep 80 mg Q4W	Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
OG002

Secondary

Change in Physical Function as Assessed by HAQ-DI From Baseline to Week 16

The HAQ-DI consists of 20 questions divided into eight categories: dressing, arising, eating, walking, hygiene, reaching, grip, and other activities. Each item is scored on a scale from 0 to 3, where 0 = no difficulty, 1 = some difficulty, 2 = much difficulty, and 3 = unable to perform. The final HAQ-DI score is calculated as the average of the highest scores in each category, resulting in a range from 0 (no disability) to 3 (severe disability). Higher scores indicate greater functional impairment. A negative change indicates an improvement in functional impairment.

Full Analysis Set: all participants randomized who received at least one administration of test material was included in the summaries and analyses.

Posted

Least Squares Mean

95% Confidence Interval

Score on scale

Baseline and Week 16

ID	Title	Description
OG000	Period 1: Placebo QW	Participants received placebo as a SC injection QW for up to Week 16.
OG001	Izokibep 80 mg Q4W	Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
OG002	Izokibep 160 mg Q2W

Secondary

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and AE of Special Interest During Period 1

An AE was any untoward medical occurrence in a participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received study treatment. Clinically significant changes in vital signs, electrocardiograms and laboratory tests recorded after treatment administration were documented as TEAEs.

TEAEs were considered serious if they led to death, were life-threatening, required hospitalization or its prolongation, caused disability, resulted in congenital anomalies or were considered medically important.

The events of special interest monitored were : candida infection; inflammatory bowel disease; suicidal ideation; malignancies; major adverse cardiovascular and cerebrovascular events (cerebrovascular accident and transient ischemic attack, nonfatal myocardial infarction or unstable angina, cardiovascular death); tuberculosis; infections (opportunistic, serious, or fungal); cytopenia; systemic hypersensitivity reactions.

Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.

Posted

Count of Participants

Participants

Up to Week 16, or 4 weeks after participant's last dose in case of treatment discontinuation

ID	Title	Description
OG000	Period 1: Placebo QW	Participants received placebo as a SC injection QW for up to Week 16.
OG001	Izokibep 80 mg Q4W

Secondary

Number of Participants Who Experienced TEAEs, Serious TEAEs and AE of Special Interest During Period 2

Safety Analysis Set: All participants randomized who received at least one administration of test material during the study.

Posted

Count of Participants

Participants

First dose of study treatment on or after Week 16 up to Week 55

ID	Title	Description
OG000	Period 2: Placebo/Izokibep 160 mg QW	Participants received izokibep 160 mg as a SC injection QW from Week 16 up to Week 52.
OG001	Izokibep 80 mg Q4W

Secondary

Number of Participants With a Positive Treatment-emergent Anti-drug Antibody (ADA) Result

Blood samples were collected at different timepoints throughout the study. ADA is considered "Positive" if any titer value is available.

ADA Analysis Set: Included all participants include who received at least one administration of izokibep and had both a baseline ADA measurement and at least one post-dose ADA measurement.

Posted

Count of Participants

Participants

Baseline to Week 65

ID	Title	Description
OG000	Period 1: Placebo QW; Period 2: Izokibep 160 mg QW	Participants received placebo as a SC injection QW for up to Week 16. Then, participants received izokibep 160 mg as a SC injection QW from Week 16 up to Week 52.
OG001	Izokibep 80 mg Q4W	Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
OG002	Izokibep 160 mg Q2W	Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG0031 affected113 at risk EG0041 affected112 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0011 affected114 at risk EG0020 affected8 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0011 affected114 at risk EG0020 affected8 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Inflammation	General disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Appendicitis	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0011 affected114 at risk EG0020 affected8 at risk EG003
Bursitis infective	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0011 affected114 at risk EG0020 affected8 at risk EG003
Cellulitis	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Device related infection	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0001 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Periumbilical abscess	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Pneumonia	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Psoas abscess	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0011 affected114 at risk EG0020 affected8 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Wernicke-Korsakoff syndrome	Nervous system disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Varicose vein	Vascular disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery disease	Cardiac disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG0030 affected113 at risk EG0040 affected112 at risk
Angina unstable	Cardiac disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0017 affected114 at risk EG0021 affected8 at risk EG003
Tooth disorder	Gastrointestinal disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Injection site erythema	General disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG00153 affected114 at risk EG0022 affected8 at risk EG003
Injection site pruritus	General disorders	MedDRA (27.1)	Systematic Assessment	EG0001 affected118 at risk EG00127 affected114 at risk EG0022 affected8 at risk EG003
Injection site swelling	General disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG00113 affected114 at risk EG0021 affected8 at risk EG003
Injection site pain	General disorders	MedDRA (27.1)	Systematic Assessment	EG0001 affected118 at risk EG0018 affected114 at risk EG0020 affected8 at risk EG003
Injection site rash	General disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Fatigue	General disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Swelling face	General disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG00114 affected114 at risk EG0020 affected8 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0004 affected118 at risk EG0016 affected114 at risk EG0022 affected8 at risk EG003
COVID-19	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0002 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0001 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Oral herpes	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0001 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Abscess limb	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Folliculitis	Infections and infestations	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0020 affected8 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003
Headache	Nervous system disorders	MedDRA (27.1)	Systematic Assessment	EG0000 affected118 at risk EG0010 affected114 at risk EG0021 affected8 at risk EG003

ID	Title	Description
BG000	Period 1: Placebo QW	Participants received placebo as a SC injection QW up to Week 16.
BG001	Izokibep 80 mg Q4W	Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
BG002	Izokibep 160 mg Q2W	Participants received izokibep 160 mg as a SC injection every Q2W up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.
BG003	Izokibep 160 mg QW	Participants received izokibep 160 mg as a SC injection QW up to Week 52.
BG004	Total	Total of all reporting groups

ID	Term
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D007592	Joint Diseases
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo QW - Period 1	Participants received placebo as a SC injection QW for up to Week 16.	118	1	118	9	118
EG001	Placebo/Izokibep 160 mg QW - Period 2	Participants received izokibep 160 mg as a SC injection QW from Week 16 up to Week 52.	114	4	114	65	114
EG002	Izokibep 80 mg Q4W	Participants received izokibep 80 mg as a SC injection every 4 weeks (Q4W) for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.	8	2	8	6	8
EG003	Izokibep 160 mg Q2W	Participants received izokibep 160 mg as a SC injection every Q2W for up to Week 52. Matching placebo QW was administered for weeks in-between izokibep to maintain the blind.	113	8	113	78	113
EG004	Izokibep 160 mg QW	Participants received izokibep 160 mg as a SC injection QW for up to Week 52.	112	4	112	84	112