Clinical trials: Secukinumab
Spondylitis, Ankylosing
Extension in AS: Sustainability of Benefits, Safety and Tolerability
This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as…
- Trial name
- MEASURE 1 ext (NCT01863732)
- Testing
- Secukinumab
- Where
- 56 sites in United States, Belgium and 12 more
- Volunteers
- 274 people
- Sponsor
- Novartis Pharmaceuticals
Psoriasis
Evaluation of Cardiovascular Risk Markers in Psoriasis Patients Treated With Secukinumab
The purpose of this study was to explore the effect of treatment with 300 mg or with 150 mg secukinumab (administered weekly for 4 weeks followed by four-weekly administration) on endothelial dysfunction and arterial stiffness…
- Trial name
- CARIMA (NCT02559622)
- Testing
- Secukinumab
- Where
- 23 sites in Germany
- Volunteers
- 151 people
- Sponsor
- Novartis Pharmaceuticals
Psoriatic Arthritis, Axial Spondyloarthritis
Study of Efficacy and Safety of Secukinumab in Psoriatic Arthritis and Axial Spondyloarthritis Patients With Active Enthesitis Including One Achilles Tendon Site
The purpose of this study was to demonstrate efficacy, including effects on inflammation by magnetic resonance imaging (MRI) assessments, of secukinumab on Achilles tendon enthesitis for up to 1 year with a primary focus at Week…
- Conditions
- Psoriatic Arthritis, Axial Spondyloarthritis, Enthesitis
- Trial name
- ACHILLES (NCT02771210)
- Testing
- Secukinumab
- Where
- 55 sites in Bulgaria, Czechia and 6 more
- Volunteers
- 204 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Plaque Psoriasis
Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis
This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.
- Trial name
- FIXTURE (NCT01358578)
- Testing
- secukinumab (AIN457), etanercept
- Where
- 152 sites in United States, Argentina and 21 more
- Volunteers
- 1,306 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
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
The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α…
- Trial name
- REASSURE (NCT01377012)
- Testing
- Secukinumab (AIN457)
- Where
- 142 sites in United States, Argentina and 14 more
- Volunteers
- 637 people
- Sponsor
- Novartis Pharmaceuticals
Spondylitis, Ankylosing
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis
The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and…
- Trial name
- MEASURE4 (NCT02159053)
- Testing
- Secukinumab
- Where
- 90 sites in United States, Australia and 17 more
- Volunteers
- 350 people
- Sponsor
- Novartis Pharmaceuticals
Non-radiographic Spondyloarthritis
Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis
The purpose of this study was to demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week…
- Trial name
- PREVENT (NCT02696031)
- Testing
- Secukinumab
- Where
- 139 sites in United States, Australia and 22 more
- Volunteers
- 555 people
- Sponsor
- Novartis Pharmaceuticals
Psoriasis
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
Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety, tolerability and efficacy of secukinumab administered…
- Trial name
- IPSI-PSO (NCT02595970)
- Testing
- Secukinumab
- Where
- 17 sites in France
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients
This study aims to confirm if patients with a specific biomarker might have a better response to secukinumab treatment. To meet this purpose, exploratory biomarker studies will be done.
- Trial name
- NCT01426789
- Testing
- Secukinumab
- Where
- 36 sites in United States, Belgium and 3 more
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Ankylosing Spondyloarthritis
Study of Efficacy and Safety of Secukinumab in Patients With Ankylosing Spondylitis
The purpose of this trial is to demonstrate the clinical efficacy at week 16; and to demonstrate safety and tolerability of secukinumab compared to placebo in patients with ankylosing spondylitis at week 16 and long term safety…
- Trial name
- NCT02896127
- Testing
- Secukinumab
- Where
- 44 sites in China, Czechia and 2 more
- Volunteers
- 458 people
- Sponsor
- Novartis Pharmaceuticals
Rotator Cuff Tendinopathy
Study of Efficacy and Safety of Secukinumab in Participants With Moderate-severe Rotator Cuff Tendinopathy
The purpose of the present study was to assess the efficacy of secukinumab 300 mg s.c. (subcutaneous) compared to placebo, each in combination with standard of care, in improving signs, symptoms and physical function in…
- Trial name
- NCT05758415
- Testing
- Secukinumab
- Where
- 24 sites in United States, China and 4 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Type 1 Diabetes Mellitus
Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus
This study will assess the safety and efficacy of secukinumab on the preservation of pancreatic beta cells in patients with newly-diagnosed type 1 diabetes mellitus.
- Trial name
- NCT02044848
- Testing
- Secukinumab
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Novartis Pharmaceuticals
Psoriasis
Secukinumab in Tumor Necrosis Factor (TNF) - Inadequate Response (IR) Psoriasis Participants.
This study was designed to prove and quantify the hypothesis that secukinumab is effective, safe and well tolerated in the treatment of moderate to severe chronic plaque-type psoriasis in patients who are inadequate responders to…
- Trial name
- SIGNATURE (NCT01961609)
- Testing
- Secukinumab (AIN457)
- Where
- 54 sites in Ireland, United Kingdom
- Volunteers
- 235 people
- Sponsor
- Novartis Pharmaceuticals
Psoriatic Arthritis
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study…
- Trial name
- FUTURE 1 ext (NCT01892436)
- Testing
- Secukinumab
- Where
- 94 sites in United States, Argentina and 16 more
- Volunteers
- 460 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Severe Plaque-type Psoriasis
Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis
This was a multicenter, randomized, double-blind, placebo- and active-controlled (etanercept in single blinded arm) study in pediatric subjects aged 6 years to less than 18 years with severe chronic plaque psoriasis.
- Trial name
- NCT02471144
- Testing
- Experimental : Secukinumab low dose, Experimental: Secukinumab high dose, Active Comparator: Etanercept
- Where
- 46 sites in United States, Belgium and 17 more
- Volunteers
- 162 people
- Sponsor
- Novartis Pharmaceuticals
Psoriatic Arthritis
Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis
The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to…
- Trial name
- FUTURE5 (NCT02404350)
- Testing
- Secukinumab
- Where
- 172 sites in United States, Argentina and 26 more
- Volunteers
- 997 people
- Sponsor
- Novartis Pharmaceuticals
Necrobiosis Lipoidica Diabeticorum
Secukinumab for NLD (Cosentyx) in Patients With Necrobiosis Lipoidica Diabeticorum (NLD)
This study investigates the efficacy of secukinumab in necrobiosis lipoidica diabeticorum (NLD).
- Trial name
- NCT03791060
- Testing
- Secukinumab
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Beth Israel Deaconess Medical Center
Psoriatic Arthritis
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
To demonstrate that the efficacy of secukinumab 300 mg at Week 16 was superior to placebo in adult patients with active PsA based on the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response.
- Trial name
- NCT02798211
- Testing
- Secukinumab 300 mg, Secukinumab 150 mg
- Where
- 58 sites in United States, Puerto Rico
- Volunteers
- 258 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)
This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy.
- Trial name
- NCT00928512
- Testing
- Secukinmab
- Where
- 58 sites in United States, Belgium and 9 more
- Volunteers
- 237 people
- Sponsor
- Novartis Pharmaceuticals
Anklyosing Spondylitis
16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis
This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor
- Trial name
- MEASURE2 (NCT01649375)
- Testing
- Secukinumab (75 mg), Secukinumab (150 mg)
- Where
- 53 sites in United States, Austria and 11 more
- Volunteers
- 219 people
- Sponsor
- Novartis Pharmaceuticals