Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis
NCT ID: NCT02826603
Last Updated: 2019-07-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1114 participants
INTERVENTIONAL
2016-06-22
2018-07-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis
NCT02074982
Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
NCT03066609
Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab
NCT03553823
Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab
NCT02008890
Secukinumab Study in PSOriasis Exploring pruRITUS Intensity and Lesional Biomarkers
NCT02362789
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Secukinumab
Secukinumab
Secukinumab
300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48
Ustekinumab
Ustekinumab
Ustekinumab
Per approved label, 45 mg or 90 mg s.c. based on subject weight (at randomization visit) to be administered at randomization, Week 4, 16, 28 and 40. At other timepoints subjects will receive placebo injections.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Secukinumab
300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48
Ustekinumab
Per approved label, 45 mg or 90 mg s.c. based on subject weight (at randomization visit) to be administered at randomization, Week 4, 16, 28 and 40. At other timepoints subjects will receive placebo injections.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chronic plaque-type psoriasis present for at least 6 months before randomization
* Moderate to severe plaque psoriasis as defined at randomization by:
* PASI score of ≥12 and
* Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and
* IGA mod 2011 ≥3 (based on a scale of 0-4)
* Candidate for systemic therapy, defined as having psoriasis inadequately controlled by:
* Topical treatment (including topical corticosteroids) and/or
* Phototherapy and/or
* Previous systemic therapy
Exclusion Criteria
* Drug-induced psoriasis
* Ongoing use of prohibited treatments
* Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23
* Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation
* Pregnant or nursing (lactating) women
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Anniston, Alabama, United States
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Mobile, Alabama, United States
Novartis Investigative Site
Glendale, Arizona, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Scottsdale, Arizona, United States
Novartis Investigative Site
Scottsdale, Arizona, United States
Novartis Investigative Site
Tucson, Arizona, United States
Novartis Investigative Site
Fort Smith, Arkansas, United States
Novartis Investigative Site
Hot Springs, Arkansas, United States
Novartis Investigative Site
Rogers, Arkansas, United States
Novartis Investigative Site
Bakersfield, California, United States
Novartis Investigative Site
Beverly Hills, California, United States
Novartis Investigative Site
California City, California, United States
Novartis Investigative Site
Encinitas, California, United States
Novartis Investigative Site
Fresno, California, United States
Novartis Investigative Site
Fullerton, California, United States
Novartis Investigative Site
Irvine, California, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Oceanside, California, United States
Novartis Investigative Site
Sacramento, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Santa Monica, California, United States
Novartis Investigative Site
Santa Rosa, California, United States
Novartis Investigative Site
Denver, Colorado, United States
Novartis Investigative Site
Trumbull, Connecticut, United States
Novartis Investigative Site
Aventura, Florida, United States
Novartis Investigative Site
Boca Raton, Florida, United States
Novartis Investigative Site
Cape Coral, Florida, United States
Novartis Investigative Site
Coral Gables, Florida, United States
Novartis Investigative Site
Fort Myers, Florida, United States
Novartis Investigative Site
Jacksonville, Florida, United States
Novartis Investigative Site
Orange Park, Florida, United States
Novartis Investigative Site
South Miami, Florida, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
West Palm Beach, Florida, United States
Novartis Investigative Site
Alpharetta, Georgia, United States
Novartis Investigative Site
Atlanta, Georgia, United States
Novartis Investigative Site
Macon, Georgia, United States
Novartis Investigative Site
Marietta, Georgia, United States
Novartis Investigative Site
Newnan, Georgia, United States
Novartis Investigative Site
Skokie, Illinois, United States
Novartis Investigative Site
Springfield, Illinois, United States
Novartis Investigative Site
Indianapolis, Indiana, United States
Novartis Investigative Site
New Albany, Indiana, United States
Novartis Investigative Site
Louisville, Kentucky, United States
Novartis Investigative Site
Owensboro, Kentucky, United States
Novartis Investigative Site
Owensboro, Kentucky, United States
Novartis Investigative Site
Baton Rouge, Louisiana, United States
Novartis Investigative Site
Lake Charles, Louisiana, United States
Novartis Investigative Site
Lake Charles, Louisiana, United States
Novartis Investigative Site
Metairie, Louisiana, United States
Novartis Investigative Site
New Orleans, Louisiana, United States
Novartis Investigative Site
Rockville, Maryland, United States
Novartis Investigative Site
Rockville, Maryland, United States
Novartis Investigative Site
Beverly, Massachusetts, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Brighton, Massachusetts, United States
Novartis Investigative Site
Quincy, Massachusetts, United States
Novartis Investigative Site
Fridley, Minnesota, United States
