Cosentyx

(Secukinumab)

ApprovedMonoclonal antibody

Secukinumab is used to treat autoimmune diseases where the body's immune system attacks itself, including psoriasis, psoriatic arthritis, ankylosing spondylitis, and other inflammatory conditions. It works by blocking a protein in the immune system that causes inflammation and tissue damage.[2] Cosentyx is currently approved and in use across 19 indications[4].[1]

Cosentyx is one of 396 monoclonal antibody programs targeting Ankylosing Spondylitis. It is currently in Approved.

Indications

159

Total Trials

Active Trials

395

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Ankylosing SpondylitisNot yet recruiting

Metabolic SyndromeCompleted

Polymyalgia RheumaticaCompleted

Efficacy and SafetyCompleted

Immune System DiseaseUnknown

SpondyloarthropathyUnknown

Psoriasis VulgarisUnknown

Axial SpondyloarthritisActive, not recruiting

Rheumatic DiseaseRecruiting

Hidradenitis Suppurativa (HS)Recruiting

Ankylosing SpondylitisApproved

Not yet recruiting

Metabolic SyndromeApproved

Completed

Polymyalgia RheumaticaPhase 3

Completed

Efficacy and SafetyPhase 2

Completed

Immune System DiseasePreclinical

Unknown

SpondyloarthropathyPreclinical

Unknown

Psoriasis VulgarisPreclinical

Unknown

Axial SpondyloarthritisApproved

Active, not recruiting

Rheumatic DiseasePhase 2

Recruiting

Hidradenitis Suppurativa (HS)Approved

Recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

317 competitors in COVID-19

#DrugCompanyPhaseTrials

Cosentyx

Novartis

Approved

2 2

Stivarga

Bayer

Preclinical

1 3

Aimovig

Amgen

Preclinical

1 4

Aldactone

Pfizer

Preclinical

1 5

Nexavar

Bayer

Preclinical

1 6

Calciferol

Activella

Angiomax

BBaxter Healthcare Corporation

Preclinical

2 9

Tricor

JJagotec

Preclinical

1 10

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Recruiting

Ankylosing Spondylitis

NCT06905288

Q1 2027

Phase 3Active, not recruiting

Psoriasis

NCT06945107

Q2 2027

Recruiting

Depressive Symptoms

NCT06786936

Recruiting

Hidradenitis Suppurativa

NCT07243782

Q4 2027

N/ARecruiting

Hidradenitis Suppurativa

NCT06707246

Post-ApprovalNot yet recruiting

Psoriasis

NCT04239859

Clinical

Trials by Indication[1]

Psoriasis53 trials

Plaque Psoriasis Efficacy and Safety With Secukinumab

Completed· Novartis logo

Novartis·Phase 3·NCT02409667·16,487 enrolled

Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers

Completed· Novartis logo

Novartis·Phase 3·NCT02362789·132 enrolled

A Study to Evaluate Clear Skin Effect on Quality of Life in Patients With Plaque Psoriasis.

Completed· Novartis logo

Novartis·Phase 4·NCT02752776·1,660 enrolled

Show 50 more trials

Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

Completed· Novartis logo

Novartis·Phase 3·NCT03066609·543 enrolled

Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis

Completed· Novartis logo

Novartis·Phase 3·NCT03589885·122 enrolled

Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis (Phase IV)

Completed·UUniversity of Pennsylvania·Phase 4·NCT04535999·16 enrolled

Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis

Completed· Novartis logo

Novartis·Phase 3·NCT03668613·84 enrolled

Oral Chinese Herbal Medicine Concurrent With Secukinumab for Severe Plaque Psoriasis

Unknown status·GGuangdong Provincial Hospital of Traditional Chinese Medicine·Phase 1·NCT04414605·10 enrolled

Exploratory Evaluation of Biomarkers Associated With Treatment Response to Cosentyx (Secukinumab) in Psoriasis Patients

Completed·DDiamant Thaci··NCT03149900·40 enrolled

Effects of Treatment With Biological Agents on Vascular and Cardiac Function in Psoriasis

Unknown status·UUniversity of Athens·Phase 4·NCT02144857·200 enrolled

Outcomes With Treatment and Withdraw of Secukinumab in Patients With Plaque Psoriasis

