Efficacy and Safety of 2 Secukinumab Regimens in 90kg or More Weight Group With Moderate/Severe Chronic Plaque Psoriasis
A Randomized, Double-blind, Multicenter Study Assessing Short and Long-term Efficacy, Safety, and Tolerability of Sub-cutaneous Secukinumab in Subjects of Body Weight 90 kg or Higher With Moderate to Severe Chronic Plaque-type Psoriasis
2 other identifiers
interventional
331
7 countries
67
Brief Summary
The purpose of this study is to assess secukinumab high dose (every 2 weeks) vs standard dose (every 4 weeks) in heavy body weight subjects with moderate to severe plaque psoriasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2018
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2018
CompletedFirst Posted
Study publicly available on registry
April 20, 2018
CompletedStudy Start
First participant enrolled
June 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2020
CompletedResults Posted
Study results publicly available
June 7, 2021
CompletedOctober 11, 2021
October 1, 2021
1.2 years
March 29, 2018
May 11, 2021
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects Who Achieve 90% or Greater Reduction in Psoriasis Area and Severity Index (PASI) Score - Week 16 (Full Analysis Set)
A subject was considered as a PASI 90 responder if s/he achieved a reduction of 90% or more of the PASI score, compared to baseline, at a given time point.The head, trunk, upper limbs and lower limbs were assessed separately for erythema, thickening, and scaling. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0, i.e., higher scores represent more severity.
16 weeks
Secondary Outcomes (2)
Percentage of Subjects Who Achieve Investigator Global Assessment (IGA Modified 2011) Score of 0 or 1 - Week 16 (Full Analysis Set)
16 weeks
Absolute and Relative Frequencies for Deaths, Other Serious or Clinically Significant Adverse Events or Related Discontinuations - Entire Study Period (Safety Set)
Adverse events were reported from first dose of study treatment until end of study treatment plus 8 weeks post treatment, up to a maximum timeframe of 470 days.
Study Arms (3)
Secukinumab 300 mg every 2 weeks (Q2W)
EXPERIMENTAL2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter every 2 weeks. Subjects remained on secukinumab 300 mg every 2 weeks until the end of treatment.
Secukinumab 300 mg every 4 weeks (Q4W)
ACTIVE COMPARATOR2 injections of secukinumab 150 mg once weekly up to week 4 and thereafter Q4W. Includes both subjects randomized to remain on Q4W the entire treatment period, and subjects that were Psoriasis Area and Severity Index (PASI) 90 responders at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group.
Secukinumab 300 mg every 4 weeks non-responders up-titration (Q4W NR up)
ACTIVE COMPARATOR2 injections of secukinumab 150 mg once weekly up to week 4, then Q4W up to Week 16 and thereafter Q2W. Includes Psoriasis Area and Severity Index (PASI) 90 non-responders (NR) at Week 16 from the secukinumab 300 mg Q4W possible up-titrate group (subjects randomized to switch to Q2W if PASI 90 non-responder at Week 16).
Interventions
sub-cutaneous secukinumab prefilled syringe 150 mg
Eligibility Criteria
You may qualify if:
- Written informed consent must have been obtained before any assessment was performed. Where relevant, a legal representative will also have signed the informed study consent according to local laws and regulations.
- Subjects must have been able to understand and communicate with the investigator and comply with the requirements of the study.
- Men or women at least 18 years of age at time of screening.
- Body weight of ≥ 90 kg at the time of randomization.
- Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
- Moderate to severe psoriasis as defined at randomization by:
- Psoriasis Area and Severity Index (PASI) score of 12 or greater, and
- Investigator's Global Assessment (IGA) mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and
- Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.
- Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by:
- topical treatment and/or,
- phototherapy and/or,
- previous systemic therapy.
You may not qualify if:
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at screening or Randomization.
- Ongoing use of prohibited treatments. Washout periods detailed in the protocol have to be adhered to. Subjects not willing to limit ultraviolet (UV) light exposure (e.g., sunbathing and / or the use of tanning devices) during the course of the study will be considered not eligible for this study since UV light exposure is prohibited. Note: administration of live vaccines 6 weeks prior to Randomization or during the study period is also prohibited.
- Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting Interleukin-17 (IL-17) or the IL-17 receptor.