Novartis Investigative Site
Jackson, Mississippi, United States
Novartis Investigative Site
Saint Joseph, Missouri, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Las Vegas, Nevada, United States
Novartis Investigative Site
East Windsor, New Jersey, United States
Novartis Investigative Site
Verona, New Jersey, United States
Novartis Investigative Site
Albuquerque, New Mexico, United States
Novartis Investigative Site
Forest Hills, New York, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Rochester, New York, United States
Novartis Investigative Site
Chapel Hill, North Carolina, United States
Novartis Investigative Site
Charlotte, North Carolina, United States
Novartis Investigative Site
Durham, North Carolina, United States
Novartis Investigative Site
Greensboro, North Carolina, United States
Novartis Investigative Site
High Point, North Carolina, United States
Novartis Investigative Site
Rocky Mount, North Carolina, United States
Novartis Investigative Site
Winston-Salem, North Carolina, United States
Novartis Investigative Site
Cincinnati, Ohio, United States
Novartis Investigative Site
Cleveland, Ohio, United States
Novartis Investigative Site
Columbus, Ohio, United States
Novartis Investigative Site
Dublin, Ohio, United States
Novartis Investigative Site
Fairborn, Ohio, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Oregon City, Oregon, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Exton, Pennsylvania, United States
Novartis Investigative Site
Jenkintown, Pennsylvania, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
Plymouth Meeting, Pennsylvania, United States
Novartis Investigative Site
Anderson, South Carolina, United States
Novartis Investigative Site
Charleston, South Carolina, United States
Novartis Investigative Site
Greer, South Carolina, United States
Novartis Investigative Site
Goodlettsville, Tennessee, United States
Novartis Investigative Site
Knoxville, Tennessee, United States
Novartis Investigative Site
Murfreesboro, Tennessee, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
Arlington, Texas, United States
Novartis Investigative Site
Austin, Texas, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Pflugerville, Texas, United States
Novartis Investigative Site
San Antonio, Texas, United States
Novartis Investigative Site
Murray, Utah, United States
Novartis Investigative Site
Norfolk, Virginia, United States
Novartis Investigative Site
Everett, Washington, United States
Novartis Investigative Site
Seattle, Washington, United States
Novartis Investigative Site
Spokane, Washington, United States
Novartis Investigative Site
Walla Walla, Washington, United States
Novartis Investigative Site
Wenatchee, Washington, United States
Novartis Investigative Site
Madison, Wisconsin, United States
Novartis Investigative Site
St. John's, Newfoundland and Labrador, Canada
Novartis Investigative Site
Etobicoke, Ontario, Canada
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
Sainte-Hyacinthe, Quebec, Canada
Novartis Investigative Site
Hradec Králové, CZE, Czechia
Novartis Investigative Site
Prague, , Czechia
Novartis Investigative Site
Guatemala City, , Guatemala
Novartis Investigative Site
Guatemala City, , Guatemala
Novartis Investigative Site
Debrecen, , Hungary
Novartis Investigative Site
Pécs, , Hungary
Novartis Investigative Site
Szeged, , Hungary
Novartis Investigative Site
Kopavogur, , Iceland
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Novartis Investigative Site
Johor Bahru, , Malaysia
Novartis Investigative Site
Warsaw, Mazowian, Poland
Novartis Investigative Site
Gdansk, , Poland
Novartis Investigative Site
Lodz, , Poland
Novartis Investigative Site
Lodz, , Poland
Novartis Investigative Site
Olsztyn, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Košice, Slovak Republic, Slovakia
Novartis Investigative Site
Bojnice, , Slovakia
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Seocho Gu, South Korea
Novartis Investigative Site
Gwangju, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Hanoi, , Vietnam
Novartis Investigative Site
Ho Chi Minh City, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Alpalhao M, Duarte J, Diogo R, Vandemeulebroecke M, Ortmann CE, Kasparek T, Filipe P. Lower Limbs are the Most Difficult-to-Treat Body Region of Patients with Psoriasis: Pooled Analysis of CLEAR and CLARITY Studies of Secukinumab Versus Ustekinumab by Body Region. BioDrugs. 2022 Nov;36(6):781-789. doi: 10.1007/s40259-022-00558-2. Epub 2022 Nov 5.
Conrad C, Ortmann CE, Vandemeulebroecke M, Kasparek T, Reich K. Nail Involvement as a Predictor of Differential Treatment Effects of Secukinumab Versus Ustekinumab in Patients with Moderate to Severe Psoriasis. Dermatol Ther (Heidelb). 2022 Jan;12(1):233-241. doi: 10.1007/s13555-021-00654-1. Epub 2021 Dec 6.
Bagel J, Blauvelt A, Nia J, Hashim P, Patekar M, de Vera A, Ahmad K, Paguet B, Xia S, Muscianisi E, Lebwohl M. Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52-week results from a double-blind phase 3b trial (CLARITY). J Eur Acad Dermatol Venereol. 2021 Jan;35(1):135-142. doi: 10.1111/jdv.16558. Epub 2020 Jun 8.
Bagel J, Nia J, Hashim PW, Patekar M, de Vera A, Hugot S, Sheng K, Xia S, Gilloteau I, Muscianisi E, Blauvelt A, Lebwohl M. Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results). Dermatol Ther (Heidelb). 2018 Dec;8(4):571-579. doi: 10.1007/s13555-018-0265-y. Epub 2018 Oct 17.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-002898-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457A2326
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.