Not yet recruiting·SSingapore General Hospital·Phase 4·NCT04239859·40 enrolled

A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis

Completed·BBond Avillion 2 Development LP·Phase 2·NCT03384745·313 enrolled

A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT03535194·1,484 enrolled

A 24-week, Multicenter, proSpective stUdy to Evaluate the PASI 90 Clinical Response Rate and the Safety PRofile of sEcukinuMab 300 mg in Cw6-negativE and Cw6-positive Patients With Moderate to Severe Chronic Plaque-type Psoriasis (SUPREME)

Completed· Novartis logo

Novartis·Phase 3·NCT02394561·434 enrolled

Secukinumab Efficacy Without the Initial Loading Dose in Patients With Psoriasis

Completed·UUniversita di Verona··NCT03828643·156 enrolled

A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Completed· UCB logo

UCB·Phase 3·NCT03536884·743 enrolled

Safety and Efficacy of Secukinumab in Mild Psoriasis

Completed·JJames G. Krueger, MD, PhD·Phase 2·NCT03131570·23 enrolled

A Study to Evaluate the Efficacy and Safety of Secukinumab in Adult Patients With Skin Types IV-VI With Moderate to Severe Plaque Psoriasis

Completed·SSaakshi Khattri·Phase 4·NCT04571567·20 enrolled

Evaluation of Cardiovascular Risk Markers in Psoriasis Patients Treated With Secukinumab

Completed· Novartis logo

Novartis·Phase 3·NCT02559622·151 enrolled

Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI), as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Patients With Moderate to Severe Psoriasis

Completed· Novartis logo

Novartis·Phase 3·NCT02595970·120 enrolled

Study of the Efficacy of Early Intervention With Secukinumab 300 mg s.c. Compared to Narrow-band UVB in Patients With New-onset Moderate to Severe Plaque Psoriasis

Completed· Novartis logo

Novartis·Phase 4·NCT03020199·196 enrolled

Secukinumab Therapy for the Treatment of Moderate to Severe Plaque Psoriasis With Response Monitoring Using Optical Coherence Tomography (OCT).

Unknown status·NNarrows Institute for Biomedical Research·Phase 4·NCT03307447·30 enrolled

A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China

Completed· Novartis logo

Novartis··NCT04894890·1,002 enrolled

Secukinumab Dosage Optimisation in Partial Responders With Moderate to Severe Plaque-type Psoriasis

Completed· Novartis logo

Novartis·Phase 3·NCT02474069·772 enrolled

Study of Secukinumab Compared to Fumaderm® in Adults With Moderate to Severe Psoriasis.

Completed· Novartis logo

Novartis·Phase 3·NCT02474082·202 enrolled

A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03090100·1,048 enrolled

Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients

Completed· Novartis logo

Novartis·Phase 4·NCT03055494·102 enrolled

Efficacy and Safety of Subcutaneous Secukinumab in Adults With Moderate to Severe Scalp Psoriasis

Completed· Novartis logo

Novartis·Phase 3·NCT02267135·102 enrolled

First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks

Completed· Novartis logo

Novartis·Phase 3·NCT01555125·177 enrolled

Open-label Study of Subcutaneous Secukinumab to Evaluate Efficacy and Safety in Patients With Plaque Psoriasis Who Had Inadequate Response to Cyclosporine A

Completed· Novartis logo

Novartis·Phase 4·NCT02547714·34 enrolled

Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque Psoriasis

Completed· Novartis logo

Novartis·Phase 3·NCT03504852·331 enrolled

Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis

Completed· Novartis logo

Novartis·Phase 3·NCT01358578·1,306 enrolled

Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)

Completed· Novartis logo

Novartis·Phase 3·NCT01636687·182 enrolled

Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

Completed· Novartis logo

Novartis·Phase 3·NCT01544595·1,147 enrolled

Study to Evaluate the Effect of Secukinumab Compared to Placebo on Aortic Vascular Inflammation in Subjects With Moderate to Severe Plaque Psoriasis

Completed· Novartis logo

Novartis·Phase 4·NCT02690701·91 enrolled

Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year

Completed· Novartis logo

Novartis·Phase 3·NCT01365455·738 enrolled

Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis

Completed· Novartis logo

Novartis·Phase 3·NCT01412944·43 enrolled

Outcome of Treatment With Secukinumab in the Treatment of Moderate to Severe Plaque Psoriasis at Tertiary Care Hospital.

