Granted Patent
B2
US 12,594,332 · App. 18/983,037 · Granted Apr 7, 2026
Methods of treating psoriasis with secukinumab
Inventors:
Achim Guettner (Binzen, DE); Matthias Machacek (Allschwil, CH); Charis Papavassilis (Loerrach, DE); Oliver Sander (Basel, CH)
Assignee:
NOVARTIS AG
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Abstract
The disclosure relates to novel regimens for treating psoriasis, which employ a therapeutically effective amount of an IL-17 antagonist, e.g., an IL-17 binding molecule, e.g., an IL-17 antibody, such as the secukinumab antibody, or an IL-17 receptor binding molecule, e.g., an IL-17 receptor antibody.
Claims (11)
1 . A method of treating psoriasis, comprising administering to a patient in need thereof about 150 mg secukinumab by subcutaneous injection at each of weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter.
2 . The method of claim 1 , wherein the patient has plaque psoriasis.
3 . The method of claim 2 , wherein the patient is a candidate for systemic therapy or phototherapy.
4 . The method of claim 1 , wherein the patient had plaque psoriasis at week 0.
5 . The method of claim 4 , wherein the patient had moderate to severe plaque psoriasis at week 0.
6 . The method of claim 5 , wherein the patient was a candidate for systemic therapy or phototherapy at week 0.
7 . A method of treating psoriasis, comprising administering to a patient in need thereof about 150 mg secukinumab by subcutaneous injection 4 or 5 times in a month and every 4 weeks thereafter, wherein the secukinumab administrations in the month are separated by about one week.
8 . The method of claim 7 , wherein the patient has plaque psoriasis.
9 . The method of claim 8 , wherein the patient has moderate to severe plaque psoriasis.
10 . The method of claim 9 , wherein the patient is a candidate for systemic therapy or phototherapy.
11 . A method of treating moderate to severe plaque psoriasis, comprising administering to a patient in need thereof about 150 mg secukinumab by subcutaneous injection at each of weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter until the patient achieves a Psoriasis Area and Severity Index (PASI) 90 response.
Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jun 11, 2026
From: NOVARTIS AG
To: NOVARTIS PHARMA AG
Reel/Frame 075712/0291 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Feb 28, 2025
From: GUETTNER, ACHIM; MACHACEK, MATTHIAS; PAPAVASSILIS, CHARIS; SANDER, OLIVER
To: NOVARTIS AG
Reel/Frame 070369/0376 →
Continuity (6)
Continuation
13876367
Provisional Application
61391388
· Oct 8, 2010
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Trialtrove ID 081770, Aug. 2008, A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Two Single IV Infusions of AIN457 1…
[cited by applicant]
Trialtrove ID 086003, Sep. 10, 2008, Phase II Single Dose, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy of Three Dose Levels of AIN457 in Patients with Chronic …
[cited by applicant]
Trialtrove ID 101212, Jan. 2009, Double Blind, Placebo Controlled, Parallel Group Study with an Open Label Reference Arm to Assess the Effects of Intravenously Administered AIN457 on Ozone Induced Neutrophilia Compared …
[cited by applicant]
Trialtrove ID 101213, Mar. 16, 2009, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Proof-of-Concept Study to Assess the Efficacy of AIN457 in Patients with Moderate to Severe Ankylosing Spondylitis.
[cited by applicant]
Trialtrove ID 101786, Dec. 12, 2008, Phase II Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled Multiple-Loading Dose Regimen Study to Assess the Safety, Efficacy and Duration of Response of AIN…
[cited by applicant]
Trialtrove ID 102154, Mar. 18, 2009, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Proof-of-Concept Study to Assess the Efficacy of AIN457 in Patients with Psoriatic Arthritis.
[cited by applicant]
Trialtrove ID 111067, Jul. 14, 2009, A 16-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous AIN457 Follo…
[cited by applicant]
Trialtrove ID 111963, Jul. 28, 2009, A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study ofSubcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in…
[cited by applicant]
Trialtrove ID 111976, Jul. 2009, A Multicenter, R-D/B-P/C, Parallel-Group Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Two Single IV Infusions of AIN457 10 mg/kg (Anti IL-17 Monoclonal Antib…
[cited by applicant]
Trialtrove ID 117251, Dec. 22, 2009, A Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusions of AIN457 (10 mg/kg) Versus Placebo on Disease Activity (MRI Scans) in Pat…
[cited by applicant]
Trialtrove ID 118356, Aug. 30, 2009, A 52 Week Open Label Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti IL-17 Monoclonal Antibody) in Patients with Moderate to Severe Crohn's Disease.