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 4 weeks until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
- Pregnant or nursing (lactating) women
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for skin Bowen's disease, or basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
- History of hypersensitivity to any of the study drug constituents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Novartis Investigative Site
Birmingham, Alabama, 35205, United States
Novartis Investigative Site
Phoenix, Arizona, 85032, United States
Novartis Investigative Site
Rogers, Arkansas, 72758, United States
Novartis Investigative Site
Irvine, California, 92697, United States
Novartis Investigative Site
Sacramento, California, 95817, United States
Novartis Investigative Site
Sacramento, California, 95819, United States
Novartis Investigative Site
San Diego, California, 92123, United States
Novartis Investigative Site
Santa Monica, California, 90404, United States
Novartis Investigative Site
Centennial, Colorado, 80111, United States
Novartis Investigative Site
Tampa, Florida, 33612, United States
Novartis Investigative Site
West Palm Beach, Florida, 33409, United States
Novartis Investigative Site
Alpharetta, Georgia, 30022, United States
Novartis Investigative Site
Snellville, Georgia, 30078, United States
Novartis Investigative Site
Skokie, Illinois, 60077, United States
Novartis Investigative Site
Indianapolis, Indiana, 46256, United States
Novartis Investigative Site
New Albany, Indiana, 47150, United States
Novartis Investigative Site
Louisville, Kentucky, 40241, United States
Novartis Investigative Site
Owensboro, Kentucky, 42303, United States
Novartis Investigative Site
Boston, Massachusetts, 02111, United States
Novartis Investigative Site
New Brighton, Minnesota, 55112, United States
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Saint Joseph, Missouri, 64506, United States
Novartis Investigative Site
East Windsor, New Jersey, 08520, United States
Novartis Investigative Site
Verona, New Jersey, 07044, United States
Novartis Investigative Site
Forest Hills, New York, 11375, United States
Novartis Investigative Site
New York, New York, 10025 1737, United States
Novartis Investigative Site
Charlotte, North Carolina, 28277, United States
Novartis Investigative Site
Winston-Salem, North Carolina, 27157, United States
Novartis Investigative Site
Fairborn, Ohio, 45324, United States
Novartis Investigative Site
Oregon City, Oregon, 97045, United States
Novartis Investigative Site
Portland, Oregon, 97210, United States
Novartis Investigative Site
Charleston, South Carolina, 29414, United States
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Houston, Texas, 77056, United States
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Mesquite, Texas, 75150, United States
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Pflugerville, Texas, 78660, United States
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San Antonio, Texas, 78218, United States
Novartis Investigative Site
Norfolk, Virginia, 23507, United States
Novartis Investigative Site
Wenatchee, Washington, 98801, United States
Novartis Investigative Site
Madison, Wisconsin, 53717, United States
Novartis Investigative Site
Calgary, Alberta, T2G 1B1, Canada
Novartis Investigative Site
Red Deer, Alberta, T4N 6V7, Canada
Novartis Investigative Site
Etobicoke, Ontario, M8X 1Y9, Canada
Novartis Investigative Site
Guelph, Ontario, N1L 0B7, Canada
Novartis Investigative Site
Hamilton, Ontario, L8N 1V6, Canada
Novartis Investigative Site
Québec, G1V 4X7, Canada
Novartis Investigative Site
Prague, Prague 1, 11000, Czechia
Novartis Investigative Site
Nový Jičín, 741 01, Czechia
Novartis Investigative Site
Bochum, 44793, Germany
Novartis Investigative Site
Frankfurt, 60590, Germany
Novartis Investigative Site
Hamburg, 20246, Germany
Novartis Investigative Site
Hamburg, 20537, Germany
Novartis Investigative Site
Kiel, 24105, Germany
Novartis Investigative Site
Leipzig, 04103, Germany
Novartis Investigative Site
Debrecen, 4032, Hungary
Novartis Investigative Site
Pécs, 7623, Hungary
Novartis Investigative Site
Szeged, H 6725, Hungary
Novartis Investigative Site
Rozzano, MI, 20089, Italy
Novartis Investigative Site
Modena, MO, 41124, Italy
Novartis Investigative Site
Perugia, PG, 06100, Italy
Novartis Investigative Site
Siena, SI, 53100, Italy
Novartis Investigative Site
Napoli, 80138, Italy
Novartis Investigative Site
Chelyabinsk, 454092, Russia
Novartis Investigative Site
Kazan', 420012, Russia
Novartis Investigative Site
Krasnodar, 350020, Russia
Novartis Investigative Site
Lipetsk, 398005, Russia
Novartis Investigative Site
Saint Petersburg, 197022, Russia
Novartis Investigative Site
Saratov, 410012, Russia
Novartis Investigative Site
Yekaterinburg, 620023, Russia
Related Publications (1)
Augustin M, Reich K, Yamauchi P, Pinter A, Bagel J, Dahale S, You R, Bruin G, Djimopoulos J, Paguet B, Charef P, Patekar M, Keefe D. Secukinumab dosing every 2 weeks demonstrated superior efficacy compared with dosing every 4 weeks in patients with psoriasis weighing 90 kg or more: results of a randomized controlled trial. Br J Dermatol. 2022 Jun;186(6):942-954. doi: 10.1111/bjd.20971. Epub 2022 Apr 8.
PMID: 34981829DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2018
First Posted
April 20, 2018
Study Start
June 25, 2018
Primary Completion
September 13, 2019
Study Completion
July 15, 2020
Last Updated
October 11, 2021
Results First Posted
June 7, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.