Completed·JJinnah Postgraduate Medical Centre·Phase 4·NCT05891964·50 enrolled

Secukinumab in Tumor Necrosis Factor (TNF) - Inadequate Response (IR) Psoriasis Participants.

Completed· Novartis logo

Novartis·Phase 3·NCT01961609·235 enrolled

Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis

Completed· Novartis logo

Novartis·Phase 3·NCT01806597·205 enrolled

Brain Changes in Psoriasis After Secukinumab Treatment

Completed·UUniversity of Miami·Phase 4·NCT04717466·20 enrolled

Risankizumab Versus Secukinumab for Participants With Moderate to Severe Plaque Psoriasis

Completed· AbbVie logo

AbbVie·Phase 3·NCT03478787·327 enrolled

Impact of Secukinumab on Clinical and Patient Reported Outcomes in Patients With Psoriasis

Completed· Novartis logo

Novartis··NCT05513014·1,518 enrolled

Treatment Effectiveness Among Psoriasis Patients Treated With Cosentyx (Secukinumab)

Completed· Novartis logo

Novartis··NCT05320159·17,743 enrolled

Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients

Completed· Novartis logo

Novartis·Phase 2·NCT01537432·36 enrolled

Characteristics of Patients Treated With Secukinumab for Moderate to Severe Plaque Psoriasis

Completed· Novartis logo

Novartis··NCT05650060·163 enrolled

Comparative Study of CMAB015 and Secukinumab for Patients With Moderate to Severe Plaque Psoriasis

Active, not recruiting·TTaizhou Mabtech Pharmaceutical Co.,Ltd·Phase 3·NCT06398652·336 enrolled

A Study of Switching to Picankibart in Chinese Patients With Plaque Psoriasis With an Inadequate Response to Interleukin-17 Monoclonal Antibody Therapy

Active, not recruiting·IInnovent Biopharmaceutical Technology (Hangzhou) Co., LTD.·Phase 3·NCT06945107·308 enrolled

Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis

Completed· Novartis logo

Novartis·Phase 3·NCT02826603·1,114 enrolled

Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability of CJM112 in Psoriasis

Completed· Novartis logo

Novartis·Phase 1·NCT01828086·95 enrolled

Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis

Completed· Novartis logo

Novartis·Phase 3·NCT01807520·198 enrolled

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Completed·RRadboud University Medical Center·Phase 4·NCT04340076·244 enrolled

Immunologic Response to Secukinumab in Plaque Psoriasis

Completed·UUniversity of California, San Francisco·Phase 4·NCT02592018·15 enrolled

Psoriatic Arthritis19 trials

24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis

Completed· Novartis logo

Novartis·Phase 3·NCT01989468·414 enrolled

Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis

Completed· Novartis logo

Novartis·Phase 3·NCT01892436·460 enrolled

Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement

Completed· Novartis logo

Novartis·Phase 3·NCT02721966·503 enrolled

Show 16 more trials

Ultrasound Enthesitis Response in Psoriatic Arthritis

Completed·BBelfast Health and Social Care Trust··NCT03955861·80 enrolled

An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)

Completed· Novartis logo

Novartis·Phase 3·NCT03769168·55 enrolled

Efficacy of Secukinumab Compared to Ustekinumab in Adults With Active Psoriatic Arthritis and Failure of TNFα-Inhibitor Treatment

Completed· Novartis logo

Novartis·Phase 3·NCT04632927·119 enrolled

Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis

Completed· Novartis logo

Novartis·Phase 3·NCT02745080·853 enrolled

Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA)

Completed· Novartis logo

Novartis·Phase 3·NCT03031782·86 enrolled

An Efficacy Study of Secukinumab in Plaque Psoriasis Patients With Subclinical Psoriatic Arthritis as Measured by Musculoskeletal Ultrasound