[cited by applicant]
Trialtrove ID 123037, Mar. 1, 2010, A Randomized, Double-blind, Placebo Controlled, Multicenter Dose Ranging Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Pa…
[cited by applicant]
Trialtrove ID 126068, Apr. 14, 2010, An Open Label, Non-randomized Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti Interleukin-17 Monoclonal Antibody) in Patients with Moderate to Severe Ankylosi…
[cited by applicant]
Trialtrove ID 128101, Apr. 2010, A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Patients with Moderate to Severe Chronic Plaque-type Psoriasis.
[cited by applicant]
Trialtrove ID 128557, Jun. 2011, A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy after Twelve Weeks of Treatment, Compared to Placebo a…
[cited by applicant]
Trialtrove ID 128645, Sep. 2011, A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate theEfficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to…
[cited by applicant]
Trialtrove ID 131793, Jun. 10, 2010, An Open Label Non-randomized Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti Interleukin-17 Monoclonal Antibody) in Patients with Psoriatic Arthritis.
[cited by applicant]
Trialtrove ID 138695, Nov. 20, 2010, A Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study of Intravenous ACZ885 or AIN457 in Dry Eye Syndrome.
[cited by applicant]
Trialtrove ID 146855, Jul. 2011, A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up …
[cited by applicant]
Trialtrove ID 147040, Aug. 2011, A Randomized, Double-blind, Placebo-controlled Study of Efficacy, Safety and Tolerability ofSecukinumab at 12 Weeks Administered with an i.v. or s.c. Loading Regimen Compared to Placebo …
[cited by applicant]
Trialtrove ID 147500, Sep. 2011, A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up …
[cited by applicant]
Trialtrove ID 147571, Jan. 2011, A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy after Twelve Weeks of Treatment, and to Assess the Safety, Tolerabil…
[cited by applicant]
Trialtrove ID 148447, Aug. 1, 2011, A Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years…
[cited by applicant]
Trialtrove ID 150779, Aug. 2011, A Randomized, Double-blind, Multicenter Study of Subcutaneous Secukinumab, Assessing Psoriasis Area and Severity Index (PASI) Response and Maintenance of Response in Subjects with Modera…
[cited by applicant]
Trialtrove ID 151251, Dec. 2, 2011, A Randomized, Double-blind, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in …
[cited by applicant]
Trialtrove ID 152134, Aug. 2011, A Multicenter, 12 Week, Randomized, Double-blind, Placebo-controlled Biomarker Study of Secukinumab (AIN457) in Rheumatoid Arthritis Patients Followed by an Open Label Extension.
[cited by applicant]
Trialtrove ID 152773, Jan. 14, 2011, Open label, single-dose study to evaluate the efficacy of influenza and meningococcal vaccination in healthy subjects exposed to 150 mg AIN457 s.c.
[cited by applicant]
Trialtrove ID 152884, Feb. 2012, A 1-year Open Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of AIN457 in Patients with Relapsing-remitting Multiple Sclerosis.
[cited by applicant]
Trialtrove ID 157295, Mar. 2012, A Randomized, Double-blind, Placebo Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous Administration of Secukinumab (AIN457) in Patients w…
[cited by applicant]
Trialtrove ID 162826, Jan. 2012, Phase II Randomized Double Blinded Placebo Controlled, Multiple-dose Regimen Study to Assess the Rate of Histological Clearance and Effect on Molecular Pathways as Well as on Biomarkers …
[cited by applicant]
Trialtrove ID 163005, Feb. 2012, An Exploratory Study to Investigate the Distribution of Secukinumab (AIN457) Into Dermal Interstitial Fluid Using Open Flow Microperfusion After a Single Subcutaneous Administration of 3…
[cited by applicant]
Trialtrove ID 163568, Jun. 2012, A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Long-term Efficacy, Safety, and Tolerability up to 2 Y…
[cited by applicant]
Trialtrove ID 163991, May 2012, A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess …
[cited by applicant]
Trialtrove ID 170947, Oct. 2012, A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Autoinjectors to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the …
[cited by applicant]
Trialtrove ID 171256, Jan. 2012, Extension Study of Secukinumab Prefilled Syringes in Subjects with Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Secukinumab Core Studies.
[cited by applicant]
Trialtrove ID 171269, Sep. 2012, A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients with Active Rheumatoid Arthritis.
[cited by applicant]
Trialtrove ID 171802, Oct. 2012, A Randomized, Double-blind, Placebo-controlled Phase III Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 16 Weeks and to Assess the Lon…
[cited by applicant]
Trialtrove ID 175435, Oct. 1, 2012, A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the …
[cited by applicant]
Trialtrove ID 179377, Apr. 2013, A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Lon…
[cited by applicant]
Trialtrove ID 182998, Jun. 2013, A Randomized, Double-blind, Placebo-controlled, Multicenter, Study to Demonstrate the Efficacy at 16 Weeks of Secukinumab 150 and 300 mg s.c. and to Assess Safety, Tolerability and Long …
[cited by applicant]
Trialtrove ID 183013, Jun. 2013, A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Demonstrate Efficacy at 16 Weeks of Secukinumab 150 and 300 mg s.c. and to Assess Safety, Tolerability and Long-term …
[cited by applicant]
Trialtrove ID 184542, Jun. 2013, A Randomized, Double-blind, Placebo and Positive Controlled, Single and Multiple Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJM112…
[cited by applicant]
Trialtrove ID 187318, Nov. 2013, An Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients with Active Ankylosing Spondylitis.