Withdrawn· Novartis logo

Novartis·Phase 4·NCT04488185

Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)

Completed· Novartis logo

Novartis·Phase 3·NCT01392326·606 enrolled

Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis

Completed· Novartis logo

Novartis·Phase 3·NCT01752634·397 enrolled

An Efficacy Study of Secukinumab In Enthesitis of Psoriatic Arthritis Patients

Unknown status·PPeking Union Medical College Hospital·Phase 1·NCT04967950·60 enrolled

Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis (PsA) After 16 Weeks of Treatment Compared to Placebo

Completed· Novartis logo

Novartis·Phase 4·NCT02798211·258 enrolled

Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

Unknown status·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT04610476·270 enrolled

16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis

Completed· Novartis logo

Novartis·Phase 3·NCT02294227·341 enrolled

Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study

Completed· Novartis logo

Novartis··NCT05677542·758 enrolled

Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis

Completed· Novartis logo

Novartis·Phase 3·NCT02404350·997 enrolled

Effect of Secukinumab in the Treatment of Psoriatic Arthritis

Completed·UUniversity of Liverpool·Phase 2·NCT02854163·30 enrolled

Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon Site

Completed· Novartis logo

Novartis·Phase 3·NCT02771210·204 enrolled

Ankylosing Spondylitis11 trials

The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients

Unknown status·QQilu Hospital of Shandong University·Phase 4·NCT05527444·100 enrolled

Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis

Completed· Novartis logo

Novartis·Phase 4·NCT02763046·211 enrolled

A Study Evaluating the Efficacy of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis

Recruiting·TTongji Hospital·Phase 4·NCT05303285·100 enrolled

Show 8 more trials

Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis

Completed· Novartis logo

Novartis·Phase 3·NCT02750592·30 enrolled

Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis

Completed· Novartis logo

Novartis·Phase 3·NCT02896127·458 enrolled

Interleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis

Not yet recruiting·TThe Affiliated Hospital Of Guizhou Medical University·Phase 4·NCT06833112·10 enrolled

16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis

Completed· Novartis logo

Novartis·Phase 3·NCT02159053·350 enrolled

16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis

Completed· Novartis logo

Novartis·Phase 3·NCT01358175·371 enrolled

16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

Completed· Novartis logo

Novartis·Phase 3·NCT01649375·219 enrolled

16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients

Completed· Novartis logo

Novartis·Phase 3·NCT02008916·226 enrolled

Real-world Observational Study to Evaluate the Effectiveness of Secukinumab in Biologic-naive Ankylosing Spondylitis Patients in Korea

Recruiting· Novartis logo

Novartis··NCT06905288·70 enrolled

Arthritis8 trials

Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis

Completed·—·Phase 4·NCT03445845·300 enrolled

Study to Demonstrate the Efficacy and Safety of Secukinumab up to 224 Weeks in Subjects With Active Peripheral Spondyloarthritis (pSpA).

Withdrawn· Novartis logo

Novartis·Phase 3·NCT05206591

AScalate: Treat-to-target in Axial Spondyloarthritis

Completed· Novartis logo

Novartis·Phase 3·NCT03906136·304 enrolled

Show 5 more trials

Treat-to-target With Secukinumab in Axial Spondyloarthritis

Unknown status·PProfessor Mikkel Østergaard·Phase 4·NCT03639740·88 enrolled

Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis

Completed· Novartis logo

Novartis·Phase 3·NCT02696031·555 enrolled

Mechanism of Action of Anti-IL17 Therapy in Peripheral Spondyloarthritis

Completed·—·Phase 3·NCT03358134·20 enrolled

Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis

Completed· Novartis logo

Novartis·Phase 3·NCT04732117·137 enrolled

Psoriasis-Arthritis & Bone Program

Completed·UUniversity of Erlangen-Nürnberg Medical School·Phase 2·NCT02483234·40 enrolled

Hidradenitis Suppurativa7 trials

Regulatory Post-Marketing Surveillance in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cosentyx®(Secukinumab) in Korea

Recruiting· Novartis logo

Novartis··NCT07243782·76 enrolled

A Randomized Trial Comparing the Efficacy and Safety of Secukinumab with Tofacitinib in the Treatment of Moderate to Severe Hidradenitis Suppurativa in Chinese Patients

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·N/A·NCT06707246·60 enrolled

Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)

Completed· Novartis logo

Novartis·Phase 3·NCT03713632·545 enrolled

Show 4 more trials

This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).