[cited by applicant]
Trialtrove ID 188301, Jun. 2013, A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients…
[cited by applicant]
Trialtrove ID 189840, Sep. 2013, A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability ofSecukinumab in Patients with Active Psoriatic Arthritis.
[cited by applicant]
Trialtrove ID 190419, N/A, A Randomized, Double-blind, Double-dummy, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Asse…
[cited by applicant]
Trialtrove ID 190457, Sep. 2013, A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability ofSecukinumab in Subjects with Active Rheumatoid Arthritis.
[cited by applicant]
Trialtrove ID 194579, Aug. 2013, A Multi-center, Open Label Study of Subcutaneous Secukinumab in Prefilled Syringes as Mono- or Co-therapy to Assess the Efficacy, Safety and Tolerability up to 52 Weeks in Japanese Subje…
[cited by applicant]
Trialtrove ID 195065, N/A, Association Of HLA-DRB1 Alleles With Clinical Responses To The Anti-Interleukin-17A MonoclonalAntibody Secukinumab In a Cohort Of Patients With Active Rheumatoid Arthritis: An Exploratory Phas…
[cited by applicant]
Trialtrove ID 195312, Oct. 2013, Secukinumab In Patients with Moderate to Severe Active, Chronic Plaque Psoriasis Who Have Failed on TNF alpha antaGoNists: A Clinical Trial Evaluating Treatment results.
[cited by applicant]
Trialtrove ID 197625, Apr. 1, 2014, A Phase III, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and Long Term Safety and Efficacy up …
[cited by applicant]
Trialtrove ID 198998, Dec. 2013, A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psoriasis Area and S…
[cited by applicant]
Trialtrove ID 199025, Mar. 2014, A Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to …
[cited by applicant]
Trialtrove ID 199854, Mar. 21, 2014, A 52-week, multicenter, randomized, double-blind study of subcutaneous secukinumab to Demonstrate efficacy as Assessed by Psoriasis Area and Severity Index at 16 weeks of treatment C…
[cited by applicant]
Trialtrove ID 201436, Feb. 2014, A Randomized, Double-blind, Multiple Dose, Placebo-controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Efficacy of Secukinumab in Adult and Pedia…
[cited by applicant]
Trialtrove ID 210649, Mar. 2015, A Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab (150 mg) With and Without a Subcutaneous Loading Regimen to Assess Efficacy, Safet…
[cited by applicant]
Trialtrove ID 218983, Sep. 2014, A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Efficacy of Subcutaneous Secukinumab [300 mg] as Assessed by the Psoriasis Scalp Seve…
[cited by applicant]
Trialtrove ID 221001, Mar. 2015, A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab (150 mg) in Pre-filled Syringe, with or without Loading Regimen, to Demonstrate Ef…
[cited by applicant]
Trialtrove ID 251464, N/A, Exploratory study on the kinetics of psoriasis symptoms, pruritus intensity and lesional biomarkersin patients with moderate to severe plaque-type psoriasis treated with subcutaneous secukinum…
[cited by applicant]
Trialtrove ID 253309, N/A, Double-blind, randomized, placebo-controlled, active comparator (etanercept as single-blinded arm)multicentre trial with secukinumab in children from 6 to less than 18 years of age with severe…
[cited by applicant]
Trialtrove ID 253310, N/A, Double-blind, placebo-controlled multicentre trial with secukinumab in children from 6 to less than 18 years of age with moderate plaque psoriasis to demonstrate the efficacy of secukinumab as…
[cited by applicant]
Trialtrove ID NCT00685399, Jun. 1, 2008, An Open-label Proof-of-concept Study With a Double-masked, Dose-ranging Component to Assess the Effects of AIN457 in Patients With Noninfectious Uveitis.
[cited by applicant]
Trialtrove ID NCT00995709, Oct. 1, 2009, A 24 Week Multicenter, Randomized, Double-masked, Placebo Controlled Study to Assess the Difference in the Rate of Recurrent Exacerbations in Beh ?? ets Patients With Posterior o…
[cited by applicant]
Trialtrove ID NCT01032915, Feb. 1, 2010, A 24 Week Multi-center, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study of AIN457 Versus Placebo for Maintaining Uveitis Suppression When Reducing Sys…
[cited by applicant]
Trialtrove ID NCT01090310, Aug. 1, 2010, A 38-week Extension to a 24-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study of AIN457 Versus Placebo for Maintaining Uveitis Suppres…
[cited by applicant]
Trialtrove ID NCT01093846, Mar. 1, 2010, A 38-week Extension to a 24 Week Multicenter, Randomized, Double-masked, Placebo Controlled Study to Assess the Difference in the Rate of Recurrent Exacerbations in Beh??et's Pat…
[cited by applicant]
Trialtrove ID NCT01095250, Apr. 1, 2010, A 28-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study to Assess AIN457 Versus Placebo in Inducing and Maintaining Uveitis Suppression…
[cited by applicant]
Trialtrove ID NCT01103024, Dec. 1, 2010, A 34-week Extension to a 28-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study to Assess AIN457 Versus Placebo in Inducing and Maintain…
[cited by applicant]
Trialtrove ID NCT01327664, Mar. 1, 2011, A Multicenter, Open-label Study to Evaluate the Long Term Clinical Use of Treatment With AIN457 in Patients Completing Clinical Trials Investigating AIN457 for the Treatment of N…
[cited by applicant]
Trialtrove ID NCT01364389, Feb. 1, 2011, A 2-week Single-blind, Randomized, 3-arm Proof of Concept Study of the Effects of AIN457 (Anti-IL17 Antibody), ACZ885 (Canakinumab, Anti-IL1b Antibody), or Corticosteroids on Ini…
[cited by applicant]
Van Cranenburgh, et al., Satisfaction with treatment among patients with psoriasis: a web-based survey study, British Journal of Dermatology, 169, 398-405, 2013.
[cited by applicant]
Walsh, Cosentyx Gets FDA Nod for Psoriasis, Medpage Today, Jan. 21, 2015.
[cited by applicant]
Walsh, Novel Antibody Obliterates Psoriasis, Medpage Today, Jul. 9, 2014.
[cited by applicant]
Wang, et al., Monoclonal Antibody Pharmacokinetics and Pharmacodynamics, Clinical Pharmacology and Therapeutics, 84(5), 548-558, Nov. 2008.
[cited by applicant]
Worcester, New psoriasis drugs offer treatment advantages, Rheumatology News, Feb. 27, 2015.
[cited by applicant]
Wyatt, New psoriasis drug shows potential in UAB-led phase III trial, Jul. 16, 2014.
[cited by applicant]
Zhang, et al., Increased Th17 cells are accompanied by FoxP3+ Treg cell accumulation and correlated with psoriasis disease severity, Clinical Immunology, 135, 108-117, 2010.
[cited by applicant]
Zhao, et al., Clinical pharmacology considerations in biologics development, Acta Pharmacologica Sinica, 33, 1339-1347, 2012.
[cited by applicant]
Stoll, et al., AIN457 demonstrated to be an effective, fast-acting drug for the treatment of chronic plaque type psoriasis in a proof-of-concept trial, 18th Congr Eur Acad Dermatol Venereol (EADV), Abstract P1138, Oct. …
[cited by applicant]
Tak, et al., A1N457 Shows a Good Safety Profile and Clinical Benefit in Patients with Active Rheumatoid Arthritis (RA) Despite Methotrexate Therapy: 16-Weeks Results From a Randomized Proof-of-Concept Trial, ACR/ARHP Sc…
[cited by applicant]
Draelos, et al., AIN457 demonstrated to be an effective, fast-acting drug for the treatment of chronic plaque type psoriasis in a proof-of-concept study, 18th Congress of EADV, poster P1138, Oct. 2009.
[cited by applicant]
NHSC Publication, May 2010, AIN-457 for posterior uveitis, 5 pages.
[cited by applicant]
U.S. Appl. No. 13/876,367, Granted.
[cited by applicant]
U.S. Appl. No. 15/630,577, Granted.
[cited by applicant]
U.S. Appl. No. 16/720,351, Granted.
[cited by applicant]
U.S. Appl. No. 17/127,738, Abandoned.
[cited by applicant]
U.S. Appl. No. 17/165,724, Abandoned.
[cited by applicant]
U.S. Appl. No. 18/061,227, Pending.
[cited by applicant]
U.S. Appl. No. 18/983,030, Pending.
[cited by applicant]
U.S. Appl. No. 18/983,034, Pending.
[cited by applicant]
U.S. Appl. No. 14/911,387, Granted.
[cited by applicant]
U.S. Appl. No. 17/735,535, Granted.
[cited by applicant]
U.S. Appl. No. 17/735,535, Abandoned.
[cited by applicant]
U.S. Appl. No. 18/068,276, Pending.
[cited by applicant]
U.S. Appl. No. 16/319,174, Abandoned.
[cited by applicant]
U.S. Appl. No. 17/938,846, Pending.
[cited by applicant]