Completed· Novartis logo

Novartis·Phase 3·NCT03713619·544 enrolled

Secukinumab Treatment for Moderate to Severe Hidradenitis Suppurativa

Recruiting·PPeking Union Medical College··NCT07109765·50 enrolled

Exploratory Trial Evaluating Cosentyx (Secukinumab) for Patients With Moderate-to-Severe Hidradenitis Suppurativa

Completed·TTufts Medical Center·Phase 1·NCT03099980·20 enrolled

A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab to Demonstrate Long-term Efficacy, Safety and Tolerability in Subjects With Moderate to Severe Hidradenitis Suppurativa

Completed· Novartis logo

Novartis·Phase 3·NCT04179175·702 enrolled

37 more indications

Secukinumab4 trials

Study of Secukinumab With 2 mL Pre-filled Syringes

Completed· Novartis logo

Novartis·Phase 3·NCT02748863·214 enrolled

Distribution of Secukinumab (AIN457) Into Dermal Interstitial Fluid After a Single Subcutaneous Administration of 300 mg

Completed· Novartis logo

Novartis·Phase 1·NCT01539213·16 enrolled

Managed Access Programs for AIN457, Secukinumab

Available· Novartis logo

Novartis··NCT05583604

Show 1 more trial

PsA Secukinumab XCT Structural Progression Study

Completed·—·Phase 4·NCT03623867·40 enrolled

Tendinopathy4 trials

Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy

Terminated· Novartis logo

Novartis·Phase 3·NCT05758415·60 enrolled

Study of Efficacy, Safety and Tolerability of AIN457 in Patients With Active Overuse Tendinopathy

Completed· Novartis logo

Novartis·Phase 2·NCT03344640·96 enrolled

Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy

Terminated· Novartis logo

Novartis·Phase 3·NCT05722522·33 enrolled

Show 1 more trial

Study of Efficacy and Safety of AIN457/Secukinumab in Patients With Rotator Cuff Tendinopathy

Completed· Novartis logo

Novartis·Phase 3·NCT05569174·62 enrolled

Rheumatoid Arthritis4 trials

Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents

Completed· Novartis logo

Novartis·Phase 3·NCT01377012·637 enrolled

Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.

Terminated· Novartis logo

Novartis·Phase 3·NCT01770379·242 enrolled

Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate

Completed· Novartis logo

Novartis·Phase 2·NCT01359943·221 enrolled

Show 1 more trial

A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients

Completed· Novartis logo

Novartis·Phase 2·NCT01426789·100 enrolled

Giant Cell Arteritis3 trials

A Placebo-controlled Phase 2 Trial to Investigate the Safety and Efficacy of Secukinumab in Giant Cell Arteritis

Completed· Novartis logo

Novartis·Phase 2·NCT03765788·52 enrolled

Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission

Completed· Novartis logo

Novartis·Phase 3·NCT05380453·151 enrolled

Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)

Completed· Novartis logo

Novartis·Phase 3·NCT04930094·355 enrolled

Metabolic Syndrome3 trials

Comparison of Secukinumab 300 mg Combined With a Lifestyle Intervention to Secukinumab Alone for the Treatment of Moderate to Severe Psoriasis Patients With Concomitant Metabolic Syndrome

Completed· Novartis logo

Novartis·Phase 4·NCT03440736·781 enrolled

Methotrexate Versus Secukinumab Safety in Psoriasis Patients With Metabolic Syndrome

Unknown status·UUniversita di Verona·Phase 4·NCT04469829·70 enrolled

A Prospective, Randomized, Open-Label, Parallel-Controlled Study to Evaluate the Efficacy and Safety of Targeted Interleukin-17A (IL-17A) Inhibitor (Secukinumab) on Cardiovascular and Renal Endpoints in Patients With Cardiorenal Metabolic Syndrome Complicated With Atherosclerotic Cardiovascular Disease

Not yet recruiting·PPeking University Third Hospital·Approved·NCT07704190·100 enrolled

Efficacy and Safety3 trials

Prospective, Bayesian, Randomized, Controlled, Open-label, Parallel-group, Phase II Interventional Study Evaluating Efficacy and Safety of Secukinumab in Active Severe Takayasu Patients

Not yet recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT07477795·52 enrolled

The Efficacy and Safety of Secukinumab in Patients With Ichthyoses

Completed·NNorthwestern University·Phase 2·NCT03041038·20 enrolled

A Study to Evaluate the Efficacy and Safety of LZM012

Unknown status·LLivzon Pharmaceutical Group Inc.·Phase 3·NCT06110676·918 enrolled

Atopic Dermatitis3 trials

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

Secukinumab for Treatment of Atopic Dermatitis

Completed·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT02594098·41 enrolled

Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis

Completed·GGWT-TUD GmbH·Phase 2·NCT03568136·22 enrolled

Intravenous2 trials

Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab in Patients With GCA or PMR

Completed· Novartis logo

Novartis·Phase 1·NCT06130540·65 enrolled

Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA

Completed· Novartis logo

Novartis·Phase 3·NCT04156620·527 enrolled

COVID-192 trials

COVID-19 VaccinE Response in Rheumatology Patients

Completed·JJeffrey Curtis·Phase 4·NCT05080218·841 enrolled

COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19

Completed·LLomonosov Moscow State University Medical Research and Educational Center·Phase 2·NCT04403243·70 enrolled

Pyoderma Gangrenosum2 trials

Secukinumab for the Inflammatory Phase of Pyoderma Gangrenosum

Withdrawn·WWake Forest University Health Sciences·Phase 2·NCT04274166

Single-arm Study to Assess a Potential Effect of Anti-IL-17 (Secukinumab) in the Treatment of Pyoderma Gangrenosum

Completed·TTechnical University of Munich·Phase 1/2·NCT02733094·8 enrolled

Immunogenicity2 trials

Pharmacokinetic, Safety and Immunogenicity Study of New Process CMAB015 and Cosentyx in Healthy Volunteers

Not yet recruiting·TTaizhou Mabtech Pharmaceutical Co.,Ltd·Phase 1·NCT07254325·114 enrolled

Pharmacokinetic, Safety and Immunogenicity Study of CMAB015 and Cosentyx in Healthy Volunteers

Completed·TTaizhou Mabtech Pharmaceutical Co.,Ltd·Phase 1·NCT05734482·130 enrolled

Lupus Nephritis2 trials

Study of Safety, Efficacy and Tolerability of Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis

Terminated· Novartis logo

Novartis·Phase 3·NCT04181762·275 enrolled

Open-label Extension Study of Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Lupus Nephritis

Terminated· Novartis logo

Novartis·Phase 3·NCT05232864·31 enrolled

Axial Spondyloarthritis2 trials

A Pragmatic Randomized Pilot Trial of Interleukin-17 Inhibition Versus Janus Kinase Inhibition After Tumor Necrosis Factor-alpha Inhibitor Failure in Axial Spondyloarthritis

Not yet recruiting·TThe University of Texas Health Science Center, Houston·Approved·NCT07770646·40 enrolled

A Multicenter Study of Secukinumab, With a Randomized Double-blind, Placebo-controlled Withdrawal-retreatment Period, to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

Active, not recruiting· Novartis logo

Novartis·Approved·NCT05622708·240 enrolled

Polymyalgia Rheumatica2 trials

A Multi-center, Open-label Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Safety and Tolerability in Polymyalgia Rheumatica (PMR)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT06331312·162 enrolled

A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Evaluate Efficacy and Safety of Secukinumab Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

Completed· Novartis logo

Novartis·Phase 3·NCT05767034·381 enrolled

Type 1 Diabetes Mellitus1 trial

Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus

Terminated· Novartis logo

Novartis·Phase 2·NCT02044848·5 enrolled

Necrobiosis Lipoidica1 trial

Secukinumab for NLD (Cosentyx) in Patients With Necrobiosis Lipoidica Diabeticorum (NLD)

Terminated·—·Phase 2·NCT03791060·4 enrolled

Lichen Planus1 trial

PoC Study to Evaluate the Efficacy and Safety of Secukinumab 300 mg in Patients With Lichen Planus

Completed· Novartis logo

Novartis·Phase 2·NCT04300296·111 enrolled

Overweight1 trial

Metformin Combined With Secukinumab for Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients

Not yet recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Phase 4·NCT07485764·186 enrolled

Intravenous Administration1 trial

The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients

Completed· Novartis logo

Novartis·Phase 2·NCT01250171·72 enrolled

Vitiligo1 trial

Secukinumab in Active Non-segmental Vitiligo

Completed·UUniversity Hospital, Ghent·Phase 4·NCT05676333·8 enrolled

Rosacea1 trial

Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea

Completed·AAnne Chang·Phase 1/2·NCT03079531·24 enrolled

AIN1 trial

Extension in AS: Sustainability of Benefits, Safety and Tolerability

Completed· Novartis logo

Novartis·Phase 3·NCT01863732·274 enrolled

Thyroid Eye Disease1 trial

A Study of the Efficacy and Safety of Secukinumab 300 mg in Patients With Thyroid Eye Disease (TED)

Terminated· Novartis logo

Novartis·Phase 3·NCT04737330·28 enrolled

Treatment1 trial

Anti-IL-17 a New Treatment for Contact Dermatititis

Unknown status·TTanja Todberg, MD·Phase 3·NCT02778711·20 enrolled

IrAE1 trial

IL-17 Blockade to Decrease irAEs (REPLAY)

Not yet recruiting·—·Phase 1·NCT07237594·4 enrolled

Pustular Psoriasis1 trial

Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab

Completed· Novartis logo

Novartis·Phase 3·NCT02008890·237 enrolled

Ichthyosis1 trial

Scientific Substantiation and Assessment of the Effectiveness of Pathogenetic Methods of Therapy for Congenital Ichthyosis in Children

Unknown status·NNational Medical Research Center for Children's Health, Russian Federation·Phase 4·NCT04996485·50 enrolled

Generalized Pustular Psoriasis1 trial

Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)

Completed· Novartis logo

Novartis·Phase 3·NCT01952015·12 enrolled

Depressive Symptoms1 trial

Evaluating the Role of IL-17 as an Orchestrator of Peripheral-central Cross Talk in Depressive Symptoms

Recruiting·NNHS Greater Glasgow and Clyde··NCT06786936·50 enrolled

Discoid Lupus Erythematosus1 trial

A Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus

Withdrawn·MMassachusetts General Hospital·Phase 2·NCT03866317

Alopecia Areata1 trial

A Study of Secukinumab for the Treatment of Alopecia Areata

Terminated·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT02599129·11 enrolled

Hidradenitis Suppurativa (HS)1 trial

An Open-label, Multicenter Study Assessing Efficacy and Safety of Secukinumab up to One Year in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa

Recruiting· Novartis logo

Novartis·Approved·NCT07489573·36 enrolled

Juvenile Psoriatic Arthritis1 trial

An Open-label, Multicenter Study to Evaluate Pharmacokinetics, Safety and Tolerability up to 6 Years of Intravenous Secukinumab Infusions in Pediatric Participants With Juvenile Psoriatic Arthritis

Recruiting· Novartis logo

Novartis·Phase 1·NCT06751238·20 enrolled

Inflammation1 trial

An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Secukinumab Study and Are Judged by the Investigator to Benefit From Continued Secukinumab Treatment

Recruiting· Novartis logo

Novartis·Approved·NCT04638647·1,000 enrolled

Rheumatic Disease1 trial

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Recruiting·NNYU Langone Health·Phase 2·NCT07138898·80 enrolled

Colorectal Cancer1 trial

MOUNTAINEER-03: Tucatinib + T-DXd in HER2+ CRC

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT06600009·400 enrolled

Unspecified1 trial

EBIO - Enthesitis Biopsy Study

Unknown status·UUniversity of Erlangen-Nürnberg Medical School·Phase 4·NCT04887597·10 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 21, 2015

COSENTYX

BLA BLA125504

Jan 21, 2015

COSENTYX

NDA BLA125504

Jan 15, 2016

COSENTYX

NDA BLA125504

Sep 15, 2017

COSENTYX

NDA BLA125504

Jan 23, 2018

COSENTYX

NDA BLA125504

Jun 19, 2018

COSENTYX

NDA BLA125504

Jan 29, 2020

COSENTYX

NDA BLA125504

Jun 16, 2020

COSENTYX

NDA BLA125504

May 28, 2021

COSENTYX

NDA BLA125504

Dec 22, 2021

COSENTYX

NDA BLA125504

Dec 22, 2021

COSENTYX

NDA BLA125504

May 11, 2023

COSENTYX

NDA BLA125504

Jul 24, 2023

COSENTYX

NDA BLA125504

Jul 24, 2023

COSENTYX

NDA BLA125504

Jul 24, 2023

COSENTYX

NDA BLA125504

Oct 6, 2023

COSENTYX

BLA BLA761349

Oct 6, 2023

COSENTYX

NDA BLA125504

Oct 31, 2023

COSENTYX

NDA BLA125504

Nov 21, 2023

COSENTYX

NDA BLA125504

Nov 21, 2023

COSENTYX

NDA BLA761349

Apr 4, 2024

COSENTYX

NDA BLA761349

Aug 16, 2024

COSENTYX

NDA BLA761349

Aug 16, 2024

COSENTYX

NDA BLA125504

Oct 4, 2024

COSENTYX

NDA BLA125504

Oct 4, 2024

COSENTYX

NDA BLA761349

Mar 12, 2025

COSENTYX

NDA BLA125504

Mar 12, 2025

COSENTYX

NDA BLA761349

Aug 6, 2025

COSENTYX

NDA BLA125504

Aug 6, 2025

COSENTYX

NDA BLA761349

Mar 12, 2026

COSENTYX

NDA BLA761349

Mar 12, 2026

COSENTYX

NDA BLA125504

Apr 17, 2026

COSENTYX

NDA BLA761349

Apr 17, 2026

COSENTYX

NDA BLA761349

Apr 17, 2026

COSENTYX

NDA BLA125504

Apr 17, 2026

COSENTYX

NDA BLA125504

Sources

References

[1]
ClinicalTrials.gov — 159 trial records for Secukinumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cosentyx drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Secukinumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Secukinumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761349). U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Secukinumab. U.S. National Library of Medicine.
[7]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: IL-17A Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Novartis

Key Publications[6]

Secukinumab in Axial Spondyloarthritis: MEASURE-5 Results

Ann Rheum DisJan 19, 2023DOI: 10.1136/ard-2023-223456

Cosentyx

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q4 2027

Trials by Indication[1]

Psoriasis53 trials

Psoriatic Arthritis19 trials

Ankylosing Spondylitis11 trials

Arthritis8 trials

Hidradenitis Suppurativa7 trials

Secukinumab4 trials

Tendinopathy4 trials

Rheumatoid Arthritis4 trials

Giant Cell Arteritis3 trials

Metabolic Syndrome3 trials

Efficacy and Safety3 trials

Atopic Dermatitis3 trials

Intravenous2 trials

COVID-192 trials

Pyoderma Gangrenosum2 trials

Immunogenicity2 trials

Lupus Nephritis2 trials

Axial Spondyloarthritis2 trials

Polymyalgia Rheumatica2 trials

Type 1 Diabetes Mellitus1 trial

Necrobiosis Lipoidica1 trial

Lichen Planus1 trial

Overweight1 trial

Intravenous Administration1 trial

Vitiligo1 trial

Rosacea1 trial

AIN1 trial

Thyroid Eye Disease1 trial

Treatment1 trial

IrAE1 trial

Pustular Psoriasis1 trial

Ichthyosis1 trial

Generalized Pustular Psoriasis1 trial

Depressive Symptoms1 trial

Discoid Lupus Erythematosus1 trial

Alopecia Areata1 trial

Hidradenitis Suppurativa (HS)1 trial

Juvenile Psoriatic Arthritis1 trial

Inflammation1 trial

Rheumatic Disease1 trial

Colorectal Cancer1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

Related News